J Deutsche Derma Gesell - 2022 - Balakirski - Therapy of Psoriasis During Pregnancy and Breast Feeding

CME Article
Submitted: 8.8.2021 DOI: 10.1111/ddg.14789

Accepted: 9.3.2022
Dagmar Wilsmann-Theis
Finanzielle Interessen: Ja, von einer anderen
Institution
Erklärung zu nicht-finanziellen
Interessen: Nein
Therapy of psoriasis during pregnancy
Galina Balakirski
Finanzielle Interessen: Ja, von einer anderen
and breast-feeding
Institution
Interessen: Nein
Sascha Gerdes
Finanzielle Interessen: Nein Summary
Interessen: ADF, BvDD, DDG There have been multiple systemic drugs approved for the therapy of psoriasis vul-
garis and psoriasis arthritis (PsA) in the last decade. However, treatment decisions
Stefan Beissert
Finanzielle Interessen: Nein are difficult to make in women planning a pregnancy and in pregnant and lactating
Erklärung zu nicht-finanziellen women due to the paucity of data for such cases. The strongest evidence for psoriasis
Interessen: Nein therapy during pregnancy exists for topical corticosteroids. Medically controlled use
Falk Ochsendorf of UVB-therapy is also considered safe. The best evidence regarding systemic therapy
Finanzielle Interessen: Nein during pregnancy and lactation is available for the group of TNF-alpha inhibitors,
Erklärung zu nicht-finanziellen which is also reflected in the respective medical product information. This is especi-
Interessen: Nein
ally important in cases of psoriatic arthritis. Among traditional systemic therapeutics,
Ralph von Kiedrowski
the largest clinical experience exists for ciclosporin, which, if medically necessary,
Finanzielle Interessen: Nein
may be continued during gestation. However, TNF-alpha inhibitors, especially the
Interessen: BvDD, DDG pegylated form, should be preferred in case of pregnancy. Furthermore, an elective
pregnancy termination is not necessary due to systemic therapy of psoriasis with
Galina Balakirski1, Sascha many further substances during the first pregnancy weeks. The current work provi-
Gerdes2, Stefan Beissert3, Falk des a comprehensive review of the scientific literature on treatment of psoriasis du-
Ochsendorf4, Ralph von ring pregnancy and lactation. Based on the available scientific information, severity
Kiedrowski5, Dagmar of psoriasis and patient’s comorbidities, the best possible therapeutic approach can
Wilsmann-Theis6 be found in consensus with the patient.
(1) Center for Dermatology, Allergology
and Dermatosurgery, HELIOS University
Hospital Wuppertal, Witten/Herdecke
University, Wuppertal, Germany
Introduction
(2) Psoriasis Center, Department of
Dermatology, Venereology and Allergo- Numerous new, systemic treatments for psoriasis vulgaris (PV) and psoriasis ar-
logy, University Hospital Schleswig- thritis (PsA) have been approved in the last decade. This allows an individualized
Holstein – Campus Kiel, Germany treatment based on patient-related risk factors such as joint involvement and other
(3) Department and Clinic for Dermato- comorbidities [1, 2]. However, women who wish to become pregnant, as well as
logy, University Hospital Carl Gustav pregnant and breast-feeding women, are particularly difficult to treat because the
Carus, Dresden, Germany therapy should not only provide an optimal control of maternal disease but also
(4) Department of Dermatology, avoid harming the child. Epidemiological studies have shown that one of the in-
Venereology and Allergology, University cidence peaks for psoriasis is between the 20th and the 29th year of life [3]. Thus,
Hospital Frankfurt am Main, Frankfurt, many of psoriasis patients are women of reproductive age, that possibly require
Germany systemic treatment, depending on the extent of their disease. Many young women
(5) Specialized Dermatological Practice, with psoriasis also report that the disease has a large impact on their family plan-
Selters/Westerwald, Germany ning and therapeutic decisions [4].
(6) Department and Clinic for Since there are hardly any prospective studies on pregnant women with pso-
Dermatology and Allergology, University riasis, treatment decisions are based on the attending physician’s experience with
Hospital Bonn, Germany the various medications, the summary of product characteristics (SmPC), and the
scientific literature (case series, published registry data, case reports) [2, 5, 6]. The-
Section Editor re are also analyses from rheumatological and gastrointestinal cohorts for some
Prof. Dr. Trautinger, St. Pölten drugs [7–9]. Systemic anti-inflammatory treatment for rheumatoid arthritis (RA)
© 2022 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by John Wiley & Sons Ltd on behalf of Deutsche Dermatologische Gesellschaft. | JDDG | 1610-0379/2022/2005 653
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CME Article
or Crohn’s disease/ulcerative colitis may basically be interpreted as protective for

the unborn child. However, this risk-benefit analysis cannot be readily applied to
patients with psoriasis.
Psoriasis during pregnancy

According to the data from cohort stu- The hormonal changes during pregnancy influence the maternal immune system
dies, skin condition improved in almost to prevent “rejection” of the fetus (which may be considered a “semi-allograft”)
60 % of pregnant women, remained [10]. The increase in blood levels of progesterone and estrogens results in stimu-
stable in 20 %, and deteriorated in 20 % lation of the (humoral) Th2 immune response and suppression of the (cellular)
of cases. Directly after delivery, about Th1 immune response. For this reason, Th1-mediated diseases such as PV tend to
65 % of affected patients reported an improve, at least in early pregnancy [11]. However, in the last weeks of pregnancy,
increase of severity of PV or PsA. the balance tilts in favor of the Th1 immune response, providing better protection
from infections for mother and infant post partum [12]. The course of psoriasis
during pregnancy is unpredictable: According to the data from cohort studies, skin
condition improved in almost 60 % of pregnant women, remained stable in 20 %,
and deteriorated in 20 % of cases [13, 14]. Directly after delivery, about 65 % of
affected patients reported an increase of severity of PV or PsA [14]. Furthermore,
discontinuation of systemic treatments before pregnancy, or in the first trimester
of pregnancy, was associated with increased PsA activity during pregnancy and
postpartum, compared to continued treatment [15, 16]. It is of note, that the treat-
ment of PsA requires a stable interdisciplinary cooperation with rheumatologists,
and is especially important in the challenging situation of pregnancy and lactation.
In rare cases, existing plaque psoriasis has been reported to transform into
generalized pustular psoriasis (“generalized pustular psoriasis of pregnancy”/im-
petigo herpetiformis) (Figure 1) [16]. These experiences should be considered when
counseling psoriasis patients who wish to become pregnant.
Pregnancy in psoriasis patients

The impact of PV on the course of pregnancy cannot be conclusively evaluated
[17–24]. Data from the available pregnancy cohorts, however, indicate that disease
activity can negatively impact both the pregnancy itself and the intrauterine fetal
Figure 1 28-year old patient in the 37th week of gestation with an extensive gene-
ralized pustular psoriasis/impetigo herpetiformis.
654 © 2022 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by John Wiley & Sons Ltd on behalf of Deutsche Dermatologische Gesellschaft. | JDDG | 1610-0379/2022/2005
CME Article
development. Patients with moderate to severe PV appear to carry an increased risk

of pregnancy complications such as miscarriages, premature births, or premature
rupture of membranes compared to the general population [18, 19, 24]. In additi-
on, infants born from women with severe PV had more often too low birthweights
compared to the general population [20, 24]. In contrast, other studies reported
that infants born from severely affected psoriasis patients tend to have macrosomia
[18, 19]. Regarding to the maternal pregnancy complications, there have been re-
ports on, increased risks of gestational diabetes [24] and gestational hypertension
in psoriasis patients [18, 21, 24]. There are only few scientific publications, that did
not find any impact of maternal PV on the course of pregnancy [22, 25]. Especially
increased numbers of premature births and stillbirths have been described in pso-
riasis patients with generalized pustular form, regardless of the treatment used [26].
Topical treatment
The strongest evidence on psoriasis The most comprehensive evidence on psoriasis treatment during pregnancy is avai-
treatment during pregnancy is available lable for topical corticosteroids, making them to the primary recommendation in
for topical corticosteroids, making them cases of appropriate indication [5, 27]. The most current Cochrane review (sta-
to the primary recommendation in tus: July 2015), summarizes the results of 14 observational studies (five cohort
cases of appropriate indication. studies and nine case control studies with a total of 1,601,515 participants) on
the use of topical corticosteroids (TCS) during pregnancy [28]. The review found
no evidence suggesting that the use of mild to moderate potency TCS (class I–III)
during pregnancy might result in an increased risk of congenital malformations
(especially cleft palate), premature births, or fetal death. To our knowledge there
are no published studies on TCS use in humans that analyzed TCS levels in the
fetus after maternal exposure. A retrospective study with 2,658 pregnant patients
treated with TCS did not find an increased risk of fetal complications after the use
of high potency to very high potency TCS compared to non-exposed pregnancies.
However, the risk of low birthweight increased slightly after a cumulative dose of
high to very high potency TCS (such as clobetasol propionate) of more than 300 g
(number needed to harm: 168) [29]. It is also recommended to use modern TCS
with a favorable therapeutic index (TIX) of about 2, to reduce potential side effects
such as skin atrophy in long-time treatment. The authors also state that modern
compounds (such as methylprednisolone aceponate or mometasone furoate) are to
be preferred during pregnancy. If this treatment is effective, it is recommended to
taper off the TCS and, if appropriate, switch to a so-called “proactive therapy” (for
example application two or three times a week) to prevent recurrence and minimi-
ze the cumulative dose.
The topical calcineurin inhibitors (TCI) pimecrolimus and tacrolimus are firm-
ly established options for psoriasis treatment of the face and intertriginous areas,
despite lacking approval for psoriasis therapy [2]. There are no studies investigating
the use of TCI in pregnant psoriasis patients. However, there are comprehensive
data on treating pregnant patents with high-dose, systemic calcineurin inhibitors
such as tacrolimus after transplantation of a solid organ [30–32]. Here, no evidence
of congenital malformations was found, but premature births and low birthweight
were common. However, it is unclear if these effects might have been caused by the
patients’ underlying disease and not by the medication. Pharmacokinetic studies
have also shown that topical tacrolimus ointment 0.1 % causes only very little sys-
temic absorption, possibly due to its large molecular size [32, 33]. We conclude that
small-scale use in the steroid-sensitive areas will not lead to systemic effects.
Off-label use of TCI in steroid-sensitive areas during pregnancy can therefore
be considered, with a preference for pimecrolimus according to the “Red List”, the
CME Article
German medicines directory (Rote Liste, www.rote-liste.de). Proactive, drug-sparing

