Poster abstracts
patients (42.0%/47.5%; 63.0%/61.6%). At week 52, risankizumab-
treated patients achieved significantly higher response rates versus
ustekinumab. In both trials, treatment-emergent adverse event
(TEAE) rates were comparable across treatment groups throughout
the study duration. The most frequently reported TEAE was upper
respiratory tract infection.
Conclusion: Risankizumab was consistently superior to both pla-
cebo and ustekinumab in the treatment of moderate-to-severe pla-
que psoriasis. TEAE profiles were similar between risankizumab
and ustekinumab, and there were no unexpected safety findings.
P063
EFFICACY AND SAFETY OF GUSELKUMAB
ADMINISTERED WITH A NOVEL SELF-INJECTION
DEVICE FOR THE TREATMENT OF MODERATE-TO-
SEVERE PSORIASIS: RESULTS FROM THE PHASE III
ORION SELF-DOSE STUDY THROUGH WEEK 16
Laura Ferris 1 , Elyssa Ott 2 , Gigi Jiang 2 , H. Chih-Ho Hong 3 , Woj-
ciech Baran 4
1
University of Pittsburgh, Pittsburgh, PA, 2 Janssen Research & Develop-
ment, LLC, Spring House, PA, 3 UBC Department of Dermatology and Skin
Science, Vancouver, BC and Probity Medical Research, Surrey, 4 Depart-
ment of Dermatology, Venereology and Allergology, Wroclaw Medical Uni-
versity, Wroclaw, Poland
Objective:To evaluate the efficacy and safety of guselkumab
(GUS) administered using a novel, self-injection device in adult
patients with moderate-severe plaque psoriasis (PsO).
Methods: ORION is a Phase 3, multicenter, randomized, double-
blind, PBO-controlled study evaluating GUS administered using
a self-SC injection device that delivers the contents of a pre-filled
syringe. Patients of age≥18 years with moderate-severe PsO for
at least 6 months, IGA score ≥3, PASI score ≥12, and BSA ≥10%,
and were candidates for/or may have previously received systemic
therapy or phototherapy, were eligible for the study. At baseline,
78 patients were randomized to PBO (n = 16) at wks 0, 4, and
12 with crossover to GUS 100mg at wks 16, 20, and28 or GUS
(n = 62) at wks 0, 4, 12, 20, and 28. The co-primary endpoints were
the proportions of patients achieving 1) an IGA score of cleared
(0) or minimal (1) and 2) a PASI 90 response at wk16 (GUS vs
PBO). Major secondary endpoints were the proportions of patients
achieving an IGA score of 0 and a PASI 100 response at wk16.
Results through wk16 are presented.
Results: Baseline demographics and PsO disease characteristics
were generally similar between the PBO and GUS-treatment
groups. At wk16, significantly higher proportions of GUS vs PBO
patients achieved an IGA score of 0/1 (80.6% vs. 0.0%, p < 0.001)
and a PASI 90 response (75.8% vs. 0.0%, p < 0.001). In addition,
significantly higher proportions of GUS vs PBO patients achie-
ved an IGA score of 0 (56.5% vs 0.0, p < 0.001) and a PASI 100
response (50.0% vs 0.0, p < 0.001) at wk16.
Through wk16, the proportions of patients with ≥1 AE were
comparable between the treatment groups (GUS: 62.9%, PBO:
68.8%; respectively). Discontinuation rates due to AEs were 1.6%
for GUS patients and 6.3% for PBO patients. Two patients in the
GUS group had SAEs (1 chest discomfort and 1 atypical chest
pain). There were no serious infections, malignancies, or deaths.
Conclusion: GUS administered using a novel self-injection device
was efficacious and well-tolerated in patients with moderate-severe
PsO. The efficacy and safety profile of GUS administered with
this device was consistent with previously reported findings from
the pivotal phase 3 studies in which GUS was administered using
a different self-injection device.
P064
EFFICACY OF TILDRAKIZUMAB IN ETANERCEPT
PARTIAL RESPONDERS OR NONRESPONDERS
29
Jeffrey Crowley 1 , Kim A Papp 2 , Chih-ho Hong 3 , Jeff Parno 4 , Alan
M Mendelsohn 4 , Qing Li 5 , Nicole Cichanowitz 5 , Carmen La Rosa 5
Bakersfield Dermatology, Bakersfield, CA, USA, 2 Probity Medical Re-
search, Waterloo, ON, Canada, 3 University of British Columbia, Depart-
ment of Dermatology and Skin Science and Probity Medical Research,
Surrey, BC, Canada, 4 Sun Pharmaceutical Industries, Inc., Princeton, NJ,
USA, 5 Merck & Co., Inc., Kenilworth, NJ, USA
1
Introduction: Etanercept (ETN) is an anti-tumor necrosis fac-
tor medication that was among the first biologics approved for
psoriasis. Additional medications have been developed or are in
development for psoriasis, and patients who do not adequately
respond to ETN may benefit from these more recent biologics.
Objectives: To evaluate the efficacy of tildrakizumab (TIL), a
high-affinity, humanized, anti-interleukin-23p19 antibody in
patients (pts) with moderate to severe chronic plaque psoriasis
who were partial responders (Psoriasis Area and Severity Index
[PASI] ≥50– < 75) or nonresponders (PASI < 50) to ETN and were
subsequently rerandomized to TIL in a phase 3 trial.
Methods: Pts with psoriasis (≥10% body surface area, Physician’s
Global Assessment [PGA] ≥3, and PASI score ≥12) participated
in a 3-part, 52-week, randomized controlled trial (reSURFACE
2; NCT01729754) [1]. In Part 1 (Week [W]0–W12), pts were
randomized to subcutaneous TIL 200 mg, TIL 100 mg, or placebo
(PBO) administered at W0 and W4, or ETN 50 mg administered
2x/week. In Part 2 (W12–W28), TIL- and ETN-treated pts remai-
ned on the same treatment (TIL administered at W16; ETN 1x/
week), whereas PBO-treated pts w