AB0912 Two-year efficacy and safety of guselkumab for treatment of moderate-to-severe psoriasis: phase 3 voyage 1 trial

Abstract

Background

Guselkumab (GUS) is an interleukin-23 inhibitor recently approved in the US for treatment of moderate-to-severe psoriasis.

Objectives

Efficacy and safety data for up to 100 wks of GUS treatment are reported.

Methods

In the VOYAGE 1 Phase 3, randomised, double-blind, placebo/active comparator-controlled trial, 837 patients were randomised at baseline to placebo (PBO) at wks0/4/12 then GUS 100 mg at wks16/20 and q8w (n=174); GUS at wks0/4/12, and q8w (n=329); or adalimumab (ADA) 80 mg at wk 0, 40 mg at wk1, and q2w through wk47 then GUS at wk52 and q8w (n=334). Efficacy was assessed using nonresponder imputation through wk48 and treatment failure rules from wks52-100.

Results

Among patients randomised to GUS, or PBO→GUS at wk16, efficacy (PASI, Psoriasis Area and Severity Index; IGA, Investigator's Global Assessment) was maintained from wks52-100 with continuous GUS treatment. Among those randomised to ADA (→GUS at wk52), efficacy improved from wks52-100. Similar findings were observed for patient-reported outcomes (PSSD, Psoriasis Symptoms and Signs Diary; DLQI, Dermatology Life Quality Index; table 1). Through wk100, there were no disproportionate increases in rates of Adverse Events (AEs) compared with rates through wk48. Serious AE rates were low and remained stable; no TB, opportunistic infections, or serious hypersensitivity reactions were reported.

Abstract AB0912 - Table 1 Efficacy assessments in VOYAGE 1 (wks48/52-100); n% PBO→GUS GUS ADA→GUS wk52 wk100 wk52 wk100 wk52 wk100 n 161 158 307 290 279 275 PASI90 127 (78.9) 130 (82.3) 246 (80.1) 238 (82.1) 141 (50.5) 223 (81.1) PASI100 75 (46.6) 87 (55.1) 155 (50.5) 142 (49.0) 67 (24.0) 142 (51.6) Mean%PASI improvement(SD) 94.6 (9.1) 95.5 (7.8) 92.3 (17.3) 93.1 (16.6) 77.6 (31.9) 94.2 (12.6) IGA0/1 142 (88.2) 134 (84.8) 254 (82.7) 239 (82.4) 168 (60.4) 231 (84.0) IGA0 86 (53.4) 93 (58.9) 165 (53.7) 156 (53.8) 76 (27.3) 153 (55.6) - - - - - ADA ADA→GUS - wk48 wk100 wk48 wk100 wk48 wk100 PSSD symptom score=0^ab 46/129 (35.7) 49/118 (41.5) 104/248 (41.9) 89/225 (39.6) 63/273 (23.1) 94/225 (41.8) PSSD sign score=0^ab 37/129 (28.7) 44/118 (37.3) 89/248 (35.9) 69/225 (30.7) 51/274 (18.6) 66/226 (29.2) DLQI0/1^ac 111/159 (69.8) 126/152 (82.9) 200/320 (62.5) 202/284 (71.1) 124/319 (38.9) 194/262 (74.0)

PASI90/100, 90.100% improvement in PASI score, IGA0/1=minimal or cleared(0) psoriasis, ^aData not collected at wk52, ^bPts with baseline PSSD scores>0, ^cPts with baseline DLQI scores>1

Conclusions

Efficacy among GUS patients was maintained through 2 years of continuous treatment. Efficacy among ADA→GUS patients improved from wks52-100. GUS was well-tolerated, with a similar safety profile as previously reported.

Disclosure of Interest

C. Griffiths Grant/research support from: Janssen Research and Development, LLC, K. Papp Grant/research support from: Janssen Research and Development, LLC, A. Kimball Grant/research support from: Janssen Research and Development, LLC, B. Randazzo Employee of: Janssen Research and Development, LLC, Y. Wasfi Employee of: Janssen Research and Development, LLC, S. Li Employee of: Janssen Research and Development, LLC, Y.-K. Shen Employee of: Janssen Research and Development, LLC, A. Blauvelt Grant/research support from: Janssen Research and Development, LLC