use, as generally approved for tacrolimus ointment, clearly makes sense as well.
There are no publications on the use of other common topical PV medications
during pregnancy, such as vitamin D3 analogs or dithranol [34]. As there are
no negative reports on the use of dithranol in pregnancy, it might be allowed in
moderately affected patients (up to 10 % of body surface) for a limited period of
several weeks under close control of trained medical staff (for example in inpati-
ent or daycare setting) to reduce possible side effects as extended burns or skin ir-
ritations. Topical vitamin D3 analogs may be used with stringent indications and
in small areas if TCS cannot be used [5, 6]. The same limitations also apply for
the combination of betamethasone dipropionate and calcipotriol: it should only
be used if the potential benefit justifies the potential risks. Breast-feeding mothers
should not apply any topical medication to the breasts (www.rote-liste.de) [5].
Tazarotene (a topical retinoid) is contraindicated in women who wish to be-
come pregnant and in pregnant women [5]. Although animal studies have shown
hardly any absorption after topical application, this drug is teratogenic after oral
use, as are all substances in this pharmacological compound class [35]. Tazaro-
tene is currently not marketed in Germany, Austria, or Switzerland; however it
can be ordered as a cream or gel through international pharmacies. Note that
topical retinoids are also available in combination with urea for treating scaly
skin conditions – these products are also contraindicated during gestation and
while planning pregnancy. Products containing salicylic acid are contraindicated
during pregnancy as well, due to possible absorption [5]. Although there is as yet
no evidence of teratogenic effects from topical tar preparations in humans [36],
this has been documented in animal studies (inhalative application in rats) [37].
In psoriasis patients who used topical tar preparations, excretion of polycyclic
aromatic hydrocarbon compounds in the urine has been detected. This may in-
dicate systemic absorption [38]. Therefore, use of topical tar preparations is also
not recommended in pregnant women [5]. A summary of our recommendations
with notes on topical treatments during pregnancy and lactation according to the
“Red List” is presented in Table 1.
Phototherapy and photochemotherapy

Controlled use of UV phototherapy Controlled use of UV phototherapy during pregnancy is considered safe [2]. Due to
during pregnancy is considered safe. possible photodegeneration of folic acid in the course of UV therapy [39–41], folic
Due to possible photodegeneration of acid levels should be monitored in pregnant patients. Current data indicate that cu-
folic acid in the course of UV therapy, mulative UV doses of > 40 J/cm 2 and single doses of > 2 J/cm 2 may result in a 20–30
folic acid levels should be monitored in % reduction of serum folate levels. Thus there is a general recommendation that
pregnant patients. women who are planning to become pregnant should use folic acid supplements
even without apparent folic acid deficiency [42]. The authors therefore recommend
that pregnant patients receiving UVB therapy should use folic acid supplements at
the standard dose of 0.8 mg per day.
The authors recommend that pregnant There is no direct evidence of teratogenic effects elicited by PUVA treatment
patients receiving UVB therapy should during pregnancy. Due to limited experience, however, this is not explicitly recom-
use folic acid supplements at the stan- mended in the national guideline [2]. The available publications on PUVA therapy
dard dose of 0.8 mg per day. in pregnant patients with PV or eczema [43–46] did not find any increased risk of
teratogenicity, premature births, or other pregnancy complications; however, the
number of patients was relatively small (n = 87) with varying psoralen exposure.
UVA causes methoxsalen to bind to DNA and inhibit cell division [47]. Thus pso-
ralen treatment carries a theoretical risk of mutagenicity and teratogenicity and is
not recommended during pregnancy.
CME Article
Table 1 Summary of recommendations for the use of topical therapy during pregnancy and breast-feeding.
Substance class Compound Additional notes – Remarks in the Red List*, 2020 version Group according to
Red List
Corticosteroids Basically Systemic effects are possible with high-class steroids and long-
term application
Do not apply to the breasts in breast-feeding women
Prednicarbate Pregnancy: Extensive use (>30% of body surface) is contraindi- Gr. 3

cated in the 1st trimester; in the 2nd and 3rd trimester it is possible La1
with stringent indication
Lactation: Extensive use is contraindicated
Application to the breasts is contraindicated
Methylprednisolone- Pregnancy: Stringent indication, use should not exceed three Gr. 3
acetate weeks if a solution is used La1
Lactation: Stringent indication
Mometasone- Pregnancy: Treated area should be kept as small as possible, Gr. 6
furoate/ duration as short as possible. Stringent indication. La 2
Betamethasone/ Lactation: Stringent indication, any contact of the treated areas
Clobetasol with the infant must be avoided. Do not apply to the breasts. Dis-
continue breast-feeding if higher doses are required.
Limited recommendation after individual counseling
Vitamin-D3 analogs Calcipotriol Pregnancy: Use only if absolutely necessary Gr. 6

Lactation: Use with care, do not apply to the breasts during La1
lactation
Tacalcitol Pregnancy: Avoid application Gr. 4
Lactation: Application not indicated La1
Calcitriol Pregnancy: Contraindication Gr. 5
Lactation: Contraindication La1
Fixed combination Calcipotriol + Beta- Pregnancy: Stringent indication Gr. 6

methasone Lactation: Stringent indication La2
dipropionate
Cignolin* (Dithranol) No more than 30 % of body surface, only after careful benefit-risk N/A
analysis
Do not apply to lactating breasts
Calcineurin inhi- All Use is possible during pregnancy in steroid-sensitive areas (such
bitors as the face or intertriginous areas)
Pimecrolimus/ Pregnancy:/Stringent indication Gr.4/Gr. 6

Tacrolimus Lactation:/Not recommended. Tacrolimus is excreted in breast milk. La1/kA
Not recommended / contraindicated
Salicylates Risk of absorption, do not use concentrations above 1 % N/A

