Moderate to Severe Atopic Dermatitis: Targeted

Pathways and Strategies to Personalize Patient Care

Supported by an educational grant from Incyte Corporation.

About These Slides
 Please feel free to use, update, and share some or all of these slides in
your noncommercial presentations to colleagues or patients
 When using our slides, please retain the source attribution:

Slide credit: ProCE.com

 These slides may not be published, posted online, or used in

commercial presentations without permission. Please contact
info@ProCE.com for details

Slide credit: ProCE.com

Faculty
Sarah Lant, PharmD
Clinical Pharmacist Specialist
University of Chicago Medicine
Chicago, Illinois

Jamie L. McConaha, PharmD, NCTTP, BCACP, CDCES

Associate Professor of Pharmacy Practice
Duquesne University School of Pharmacy
Pittsburgh, Pennsylvania

Slide credit: ProCE.com

Disclosures
The faculty reported the following relevant financial relationships or
relationships to products or devices they have with ineligible companies
related to the content of this educational activity:
Sarah Lant, PharmD, has disclosed that she has received consulting fees
from Lilly.
Jamie L. McConaha, PharmD, NCTTP, BCACP, CDCES, has no relevant
conflicts of interest to report.
The planners/managers reported the following relationships.
ProCE staff and planners have no relevant conflicts of interest to report.

Slide credit: ProCE.com

Learning Objectives
By the end of this presentation, learners will be able to:
 Describe the underlying pathophysiology of moderate to severe AD,
including inflammatory pathways and associated drug targets
 Summarize the safety and efficacy of current and emerging targeted
treatments for moderate to severe AD in children, adolescents, and adults
 Incorporate shared decision-making and patient engagement into
treatment selection for moderate to severe AD
 Identify recommendations and best practices for herpes zoster and
COVID-19 vaccination in patients with AD who are receiving
immunosuppressants and immunomodulatory therapies
Slide credit: ProCE.com
Background and Pathophysiology of
Atopic Dermatitis

Slide credit: ProCE.com

 Atopic Dermatitis
 AD is a chronic, inflammatory
skin disease that causes pruritic
skin lesions and follows a
relapsing course
 AD is often associated with
elevated serum immunoglobulin
(IgE) levels and a personal or
family history of allergic rhinitis
and asthma

Eichenfield. J Am Acad Dermatol. 2014;70:338. Slide credit: ProCE.com

 Epidemiology
 AD affects up to 25% of children and 2%-3% of adults
 Most common onset at 3-6 mo of age
‒ 60% of patients develop an AD eruption in the first yr of life and 90% by 5
yr of age
 AD resolves in many children by adulthood, but 10%-30% continue to
be affected
 Small percentage of patients first develop AD symptoms as adults
 African American and Asian American children develop AD more often
than white children in the US
Eichenfield. J Am Acad Dermatol. 2014;70:338. aad.org/public/diseases/eczema/types/atopic-dermatitis. Slide credit: ProCE.com
 Pathophysiology

Epidermal
Barrier
Dysfunction

AD
Pathogenesis
Abnormal
Environmenta
Immune
l Factors
Response

Sayaseng. J Pediatr Health Care. 2018;32:S2. Slide credit: ProCE.com

 Pathophysiology: Epidermal Barrier Dysfunction
 Epidermal barrier dysfunction in AD is a result of deficiency or dysfunction in
the skin matrix (structural proteins and lipids joined by tight junctions and
desmosomes) along with a lack of keratinocyte differentiation
 Mutation of the filaggrin (FLG) gene that encodes the profilaggrin/filaggrin
proteins can cause disruption in epidermal hydration and barrier function
‒ Increased skin pH
‒ Increased transepidermal water loss
‒ Decreased resistance to Staphylococcus aureus
‒ Keratinization dysfunction

Eichenfield. J Am Acad Dermatol. 2014;70:338. Sayaseng. J Pediatr Health Care. 2018;32:S2. Kader. Cells. 2021;10:1392. Slide credit: ProCE.com
 Pathophysiology: Environmental Factors

