Christopher E M Griffiths1, Kim A Papp2, Michael Song3, Megan Miller3, Yin You3, Yaung-Kaung Shen3, Chenglong Han3, Andrew Blauvelt4. 1. Dermatology Centre, Salford Royal Hospital, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, UK. 2. K Papp Clinical Research and Probity Research, Inc, Waterloo, Canada. 3. Janssen Research & Development, LLC, Spring House, PA, USA. 4. Oregon Medical Research Center, Portland, OR, USA.
Abstract
OBJECTIVES: To evaluate the efficacy of guselkumab through four years of continuous treatment for psoriasis. METHODS: In the phase 3 VOYAGE 1 trial, 837 patients with moderate-to-severe psoriasis were randomized to receive guselkumab 100 mg every-8-weeks, placebo, or adalimumab 40 mg every-2-weeks. Patients in the placebo and adalimumab groups crossed over to receive guselkumab at weeks 16/52, respectively; eligible patients received open-label guselkumab through week 204. Efficacy endpoints (i.e., PASI 75/90/100, IGA 0/1, and IGA 0) were analyzed in the guselkumab group using different methodologies: prespecified treatment failure rules (TFR, patients discontinued due to lack of efficacy, psoriasis worsening, or protocol-prohibited psoriasis treatment considered nonresponders); nonresponder imputation (NRI, patients with missing data counted as nonresponders); and As Observed (OBS, no imputation). Safety was evaluated through week 204. RESULTS: At week 204, PASI 90 response rates were 82.2%, 68.4%, and 84.3%, respectively, based on TFR, NRI, and OBS analyses; corresponding proportions at week 52 were 79.7%, 75.5%, and 80.6%. Similarly, PASI 75, PASI 100, IGA 0/1, and IGA 0 responses were maintained from week 52 through week 204. No new safety signals were identified. CONCLUSIONS: High efficacy response rates were maintained through four years of continuous guselkumab treatment for psoriasis.
OBJECTIVES: To evaluate the efficacy of guselkumab through four years of continuous treatment for psoriasis. METHODS: In the phase 3 VOYAGE 1 trial, 837 patients with moderate-to-severe psoriasis were randomized to receive guselkumab 100 mg every-8-weeks, placebo, or adalimumab 40 mg every-2-weeks. Patients in the placebo and adalimumab groups crossed over to receive guselkumab at weeks 16/52, respectively; eligible patients received open-label guselkumab through week 204. Efficacy endpoints (i.e., PASI 75/90/100, IGA 0/1, and IGA 0) were analyzed in the guselkumab group using different methodologies: prespecified treatment failure rules (TFR, patients discontinued due to lack of efficacy, psoriasis worsening, or protocol-prohibited psoriasis treatment considered nonresponders); nonresponder imputation (NRI, patients with missing data counted as nonresponders); and As Observed (OBS, no imputation). Safety was evaluated through week 204. RESULTS: At week 204, PASI 90 response rates were 82.2%, 68.4%, and 84.3%, respectively, based on TFR, NRI, and OBS analyses; corresponding proportions at week 52 were 79.7%, 75.5%, and 80.6%. Similarly, PASI 75, PASI 100, IGA 0/1, and IGA 0 responses were maintained from week 52 through week 204. No new safety signals were identified. CONCLUSIONS: High efficacy response rates were maintained through four years of continuous guselkumab treatment for psoriasis.
Entities:
Keywords:
Biologics; guselkumab; long-term; maintenance of response; psoriasis
Authors: Christopher T Ritchlin; Philip S Helliwell; Wolf-Henning Boehncke; Enrique R Soriano; Elizabeth C Hsia; Alexa P Kollmeier; Soumya D Chakravarty; Federico Zazzetti; Ramanand A Subramanian; Xie L Xu; Qing C Zuraw; Shihong Sheng; Yusang Jiang; Prasheen Agarwal; Bei Zhou; Yanli Zhuang; May Shawi; Chetan S Karyekar; Atul Deodhar Journal: RMD Open Date: 2021-02
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