Contraindicated in the 3rd trimester, stringent indications in the 1st
and 2nd trimester.
Tazarotene* Known teratogenic potential
Tar Associated with miscarriage and congenital malformations
*Red List: The Red List (Rote Liste) is the official drug directory in Germany and lists all pharmaceuticals approved in Germany and the EU.
Group classification according to the Red List:
Group 3: Extensive use in humans did not reveal any embryotoxic or teratogenic effects. Animal studies provided evidence of embryoto-
xicity or/and teratogenicity, however, these effects seem to be relevant for humans.
Group 4: Sufficient experience in humans is not available. Animal studies did not provide any evidence of embryotoxic or teratogenic
effects.
Group 5: Sufficient experience in humans is not available.
Group 6: Sufficient experience in humans is not available. Animal studies indicated embryotoxic or teratogenic effects.
Lactation La1: It is unknown whether the substance is excreted into breast milk.
La2: *Status according to the Red List 2018, as the substance has been no longer listed in the Red List 2020
Abbr.: N/A, not available.
CME Article
Systemic treatment
Conventional systemic treatments
Fumaric acid esters
There are no data on exposure to fuma- There are no reports in the scientific literature on the treatment of pregnant psoria-
ric acid esters after the first trimester sis patients with fumaric acid esters. There is, however, some evidence on exposure
of pregnancy. If systemic treatment is to fumaric acid esters during the first trimester of pregnancy from clinical trials
required in pregnant patients, other on treatment of multiple sclerosis [48, 49]. Here, no indication of teratogenic po-
options with a better evidence than fu- tential was found. There are no data on exposure to fumaric acid esters after the
maric acid esters should be prioritized. first trimester of pregnancy. If systemic treatment is required in pregnant patients,
If a patient becomes pregnant while on other options with a better evidence than fumaric acid esters should be prioritized.
treatment with fumaric acid esters, this If a patient becomes pregnant while on treatment with fumaric acid esters, this
medication should be discontinued, medication should be discontinued, with close clinical and sonographic follow up
with close clinical and sonographic of the patient and fetus by a gynecologist until birth. However, according to the
follow up of the patient and fetus by a state-sponsored information website www.embryotox.de, elective termination of
gynecologist until birth. pregnancy based solely on previous treatment with fumaric acid esters in early
pregnancy is not justified [50].
Maximum concentrations of methylhydrogen fumarate (the first metabolite of
dimethyl fumarate) in the blood are reached about 5–6 hours after ingestion, and
mean elimination half-life is about 80 minutes [51]. Thus more than 99 % of the
compound is eliminated from the blood within about ten hours, and exposure will
quickly cease after the medication has been discontinued.
There are no studies on the secretion of dimethyl fumarate or its metabolites in
breast milk [51, 52], but due to the relatively small molecule size and lack of protein
binding properties, this is suspected to be the case [53, 54]. Since oral ingestion of
the substances may lead to side effects in the infant (such as lymphocytopenia), this
treatment is not recommended during lactation [50, 51, 53].
Methotrexate
Methotrexate is contraindicated during Methotrexate (MTX) is contraindicated during pregnancy. Animal studies have
pregnancy. Animal studies have shown shown that the substance is teratogenic [54, 55] and as a folic acid antimetabo-
that the substance is teratogenic. lite leads to various fetal malformations [56, 57]. There are case reports in the
current scientific literature on children with hypoplastic limbs and craniofacial
abnormalities or motoric and cognitive developmental retardation born from pso-
riasis patients exposed to MTX during the first trimester of pregnancy (n = 2) [58,
59]. Based on these findings, MTX is not allowed to be used in pregnant patients
or if pregnancy is planned. A prospective observational study in 28 patients who
received low-dose MTX treatment during the first trimester of pregnancy did not
find any increased teratogenicity [60]. However, there are several scientific reports
documenting embryopathies associated even with low doses of MTX in early preg-
nancy [61, 62]. Patients of reproductive age treated with MTX must therefore be
properly informed about its teratogenicity and the necessity of consistent and ef-
fective contraception. According to the German S3 guideline, contraception needs
to be continued until three months after discontinuation of treatment with MTX
[2]. The SmPC even recommends that contraception be maintained until at least
six months after treatment discontinuation [63]. In contrast, the EULAR recom-
mendation estimates the washout time before conception at 1–3 months [64]. A
prospective, multicenter cohort study with 136 patients who received MTX within
twelve weeks before conception found no increased malformation rates in the in-
fants [56]. In this cohort, 50 % of the patients discontinued their medication only
CME Article
Patients of reproductive age treated between two weeks before the last menstrual period and the actual conception.
with MTX must be properly informed According to the information portal www.embryotox.de, MTX should be discon-
about its teratogenicity and the neces- tinued immediately in unplanned pregnancies, or treatment switched to an alter-
sity of consistent and effective contra- native option that is safe during pregnancy. The patients should be offered close
ception. According to the German S3 ultrasound monitoring [65].
guideline, contraception needs to be Small amounts of methotrexate are excreted into breast milk, so the SmPC dis-
continued until three months after dis- courages breast-feeding during MTX treatment [63]. There are some case reports
continuation of treatment with MTX. on the exact concentration of MTX in breast milk [64–68]. It could be shown that
excretion of MTX into breast milk is low and reaches its maximum concentration
about 2–6 hours after oral or subcutaneous application. After 24 hours, MTX
concentrations in the breast milk were undetectable in some cases [68]. Due to
these findings, some authors consider breast-feeding while on MTX treatment to
be possible. Women are advised to discard their breast milk on the day of MTX
application but breast-feed normally on the other days of the week [65, 69]. We do
not recommend MTX for breast-feeding women due to the available better treat-
ment alternatives for psoriasis during lactation.
Ciclosporin
There is comprehensive evidence on There is comprehensive evidence on the use of ciclosporin during pregnancy from
the use of ciclosporin during pregnancy the fields of transplantation medicine and rheumatology. No evidence of teratoge-
from the fields of transplantation medi- nicity has been found [70–72]. Increased rates of premature births and lower birth
cine and rheumatology. No evidence of weights compared to the general population have been reported, but this may con-
teratogenicity has been found. Increa- ceivably be attributed to the underlying diseases of the patients. Ciclosporin has also
sed rates of premature births and lower been reported to be safe and effective in patients with habitual miscarriages [73].
birth weights compared to the general There are 22 reports in the current scientific literature on ciclosporin use in 23
population have been reported, but pregnant psoriasis patients (Table S1, online supporting information). Nineteen of
this may conceivably be attributed to these cases concerned generalized pustular psoriasis [74–93].
the underlying diseases of the patients. Based on this wide-ranging evidence on the safety of ciclosporin treatment du-
ring pregnancy, it may be continued or initiated if indicated. It should be noted,
however, that the SmPC recommends against its use in pregnant woman and states
that the compound should only be used during pregnancy if the potential benefit for
the mother justifies the potential risk for the fetus [94]. In addition, the risk of de-
veloping hypertension should be kept in mind as a potential side effect of ciclosporin,
especially during pregnancy. According to the manufacturer’s information, the eli-
mination half-life of ciclosporin in the blood varies between 6.3 and 20.4 hours in
healthy volunteers and patients with severe liver dysfunction, respectively, so it can
be assumed that exposure ceases a few days after therapy discontinuation. Consis-
tent contraception beyond discontinuation is not explicitly recommended, either in
the SmPC or in the current S3 guidelines. The above mentioned guideline considers
pregnancy to be “only” a relative contraindication for ciclosporin treatment [2, 95,
96]. Based on long-term experience with ciclosporin treatment in pregnant patients,
this compound constitutes the conventional treatment of choice during pregnancy
(Table 2); it does, however, require close monitoring due to the potential side effects.
During ciclosporin therapy, breast-fee- There is evidence that the compound is excreted into breast milk, therefore the
ding of the infant can be considered if SmPC recommends that women treated with ciclosporin should avoid breast-fee-
the mother explicitly wishes it. Howe- ding [97]. However, there are several case reports showing that when ciclosporin
ver, in this case close monitoring of the is taken by nursing mothers, the infants’ blood levels of the substance are usually
infant’s serum ciclosporin level would very low or even below the limit of detection [98–102]. Thus, during ciclosporin
be needed. therapy, breast-feeding of the infant can be considered if the mother explicitly wis-
hes it. However, in the opinion of the authors, this is impractical, since in this case
monitoring of the infant’s serum ciclosporin level would be needed.
660
Table 2 Summary of the current recommendations on the use of systemic therapy during pregnancy and breast-feeding from the different sources. The wording of the
single sources has been preserved. The internet portal www.embryotox.de was accessed on 10.12.2021.
Preparation Summary of Product Website www.embryotox.de National Guidelines [96] Internati- Data on exposure during preg-
Characteristics onal Guidelines [64] and [141] nancy and lactation in humans
CME Article
Conventional treatment
Fumaric acid esters There is limited evidence on the Due to lack of data, FAE treat- Fumarates are contraindicated for Pregnancy: no teratogenicity
(FAE) / Dimethyl use of DMF in pregnant women. ment should be avoided during women of child-bearing age who are found in the 1st trimester.
fumarate (DMF) Animal experiments have shown pregnancy. not using appropriate contraception. Lactation: no data.
reproductive toxicity; use during If possible, FAE should also be Fumarates should not be used by wo-
pregnancy is contradindicated. avoided during lactation. men who are pregnant or breast-fee-
(status 10/2020) ding or who desire to get pregnant.
Methotrexate MTX in non-oncological indica- If pregnancy is desired, treat- MTX is contraindicated in women Pregnancy: some reports on
(MTX) tions is contraindicated during ment should be switched from who desire to get pregnant; its use malformations in neonates,
pregnancy and lactation. MTX to a safer drug. There is no before a planned pregnancy or du- some data on normal neonates
During treatment and for at clear recommendation for the ring pregnancy is not recommended. after MTX use during the 1st tri-
least six months after disconti- use of MTX during lactation: MTX should be discontinued three mester.
nuation of MTX, reliable cont- Breast-feeding while on low-do- months before a planned pregnan- Lactation: excretion into breast
raception must be used (status se treatment is considered cy. MTX should not be used during milk was measured.
08/2018) acceptable since excretion into lactation.
breast milk is low.
Leflunomide (Lefl) Lefl is contraindicated during Lefl should if possible be N/A [96] Pregnancy: Individual case
pregnancy. avoided during pregnancy. Lefl should be avoided during preg- reports on adverse pregnancy
Breast-feeding women must not Breast-feeding women should nancy and lactation [64]. results, as well as no increased
receive leflunomide. be switched to a drug with bet- rates of malformation. Lactati-
Status 07/2021 ter documentation. on: is excreted into breast milk.
Ciclosporin (CsA) CsA should not be used during For appropriate indications, CsA If indicated, CsA treatment can be Pregnancy: no evidence of tera-
pregnancy unless the potential can be prescribed during preg- continued during pregnancy with togenicity; premature births or
benefit for the woman justifies nancy. tight monitoring. Use of CsA during increased maternal complica-
the potential risk for the fetus. A patient with well-established lactation is contraindicated [96]. CsA tions such as hypertension and
The alcohol content of CsA CsA medication should not be can be used during pregnancy and is pre-eclampsia may be caused by
capsules should also be conside- switched due to breast-feeding. compatible with lactation [64]. CsA is maternal disease.
red during pregnancy. the conventional treatment of choice Lactation: proven excretion. into
Women treated with CsA should before and during pregnancy but breast milk. No reports on any
not breast-feed. is contraindicated during lactation effect on the infant.
(Status 02/2021) [141].
© 2022 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by John Wiley & Sons Ltd on behalf of Deutsche Dermatologische Gesellschaft. | JDDG | 1610-0379/2022/2005
Table 2 Continued.
Acitretin (Aci) Aci is contraindicated during N/A Aci is teratogenic and contraindica- Pregnancy: high risk of retinoid
CME Article
pregnancy and also during lac- ted for any woman of reproductive syndrome with conspicuous
tation. Reliable contraception age including women who desire craniofacial features, cardiac
must be used consistently du- to get pregnant, breast-feeding wo- malformations, and mental re-
ring treatment and for at least men, and women who cannot ensure tardation.
three years after discontinuati- appropriate contraception for three Lactation: excreted into breast
on. (Status 01/2017) years after treatment [96]. milk.
Treatment with biologics
