Spondyloarthritis & psoriatic arthritis
Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis
Authors' conclusion
The safety profile of GUS in TNFi-experienced patients was consistent with that in TNFi-naïve patients, which remained favorable for up to 2 years.
Study context
- Population
- Patients with active PsA, tumor necrosis factor inhibitor (TNFi)-naïve and TNFi-experienced, from the Phase 2, DISCOVER-1, DISCOVER-2 and COSMOS studies1,138 TNFi-naïve, 416 TNFi-experienced
- Participants
- 1,554 patients
- Comparison
- Guselkumab 100 mg Q4W or Q8W vs placebo, by prior TNFi exposure
- Guselkumab (GUS) Q4Wn = 373
- GUS Q8Wn = 664
- Placebo (PBO)n = 517reference
- Outcome
- Time-adjusted AE rates (events/100 PY) and clinical laboratory findings
- Follow-up
- PBO-controlled period (week 24) and through end of study (≤ 2 years)
Methodological detailsplacebo-controlled, crossover from placebo to GUS at week 24, phase II/III
- Placebo-controlled
- Crossover from placebo to GUS at week 24
- Phase II/III
Pooled result
As reported in the abstract
AE rate, events/100 PY, by prior TNFi use · week 24
Further pooled results
AE rate, events/100 PY, all GUS-treated patients (incl. PBO crossover), long-term · end of study (≤ 2 years)
Safety
Adverse event (AEs) leading to discontinuation, serious AEs, other AEs of interest, elevated hepatic transaminases, decreased neutrophil counts · week 24 and end of study
- Consistent between PBO and GUS-treated patients through week 24 regardless of prior TNFi use; remained low through end of studies
Original publication
Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. J Rheumatol. Published 15 January 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →