Kristian Reich1, April W Armstrong2, Peter Foley3, Michael Song4, Megan Miller4, Y K Shen4, Yin You4, Chenglong Han5, Kenneth B Gordon6. 1. Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. kreich@jerucon.com. 2. Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. 3. Department of Medicine, The University of Melbourne, St. Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, Carlton, VIC, Australia. 4. Janssen Research & Development, LLC, Spring House, PA, USA. 5. Janssen Global Services, LLC, Malvern, PA, USA. 6. Medical College of Wisconsin, Milwaukee, WI, USA.
Abstract
BACKGROUND: Guselkumab effectively treats moderate-to-severe psoriasis. OBJECTIVES: Results of continuous guselkumab treatment through 4 years from VOYAGE 2 are presented. METHODS: At baseline, 992 patients were randomized to receive guselkumab 100 mg every 8 weeks, placebo, or adalimumab 40 mg every 2 weeks. Placebo-treated patients crossed over to guselkumab at week 16. Weeks 28-76 incorporated randomized withdrawal, and all patients received open-label guselkumab through to week 204. Efficacy was analyzed using pre-specified treatment failure rules (patients were considered nonresponders after discontinuing due to lack of efficacy, worsening of psoriasis, or use of a prohibited treatment). There was no missing data imputation after treatment failure rules. Safety was analyzed through 4 years. RESULTS: The proportions of guselkumab-treated patients who achieved and maintained designated clinical responses at weeks 100 and 204, respectively, were as follows: at least a 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75): 94.1% and 92.3%; PASI 90: 79.1% and 79.7%; PASI 100: 48.4% and 51.0%; Investigator's Global Assessment (IGA) score of 0/1: 83.1% and 81.9%; IGA score of 0: 52.7% and 52.7%; Dermatology Life Quality Index score of 0/1: 70.2% and 69.1%; Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0: 35.7% and 39.7%; PSSD sign score of 0: 22.0% and 27.2%; ≥ 5% improvement in Short Form-36 (SF-36) physical component score: 48.8% and 45.0%; ≥ 5% improvement in SF-36 mental component score: 45.1% and 43.2%; Hospital Anxiety and Depression Score (HADS)-anxiety score ≥ 8: 22.9% and 21.7%; and HADS-depression score ≥ 8: 16.6% and 21.0%. Similar findings were reported for the adalimumab → guselkumab group. No new safety signals were identified. CONCLUSIONS:High efficacy levels were maintained from week 100 through to week 204 with continuous guselkumab treatment, across multiple endpoints, in VOYAGE 2. Guselkumab was well tolerated. CLINICAL TRIAL REGISTRATION: NCT02207244.
RCT Entities:
BACKGROUND:Guselkumab effectively treats moderate-to-severe psoriasis. OBJECTIVES: Results of continuous guselkumab treatment through 4 years from VOYAGE 2 are presented. METHODS: At baseline, 992 patients were randomized to receive guselkumab 100 mg every 8 weeks, placebo, or adalimumab 40 mg every 2 weeks. Placebo-treated patients crossed over to guselkumab at week 16. Weeks 28-76 incorporated randomized withdrawal, and all patients received open-label guselkumab through to week 204. Efficacy was analyzed using pre-specified treatment failure rules (patients were considered nonresponders after discontinuing due to lack of efficacy, worsening of psoriasis, or use of a prohibited treatment). There was no missing data imputation after treatment failure rules. Safety was analyzed through 4 years. RESULTS: The proportions of guselkumab-treated patients who achieved and maintained designated clinical responses at weeks 100 and 204, respectively, were as follows: at least a 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75): 94.1% and 92.3%; PASI 90: 79.1% and 79.7%; PASI 100: 48.4% and 51.0%; Investigator's Global Assessment (IGA) score of 0/1: 83.1% and 81.9%; IGA score of 0: 52.7% and 52.7%; Dermatology Life Quality Index score of 0/1: 70.2% and 69.1%; Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0: 35.7% and 39.7%; PSSD sign score of 0: 22.0% and 27.2%; ≥ 5% improvement in Short Form-36 (SF-36) physical component score: 48.8% and 45.0%; ≥ 5% improvement in SF-36 mental component score: 45.1% and 43.2%; Hospital Anxiety and Depression Score (HADS)-anxiety score ≥ 8: 22.9% and 21.7%; and HADS-depression score ≥ 8: 16.6% and 21.0%. Similar findings were reported for the adalimumab → guselkumab group. No new safety signals were identified. CONCLUSIONS: High efficacy levels were maintained from week 100 through to week 204 with continuous guselkumab treatment, across multiple endpoints, in VOYAGE 2. Guselkumab was well tolerated. CLINICAL TRIAL REGISTRATION: NCT02207244.
Authors: Iain B McInnes; Proton Rahman; Alice B Gottlieb; Elizabeth C Hsia; Alexa P Kollmeier; Xie L Xu; Yusang Jiang; Shihong Sheng; May Shawi; Soumya D Chakravarty; Désirée van der Heijde; Philip J Mease Journal: Arthritis Rheumatol Date: 2022-02-07 Impact factor: 15.483