TNF-a inhibitors There is no specific recommendation
for individual TNF inhibitors.
It is however recommended to dis-
continue treatment with biologics in
the 2nd and 3rd trimester of pregnancy
(except Certolizumab-pegol, see
below) [96]
Etanercept (ETA) ETA should only be used during After careful risk-benefit analysis ETA treatment can be continued du- Pregnancy: hitherto no evidence
pregnancy if this is imperative. and consideration of other safe ring pregnancy until the 30th to 32nd of an increased risk of malfor-
Infants should not receive live alternatives, ETA can be used week, but if indicated also during the mation.
vaccines within 16 weeks after throughout the duration of whole duration. Use of ETA is compa- Lactation: low amounts excre-
the last ETA dose given to the pregnancy. Breast-feeding while tible with breast-feeding [64]. ted into breast milk. It is still
mother. During lactation, treat- on ETA appears to be acceptable unknown if these amounts may
ment decisions should be taken for term infants. affect the infant after ingestion.
individually. (Status 05/2021)
Adalimumab (ADA) ADA should only be used during ADA treatment commenced ADA treatment can be continued du- Pregnancy: no evidence of in-
pregnancy if this is imperative. before pregnancy can be cont- ring pregnancy until the 20th week, creased risk of malformations
Infants should not receive live inued during pregnancy if indi- but if indicated also during the whole from studies, registries, case
vaccines within 5 months after cated. An individual risk-benefit pregnancy. Use of ADA is compatible series, and case reports. In late
the last ADA dose given to the analysis is required to decide if with breast-feeding [64]. pregnancy, ADA can pass the
mother. ADA can be used during discontinuing ADA in late preg- placental barrier into the fetal
lactation. nancy is justified or expedient. circulation.
Status 07/2021 Breast-feeding while on ADA is Lactation: low amounts excre-
acceptable. ted into breast milk. Ingestion
by the infant does not appear to
elicit relevant biological effects.
Continued
661
662
Table 2 Continued.
Infliximab (INFX) INFX should only be used After careful risk-benefit analysis INFX treatment can be continued du- Pregnancy: no clear evidence of
CME Article
during pregnancy if clearly and consideration of other safe ring pregnancy until the 20th week, increased risk of malformations.
needed. Infants should not alternatives, INFX can be used but if indicated also during the who- In late pregnancy, INFX can pass
receive live vaccines within 6 during pregnancy. In late preg- le duration. Use of ADA is compatible the placental barrier into the
months after the last INFX dose nancy (after week 30), treatment with breast-feeding [64]. fetal circulation.
given to the mother. INFX could should be limited to well-foun- Lactation: low amounts excre-
be considered for use during ded indications. Breast-feeding ted into breast milk. Ingestion
breast-feeding. (Stand 09/2021) while on INFX is acceptable. by the infant does not appear to
elicit relevant biological effects.
Certolizumab-pe- This compound should only be If pregnancy is planned, other, For women planning a pregnancy or Pregnancy: comprehensive pros-
gol (CZP) used during pregnancy if clearly more extensively studied immu- who require treatment in the 2nd or pective analyses show no specific
needed. It is recommended to nosuppressants including the 3rd trimester, CZP can be recommen- fetal or maternal risks; negligible
wait at least 5 months after the TNF-α inhibitors ADA, ETA, and ded as a treatment of first choice (if amounts can pass the placental
last application during pregnan- INFX should be considered. If treatment with a biologic is consi- barrier into the fetal circulation.
cy before any live vaccine for the TNF-α treatment is first initiated dered essential). CZP is the biologic Lactation: excretion into breast
infant. CZP can be used during during pregnancy, CZP should of first choice if a treatment with milk in minimal amounts, so-
lactation. Status 09/2021 be considered as first choice due biologics becomes necessary before metimes not detectable at all.
to its low levels of transplacental a planned pregnancy, during preg-
passage. nancy, or during lactation [64].
Breast-feeding while on CZP is
acceptable.
Golimumab (GOL) GOL must only be used du- N/A N/A [96] Pregnancy: limited experience
ring pregnancy if this is clearly Safer therapeutic alternatives than without evidence of specific
medically indicated. Infants GOL should be considered during risks of malformation; transpla-
should not receive live vaccines pregnancy. Use of GOL is compatible cental passage of GOL into the
within 6 months after the last with breast-feeding fetal /neonatal circulation has
GOL dose given to the mother. [141]. been found during the whole
During GOL treatment, and duration of pregnancy.
for at least six months after dis- Lactation: no available data.
continuation, women must not
breast-feed. (Status 10/2020)
Continued
Table 2 Continued.
IL17 inhibitors
CME Article
Secukinumab It is preferable to avoid the use N/A There is no specific recommendation Pregnancy: several case reports
(SECU) of SECU during pregnancy. for SECU. and case series without eviden-
Breast-feeding is not recommen- ce of increased risk of malforma-
ded during treatment: It should tion (however duration of expo-
be decided if breast-feeding is sure is very heterogeneous).
discontinued during and up to Lactation: no experience in hu-
20 weeks after treatment, or if mans
treatment should be discontinu-
ed. (Status 08/2021)
Ixekizumab (IXE) It is preferable to avoid the N/A There is no specific recommendation Pregnancy: few case reports, so
use of IXE during pregnancy. for IXE. the evidence is insufficient for
Breast-feeding is not recommen- any conclusions. Lactation: no
ded during treatment: It should experience in humans.
be decided if breast-feeding or
ed. (Stand 08/2021)
Brodalumab (BRO) It is preferable to avoid the use N/A There is no specific recommendation There is no published experience
of BRO during pregnancy. for BRO. in humans.
Breast-feeding is not recommen- Pregnancy: no teratogenic
ded during treatment: It should or fetotoxic effects in animal
be decided if breast-feeding or experiments.
ed. (Status 07/2020)
Bimekizumab It is preferable to avoid the use N/A N/A There is no published experien-
(BIM) of BIM during pregnancy. ce in humans.
be decided if breast-feeding or experiments.
ed. (Stand 08/2021)
Continued
663
664
Table 2 Continued.
IL23 inhibitors
CME Article
Ustekinumab It is preferable to avoid the use N/A There is no specific recommendation Pregnancy: limited evidence
(USTE) of USTE during pregnancy. for USTE. on USTE during pregnancy and
Breast-feeding is not recommen- USTE treatment may be considered lactation, however no evidence
ded during treatment: It should during pregnancy but should be of teratogenic effects or any
be decided if breast-feeding avoided during lactation [64]. negative impact on breast-fed
should be discontinued during infants.
and up to 15 weeks after treat-
ment, or treatment should be
discontinued. (Status 02/2020)
Guselkumab (GUS) It is preferable to avoid the use N/A There is no specific recommendation Pregnancy and lactation: no
of GUS during pregnancy. for GUS. published experience in humans.
be decided if breast-feeding experiments.
should be discontinued, or tre-
atment should not be initiated.
(Status 12/2020)
Tildrakizumab It is preferable to avoid the use N/A There is no specific recommendation Pregnancy and lactation: no
(TIL) of TIL during pregnancy. for TIL. published experience in humans.
should be discontinued, or if TIL
treatment should be avoided.
(Status 11/2018)
Risankizumab It is preferable to avoid the use N/A There is no specific recommendation Pregnancy and lactation: no
(RISA) of RISA during pregnancy. for RISA. published experience in humans.
should be discontinued, or if
treatment should be avoided.
(Status 05/2021)
Continued
Table 2 Continued.
Fusion protein CTLA4
CME Article
Abatacept (ABA) ABA should not be used during N/A N/A [96]. Pregnancy: Case reports in
pregnancy unless the clinical ABA should be avoided during preg- the 1st trimester of pregnancy
condition of the woman requires nancy and lactation. [64]. showed no abnormalities.
treatment with ABA. Lactation: small amounts are
Administration of live excreted into breast milk.
vaccines to infants exposed to
ABA in utero is not recommen-
ded for 14 weeks following the
mother’s last exposure to ABA
during pregnancy. Breast-fee-
ding should be discontinued
during treatment with ABA and
for up to 14 weeks after
the last dose of ABA treatment.
(Status 12/2019)
New oral therapies – small molecules
Apremilast (APR) APR is contraindicated during N/A Use of APR before a planned preg- Pregnancy and lactation: There
pregnancy and should not be nancy as well as during pregnancy are no published experiences in
used during lactation. (Status cannot be recommended. APR humans.
04/2020) should also not be used during lac- Pregnancy: No teratogenic
tation [96]. APR is contraindicated or fetotoxic effects in animal
during pregnancy and should not be experiments.
used during lactation [64].
Tofacitinib (TOFA) It is preferable to avoid the use N/A N/A [96] Pregnancy: Individual case re-
of TOFA during pregnancy and TOFA should be discontinued if preg- ports from the 1st trimester with
lactation. (Status 11/2021) nancy is planned and should also be no evidence of teratogenicity.
avoided during lactation [64]. Lactation: No published
experiences in humans.
Upadacitinib (UPA) UPA is contraindicated during N/A N/A [96, 141, 64] Pregnancy and lactation: There
pregnancy and should not be are no published experiences in
used during lactation. (Status humans.
09/2021) Pregnancy: Teratogenic effects
in animal experiments.
Abbr.: N/A, not available.
665
CME Article
Retinoids
Retinoids possess proven teratogenic Retinoids possess proven teratogenic potential and are therefore contraindica-
potential and are therefore contraindi- ted during pregnancy. Fetal retinoid syndrome, caused by maternal exposure to
cated during pregnancy. retinoids in the first trimester of pregnancy, includes craniofacial abnormalities
such as malformation of the ears and auditory canals, maxillary and palatal clefts,
Patients of reproductive age treated microcephaly, as well as cardiac malformations and mental retardation [103–105].
with acitretin need to use effective con- The retinoid used in psoriasis treatment (acitretin), with an elimination time of 14
traception for at least one month before days, is metabolized to etretinate which has an elimination time of about 700 days
treatment initiation, as well as during in humans [105, 106]. Patients of reproductive age treated with acitretin need to
treatment and for three years after dis- use effective contraception for at least one month before treatment initiation, as
continuation. well as during treatment and for three years after discontinuation.
There are conflicting opinions on whether acitretin may be used during lac-
tation. The SmPC recommends against it [107]. Acitretin is excreted into breast
milk and can be detected at low levels in the infant’s circulation [108, 109]. Some
authors consider low-dose acitretin treatment of the mother as probably non-toxic
for breast-fed infants [111]. Some case reports, however, show that higher doses of
The current German S3 guideline on retinoids in children may contribute to premature closure of the epiphyses [109–
PV therapy considers breast-feeding an 111]. For this reason, use of retinoids during lactation is not justified. The current
absolute contraindication for acitretin German S3 guideline on PV therapy considers breast-feeding an absolute contrain-
treatment. dication for acitretin treatment [95, 96].
Leflunomide
It is assumed that the active metabolite Leflunomide is approved as a treatment of PsA. Since this compound is an an-
of leflunomide, A771726 or teriflunomi- ti-metabolite (pyrimidine synthesis inhibitor), teratogenic potential is assumed.
de, can be detected in serum for longer Preclinical studies of leflunomide in rats and rabbits at doses equivalent to those
periods of time after discontinuation. used in humans have shown embryotoxicity and teratogenicity [112]. Therefore
Women of reproductive age are advi- the SmPC states that leflunomide is contraindicated during pregnancy. It is also
sed to use reliable contraception for assumed that the active metabolite of leflunomide, A771726 or teriflunomide, can
up to two years after discontinuing be detected in serum for longer periods of time after discontinuation. Women
leflunomide treatment. of reproductive age are advised to use reliable contraception for up to two years
after discontinuing leflunomide treatment. As an alternative, the SmPC proposes
a washout procedure after discontinuation of leflunomide treatment [112]. This
consists of taking 8 g cholestyramine three times a day or 50 g of activated car-
bon powder four times a day, over a period of eleven days. Subsequently, plasma
concentrations of A771726 must be measured twice, with an interval of at least
14 days between the analyses. The SmPC recommends that contraception should
only be discontinued six weeks after plasma levels below 0.02 mg/l are detected
for the first time. However, according to some reports in the scientific literature,
these recommendations may be too strict [112, 113]. Based on data from pros-
pective rheumatological cohort studies with 45 and 65 pregnant women exposed
to the substance during the first trimester, no increased rates of malformation
compared to the control population were detected, though the amount of data re-
mains insufficient to exclude possible miscarriages with certainty [113–115]. Some
published case reports and case series have come to similar conclusions [116–119].
In the event of an accidental pregnancy during leflunomide medication, the above
mentioned washout measures should be taken and close ultrasound follow up of
the fetus should be performed [120].
According to the SmPC, animal studies have shown that leflunomide and its
metabolites are excreted into breast milk. Breast-feeding women must therefore
not be treated with this drug [112]. Since there is currently no experience with
CME Article
the substance in breast-feeding patients, both EULAR and the Embryotox website
concur with this recommendation [65, 120].
Treatment with biologics

