Andrew Blauvelt1, Tsen-Fang Tsai2, Richard G Langley3, Megan Miller4, Yaung-Kaung Shen4, Yin You4, Ya-Wen Yang5, Kim A Papp6, Luis Puig7. 1. Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com. 2. National Taiwan University Hospital, Taipei, Taiwan. 3. Dalhousie University, Halifax, Nova Scotia, Canada. 4. Janssen Research & Development, LLC, Spring House, Pennsylvania. 5. Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania. 6. K Papp Clinical Research and Probity Research, Inc, Waterloo, Ontario, Canada. 7. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Abstract
BACKGROUND: Guselkumab effectively treats moderate-to-severe psoriasis. OBJECTIVE: To evaluate the cumulative safety experience of guselkumab using pooled data from the VOYAGE 1 and 2 studies through 5 years. METHODS: Patients were randomized to guselkumab, placebo with crossover to guselkumab at week 16, or adalimumab. The studies were identical through week 24. VOYAGE 1 evaluated continuous guselkumab treatment (adalimumab-crossover-to-guselkumab at week 52), while VOYAGE 2 assessed randomized withdrawal/retreatment (weeks 28-76). Open-label guselkumab treatment was administered starting at week 52 in VOYAGE 1 and week 76 in VOYAGE 2 and continued through week 252. Pooled safety data were adjusted by exposure and analyzed in the guselkumab groups, including placebo-crossover-to-guselkumab (n = 1221) and adalimumab-crossover-to-guselkumab (n = 500), through week 264. RESULTS: Patients were followed for a total of 7166 patient-years (PY). Overall, 1349 of 1721 guselkumab-treated patients (78.4%) continued treatment through week 252. The rates of adverse and serious adverse events were 149/100 PY and 5.01/100 PY, respectively. Rates of adverse events of interest were low: serious infections (0.85/100 PY), nonmelanoma skin cancer (0.34/100 PY), malignancies other than nonmelanoma skin cancer (0.45/100 PY), and major adverse cardiovascular events (0.29/100 PY). Year-to-year variability was evident, but no increasing trend was observed. LIMITATIONS: No direct treatment comparisons were possible after week 52. CONCLUSION: The safety profile remained consistent and favorable during 5 years of continuous guselkumab treatment of psoriasis.
BACKGROUND: Guselkumab effectively treats moderate-to-severe psoriasis. OBJECTIVE: To evaluate the cumulative safety experience of guselkumab using pooled data from the VOYAGE 1 and 2 studies through 5 years. METHODS: Patients were randomized to guselkumab, placebo with crossover to guselkumab at week 16, or adalimumab. The studies were identical through week 24. VOYAGE 1 evaluated continuous guselkumab treatment (adalimumab-crossover-to-guselkumab at week 52), while VOYAGE 2 assessed randomized withdrawal/retreatment (weeks 28-76). Open-label guselkumab treatment was administered starting at week 52 in VOYAGE 1 and week 76 in VOYAGE 2 and continued through week 252. Pooled safety data were adjusted by exposure and analyzed in the guselkumab groups, including placebo-crossover-to-guselkumab (n = 1221) and adalimumab-crossover-to-guselkumab (n = 500), through week 264. RESULTS: Patients were followed for a total of 7166 patient-years (PY). Overall, 1349 of 1721 guselkumab-treated patients (78.4%) continued treatment through week 252. The rates of adverse and serious adverse events were 149/100 PY and 5.01/100 PY, respectively. Rates of adverse events of interest were low: serious infections (0.85/100 PY), nonmelanoma skin cancer (0.34/100 PY), malignancies other than nonmelanoma skin cancer (0.45/100 PY), and major adverse cardiovascular events (0.29/100 PY). Year-to-year variability was evident, but no increasing trend was observed. LIMITATIONS: No direct treatment comparisons were possible after week 52. CONCLUSION: The safety profile remained consistent and favorable during 5 years of continuous guselkumab treatment of psoriasis.
Authors: Christopher T Ritchlin; Philip J Mease; Wolf-Henning Boehncke; John Tesser; Elena Schiopu; Soumya D Chakravarty; Alexa P Kollmeier; Xie L Xu; May Shawi; Yusang Jiang; Shihong Sheng; Yanli Wang; Stephen Xu; Joseph F Merola; Iain B McInnes; Atul Deodhar Journal: RMD Open Date: 2022-03
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