Key clinical point: A dose of 100 mg guselkumab every 4 or 8 weeks (Q4W/Q8W) demonstrated a favorable and consistent safety profile for up to 2 years in both tumor necrosis factor-α inhibitor (TNFi)-naive and TNFi-experienced patients with active psoriatic arthritis (PsA).
Major finding: In TNFi-naive vs TNFi-experienced patients receiving guselkumab, adverse events rates were consistent through 24 weeks (220.8/100 person-years [PY] vs 251.6/100 PY) and remained low through 2 years (139.69/100 PY vs 174.0/100 PY).
Study details: This pooled safety analysis of four phase 2/3 trials included 1554 TNFi-naive and TNFi-experienced patients with active PsA who were randomly assigned to receive 100 mg guselkumab Q4W or Q8W for ≤2 years or placebo with a crossover at week 24 to guselkumab Q4W or Q8W.
Disclosures: The four trials were funded by Janssen Research & Development, LLC. Seven authors declared being current or former employees of Janssen or owning stock or stock options in Johnson & Johnson. Several authors reported ties with Janssen and other sources.
Source: Rahman P et al. Safety of guselkumab with and without prior TNF-α inhibitor treatment: Pooled results across four studies in patients with psoriatic arthritis. J Rheumatol. 2023 (Jan 15). Doi: 10.3899/jrheum.220928