Tumor necrosis factor (TNF)α inhibitors
The most comprehensive evidence on The most comprehensive evidence on the systemic use during pregnancy is avai-
the systemic use during pregnancy is lable for the substance class of TNF-α inhibitors [7, 9, 121–130]. One represen-
available for the substance class of TNF- tative of this group – certolizumab-pegol – can be used during both pregnancy
α inhibitors. and lactation if indicated. This is based on prospective and retrospective analyses
showing that only negligible amounts of this compound can pass the placenta into
Certolizumab-pegol, if indicated, can the fetal circulation. The amounts detected in breast milk, if any, are also very
be used during both pregnancy and low [122, 123]. IgG antibodies, and thus most biologics, can pass the placenta via
lactation. This is based on prospective active transport by specific neonatal Fc receptors binding to the Fc region of the
and retrospective analyses showing that molecule. Since certolizumab-pegol does not possess an Fc region, active transport
only negligible amounts of this com- of this substance into the fetal circulation does not occur. Passive placental transfer
pound can pass the placenta into the only plays a minor role and can be ignored [124]. However, the SmPC recommends
fetal circulation. The amounts detected that women of reproductive age should consider using appropriate contraception
in breast milk, if any, are also very low. [131]. Contrary to this recommendation, based on current evidence the compound
constitutes the biologic treatment of choice throughout pregnancy and lactation
Certolizumab-pegol is the biological (Table 2).
treatment of choice throughout There is comprehensive evidence on the use of adalimumab, another TNF-
pregnancy and lactation. α inhibitor, during pregnancy and lactation – mostly from patients with chro-
nic-inflammatory bowel diseases and rheumatoid arthritis. More than 1,000
pregnancies with ongoing adalimumab treatment have been documented in the
scientific literature [7, 9, 125–129]. This large body of evidence from other me-
dical fields may be the reason why only a small number of reports on psoriasis
patients have been published. Nine pregnancies in eight psoriasis patients trea-
ted with adalimumab over varying durations have been documented (Table S2,
online supporting information), [73, 132–136]. In summary, the available lite-
rature does not show any significant indication of teratogenicity. According to
the SmPCs, use of adalimumab during pregnancy is possible if the treatment is
clearly indicated [137].
According to the SmPCs, use of adali- There are also several hundred reports for both etanercept and infliximab on
mumab during pregnancy is possible if use during pregnancy in gastroenterological and rheumatological patients [7, 9,
the treatment is clearly indicated. 125–129] with no evidence of increased risks of malformation or teratogenicity. In
the scientific literature, reports on 89 psoriasis patients exposed to etanercept (with
92 pregnancies) could be identified [133–135, 138, 139]; the details are summari-
zed in Table S3 (online supporting information). Whereas the EULAR recommen-
dations prefer the use of etanercept (as well as certolizumab-pegol) over the other
TNF-α inhibitors in pregnant patients and those who wish to conceive [64], the
SmPC does not recommend the use of etanercept during pregnancy [140]. The new
EuroGuiDerm guideline on systemic treatment of PV likewise does not prioritize
etanercept in this context [141]. Details from eleven psoriasis patients (11 preg-
nancies) treated with infliximab are summarized in Table S3 (online supporting
information) [133, 134, 142–144]. Based on the data from other medical fields,
the SmPC for infliximab states that this substance can be used during pregnancy
if clearly indicated [145].
Based on the evidence described above, it is not required to discontinue ada-
limumab, etanercept, or infliximab in women who experience satisfactory disease
control with these substances and wish to become pregnant. If the indication is cle-
ar, continued treatment with these TNF-α inhibitors during pregnancy (especially
CME Article
Based on the evidence, it is not requi- the 1st and 2nd trimesters) should be discussed with the patient and her partner.
red to discontinue adalimumab, eta- Continued treatment is also possible throughout pregnancy, however, under the
nercept, or infliximab if disease control consideration that in the 3rd trimester, the substance will be actively transported
is satisfactory and the patient wishes through the placental barrier into the fetal circulation [146]. There is a single case
to conceive. If the indication is clear, report on an infant with intrauterine infliximab exposure during the 3rd trimester
continued treatment with these TNF-α of pregnancy who died from BCG after BCG vaccination at three months of age
inhibitors during pregnancy (especially [147]. Following administration of TNF-α inhibitors in the last trimester of preg-
the 1st and 2nd trimesters) should be nancy, the substances remain detectable in the infant’s blood for several months
discussed with the patient and her part- after birth. It is strongly recommended to delay any live vaccines to exposed infants
ner. Continued treatment is also pos- until the age of 4–6 months at the earliest [148]. Since BCG vaccination is no lon-
sible throughout pregnancy, however, ger routinely recommended in Germany, and measles-mumps-rubella and varicella
under the consideration that in the 3rd vaccination are recommended only from the age of 11 months onwards, these do
trimester, the substance will be actively not pose a problem. The only vaccination affected by intrauterine TNF-α inhibitor
transported through the placental bar- exposure is the live vaccine against rotavirus. According to the STIKO recommen-
rier into the fetal circulation. dations (STIKO: German Standing Committee on Vaccination), the vaccination
series should be initiated at the age of six to twelve weeks and should be completed
before the age of 16 and 22 weeks, respectively (depending on the vaccine), but
at the age of 24 or 32 weeks at the latest. The interval between the two (or three)
vaccinations must be at least four weeks [149]. If the mother has been treated with
a TNF-α inhibitor during late pregnancy (except certolizumab-pegol), the parents
need to decide if the rotavirus vaccination should be delayed till after the 16th
week of life, or omitted completely. This also depends on the parents’ attitude to
vaccination. Golimumab, another TNF-α inhibitor, is approved for the treatment
of PsA [150]. As opposed to the other substances in this group, there is only a
small amount of data on the use of golimumab during pregnancy. Animal studies
in macaque monkeys did not indicate any teratogenic or otherwise detrimental ef-
fects on pregnancy, fetal and postnatal development [151]. In the current scientific
literature, only one report on a pregnant PsA patient treated with golimumab could
Following administration of TNF-α inhi- be found [152]. However, there are isolated reports of patients with RA or chronic
bitors in the last trimester of pregnancy, inflammatory bowel disease, without evidence of detrimental effects [127, 152,
the substances remain detectable in 153]. Still, the number of cases reported is not very large (less than 100 patients).
the infant’s blood for several months Transplacental transfer of golimumab into the fetal/neonatal circulation in cases
after birth. It is strongly recommended of exposure throughout pregnancy has been reported [154]; therefore, the EULAR
to delay any live vaccines to exposed does not recommend its use in pregnant women [65, 150]. The SmPC states that
infants until the age of 4–6 months at golimumab should only be used in pregnancy if there is a clear medical indication
the earliest. [150].
Studies on excretion into breast milk are scarce for all TNF-α inhibitors,
and information is based on case reports and case series. Due to the size of the
molecules, however, it is assumed that only small amounts are excreted into breast
milk [7, 123]. Since the infant would have to absorb the substance via the gastroin-
testinal tract, systemic effects are not expected. The manufacturers of both certo-
lizumab-pegol and adalimumab state no objection to the use of these substances
during lactation [131, 137]. Despite similarly positive indications for etanercept
and infliximab, the manufacturers do not address this issue [143]. Live vaccines
are not recommended for breast-fed infants of women treated with infliximab
The manufacturers of both certolizu- until breast-feeding has been discontinued for six months, unless infliximab can-
mab-pegol and adalimumab state no not be detected in the infant’s serum. The manufacturer of golimumab prohibits
objection to the use of these substances breast-feeding during the therapy and for six months after the discontinuation
during lactation [131, 137]. Despite simi- of the treatment [150], although no data on golimumab use during lactation are
larly positive indications for etanercept available. Contrary to the restrictive recommendations of some manufacturers on
and infliximab, the manufacturers do use during lactation, the EULAR recommendations state that all TNF-α inhibitors
not address this issue. are permissible during lactation [65].
CME Article
Interleukin (IL)-23 inhibitors
Although there are several cases of The oldest member of the IL-23 inhibitor group, ustekinumab, binds to the p40
pregnant patients treated safely with subunit and thus also inhibits IL-12. An animal study showed no evidence of fetal
ustekinumab – mostly in gastroen- toxicity or teratogenicity [155]. Additionally, in the phase 2 and 3 clinical trials,
terological indications – the German which reported 31 pregnancies, there was no evidence of teratogenicity or further
S3 guideline and also the SmPC do not fetal risks among the followed pregnancies (exact number not specified in the pu-
currently recommend using this medi- blication) [156]. There have also been reports on 29 psoriasis patients (with 34
cation for psoriasis during gestation. pregnancies) exposed to ustekinumab; no teratogenic effects were seen (Table S5,
online supporting information) [76, 138, 139, 142, 143, 156–163]. With the li-
mited data currently available, the SmPC recommends avoiding the substance if
possible during pregnancy as a precaution [164]. No information is offered on the
use of ustekinumab during pregnancy on the website www.embryotox.de [165].
There are no reports on the use of spe- There are no reports on the use of specific IL-23p19 inhibitors such as gusel-
cific IL-23p19 inhibitors such as guselkumab, risankizumab, or tildrakizumab during pregnancy.
kumab, risankizumab, or tildrakizumab There are only very few reports on the use of ustekinumab during lactati-
during pregnancy. on [127, 132, 164]. The substance was found in breast milk in four out of six
breast-feeding patients with chronic-inflammatory bowel disease. The highest con-
centration (0.72–1.57 mg/ml) was measured during a period of 12 to 72 hours
after application of the drug. However, no negative effects were found in any of
the seven breast-fed infants (for example, no increased susceptibility to infections).
There is no published evidence on the use of specific IL-23p19 inhibitors such as
guselkumab, risankizumab, or tildrakizumab in breast-feeding women; therefo-
re, their use and the use of ustekinumab is not currently recommended in due to
limited evidence.
IL-17 inhibitors
Warren et al. reported on the currently largest pregnancy cohort treated with the
IL-17A inhibitor secukinumab [166]. No fetal or maternal risks were found in the
238 patients with psoriasis, PsA, or spondylosing ankylitis. Rates of miscarriage
or fetal malformations were comparable to the general population. Yet the publi-
cation does show some inhomogeneities regarding patients’ duration of exposure.
Altogether, 177 pregnant psoriasis patients (177 pregnancies) exposed to secukinu-
mab have been reported (Table S6, online supporting information) [133, 166–169].
With the current paucity of data, use of secukinumab in pregnancy should be
avoided for precautionary reasons according to the SmPC [170]. For the IL-17RA
blocker brodalumab and the IL17A inhibitor ixekizumab, fewer published cases of
exposure during pregnancy have been identified. The manufacturer (Lilly Safety
Although a number of pregnancies System) has documented 58 cases of maternal ixekizumab exposure in the clinical
have been observed in women exposed studies [171]. Out of 56 cases that were followed-up, 28 resulted in healthy live
to ixekizumab and secukizumab, and births, 11 in miscarriage, and 13 in elective termination of pregnancy. Exposure
no increased safety signals have been occurred in the first trimester in 56 patients and was not described in two cases.
triggered regarding congenital malfor- After market launch, another 41 cases were documented but 23 of them were not
mation, their use during pregnancy is followed-up. Of the remaining 18 cases, eleven resulted in live births (including one
not yet legitimized and further data are infant with malformation), three in miscarriages, and four in elective pregnancy
needed. termination [171].
There are no data as yet on use of the recently approved IL-17A/F inhibitor
bimekizumab in pregnant women.
Since there is currently no evidence on the use of IL-17 inhibitors during lac-
tation, the relevant SmPCs recommend that women should avoid breast-feeding
while being treated with these substances [170, 172].
CME Article
Abatacept
Abatacept is a recombinant, soluble fusion protein consisting of an extracellular
domain of the human cytotoxic T-lymphocyte antigen 4 (CTLA-4) and a frag-
ment of the Fc region of human immunoglobulin IgG1. The substance binds to
CD80/86 cells just like CTLA-4, and selectively modulates the corresponding sig-
nal. Abatacept has been approved for treatment of PsA [173].
In the preclinical studies with pregnant mice, rats, and rabbits, abatacept was
dosed at 10 mg per kg body weight (20 to 30 times the human dose), and although
the substance can at least partially pass the placenta no unwanted embryofetal ef-
fects were observed in the next generation [173]. Nevertheless, after maternal expo-
sure with 11 times the human dose (10 mg/kg body weight), offspring showed some
alterations of immune function (increases by nine times the mean T-cell dependent
antibody response) [173]. According to the SmPC, abatacept should therefore not
be used during pregnancy unless required by the woman’s clinical condition [173].
In the scientific literature, there are currently 153 case reports on abatacept expo-
sure of patients with autoimmune diseases during the 1st trimester of pregnancy
[174–176]. Although the available data are still very limited, no increased rates of
fetal malformations compared to the general population have been observed. The
manufacturer recommends that women should use reliable contraception during
treatment and for up to 14 weeks after its discontinuation. If a woman conceives
during abatacept treatment, or if this treatment is required during pregnancy, live
vaccines of the infant should be delayed until at least 14 weeks after the pregnant
woman has received the last dose.
Animal experiments in rats have observed abatacept excretion into breast milk
[173]. In one case report on a breast-feeding woman with RA treated with aba-
tacept [176], small amounts of abatacept were detected in the breast milk (about
1/200–1/300 of the maternal serum concentration). The infant was breast-fed
exclusively up to the age of twelve months without any side effects. The child was
also vaccinated against hepatitis B, haemophilus influenzae type B, and pneumo-
cocci at the age of three months, and against rotavirus at six months. A BCG
vaccine was also administered. No immune reactions or severe infections were
observed. The SmPC, however, does not recommend the use of abatacept during
lactation [173].
Newer oral treatments – small molecules

