Key clinical point: Guselkumab 100 mg every 4 weeks (Q4W) and every 8 weeks (Q8W) was well tolerated in patients with psoriatic arthritis (PsA) without any new safety concerns through 1 year of DISCOVER trials.
Major finding: At 24 weeks, combined guselkumab- and placebo-treated patients showed a similar incidence of serious adverse events (SAEs; 4.4 and 7.1/100 patient-years [PY]), adverse events (AEs) leading to discontinuation of study agent (3.8 and 4.1/100 PY), infections (49.5 and 49.9/100 PY), and serious infections (1.2 and 1.7/100 PY), respectively. At 52 weeks, the time-adjusted incidence of SAEs and AEs remained stable with both guselkumab regimens.
Study details: This was a pooled analysis of phase 3 trials DISCOVER-1, and DISCOVER-2 including 1,120 patients with active PsA who had inadequate responses to standard therapies. Patients were randomly allocated to receive subcutaneous guselkumab 100 mg at week 0, then Q4W; guselkumab 100 mg at weeks 0, 4, then Q8W; or placebo at Q4W.
Disclosures: This study was funded by Janssen Research & Development, LLC. The authors reported receiving research support, speaker bureau support, consultant fees, honoraria, and being an employee of and/or holding stocks/stock options in various sources including Janssen and Johnson & Johnson.
Source: Rahman P et al. J Rheumatol. 2021 May 1. doi: 10.3899/jrheum.201532 .