Poster abstracts
mg/wk (fig.1). After starting MTX disease activity by DAPSA
significantly decreased by the third mon. and maintained till the
end of the study (fig.2). DAPSA-REM and МDA was reached
within 9.7 ± 7.7 and 13.7 ± 7.6 mon. accordingly. By the 24 mon.
of therapy stable REM by DAPSA and MDA was seen in 10 out
of 22 pts (45.5%) and in 16 out of 22 pts (72.7%) accordingly.
Conclusions: In half of EPsA pts early administration of MTX
s/c and rapidly dose escalation is effective and well tolerated.
After achieving REM or MDA, a decrease of the dose of MTX is
possible in most cases.
11
review of the safety database. Given the limited exposure repor-
ted to date, the safe continuous use of secukinumab throughout
pregnancy requires further research.
P020
IXEKIZUMAB IMPROVES IMPACT OF GENITAL
PSORIASIS ON SEXUAL ACTIVITY: RESULTS FROM A
PHASE 3B STUDY
Jennifer Clay Cather 1 , Kim Meeuwis 2 , Russel Burge 3 , Alison Potts
Bleakman 3 , Chen-Yen Lin 3 , Alice Gottlieb 4 , Catriona Ryan 5
Modern Dermatology and Modern Research Associates, Dallas, TX, USA,
Radboud University Medical Center, Nijmegen, The Netherlands, 3 Eli Lilly
and Company, Indianapolis, IN, USA, 4 Department of Dermatology, New
York Medical College at Metropolitan Hospital, New York, NY, USA, 5 St.
Vincent’s University Hospital, Dublin, Ireland
1
P019
SECUKINUMAB IN PREGNANCY: OUTCOMES IN
PSORIASIS, PSORIATIC ARTHRITIS AND ANKYLOSING
SPONDYLITIS FROM THE GLOBAL SAFETY
DATABASE
Richard Warren 1 , Kristian Reich 2 , Richard Langley 3 , Bruce Strob-
er 4 , Dafna Gladman 5 , Atul Deodhar 6 , Teresa Bachhuber 7 , Weibin
Bao 8 , Evelyn Altemeyer 9 , Samina Hussain 10 , Jorge Safi 8
1
The Dermatology Centre, Salford Royal NHS Foundation Trust, The Uni-
versity of Manchester, UK, 2 Dermatologikum Berlin and Georg-August-
University Gottingen, Germany, 3 Dalhousie University, Halifax NS, Can-
ada, 4 University of Connecticut Health Center, Farmington, CT, USA and
Probity Medical Research, Canada, 5 Toronto Western Hospital, Toronto,
Canada, 6 Division of Arthritis & Rheumatic Diseases, Oregon Health &
Science University, USA, 7 Novartis Pharma GmbH, Nuremberg, Germany,
8
Novartis Pharmaceuticals Corporation, East Hanover, USA, 9 Novartis Ire-
land Ltd, Dublin, Ireland, 10 Novartis Healthcare Pvt. Ltd, Hyderabad, India
Introduction: Secukinumab, a fully human monoclonal antibody
selectively targeting IL-17A, is highly efficacious in the treatment
of moderate to severe psoriasis, psoriatic arthritis (PsA) and an-
kylosing spondylitis (AS), with sustained efficacy and favorable
safety profile. Long term treatment with targeted therapies such
as secukinumab may be necessary in women of childbearing
age. Pre-clinical animal studies with secukinumab, which can
cross the placenta, do not indicate harmful effects with respect to
pregnancy, embryonic/fetal development, parturition or postnatal
development, however only limited data has been reported on
human pregnancies.
Objectives: Using the Novartis global safety database, we analyzed
the outcome of pregnancies where there was maternal or paternal
e xposure to secukinumab.
Methods: The Novartis global safety database (covering all
secukinumab indications and including clinical trial and post-
marketing data) was searched for cases reporting pregnancy and
neonatal topics. All pregnancies where there was either maternal
or paternal exposure to secukinumab were included in the sys-
tematic, independently validated analysis. The cut-off date was
25th June, 2017.