Phosphodiesterase (PDE4) inhibitors
Until now, there have been no reports Apremilast, a PDE4 inhibitor, was approved for treating PV and PsA in 2015.
on cases of apremilast exposure during Until now, there have been no reports on cases of apremilast exposure during preg-
pregnancy. nancy. However, animal studies in pregnant mice have shown that doses above
20 mg/kg body weight/day resulted in a decreased number of ossified tarsal bones
in the offspring, and doses above 40 mg/kg body weight/day led to lower fetal
weight and delayed ossification of the skull bones [177]. Based on these data, use
of apremilast is not recommended in pregnant patients or those who are planning
to become pregnant. The half-life of apremilast in healthy volunteers is about nine
hours, so more than 99 % of the substance is eliminated after about 2–3 days.
Since excretion of apremilast into hu- Conception can be planned after this time.
man breast milk with an impact on neo- Preclinical studies in animals have detected the substance in the breast milk
natal development cannot be excluded, of lactating mice [177]. Since excretion of apremilast into human breast milk with
use of this substance in breast-feeding an impact on neonatal development cannot be excluded, use of this substance in
mothers is not recommended. breast-feeding mothers is not recommended.
CME Article
Janus-kinase (JAK) inhibitors

Tofacitinib and upadacitinib are currently the only JAK inhibitors approved for
treatment of PsA. It is still unclear if these substances can transit the blood-pla-
centa barrier in humans, but based on the small size of the molecules this can be
assumed. Animal studies in rats and rabbits indicate that tofacitinib is teratogenic.
High doses of exposure resulted in skeletal and cardiac malformations [178, 179].
During the clinical studies in ulcerative colitis, eleven pregnancies with ma-
ternal exposure to tofacitinib were identified. The pregnancy was terminated in
two cases, and two other women miscarried. Four pregnancies resulted in healthy
live births. There was no available information on the remaining three cases [146,
179]. Another publication reported on 31 patients with RA and 16 with psoriasis
who were treated with tofacitinib during the 1st trimester of pregnancy (except for
two RA patients). 16/31 and 9/16 pregnancies, respectively, resulted in healthy live
births. In four cases of each group (4/31 and 4/16), the pregnancy was terminated,
and miscarriage occurred in 6/31 and 1/16 patients, respectively. No data were
available for the remaining 4/31 and 2/16 patients in this cohort. One of the infants
(1/31) had a congenital malformation (pulmonary stenosis). However this infant’s
mother had received antihypertensive treatment with losartan during pregnancy.
This substance can lead to fetopathy from the 20 th week of pregnancy onwards,
with contractures of the limbs, hypoplasia of the cranial calotte, and pulmonary
hypoplasia [180, 181]. Thus, no evidence of teratogenicity was observed for tofaci-
tinib [178, 181]. There are currently no further published observations on tofaciti-
nib during pregnancy.
In Germany, tofacitinib for the treatment of PsA is only approved in combi-
nation with MTX. This treatment is contraindicated during pregnancy. Therefore,
consistent and reliable contraception is essential when treating female patients of
reproductive age.
There are currently no data on the use of tofacitinib during lactation in hum-
ans. Based on molecule size, it is assumed that the substance can be excreted into
breast milk. This has been detected in lactating rats [178]. Since effects on the
Data on the use of the small molecules infant cannot be excluded after oral ingestion, tofacitinib should not be prescribed
apremilast, tofacitinib, and upadaci- for breast-feeding women.
tinib during pregnancy and lactation There are currently no case reports on the use of upadacitinib during pregnan-
in humans are scarce or lacking com- cy, thus the SmPC is the only source of information. Animal studies in both rats
pletely. Animal studies have reported and rabbits have shown that ubadacitinib is teratogenic. Maternal exposure led
teratogenicity and excretion into breast to negative effects on bone in rat fetuses and on the heart in rabbit fetuses [182].
milk. Use of these substances during Soon after administration of ubadacitinib to lactating rats, high concentra-
pregnancy and lactation is therefore tions of the substance could be detected in their milk [182]. Based on these insights,
contraindicated. use of ubadacitinib during both pregnancy and lactation is strongly discouraged.
Conclusion
A number of innovative and well-tolerated substances for the treatment of psoriasis
have been developed during the last decade. However, the therapeutic options for
pregnant and breast-feeding women, as well as those who are planning to become
pregnant, remain limited. Psoriasis is not only a skin disease with impaired quality
of life, but also a systemic inflammation that can impact the entire pregnancy. Se-
veral cohort studies have identified various risks for premature birth or low birth
weight, depending on disease severity [18–20]. When treating psoriasis patients of
reproductive age who have not completed their family planning, the impact of this
disease on the course of pregnancy, as well as possible therapeutic options, must
be discussed. Even if contraceptive recommendations are addressed in great detail
CME Article
Compounds Recommended interruption of 1st trimester of 2nd trimester of 3rd trimester of Lactation
treatment before conception pregnancy pregnancy pregnancy
Conventional therapies
Fumaric acid esters Not required, resp. a few
days only are sufficient
Methotrexate 1–3 months
Leflunomide 2 years, resp. washout
procedures required
Ciclosporin Not required, resp. a few
days only are sufficient
Acitretin 3 years *)
Biological therapies
TNFα inhibitors
Etanercept Not required
Adalimumab Not required
Infliximab Not required
Certolizumab-pegol Not required
Golimumab 6 months *)
IL 17 inhibitors
Secukinumab 20 weeks *)
Ixekizumab 10 weeks *)
Brodalimumab 12 weeks *)
Bimekizumab 17 weeks *)
IL 23 inhibitors
Ustekinumab 15 weeks *)
Guselkumab 12 weeks *)
Tildrakizumab 17 weeks *)
Risankizumab 21 weeks *)
Small molecules
Apremilast A few days (2–3)
are sufficient
Tofacitinib 4 weeks *)
Upadacitinib 4 weeks *)
Fusion protein CTLA4
Abatacept 14 weeks *)
(+++) high preference/the use is in label if clinically necessary

