RT Journal Article
SR Electronic
T1 Safety of guselkumab with and without prior TNF-α inhibitor treatment: Pooled results across four studies in patients with psoriatic arthritis
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.220928
DO 10.3899/jrheum.220928
A1 Proton Rahman
A1 Wolf-Henning Boehncke
A1 Philip J.  Mease
A1 Alice B.  Gottlieb
A1 Iain B.  McInnes
A1 May Shawi
A1 Yanli Wang
A1 Shihong Sheng
A1 Alexa P.  Kollmeier
A1 Elke Theander
A1 Jenny Yu
A1 Evan Leibowitz
A1 A. Marilise  Marrache
A1 Laura C.  Coates
YR 2023
UL http://www.jrheum.org/content/early/2023/01/10/jrheum.220928.abstract
AB Objective Assess pooled safety results through the end of the Phase 2/3 studies of guselkumab (≤2 years) in tumor necrosis factor-α inhibitor (TNFi) -naïve and -experienced patients with psoriatic arthritis (PsA). Methods Data were pooled from the Phase 2 and DISCOVER-1 (TNFi-naïve/experienced), DISCOVER-2 (TNFi-naïve), and COSMOS (TNFi-experienced) studies. Patients with active PsA were randomized to guselkumab 100 mg every 4 or 8 weeks (Q4W+Q8W=Combined Guselkumab) or placebo with crossover to guselkumab Q4W or Q8W at Week 24. Timeadjusted adverse event (AE) rates (events/100 patient-years [PY]) and clinical laboratory findings were assessed during the placebo-controlled period and through end of study. Results Of 1554 randomized patients (n=373 [guselkumab Q4W], 664 [guselkumab Q8W], and 517 [placebo]), 1138 (73.23%) were TNFi-naive and 416 (26.76%) were TNFi-experienced. Respective AE rates through Week 24 were 220.8/100PY (TNFi-naïve) and 251.6/100PY (TNFiexperienced) in the Combined Guselkumab group and 196.1/100PY (TNFi-naïve) and 303.0/100PY (TNFi-experienced) in the Placebo group. Among all guselkumab-treated patients (including those who crossed over from placebo), low AE rates were maintained during longterm evaluation in both TNFi-naïve (139.69/100PY) and TNFi-experienced (174.0/100PY) patients. Rates/100PY of AEs leading to treatment discontinuation, serious AEs, and other AEs of interest as well as occurrence of elevated hepatic transaminase levels and decreased neutrophil counts were consistent between placebo and guselkumab-treated patients through Week 24 treatment regardless of prior TNFi use and remained low through the end of the studies. Conclusion The safety profile of guselkumab in TNFi-experienced patients was consistent with that in TNFi-naïve patients, which remained favorable for up to 2 years.