Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Bruce Strober (), Laura C. Coates, Mark G. Lebwohl, Atul Deodhar, Evan Leibowitz, Katelyn Rowland, Alexa P. Kollmeier, Megan Miller, Yanli Wang, Shu Li, Soumya D. Chakravarty, Daphne Chan, May Shawi, Ya-Wen Yang, Diamant Thaҫi and Proton Rahman
Additional contact information
Bruce Strober: Yale University
Laura C. Coates: University of Oxford
Mark G. Lebwohl: Icahn School of Medicine at Mount Sinai
Atul Deodhar: Oregon Health & Science University
Evan Leibowitz: Janssen Scientific Affairs, LLC
Katelyn Rowland: Janssen Scientific Affairs, LLC
Alexa P. Kollmeier: Janssen Research & Development, LLC
Megan Miller: Janssen Research & Development, LLC
Yanli Wang: Janssen Research & Development, LLC
Shu Li: Janssen Research & Development, LLC
Soumya D. Chakravarty: Janssen Scientific Affairs, LLC
Daphne Chan: Janssen Scientific Affairs, LLC
May Shawi: Immunology, Janssen Research & Development, LLC
Ya-Wen Yang: Janssen Pharmaceutical Companies of Johnson & Johnson
Diamant Thaҫi: University of Luebeck
Proton Rahman: Memorial University of Newfoundland

Drug Safety, 2024, vol. 47, issue 1, No 4, 39-57

Abstract: Abstract Introduction The benefit/risk profiles of biologics can be affected by comorbidities, certain demographic characteristics, and concomitant medications; therefore, it is important to evaluate the long-term safety profiles of biologics across broad patient populations. Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adults with moderate-to-severe psoriasis and/or active psoriatic arthritis (PsA). Objectives The objective of the current analysis was to evaluate guselkumab safety in a large population of patients with psoriatic disease by pooling adverse event (AE) data from 11 phase II/III studies (seven in psoriasis; four in PsA). Methods Guselkumab was generally administered as 100 mg subcutaneous injections at Week 0, Week 4, then every 8 weeks (Q8W) in psoriasis studies and at Week 0, Week 4, then every 4 weeks (Q4W) or Q8W in PsA studies. Safety data were summarized for the placebo-controlled period (Weeks 0–16 in psoriasis; Weeks 0–24 in PsA) and through the end of the reporting period (up to 5 years in psoriasis; up to 2 years in PsA). Using the integrated data, incidence rates of key AEs were determined post hoc, adjusted for duration of follow-up, and reported per 100 patient-years (PYs). AE rates were also determined in subgroups of patients defined by sex, age, body mass index (BMI), and prior biologic use. Results During the placebo-controlled period, 1061 patients received placebo (395 PYs) and 2257 received guselkumab (856 PYs). Through the end of the reporting period, 4399 guselkumab-treated patients contributed 10,787 PYs of follow-up. During the placebo-controlled period, in the guselkumab and placebo groups, respectively, rates of AEs were 281 versus 272/100 PYs, and infections were 76.0 versus 72.2/100 PYs. Rates of serious AEs (5.6 vs. 7.8/100 PYs), AEs leading to discontinuation (4.9 vs. 6.6/100 PYs), serious infections (1.0 vs. 2.3/100 PYs), malignancy (0.59 vs. 0.25 patients/100 PYs), and major adverse cardiovascular events (MACE; 0.35 vs. 0.25/100 PYs) were low and comparable between guselkumab and placebo. Among guselkumab-treated patients, safety event rates through the end of the reporting period were numerically lower than or comparable with rates observed during the placebo-controlled period: AEs, 164/100 PYs; infections, 61.2/100 PYs; serious AEs, 5.4/100 PYs; AEs leading to discontinuation, 1.8/100 PYs; serious infections, 1.0/100 PYs; malignancy, 0.6/100 PYs; and MACE, 0.3/100 PYs. No AEs of Crohn’s disease, ulcerative colitis, or active tuberculosis were reported among guselkumab-treated patients. In the psoriasis studies, no opportunistic infections were reported among guselkumab-treated patients. Three AEs of opportunistic infections were reported in guselkumab-treated patients with PsA (0.14/100 PYs; all after Week 52 in DISCOVER-2). AE rates were largely consistent across subgroups of guselkumab-treated patients defined by sex, age, BMI, and prior biologic use. Conclusions In this analysis of 4399 guselkumab-treated patients with psoriatic disease followed for 10,787 PYs, guselkumab had a favorable AE profile. AE rates were similar between guselkumab- and placebo-treated patients and were consistent throughout long-term guselkumab treatment and across broad subgroups of patients with psoriatic disease. Clinical Trials Registrations Clinicaltrials.gov identifiers: NCT01483599, NCT02207231, NCT02207244, NCT02203032, NCT02905331, NCT03090100, NCT02325219, NCT02319759, NCT03162796, NCT03158285, and NCT03796858. Graphical Abstract

Date: 2024
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DOI: 10.1007/s40264-023-01361-w

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