Results: Of 292 pregnancies reported, 141 (48.3%) came from
clinical trials, 79 (27.1%) were spontaneous reports and 72
(24.7%) were from post-marketing surveillance, with 238 cases
of maternal and 54 cases of paternal exposure. 175 patients recei-
ved secukinumab for psoriasis, 38 for PsA, 15 for AS and 62 for
other/unknown indications. The majority of patients discontinued
secukinumab in the first trimester of pregnancy; 18 did not discon-
tinue. Of 153 cases where the outcome was known, there were 73
full term normal neonates and 37 elective terminations. Rates of
spontaneous abortions were 30/292, 10.3% overall (30/153 known
outcomes, 19.6%). These are in line with previously reported rates
(15–20%) for the general population with maternal age of 30.6
(study mean). No still births ( > 20 weeks) were reported. Three
congenital abnormalities were reported following maternal and
1 paternal exposure, with no repeated pattern of abnormality. At
data cut-off, 32 pregnancies were ongoing.
Conclusions: There was no evidence for increased rates of adverse
pregnancy outcomes across indications with secukinumab in this
2
Introduction: Genital psoriasis (GP) is often associated with impai-
red sexual health. Ixekizumab (IXE) is a high-affinity monoclonal
antibody that selectively targets interleukin-17A.
Objective: To evaluate the effect of IXE on the impact of GP on
sexual activity during 12 weeks of treatment compared to placebo
(PBO) in patients with moderate-to-severe GP.
Methods: In this double-blind, placebo-controlled study, patients
(n = 149) with moderate-to-severe GP were randomized (1:1) to
receive PBO or 80 mg IXE every 2 weeks following an initial
dose of PBO or 160 mg IXE. The impact of GP on sexual activity
was measured by pre-specified patient-reported outcomes inclu-
ding the Genital Psoriasis Sexual Impact Scale (GPSIS), which
is composed of the Sexual Activity Avoidance (Avoidance) and
Impact of Sexual Activity on Genital Psoriasis Symptoms (Impact)
subscales, the Sexual Frequency Questionnaire (SFQ) item 2, and
the Dermatology Life Quality Index (DLQI) item 9. Of patients
with a baseline SFQ item 2 score ≥2, the percentage of patients
whose frequency of sexual activity was never (0) or rarely (1)
limited by GP (SFQ item 2 0/1) was examined. Among patients
with respective GPSIS subscale scores ≥3 at baseline, response
was measured as the percentage of patients whose frequency of
avoiding sexual activity was never (1) or rarely (2) impacted by GP
(GPSIS-Avoidance 1/2) and whose GP symptom worsening after
sexual activity was very low/none at all (1) or low (2) (GPSIS-
Impact 1/2). DLQI item 9 response was measured as the percentage
of patients with no (0) or a little (1) impairment of sexual activity.
Treatment comparisons were made using a logistic regression
model with missing values imputed by non-responder imputation.
Results: IXE treatment reduced the impact of GP on sexual activity
at Week 12 versus PBO as assessed by SFQ item 2 0/1 (IXE 78.4%,
PBO 21.4%; p < 0.001), GPSIS-Avoidance 1/2 (IXE 76.7%, PBO
25.7%; p < 0.001), and DLQI item 9 0/1 (IXE 92.0%, PBO 56.8%;
p < 0.001). IXE was superior to PBO as early as Week 1 for SFQ
item 2 0/1 (p < 0.05), Week 2 for DLQI item 9 0/1 (p < 0.001),
and Week 4 for GPSIS-Avoidance 1/2 (p < 0.01). GPSIS-Impact
1/2 response rates suggested a trend of reduced impact of sexual
activity on GP symptoms (IXE 85.7%, PBO 52.9%; p = 0.062).
Conclusions: During 12 weeks of treatment, IXE resulted in a rapid
and significant decrease in the impact of GP on sexual activity,
including how often GP limited sexual frequency among patients
with moderate-to-severe GP.
Cather J, Meeuwis K, Burge R, Bleakman AP, Lin C-Y, Ryan C. Ixeki-
zumab Provides Greater Improvement Versus Placebo on the Impact of
Genital Psoriasis on Sexual Activity for Patients with Moderate-to-Severe
Genital Psoriasis in a Randomized, Double-Blind Phase 3b Clinical Trial.
American Academy of Dermatology-76th Annual Meeting 2018.
P021
DOSE OPTIMIZATION OF SECUKINUMAB IN
SUBJECTS WITH MODERATE TO SEVERE PLAQUE
PSORIASIS: OPTIMISE STUDY
Kristian Reich 1 , Lluis Puig 2 , Jacek Szepietowski 3 , Carle Paul 4 ,
Acta Derm Venereol 2018