Spondyloarthritis & psoriatic arthritis

Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a Phase 3 randomized controlled study: a post hoc analysis

Arthritis Res TherPublished Post hoc analysis of the OPAL Broaden randomised trial and the OPAL Balance open-label long-term extension study

Authors' conclusion

Tofacitinib efficacy and safety were similar in patients with PsA who directly switched from ADA to tofacitinib and those who continued tofacitinib

Study context

Population
Patients with active psoriatic arthritis (PsA)
Participants
180 patients
Comparison
ADA switched directly to tofacitinib 5 mg BID vs continuing tofacitinib 5 mg BID
  • ADA→tofacitinib 5 mg BIDn = 91
  • Continuing tofacitinib 5 mg BIDn = 89reference
Methodological detailsopen-label long-term extension (LTE), Phase 3 randomised double-blind parent study
  • Open-label LTE
  • Phase 3 randomised double-blind parent study

Primary result

As reported in the abstract

Efficacy (ACR20/50/70, PASI75, Health Assessment Questionnaire-Disability Index (HAQ-DI) response, DAPSA ≤ 3.2, MDA, FACIT-Fatigue change) · Month 3 or 6 in the LTE
  • Efficacy similar between groups in the Phase 3 study, and maintained to month 3 or 6 in the LTE

Safety

Treatment-emergent adverse events (AEs), serious AEs and serious infections · Months 3 and 12

Generally similar in the Phase 3 and LTE studies, and between groups within each study

Original publication

Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a Phase 3 randomized controlled study: a post hoc analysis. Arthritis Res Ther. Published 19 December 2024. doi:10.1186/s13075-024-03442-2

Composed by AI from the published abstract and checked against it. How Briefs are made →

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