(++) preference/ the use is possible according to the label, if clearly required
(+) off-label therapy possible, there is some evidence of safety available
(+/–) probably possible, however only scarce evidence of safety available
(–) no available data or evidence of negative effects, contraindication
*) according to the current label
) There is no mandatory indication for termination of pregnancy in case of an unintended pregnancy during the therapy. However, a
detailed ultrasound workup is strongly recommended.
•) In case of an unintended pregnancy, wash-out measures according to the label information are recommended.
Figure 2 Summary of the current recommendations on systemic therapy during pregnancy and breast-feeding based on the
available evidence (consisting of label information, available scientific publications, national and international guidelines, as
well as recommendations from the internet portal www.embryotox.de) and the consensus of the authors.
CME Article
when systemic treatment is initiated, unplanned pregnancy is still possible and

requires additional, well-founded consultation. About 30–40 % of pregnancies
in Germany are unplanned; they usually occur in women aged 20 to 44. Psoriasis
frequently appears for the first time in exactly this age group, therefore, potential
pregnancy should always be considered when deciding on a specific treatment op-
tion in these patients [183].
In mild PV, low to medium potency topical corticosteroids (TCS) are usually
sufficient for disease control. In treatment-refractory cases, UVB treatment is also
an option, though maternal folic acid levels and possible development of melasma
need to be considered.
If pregnancy leads to exacerbation of the psoriasis, or if patients treated with
systemic medications become pregnant, the therapy becomes more challenging.
Our recommendations on the various systemic medications are summarized in
Figure 2. They are based on the currently available data (SmPC, scientific litera-
ture, national and international guidelines, recommendations of the website www.
embryotox.de) (Table 2) as well as the authors’ consensus. Our publication offers
a detailed overview on the use of systemic psoriasis treatments during pregnancy
and is intended as a practical guide for consultation of female psoriasis patients.
The patient and her partner need to be carefully counseled and influencing factors
such as comorbidities or the course of previous pregnancies should be considered.
A joint decision on the appropriate treatment can then be made, bearing in mind
the approval status and SmPC of the chosen medication.
Acknowledgment
Open access funding enabled and organized by Projekt DEAL.
Conflicts of interest
Galina Balakirski acted as consultant, received lecture fees, obtained financial
support and/or participated in clinical trials for the following companies: Abbvie,
Amgen, Almirall, Boehringer-Ingelheim, Celgene, Galderma, Janssen-Cilag, Leo,
Eli Lilly, Novartis, Menlo Therapeutics, Pfizer, UCB.
Dagmar Wilsmann-Theis acted as consultant, received lecture fees, obtained
financial support and/or participated in clinical trials for the following compa-
nies: Abbvie, Almirall-Hermal, Amgen, Biogen, Bristol Myers Squibb, Boehringer
Ingelheim, Celgene, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Eli
Lilly, Medac, Merck, Menlo Therapeutics, Sharp & Dohme Corp., Novartis, Pfi-
zer, UCB, VBL.
Sascha Gerdes acted as consultant, received lecture fees, obtained financial
support and/or participated in clinical trials for the following companies: AbbVie,
Affibody AB, Akari Therapeutics Plc, Almirall-Hermal, Amgen, Anaptys Bio, Ar-
genx BV, AstraZeneca AB, Biogen Idec, Bioskin, Bristol-Myers Squibb, Boehrin-
ger-Ingelheim, Celgene, Dermira, Eli Lilly, Foamix, Forward Pharma, Galderma,
Hexal AG, Incyte Inc., Janssen-Cilag, Johnson & Johnson, Kymab, Leo, Medac,
MSD, Neubourg Skin Care GmbH, Novartis, Pfizer, Principia Biopharma, Re-
generon Pharmaceutical, Sandoz Biopharmaceuticals, Sanofi-Aventis, Sienna Bio-
pharmaceuticals, Takeda, Trevi Therapeutics, UCB, Vascular Biogenics.
Stefan Beissert acted as consultant, received lecture fees, obtained financial
support and/or participated in clinical trials for the following companies: Abbvie,
Actelion Pharmaceuticals, Almirall, Amgen, Celgene, Galderma, Janssen-Cilag,
Leo, Eli Lilly, Menlo Therapeutics, MSD Sharp & Dohme, Novartis, Pfizer, Sano-
fi-Aventis, UCB, Roche-Posay, GSK, BMS, Hexal-Sandoz
CME Article
Falk Ochsendorf acted as consultant or received lecture fees from the follo-
wing companies: Galderma, GSK, Mylan, MSD.
Ralph von Kiedrowski acted as consultant, received lecture fees, obtained fi-
nancial support and/or participated in clinical trials for the following companies:
AbbVie, Almirall, Biofrontera, Biogen, Celgene, Dr. Pfleger, Foamix, Janssen-Ci-
lag, Leo, Eli Lilly, Medac, MSD, Novartis, Pfizer, Tigercat und UCB.
Source of funding
This publication was supported by a research grant from UCB Pharma GmbH, the
manufacturer of certolizumab-pegol. The support ensured that a medical doctor
could perform a detailed database analysis of the available literature and subse-
quently evaluate the results. The sponsor did not in any way influence the design of
this analysis, the conducting of the study or analysis of the data, or the decision to
submit our results for publication.
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CME Article
CME Questions/Lernerfolgskontrolle
1. Welche Aussage zur Aktivität 3. Welche Aussage zur Phototherapie 5. Wie lang soll die Auswaschzeit
der Psoriasis in der Schwangerschaft in der Schwangerschaft trifft zu? systemischen Acitretins bei einer ge-
trifft zu? a) UVA und UVB Lichttherapie dürfen bärfähigen Patientin, die nun plant,
a) Bei unbehandelter Psoriasis in der in der Schwangerschaft nicht ange- die Verhütung abzusetzen, mindestens
Schwangerschaft kommt es regel- wandt werden. sein?
mäßig zu Komplikationen während b) Man sollte die schwangeren Pati- a) 3 Monate
des Geburtsvorganges. entinnen darüber aufklären, dass b) 6 Monate
b) Die Aktivität der Psoriasisarthritis das Entstehen von Melasmen unter c) 12 Monate
ist unbeeinflusst von hormonellen Lichttherapie mit Folsäureeinnahme d) 24 Monate
Veränderungen in der Schwanger- verhindert werden könnte. e) 36 Monate
schaft, während die Psoriasis vulga- c) UVA ist der UVB Lichttherapie in der
ris hierauf sensibel reagiert. Psoriasistherapie in der Schwanger-
c) Eine Psoriasisarthritis verschlechtert schaft zu bevorzugen.
d) Sowohl eine topische als auch eine 6. Auf Ihrer Station wird eine 34-jäh-
sich im Regelfall im ersten Trime-
non der Schwangerschaft und die systemische PUVA Therapie kann rige Patientin in der 16. Schwanger-
Psoriasis vulgaris erst im zweiten problemlos in der Schwangerschaft schaftswoche aufgenommen, deren
Trimenon. angewendet werden. Psoriasis während ihrer 2. Schwan-
d) Bei knapp 60 % der Patientinnen e) Im Rahmen der UV-Therapie in der gerschaft wieder symptomatisch ge-
verschlechtert sich der Hautbefund Schwangerschaft sollte auf den worden ist. Die Patientin ist nun zur
in der Schwangerschaft, bei etwa Folsäurespiegel der Patientinnen Behandlung eines schweren Psoriasis-
20 % bleibt die Psoriasis-Aktivität geachtet werden. schubs in der Klinik, der auf topische
unverändert und bei weiteren 20 % Therapie nicht anspricht. Welches der
verbessert sich der Hautzustand folgenden Systemtherapeutika ist für
e) Bei knapp 60 % der Patientinnen 4. Welche Aussage zur traditionellen die Behandlung dieser Patientin am
