P7739
Patient preferences and willingness to pay for enhancements to subcu-
taneous injection devices used to treat psoriasis
Alfred Cividino, McMaster University, Department of Medicine, Division
Rheumatology, Hamilton, Canada; James E. Signorovitch, Analysis Group, Inc,
Boston, MA, United States; Martha Skup, AbbVie Inc, North Chicago, IL, United
States; Namita Tundia, AbbVie Inc, North Chicago, IL, United States; Parvez Mulani,
AbbVie Inc, North Chicago, IL, United States; Udayasankar Arulmani, AbbVie Inc, North
Chicago, IL, United States; Yanjun Bao, AbbVie Inc, North Chicago, IL, United States
Objectives: Subcutaneous (SC) injection is used to deliver biologic therapies for
moderate to severe psoriasis (Ps). Characteristics of the injection device may affect
patient preferences for therapy administration. This study assessed patient
preferences for enhancements to SC injectable devices.
Methods: An online survey using discrete choice experimental design was conducted
in Ps patients from a representative research panel. Patients were ¼ 18 years of age and,
based on self-report, had a medical diagnosis of Ps. Patients were asked to choose
between hypothetical therapies with varying device properties including: 27-gauge (G)
or thinner 29-G needle, manufactured without natural rubber latex (NRL) (yes/no), and
storage conditions (requires refrigeration or can be left at room temperature for up to 2
weeks). To assess the value of the enhanced device, we estimated the willingness of
patients to pay (WTP) for improvements in terms of their monthly out-of-pocket
copayment. Multivariate logistic regression was used to estimate associations between
treatment choices and device characteristics, and WTP for preferred treatment choices
was calculated. Data were analyzed for all patients and subgroups of injection-
experienced (IE) vs. injection-na€ıve (IN) patients.
Results: 65% of patients were women; average age was 56 years (mean duration of Ps
;18 years); 25% were currently using injectable therapies. A fully enhanced device
manufactured without NRL that had a 29-G needle and could be stored at room
temperature was preferred by 70% of all participants compared to a device with NRL that
had a 27-G needle and required refrigeration. WTP for enhancements was $22.87 to
reduce needle size from 27- to 29-G, $21.63 for a device without NRL, and $16.44 for
storage without refrigeration. Preference for the fully enhanced device was similar
among IE and IN patients (73% vs. 75%, respectively). Although not statistically
significant, IE patients were willing to pay more than IN patients for the enhancements
(WTP: $26.29 vs. $19.97, device without NRL; $24.35 vs. $22.43, thinner needle; $19.37
vs. $15.70, storage without refrigeration). Overall, patients were willing to add $60.94
(149%) to their $40.91 monthly Ps-specific drug copay for the fully enhanced device.
Conclusions: Regardless of previous experience with injectable therapy, Ps patients
highly valued an SC injection device without NRL that had a thinner needle and did
not require continuous refrigeration.
The design, study conduct, and financial support for the study/trial were provided by
AbbVie. AbbVie participated in the interpretation of data, review, and approval of
the abstract. Cathy Carter, MS, and Joann Hettasch, PhD, of Arbor Communications
provided medical writing and editing services in the development of this abstract.
Financial support for these services was provided by AbbVie.
P8252
Persistence of capillaroscopy pattern after treatment of psoriasis with
cyclosporine
Francesco Lacarrubba, MD, Dermatology Clinic, University of Catania, Catania,
Italy; Anna Elisa Verzı, MD, Dermatology Clinic, University of Catania, Catania,
Italy; Giuseppe Micali, MD, Dermatology Clinic, University of Catania, Catania,
Italy; Maria Letizia Musumeci, MD, PhD, Dermatology Clinic, University of
Catania, Catania, Italy
Background: Cyclosporin is a proven highly effective agent in the treatment of
intermediate to severe psoriasis. Videodermatoscopy (VD) is a noninvasive tool
which allows the in vivo observation of the vascular pattern of psoriatic plaques,
which consists of the typical ‘‘bushy’’ capillaries. This technique has been used for
enhancing the diagnosis as well as for the therapeutic monitoring of psoriasis. The
aim of this study was to evaluate the VD modification of plaque psoriasis during the
course of systemic treatment with cyclosporine.
Methods: Twenty patients (13 M, 7 F, age range: 18-70 years) with intermediate to
severe ‘‘plaque-type’’ psoriasis (Psoriasis Area Severity Index [PASI] ¼ 10) were
enrolled and treated with cyclosporine 3 or 5 mg/kg/day for 8 weeks. A ‘‘target’’
plaque was identified for each subject and clinically evaluated using a ‘‘modified’’
PASI score for erythema, scaling and infiltration degree. VD was performed in each
plaque at baseline, 2, 4 and 8 weeks using a system allowing the measurement of the
diameter of capillary ‘‘bushes’’ at 3150 magnification.
Results: At the end of the study, a significant mean reduction of the ‘‘modified’’ PASI score
(from 6.5 to 0.95) and of the diameter of capillary ‘‘bushes’’ (from 78.2 to 47.75 m) was
observed (Wilcoxon-Mann-Withney test, P \.05). Pearson coefficient test revealed a
positive correlation over time between the 2 parameters (r ¼ 0.7). However, the
improvement of vascular features was slower than clinical improvement. In particular, in
6 out 13 clinically healed cases, the persistence of capillary ‘‘bushes’’ was evident.
Conclusions: The results obtained with cyclosporine are similar to those we
obtained in a group of psoriatic patients treated with biologics, in which the
cutaneous microcirculation remained altered for a longer period of time compared
to clinical resolution, although in a lower percentage of cases. Because vascular
alterations precede epidermal hyperplasia, the microvasculature is in turn slower in
returning to its original state. This phenomenon could represent the effect of an
angiogenic continuous stimulus determined by persistent alterated keratinocytes
and low levels of circulating cytokines, elements suggestive of incomplete remission
and susceptibility to rebound. Therefore, the evaluation of the vascular pattern by
VD may provide objective information, in course of treatment, about duration and
efficacy of systemic therapy in patients affected by psoriasis.
