Article Text

Download PDFPDF

AB0912 Two-year efficacy and safety of guselkumab for treatment of moderate-to-severe psoriasis: phase 3 voyage 1 trial
Free
  1. C.E. Griffiths1,
  2. K.A. Papp2,
  3. A.B. Kimball3,
  4. B. Randazzo4,
  5. Y. Wasfi4,
  6. S. Li4,
  7. Y.-K. Shen4,
  8. A. Blauvelt5
  1. 1U of Manchester, Manchester, UK
  2. 2K. Papp Clinical Research and Probity Research Inc, Waterloo, Canada
  3. 3Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Inc, Boston
  4. 4Janssen Research and Development, LLC, Spring House
  5. 5Oregon Medical Research Center, Portland, USA

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%

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

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.