Poster abstracts
jority of pts were recruited by rheums (671, 52.7%), followed by
derms (541, 42.5%), physiatrists (36, 2.8%), and other specialties
(25, 2.0%). PsA was first suspected by a rheum in 726 (57.0%) pts
and by a derm in 541 pts (42.5%). Pt demographics and disease
characteristics were mostly comparable between rheum and derm
settings. Disease activity was higher in PsA pts in derm setting
compared with rheum setting. The mean time from symptom onset
to PsA diagnosis was 24 months (mo) in rheum setting and 1 mo
longer for derms. In rheum and derm settings, the mean time from
PsA diagnosis to first csDMARD were 11 and 25 mo, respectively;
whereas the mean time to first bDMARD were 52 and 55 mo, re-
spectively. The mean time from first csDMARD to first bDMARD
was 42 mo for rheums; while it was 3 months shorter for derms.
Conclusion: Although the duration from symptom onset to PsA
diagnosis was similar between rheum and derm setting, there were
differences in the timing of introduction of different DMARD
classes. Notably, mean time to first csDMARD was significantly
shorter in rheum setting. PsA pts in derm setting had significantly
higher disease activity. These data lend further support to the need
for rheum-derm collaborative approach to optimize management
of pts with PsA.
P045
SPEED OF RESPONSE OF GUSELKUMAB COMPARED
WITH ADALIMUMAB FOR THE TREATMENT OF
MODERATE-TO-SEVERE PSORIASIS: RESULTS
THROUGH WEEK 24 FROM THE PHASE 3, DOUBLE-
BLINDED, PLACEBO- AND ACTIVE COMPARATOR-
CONTROLLED VOYAGE 1 AND VOYAGE 2 TRIALS
Andrew Blauvelt 1 , Stephen Tyring 2 , Sandra Philipp 3 , David Adam 4 ,
Michael Song 5 , Yasmine Wasfi 5 , Yin You 6 , Yaung-Kaung Shen 5 ,
Jerry Bagel 6
Oregon Medical Research Center, Portland, OR, 2 Center for Clinical Stu-
dies, Webster, TX, USA, 3 Dermatology, Charité, Universitaetsmedizin Ber-
lin, Berlin, Germany, 4 CCA Medical Research Corp. Ajax, ON, and Probity
Medical Research, Waterloo, ON, Canada, 5 Janssen Research & Develop-
ment, LLC, Spring House, PA, 6 Psoriasis Treatment Center of Central NJ,
East Windsor, NJ, USA
1
Background: VOYAGE 1 and 2 were two phase 3 double-blinded,
placebo/active comparator-controlled trials evaluating guselkumab
(GUS), a fully human monoclonal antibody targeting interleukin
(IL)-23, compared with adalimumab (ADA) in the treatment of
patients with moderate-to-severe plaque psoriasis. Here, we report
speed of response results based on Psoriasis Area and Severity
Index (PASI) outcomes through Week 24 from pooled VOYAGE
1 and 2 data.
Methods: In VOYAGE 1 and 2, patients with plaque psoriasis
were randomized at baseline to GUS 100 mg (Weeks 0 and 4, then
every 8 weeks [q8w]; pooled n = 825), ADA (80 mg Week 0, 40
mg Week 1, then 40 mg every 2 weeks [q2w]; pooled n = 582), or
placebo (Weeks 0, 4, and 12, then GUS 100 mg at Weeks 16 and
20; pooled n = 422). Efficacy was evaluated using PASI 75, PASI
90, and PASI 100 responses (patients achieving ≥75%, ≥90%, and
100% PASI improvement from baseline, respectively) through
Week 24. Median time to achieve a response was defined as the
time taken for ≥50% of the patients to ever achieve a response.
Results: Based on the pooled VOYAGE 1 and 2 data, median
time to achieve a PASI 75 response was ≤ 8 weeks for both the
GUS and ADA groups. However, median time to achieve a PASI
90 response was ≤ 12 weeks for GUS and ≤ 16 weeks for ADA.
Median time to achieve a PASI 100 response was ≤ 24 weeks for
GUS, but was not achieved for ADA. Median time to achieve any
defined endpoint was not achieved for the placebo group.
Conclusions: Taken together, these results demonstrate that pa-
tients with moderate-to-severe psoriasis treated with GUS rapidly
achieved high levels of response, and more efficiently and more
quickly than with ADA.
21
P046
SAFETY OF CERTOLIZUMAB PEGOL OVER 48 WEEKS
IN CHRONIC PLAQUE PSORIASIS PHASE 3 TRIALS
Andrew Blauvelt 1 , Bruce Strober 2 , Richard Langley 3 , Daniel
Burge 3 , Lisa Pisenti 5 , Mohamed Yassine 5 , Sarah Kavanagh 6 , Cath-
erine Arendt 7 , Robert Roller 6 , Mark Lebwohl 8 , Kristian Reich 9
Oregon Medical Research Center, Portland, OR, 2 University of Connecti-
cut Health Center, Farmington, CT, USA, 3 Dalhousie University, Nova
Scotia, Canada, 4 Demira, Inc., Menlo Park, CA, 5 UCB Pharma, Smyrna,
GA, 6 UCB Pharma, Raleigh, NC, USA, 7 UCB Pharma, Brussels, Belgium,
8
Icahn School of Medicine at Mount Sinai, New York, NY, USA, 9 SCIderm
Research Institute, Hamburg, and Dermatologikum Berlin, Germany
1
Introduction: The Fc-free, PEGylated, anti-tumor necrosis factor
certolizumab pegol (CZP) has shown efficacy in chronic plaque
psoriasis (PSO) over 48 weeks’ treatment.[1,2]
Objectives: To report 48-week safety data for CZP in PSO.
Methods: Data were pooled from ongoing phase 3 trials of CZP
in adults with PSO (n = 962): CIMPASI-1 (NCT02326298), CIM-
PASI-2 (NCT02326272), CIMPACT (NCT02346240). Patients
(pts) had PSO ≥6 months (Psoriasis Area Severity Index ≥12,
≥10% body surface area affected, physician’s global assessment
≥3/5) and were randomized to CZP 400 mg every 2 weeks (Q2W)
or 200 mg Q2W (400 mg loading dose at Weeks 0/2/4), placebo
(PBO) for 16 weeks, or etanercept for 12 weeks (CIMPACT
only). We p