Commercial support: None identified.
AB178 J AM ACAD DERMATOL
P8635
Pityriasis rubra pilaris mixed type III/IV successfully treated with narrow-
band ultraviolet B light therapy
Antonio Massa, Serviço de Dermatologia C.H.V.N.Gaia/Espinho, Vila Nova de
Gaia, Portugal; Jo~ao Borges da Costa, Serviço de Dermatologia Hospital de Santa
Maria - CHLN, Lisboa, Portugal; Luıs Soares de Almeida, Serviço de Dermatologia
Hospital de Santa Maria - CHLN, Lisboa, Portugal; Manuel Sacramento Marques,
Serviço de Dermatologia Hospital de Santa Maria - CHLN, Lisboa, Portugal; Paulo
Filipe, Serviço de Dermatologia Hospital de Santa Maria - CHLN, Lisboa, Portugal;
Pedro Vasconcelos, Serviço de Dermatologia Hospital de Santa Maria - CHLN,
Lisboa, Portugal
Pityriasis rubra pilaris (PRP) is a rare papulosquamous disorder in childhood
characterized by follicular hyperkeratotic papules with characteristic islands of
sparing, palmoplantar keratoderma and according to Griffiths classification, PRP in
children is divided in type III classic juvenile, type IV circumscribed juvenile and
type V atypical juvenile PRP. We report an 8-year-old female patient who developed
an erythematous eruption of follicular micropapules with scaling throughout the
body, more intense on the face and trunk with thick hyperkeratotic plaques in the
knees and elbows and palmoplantar keratoderma with an yellowish-orange tint.
Histologic findings confirmed the diagnosis of PRP. Topical treatment with
emollients and calcipotriene had little improvement, so narrowband ultraviolet B
(NB-UVB) was initiated with good response, and after 18 months of follow-up, there
have been no recurrences. This case does not fill completely in type IV PRP
according to Griffiths classification also presenting a more widespread in what could
be a mixed type III/IV PRP. PRP can have spontaneous resolution but it can be
recalcitrant and difficult to treat. Although systemic retinoids are considered the first
choice for PRP treatment we chose NBUVB for its safety which proved efficacious
and that can be considered a good alternative for juvenile PRP.
Commercial support: None identified.
P7956
Pregnancy outcomes in women exposed to ustekinumab in the psoriasis
clinical development program
Brigitte W. Schaufelberg, PhD, Janssen Research & Development LLC, Spring
House, PA, United States; Elizabeth Horn, PhD, Modern Research Associates,
Dallas, TX, United States; Jennifer C Cather, MD, Modern Research
Associates/Modern Dermatology, a Baylor Health Texas Affiliate, Dallas, TX,
United States; Kassim Rahawi, PhD, Janssen Research & Development, LLC,
Spring House, PA, United States
Background: Ustekinumab (UST) is indicated for moderate to severe psoriasis (PsO)
in adult patients, with a pregnancy class B designation. No adverse developmental
outcomes (pre- and postnatal) were observed in preclinical (animal) studies of UST,
and limited published data exist concerning the effects of UST on human
pregnancies. Studies have suggested PsO may be a potential risk factor for adverse
pregnancy outcomes. To characterize pregnancy outcomes in women exposed to
UST during pregnancy, data from the UST PsO clinical development program are
presented.
Methods: Pregnancies reported with maternal use of UST from 4 PsO studies (Phase
2 [n ¼ 320] and Phase 3 [PHOENIX 1; n ¼ 766, PHOENIX 2; n ¼ 1,230, ACCEPT; n ¼
903]) were evaluated. Pregnancy outcomes were summarized using descriptive
statistics.
Results: 981 female patients received ¼ 1 dose of UST, and 29 pregnancies were
reported (despite agreement to use adequate birth control measures). Per protocol,
UST treatment was discontinued upon the report of pregnancy in all cases. Mean
maternal age was 30 yrs (range, 21-44), and mean duration of UST exposure before
the reported pregnancy was 72 6 61 wks. Pregnancy outcomes were reported for
26 of 29 pregnancies, including 14 (54%) live births (LBs), 5 (19%) spontaneous
abortions (SAs), and 7 (27%) elective abortions (EAs). All 5 SAs occurred in the first
trimester. Mean maternal age was older for patients who had SAs (35 6 5 yrs) vs. LBs
(29 6 4 yrs), and UST treatment duration prior to pregnancy report was shorter for
patients who had SAs (36 6 25 weeks) vs. LBs (98 6 57 weeks). Among the LBs,
there were no congenital anomalies, and 2 infants had neonatal jaundice treated
with phototherapy. Neonatal outcomes were generally healthy with mean birth
weight of 7 6 1 lbs (n ¼ 12), gestation age of 38 6 0.7 wks (n ¼ 9), and mean 5-min
APGAR of 9 6 0.6 (n ¼ 8).
Conclusion: Review of pregnancy outcomes after maternal exposure to UST from
the PsO clinical development program identified 29 pregnancies with 26 known
outcomes: 14 LBs and no congenital anomalies. The rate of SAs was generally
comparable to the rate reported for the general population (15-20%). Consistent
with the literature, SAs in this case series were associated with older maternal age.
Longer duration of UST exposure before the reported pregnancy was not associated
with adverse outcomes. The limited available data suggest that UST exposure may
not impact pregnancy outcomes but additional experience is needed.
Supported by Janssen Reseach & Development, LLC.
MAY 2014