Exposure to various environmental factors can cause itching and skin barrier
disruption, transepidermal water loss, or abnormal immune responses

 Soaps/detergents  Food allergies

 Climate  Airborne allergens (eg, dust mites)
 Heat/sweating  Staphylococcus aureus
 Stress  Cigarette smoke
 Infections  Disinfectants

Sayaseng. J Pediatr Health Care. 2018;32:S2. Kantor. Expert Rev Clin Immunol. 2017;13:15. Slide credit: ProCE.com
 Pathophysiology: Immunologic Factors
 Calcineurin-mediated proliferation of Th2 cells downregulates the
expression of FLG
 Th2 cells produce cytokines that irritate tissue and increase IgE
synthesis
‒ IL-4 and IL-13 are major causes or inflammation and itching
 Overactivity of PDE-4 contributes to inflammation

Sayaseng. J Pediatr Health Care. 2018;32:S2. Slide credit: ProCE.com

 Adaptive Type 2 Immune Defects

Barrier Mast cells and basophil

dysfunction degranulation IgE

B B-cell
cell
FLG
Scratching

IL-4
TSLP IL-13
IL-13

Pruritus IL-31

↑ expression of endothelial
adhesion molecules

Brunner. J Allergy Clin Immunol. 2017;139:S65. Wang. Am J Clin Dermatol. 2016;17:425. Slide credit: ProCE.com
 Burden of Disease
 AD ranks 15th among all nonfatal diseases and has the highest disease
burden among skin diseases as measured by disability-adjusted life-yr
 Quality of life can be severely affected for children, families, and adults
‒ Itching and scratching
‒ Poor sleep quality
‒ Emotional/mental health impact
‒ Interference with activities
‒ Impaired social functioning

Laughter. Br J Dermatol. 2021;184:304. Drucker. J Invest Dermatol. 2017;137:26. Slide credit: ProCE.com
 Burden of Disease
 Itch trigger avoidance can be difficult or not feasible
 Out-of-pocket costs for patients and families can be significant
‒ Direct and indirect costs estimated to be over $5.3 billion per yr in the US
‒ Copays and/or deductibles for office visits and prescription medications
‒ Moisturizers, itch relievers, dressings, hygiene products, dietary supplements, specialized
cleaning products

 Polypharmacy; prescribing multiple topical agents can be confusing and

burdensome for patients
‒ Topical treatment regimens are time-consuming and difficult to apply; can lead to
stinging, burning, and other adverse events; can stain clothing and linens; can cause
overheating and inhibit sweating
Chovatiya. Dermatitis. 2021;[Epub]. Drucker. J Invest Derm. 2017;137:26. Slide credit: ProCE.com
 Common AD Comorbidities

Asthma Urticaria

Allergic rhinitis Depression

Food allergies Anxiety

Sleep disturbance Osteoporosis/fractures

Alopecia areata Skin infection

Davis. J Am Acad Dermatol. 2022;[Epub]. Slide credit: ProCE.com
Treatment of Atopic Dermatitis

Slide credit: ProCE.com

 Goals of Treatment

Reduce symptoms
Prevent
Pruritus exacerbations
Dermatitis

Minimize Improve
therapeutic risks quality of life

uptodate.com/contents/treatment-of-atopic-dermatitis-eczema. Slide credit: ProCE.com

 AD Step-care Management
Step-up therapy
OR Step-up therapy
Systemic or phototherapy
Choose management approaches based on shared-decision making
Moderate to severe AD
Basic Management Prescription topical therapy
All AD severities All AD severities Phototherapy: NBUVB,* UVA1*
Biologics: dupilumab, tralokinumab
Emollients: liberal and frequent Corticosteroids: range of potencies
Oral systemic immunomodulators:
use Calcineurin inhibitors: tacrolimus, pimecrolimus abrocitinib, baricitinib,* upadacitinib
Bathing: warm daily baths or showers Phosphodiesterase E4 inhibitors: crisaborole azathioprine,* corticosteroids,*
using non-soap cleansers
Janus kinase inhibitors: ruxolitinib cyclosporine,* methotrexate,*
Trigger avoidance: patient-centered mycophenolate mofetil,* tacrolimus*
Reactive: 1-2 x/day during flare and for up to
approach to avoidance
1 wk beyond clearance of flare Hospitalization for wet therapy
of common and/or proven allergens
and irritants Proactive: 1-3 x/wk between flares