verbessert sich der Hautbefund antipsoriatischen Systemtherapie in unbedenklichsten?
in der Schwangerschaft, bei etwa der Schwangerschaft trifft zu? a) Acitretin
20 % bleibt die Psoriasis-Aktivität a) Ein elektiver Schwangerschaftsab- b) Certolizumab-pegol
unverändert und bei weiteren bruch sollte bei einer vorangegan- c) Ustekinumab
20 % verschlechtert sich der genen Therapie mit Fumarsäureester d) Secukinumab
Hautzustand zu Beginn der Schwangerschaft e) Methotrexat
zumindest erwogen werden.
b) Methotrexat (MTX) ist in der
Schwangerschaft kontraindiziert.
2. Welche Aussage zur topischen
Die Substanz ist als teratogen aus 7. Eine 29-jährige systemthera-
Therapie in der Schwangerschaft
Tierstudien bekannt und führt als pienaive Patientin mit einem PASI
trifft zu?
Folsäureantimetabolit zu diversen von 19 und einer aktuell manifesten
a) Topisches Tacrolimus ist mittlerweile
Fehlbildungen des Fetus. Psoriasisarthritis sowie einem Mor-
zur Behandlung der Psoriasis auch in
c) MTX geht nicht in die Muttermilch bus Crohn in der Vorgeschichte, der
der Schwangerschaft zugelassen.
über, so dass in der Fachinformation aktuell inaktiv sei, benötigt eine
b) Topische Steroide sind obsolet in der
Stillen während der Therapie erlaubt systemische Therapie. Sie ist frisch
Schwangerschaft.
ist. verheiratet und plant auch eine
c) Dithranolgemisch mit Salicylsäure
d) Es liegt nur begrenzte Evidenz zur Schwangerschaft in den nächsten
gehört zur Therapie der Wahl in der
Sicherheit einer Ciclosporin-Thera-
Schwangerschaft. Monaten, eine gynäkologische Unter-
pie in der Schwangerschaft vor, so
d) Zu topischen Vitamin-D-Analoga in suchung bei ihr und eine andrologi-
dass auch in der Fachinformation
der Schwangerschaft existieren viele sche Untersuchung bei Ihrem Mann
davon abgeraten wird.
Studiendaten. waren komplett unauffällig. Welche
e) Ciclosporin geht in die Muttermilch
e) Tazaroten (topisches Retinoid) ist bei Aussage trifft zu?
nicht über. Aus diesem Grund ist die
Kinderwunsch und in der Schwan- a) Da die Patientin schwanger werden
Therapie mit Ciclosporin während
gerschaft kontraindiziert. will, sollte von einer systemischen
der Stillzeit gemäß der Fachinforma-
tion erlaubt. Therapie grundsätzlich abgeraten
werden.
CME Article
b) Eine systemische Therapie mittels c) Die Psoriasisarthritis verbessert sich d) Retinoide sind zwar in der Schwan-
eines Interleukin-17-Blockers ist in immer in der Schwangerschaft, da- gerschaft teratogen, aber in der Still-
dieser Fallkonstellation aufgrund des her kann sie die Medikation beden- zeit unproblematisch, daher können
schnellen Wirkeinsatzes zu bevor- kenlos absetzen. diese angewandt werden.
zugen. d) Ein Spermiogramm des angehenden e) Besonders viel Erfahrung in der Pso-
c) Da die Patientin systemtherapienaiv Vaters wäre zur Therapieentschei- riasistherapie während der Stillzeit
ist und auch eine Psoriasisarthritis dung nicht zielführend, da es für die liegt bei den Januskinase-Inhibitoren
hat, ist Methotrexat das Mittel der Patientin nicht von Interesse ist, ob vor, weshalb diese in solchen Fällen
ersten Wahl. er zeugungsfähig ist. priorisiert eingesetzt werden sollten.
d) Ein anti-TNF-α-Antikörper wäre in e) Eine Auswaschphase für Leflunomid
diesem Fall das Mittel der ersten beinhaltet gemäß Fachinformation
Wahl, da es allen Ansprüchen so- die Einnahme von 8 g Cholestyramin
10. Welcher Anteil der Schwanger-
wohl in Hinblick auf die Psoriasis- fünfmal täglich oder 500 g Aktivkoh-
schaften bei in Deutschland lebenden
therapie und der Komorbidität als lepulver viermal täglich über einen
Frauen ist ungeplant?
auch in Hinblick der Möglichkeit Zeitraum von jeweils elf Tagen
a) weniger als 5 %
zur Schwangerschaft Rechenschaft
b) circa 5–10 %
trägt.
c) circa 10–20 %
e) Nur Certolizumab-pegol wäre als
9. Eine 25-jährige Psoriasispatientin d) mehr als 50 %
zugelassene Therapie bei Morbus
hatte vor der Schwangerschaft eine e) circa 30–40 %
Crohn die richtige Therapieoption.
Systemtherapie mit Ixekizumab, hier-
mit war die mittelschwere Psoriasis gut
kontrolliert. Vor der Schwangerschaft
8. Eine 37-jährige Patientin mit einer Liebe Leserinnen und Leser,
hatte sie das Medikament abgesetzt,
Psoriasis-Arthritis hat einen neuen der Einsendeschluss an die DDA für
doch nun sechs Monate nach der
Lebensgefährten kennengelernt. Sie diese Ausgabe ist der 31. Juli 2022.
Geburt hat sie die Psoriasis mit der
berichtet, nun auch Kinderwunsch Die richtige Lösung zum Thema „Der
Lokaltherapie nicht mehr im Griff, der
Einfluss der Ernährung bei entzündlichen
zu haben. Ihre aktuelle Therapie mit
PASI ist bei 19,8. Die Patientin möchte Gesichtsdermatosen“ in Heft 2 (Februar
Leflunomid möchte sie aber gerne
auf alle Fälle das Kind noch bis zum 12. 2022) ist: 1c, 2e, 3d, 4c, 5b, 6a, 7b, 8a,
beibehalten. Was soll im Aufklärungs-
Monat stillen. 9b, 10d
gespräch besprochen werden? a) Die Patientin braucht eine System-
a) Bei der kurzen Halbwertszeit kann therapie daher sollte sie auf alle Fälle Bitte verwenden Sie für Ihre Einsendung
die Therapie mit Leflunomid zu- abstillen, denn keine Systemtherapie das aktuelle Formblatt auf der folgenden
nächst fortgeführt werden und ist während der Stillzeit zu verant- Seite oder aber geben Sie Ihre Lösung
wenn der Kinderwunsch konkret worten. online unter http://jddg.akademie-dda.
wird, kann sie gleichzeitig mit der b) Da Ixekizumab gut geholfen hat, de ein.
Verhütung abgesetzt werden. kann sie dieses Medikament wieder
b) Da der aktive Metabolit Terifluno- beginnen und problemlos weiterstil-
mid über eine längere Zeit nach len.
Beendigung der Therapie im Serum c) TNF-α-Inhibitoren und hier speziell
nachweisbar ist, sollte bis zu zwei Certolizumab-pegol wären eine
Jahre nach der Behandlung eine mögliche Therapieoption während
zuverlässige Verhütungsmethode der Stillzeit.
angewandt werden.

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CME Article

Submitted: 8.8.2021 DOI: 10.1111/ddg.14789

or Crohn’s disease/ulcerative colitis may basically be interpreted as protective for

Psoriasis during pregnancy

Pregnancy in psoriasis patients

development. Patients with moderate to severe PV appear to carry an increased risk

German medicines directory (Rote Liste, www.rote-liste.de). Proactive, drug-sparing

Phototherapy and photochemotherapy

Prednicarbate Pregnancy: Extensive use (>30% of body surface) is contraindi- Gr. 3

Limited recommendation after individual counseling

Vitamin-D3 analogs Calcipotriol Pregnancy: Use only if absolutely necessary Gr. 6

Fixed combination Calcipotriol + Beta- Pregnancy: Stringent indication Gr. 6

Pimecrolimus/ Pregnancy:/Stringent indication Gr.4/Gr. 6

Not recommended / contraindicated

Salicylates Risk of absorption, do not use concentrations above 1 % N/A

Tazarotene* Known teratogenic potential

Tar Associated with miscarriage and congenital malformations

Treatment with biologics

Interleukin (IL)-23 inhibitors

Newer oral treatments – small molecules

Janus-kinase (JAK) inhibitors

(+++) high preference/the use is in label if clinically necessary

*) according to the current label

when systemic treatment is initiated, unplanned pregnancy is still possible and

69 Noviani M, Wasserman S, Clowse MEB. Breast-feeding in mothers with systemic lu-

95 Nast A, Amelunxen L, Augustin M, Boehncke WH et al. S3-Leitlinie zur Therapie der

140 Fachinformation Enbrel®, Stand März 2017. Available from: https://www.pfizermed.

161 Sheeran C, Nicolopoulos J. Pregnancy outcomes of two patients exposed to

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