Step-down therapy
Step-down therapy
Maintain basic management as needed OR OR
Maintain prescription topical therapy Maintain systemic or phototherapy
Reduce/discontinue lower-step therapies Reduce/discontinue lower-step therapies
*Not FDA approved for AD.
Chovatiya. Dermatitis. 2021;[Epub]. Slide credit: ProCE.com
Traditional Therapies

Topical Agents
 Corticosteroids
 Calcineurin inhibitors
 Phosphodiesterase inhibitors
 Coal tar
 Antimicrobials/antiseptics

Phototherapy
Systemic Agents
 Azathioprine
 Cyclosporine
 Methotrexate
 Mycophenolate mofetil
Slide credit: ProCE.com
 Topical Therapies
Class/Agent Guideline Recommendations
First line option for those who have not responded to
Corticosteroids
skin care routines and emollients*
Calcineurin inhibitors Second-line therapy for the short-term and noncontinuous
 Tacrolimus ointment (0.03 and 0.1%) chronic treatment of AD in nonimmunocompromised
 Pimecrolimus cream (0.1%) individuals
Phosphodiesterase inhibitors Safe to use in ages 3 mo and up; other agents are still
 Crisaborole currently being studied in phase III trials
Not adequate data to make a recommendation regarding
Coal tar the use of coal tar topical agents
Antimicrobials/antiseptics Not routinely recommended; no benefit found

*Dosing based on vasoconstrictive properties; use lowest dose possible for the shortest duration possible

Sidbury. J Am Acad Dermatol. 2014;71:327. Eichenfield. J Am Acad Dermatol. 2014;71:116. Crisaborole PI. Slide credit: ProCE.com
 Phototherapy
 Second line treatment for refractory AD
 UVA, UVB, or UVA/UVB can be used for
anti-inflammatory properties in patients
of any age
‒ UVB: most common (77%)
‒ Narrowband UVB: common
due to reduced adverse event profile
‒ Broadband UVB: rarely used due
to longer wavelength
‒ UVA: reserved for failure of UVB therapy;
increased wavelength and side effect profile
 Adverse events: stinging, burning, and tender skin
Musters. Cochrane Database Syst Rev. 2021;10:CD013870. Slide credit: ProCE.com
 Systemic Therapies
Class/Agent Dosing Monitoring
CBC LFT Renal TB Other
1-3 mg/kg/day TPMT
Azathioprine Pediatric: 1-4 mg/kg/day X X X X Hepatitis B and C
150-300mg/day BP x 2, Mg+, K+,
Cyclosporine X X X
Pediatric: 3-6 mg/kg/day UA
7.5-25mg/wk
Methotrexate Pediatric: 0.2-0.7 mg/kg/wk X X* X

Mycophenolate 1.0-1.5 g orally twice daily

mofetil Pediatric: 1200 mg/m2/day X X X X

*Weekly for 2-4 wk; 1 wk after each major dose increase; every 2 wk for 1 month, then every 2-3 mo while on stable doses

Sidbury. J Am Acad Dermatol. 2014;71:327. www.accessdata.fda.gov/scripts/cder/daf/. Slide credit: ProCE.com

 Place in Therapy for Traditional Agents
 Topical agents: mainstay of therapy
‒ Often used in conjunction with systemic therapies
‒ Moisturizers should be used throughout entirety of AD treatment
 Phototherapy
‒ Recommended when no improvement with nonpharmacologic,
conventional therapies and environmental/occupational modifications
 Systemic agents: off-label use
‒ Consider as alternative therapy when other agents are contraindicated or
fail, or based on individual preference/response
Sidbury. J Am Acad Dermatol. 2014;71:327. Eichenfield. J Am Acad Dermatol. 2014;71:116. Slide credit: ProCE.com
 Newer Therapies
Class Agents Route FDA AD Status Age
Available Agents
IL-4 inhibitor Dupilumab SQ injection 2017 ≥6 yr
JAK inhibitor Abrocitinib Oral 2022 ≥18 yr
Baricitinib Oral Under FDA Review ≥18 yr
Ruxolitinib Topical 2021 ≥12 yr
Upadacitinib Oral 2022 ≥12 yr
IL-13 inhibitor Tralokinumab SQ injection 2021 ≥18 yr

Abrocitinib PI. Dupilumab PI. Ruxolitinib PI. Tralokinumab PI. Upadacitinib PI. 1. Simpson. J Am Acad Dermatol. 2021;85:62.
2. Reich. JAMA Dermatol. 2020;156:1333. clinicaltrials.gov. Slide credit: ProCE.com
 Dupilumab
 Indicated for moderate to severe AD Dosing (SC Injection)
not controlled with topical therapy Adult
 Mechanism of action: Initial Maintenance
600mg 200 mg Q2W
‒ Inhibits IL-4 signaling via type I Pediatric
receptor and both IL-4 and IL-13 Weight Initial Maintenance
signaling through the type II ≥60 kg 600 mg 300 mg Q2W
receptor
30 to <60 kg 400 mg 200 mg Q2W
 Serious adverse events: 15 to <30 kg 600 mg 300 mg Q4W

‒ Injection-site reactions
‒ Ocular adverse events
Dupilumab PI. Slide credit: ProCE.com
 Dupilumab: Clinical Trial Results
Trial Study Design and Population
Phase III trials in adults with moderate to severe AD
LIBERTY AD SOLO 1 and Dupilumab monotherapy for
LIBERTY AD SOLO 21 16 wk
LIBERTY AD CHRONOS2 Dupilumab and TCS with
inadequate response to TCS
monotherapy for 52 wk
Results
 Dupilumab significantly improved all efficacy
endpoints compared with placebo (P <.0001)
 Steady and consistent improvement in symptoms
over time
 Pruritis improved within 1-3 days
 Injection-site reactions and conjunctivitis more
common in dupilumab
 More patients who received combination therapy
achieved coprimary efficacy endpoints
 Incidence of adverse events was similar between
groups

1. Thaçi. J Dermatol Sci. 2019;94:266. 2. Blauvelt. Lancet. 2017;389:2287. Slide credit: ProCE.com
 JAK Inhibitors
 Mechanism of action: Inhibition of JAK enzyme, decreases downstream
immune-mediated inflammatory response
Boxed Warnings
Serious  Oral therapy: active TB, invasive fungal infections, bacterial, viral and other
infections infections due to opportunistic pathogens; may lead to hospitalization or
death
 Topical therapy: avoid in patients with active, serious infections

Mortality Higher all-cause mortality, including sudden CV death

Malignancies Lymphoma and other malignancies have been observed
MACE CV death, MI, and stroke
Thrombosis DVT, PE, and arterial thrombosis

fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-
cancer-blood-clots-and-death Slide credit: ProCE.com
 JAK Inhibitors
Agent Dosing Common Adverse Events (>10%) and Contraindications
Topical
Ruxolitinib  Apply thin layer BID Nasopharyngitis, diarrhea, bronchitis, ear infection,
 Do not exceeding 20% BSA or increased eosinophil count, urticaria, folliculitis, tonsillitis,
60 g/wk rhinorrhea
Oral
Abrocitinib 100-200 mg by mouth daily  Nausea, infection, nasopharyngitis
 Do not initiate in patients with: active infection,
PLT <150,000, absolute lymphocytes < 500 cells/mm3,
ANC <1000 cells/mm3, Hb < 8g/dL
Baricitinib* 1-2 mg by mouth daily Upper respiratory infections, nasopharyngitis, diarrhea
Upadacitinib 15-30 mg by mouth daily Acne vulgaris, upper respiratory infections

*Under FDA review for approval, dosing may be updated.

Ruxolitinib PI. Abrocitinib PI. Baricitinib PI. Upadacitinib PI. King. Am J Clin Dermatol. 2021;22:395. Reich. JAMA Dermatol. 2020;156:1333. Slide credit: ProCE.com
 Abrocitinib: Clinical Trial Results
Trial Study Design and Population Results
Phase III clinical trials
JADE MONO-1 Abrocitinib 100 mg, 200 mg, or Monotherapy with abrocitinib was effective and well
and MONO-21,2 placebo for 12 wk in those tolerated in those with moderate to severe AD
≥12 yr of age
JADE REGIMEN3 Abrocitinib 200mg Less flares occurred with 200-mg maintenance compared
maintenance vs dose reduction 100-mg dose reduction, and placebo (18.9%, 42.6%, 80.9%)
vs withdrawal (P <.0001)
JADE-COMPARE4 Abrocitinib 100 mg, 200 mg, Efficacy outcome achieved in 48.4%, 36.6%, 36.5%, and
dupilumab 300 mg, or placebo 14.0% with 200-mg abrocitinib, 100-mg abrocitinib,
dupilumab, and placebo (P <.001)
JADE EXTEND5 Abrocitinib 100 mg or 200 mg  Significant efficacy for both treatment groups
in prior dupilumab users for  Efficacy in prior dupilumab nonresponders (67.7% and
92+ wk 80.0% EASI-75; 37.8% and 77.3% PP-NRS4 for 100 mg and
200 mg respectively)

1. Simpson. Lancet. 2020;396:255. 2. Silverberg. JAMA Dermatol. 2020;156:863. 3. Blauvelt. J Am Acad Dermatol. 2022;86:104.
4. Bieber. NEJM. 2021;384:1101. 5. Shi. J Am Acad Dermatol. 2022;[Epub]. Slide credit: ProCE.com
 Baricitinib: Clinical Trial Results

Trial Study Design and Results

Population
Phase III clinical trials in adolescents and adults with moderate to severe AD for 16 wk
BREEZE-AD51 2 mg, 1 mg, placebo  Efficacy demonstrated in 2mg vs placebo groups (P
<.001)
BREEZE-AD72 4 mg and 2 mg combined  Efficacy demonstrated in 4mg (31%) vs placebo
with TCS groups(15%) (P = .004)

1. Simpson. J Am Acad Dermatol. 2021;85:62. 2. Reich. JAMA Dermatol. 2020;156:1333. Slide credit: ProCE.com
 Upadacitinib: Clinical Trial Results

Trial Study Design and Population Results

Phase III RCTs in those ≥12 yr with moderate to severe AD
MEASURE UP 1 15 mg, 30 mg, or placebo for  Upadacitinib met statistical significance in both coprimary
and MEASURE 16 wk efficacy endpoints compared with placebo; all P <.0001
UP 21  Discontinuation due to adverse events was similar
between groups

AD Up2,3 15 mg, 30 mg, or placebo plus  All efficacy endpoints were maintained at 52 wk with
topical corticosteroids continued tolerance (no new safety risks beyond current
label observed)
Phase IIIb head-to-head RCT in adults with moderate to severe AD
Heads Up4 30-mg upadacitinib or 300-mg  Upadacitinib exhibited superior efficacy compared with
dupilumab every other wk dupilumab (P = .006) with no new safety signals

1. Guttman-Yassky. Lancet. 2021;397:2151. 2. Reich. Lancet. 2021;397:2169. 3. Silverberg. J Allergy Clin Immunol. 2022;149;977.
4. Blauvelt. JAMA Dermatol. 2021;157:1047. Slide credit: ProCE.com
 Ruxolitinib: Clinical Trial Results

Trial Study Design and Population Results

Phase II and III clinical trials with AD
TRuE-AD1 and Ruxolitinib 0.75%, 1.5%, or  Improved efficacy vs vehicle comparator (P <.0001) and
TRuE-AD21 vehicle BID for 8 wk itch reduction (P <.05)
 Infrequent application site reactions (<1%) and lower
with active treatment than vehicle

Kim, et al.2 Ruxolitinib, vehicle, or  42.5% vs 13.6% on ruxolitinib experienced itch

triamcinolone followed by improvement compared with vehicle within 36 hr
vehicle for 8 wk  Near maximal improvement was seen with ruxolitinib by
4 wk

1. Papp. J Am Acad Dermatol. 2021;85:863. 2. Kim. J Am Acad Dermatol. 2020;82:1305. Slide credit: ProCE.com
 Tralokinumab
 Indicated for moderate to severe AD Dosing
in adults not controlled with or unable (subcutaneous injection)
to use topical therapy Initial dose
600 mg as four, 150 mg injections
 Mechanism of action: Maintenance dose
‒ IL-13 cytokine inhibitor  300 mg as two, 150 mg injections, every other
wk
 Common adverse events:  In those with body weight <100 kg who
achieve clear skin after 16 wk, can decrease
‒ Ocular adverse events frequency to every 4 wk

‒ Upper respiratory tract infections

‒ Injection-site reactions

Wollenberg. Br J Dermatol. 2021;184:437. Silverberg. Br J Dermatol. 2021;184:450 Slide credit: ProCE.com

 Tralokinumab: Clinical Trials
Trial Study Design and Population Results
Phase III clinical trials in those ≥18 yr with AD
ECZTRA 1 Tralokinumab monotherapy for  Efficacy at 16 wk statistically improved in treatment group
and 21 52 wk vs placebo
 16-wk responders were randomized to Q2W or Q4W
maintenance doses or placebo
• 52-wk efficacy measures varied between the 2
studies, possibly due to differences in TCS rescue use

ECZTRA 32 Tralokinumab in combination  At Wk 16, efficacy was higher with combination therapy
with TCS compared with TCS alone at 38.9% vs 26.2%
 Maintenance with tralokinumab Q2W vs Q4W + TCS was
evaluated Wk 17-32; both frequency options
demonstrated a high level of maintenance

1. Wollenberg. Br J Dermatol. 2021;184:437. 2. Silverberg. Br J Dermatol. 2021;184:450. Slide credit: ProCE.com

 Emerging Agents
Agent Mechanism of Indication Route of Ages Studied
Action Administration
Topical Cream
Roflumilast1 PDE-4 inhibitor Mild to severe AD Topical cream ≥2 yr
Tapinarof2 Aryl hydrocarbon AD with extensive Topical cream
receptor modulator involvement ≥12 yr

Subcutaneous Injection
Lebrikizumab3 IL-13 inhibitor Adults and adolescents Subcutaneous
≥12 yr (if ≥40 kg) with injection ≥18 yr
moderate to severe AD
Nemolizumab4-6 IL-31 receptor α Adults with moderate to Subcutaneous
inhibitor severe AD injection ≥12 yr

1. NCT04845620. 2. Paller. J Am Acad Dermatol. 2021;84:632. 3. Guttman-Yassky. JAMA Dermatol. 2020;156:411.

4. Silverberg. J Allergy Clin Immunol. 2020;145:173. 5. Kabashima. J Allergy Clin Immunol. 2018;142:1121. 6. NCT03985943. Slide credit: ProCE.com
Impact of AD on Patients and Caregivers

Slide credit: ProCE.com

 Shared Decision-Making

Psychological Benefits
 Improved patient knowledge of disease and treatment options
 Improved patient–provider communication
 Patients make decisions consistent with their values
 Improved patient satisfaction

Clinical Benefits
 Improved adherence to medications
 Better treatment outcomes

Health Care Resource Benefits

 Less healthcare resource use
 Lower healthcare costs
Blaiss. Ann Allergy Asthma Immunol. 2019;122:463. Slide credit: ProCE.com
 Patient Education
 Increased knowledge of disease mechanisms and course, appropriate
use of therapies, and goals of management can improve treatment
adherence and lessen fears and misconceptions
 Pharmacists have an important role to support both patients and
providers in the management of AD
‒ Improve adherence through patient education
‒ Engage in AD therapy optimization and monitoring
‒ Recommend appropriate moisturizers and OTC products

Sidbury. J Am Acad Dermatol. 2014;71:1218. Wong. Can Pharm J (Ott). 2017;150:285. Slide credit: ProCE.com
 Medication Access Considerations
 High out-of-pocket costs due to rising costs of treatments, limited
insurance formularies, and insurer coverage requirements (eg, prior
authorization and step therapy requirements) can be a significant
barrier to AD care
 If prior authorizations are denied, appeals and peer-to-peer
conversations can be completed as a next step to obtain coverage
 Manufacturer patient assistance programs and grant foundations can
provide medication access to patients with limited or no insurance
coverage

LeBovidge. Semin Cutan Med Surg. 2017;36:131. Slide credit: ProCE.com

Immunization Considerations in Atopic Dermatitis

Slide credit: ProCE.com

Immunizations
Patients who are on immunosuppressive therapy should avoid the use of live vaccines
HIV Infection CD4 count

Routinely Immuno-
compromised Asplenia,
End-stage
renal disease, Heart or lung Chronic Men who
recommended Vaccine Pregnancy
(excluding HIV
infection)
< 15% or
< 200mm3
≥15% and
≥200 mm3
complement
deficiencies
or on
hemodialysis
disease;
alcohollism1
liver
disease Diabetes
Healthcare
personnel2
have sex
with men

live vaccines: IIV4 or RIV4

OR Contraindicated
1 dose annually

Precaution OR
LAIV4 1 dose annually

 MMR Tdap or Td 1 dose Tdap each

pregnancy 1 dose Tdap, then Td or Tdap booster every 10 yr

MMR Contraindicated* Contraindicated 1 or 2 doses depending on indication

 Varicella VAR

RZV
Contraindicated* Contraindicated

2 doses at age ≥19 yr

2 doses

2 doses at age ≥50 yr

HPV No recommended* 3 doses through age 26 yr 2 or 3 doses through age 26 yr depending on age at initial vaccination or condition

 Rotavirus Pneumococ
cal (PCV15,
1 dose PCV15 followed by PPSV23 OR 1 dose PCV20

PCV20,
PPSV23) 2 or 3 doses depending on vaccine
 Influenza HepA

(nasal spray) HepB 3 doses

(see notes) 2, 3, or 4 doses depending on vaccine or condition
1 to 2 doses depending on indication. See notes for Booster recommendations.

MenACWY
2 or 3 doses depending on vaccine and indication, see notes for booster recommendations

MenB Precaution

3 doses HSCT3
HibPrecaution for LAIV4 does not apply to alcoholism. 1 dose
1. recipients only
2. See notes for influenza; hepatitis B; measles, mumps, and rubella; and varicella vaccinations.
3. Hematopoietic stem cell transplant. Slide credit: ProCE.com
Immunizations

The following types of vaccine are generally safe for those on

immunosuppressant medications or biologic therapies:

Inactivated vaccines

Messenger RNA (mRNA) vaccines

Subunit, recombinant, polysaccharide, and conjugate vaccines

Toxoid vaccines

Viral vector vaccines

Slide credit: ProCE.com
 Immunizations

Contraindicated with prolonged, high-dose

Varicella systemic immunosuppressive therapy or other
immunosuppressive therapy

Recombinant zoster vaccine (RZV):

Herpes  Recommended for adults ≥19 yr who will be
immunosuppressed due to disease or therapy
Zoster  Recommended for adults ≥50 yr regardless of
immune status

Zoster Vaccine Recombinant, Adjuvanted PI. cdc.gov/vaccines/vpd/varicella/hcp/recommendations.html. Slide credit: ProCE.com

 COVID-19 Vaccine Recommendations
 mRNA vaccine
 No risk for disease flares or complications in patients with AD
‒ Not live attenuated vaccine
‒ Poor reactogenicity (single viral protein)
 Injection is given IM
‒ Better response than intradermal injections in patients with AD
 If systemic CS or cyclosporine therapy is planned, recommendation is to
receive SARS-CoV-2 vaccine 2 wk before starting immunosuppressive therapy
‒ If patient is already receiving this therapy, it is up to prescriber discretion
Simonetti. Hum Vaccin Immunother. 2021;17:3268. Slide credit: ProCE.com
 Dupilumab Effects on SARS-CoV-19
 Patients with AD on dupilumab more likely to be asymptomatic or have
milder COVID-19 symptoms
 No differences in antibody levels following vaccination
‒ Suggests that dupilumab does not impair antibody responses

Ungar. Ann Allergy Asthma Immunol. 2022;[Epub]. Slide credit: ProCE.com

 JAK Inhibitors and Vaccinations
 Avoid use of live vaccines
 ACR recommends JAK inhibitors be temporarily stopped in patients who
test positive for COVID-19
 February 2021 COVID-19 clinical guidance summary:
‒ Any changes to immunosuppressant therapy around the time of
vaccination should be considered on a case-by-base basis
‒ In patients with stable disease, JAK inhibitor therapy should be held for 1-
2 wks after each COVID-19 vaccine dose to maximize vaccine response

Chapman. J Am Acad Dermatol. 2022;86:414. Curtis. Arthritis Rheumatol 2021;[Epub]. Abrocitinib PI. Upadacitinib PI. Slide credit: ProCE.com
 Infection Risk on Biologic Therapy
 Retrospective review of >1,200,000 Respiratory other than
tuberculosis
patients in Italy on infection risk with Gastrointestinal other
receiving TNF inhibitor therapy 7 27
than tuberculosis
7 Sepsis
‒ Infection risk is increased in the 8 Non-herpetic skin and
soft tissue infections
first 6 mo of therapy on TNF 9 Tuberculosis
inhibitors Herpetic infections
18 Septic arthritis
‒ Observing other risk factors is key 139
Urinary tract
such as history of infection, Others
glucocorticoid use and age 27

‒ From 2006-2017 patients who had 47

received biologic therapy were
broken down and grouped based on
infection risk as depicted

Quartuccio. J Adv Res. 2019;15:87. Slide credit: ProCE.com

 COVID-19 Vaccination Recommendations in
Immunocompromised Patients

 Biologic will reduce

Facts
Concerns about  Those receiving biologics mount
immune response
COVID-19  Vaccine will cause immune response to vaccine
vaccination disease flare  Vaccines are safe in those with AD
and receiving biologics

CDC Recommendations for Moderately to Severely Immunocompromised

Children 5-11 yr Teens 12+ yr Adults 18+ yr
Primary Should received 3 doses of Should received 3 doses of Should received 3 doses of
Series Pfizer-BioNTech Pfizer-BioNTech mRNA COVID-19 vaccine
Booster Not recommended as of Should receive 1 booster of Should receive 1 booster of
May 2022 Pfizer-BioNTech 3 mo after mRNA COVID-19 vaccine
dose 3 mo after dose 3

Wack. J Am Acad Dermatol. 2021;85:1274. Slide credit: ProCE.com

PracticePoints
 There have been many unmet needs for those with moderate to severe
AD due to limited treatment options and adverse events
 New and emerging agents offer patients and providers additional
options for resolution of AD symptoms
 Pharmacists in various settings are integral members of the team to
provide medication education, monitoring, and assisting with
medication access and adherence
 Immunization education and administration in this at-risk population is
also a key role for pharmacists to undertake

Slide credit: ProCE.com