Spondyloarthritis & psoriatic arthritis
Efficacy and Safety of Tofacitinib in Ankylosing Spondylitis by Baseline C-Reactive Protein Level: Post Hoc Analysis of Phase II and Phase III Clinical Trials
Authors' conclusion
Regardless of baseline CRP, TOF was more efficacious vs placebo at week 12. The placebo-adjusted efficacy and PRO responses were generally numerically higher in patients with CRP ≥ 5 mg/L and ≥ 10 mg/L vs < 5 mg/L and < 10 mg/L.
Study context
- Population
- Patients with active ankylosing spondylitis (AS) from phase II and phase III trials69.6% ≥ 5mg/L
- Participants
- 372 patients
- Comparison
- Tofacitinib vs placebo, stratified by baseline C-reactive protein (CRP)
- Primary endpoint
- ASAS20, ASAS40, ASDAS-CRP low disease activity, Bath AS Disease Activity Index (BASDAI50) and patient-reported outcomes (PROs) (pain and fatigue), stratified by baseline CRP
- Follow-up
- Weeks 12, 16, and 48
Methodological detailssubgroup analysis by baseline CRP, placebo-controlled
- Subgroup analysis by baseline CRP
- Placebo-controlled
Primary result
As reported in the abstract
Efficacy and PRO responses by baseline CRP · week 12
- Efficacy and PRO responses generally higher for tofacitinib (TOF) vs placebo, regardless of baseline CRP
- Treatment effect (placebo-adjusted response) generally numerically higher in ≥ 5 mg/L and ≥ 10 mg/L vs < 5 mg/L and < 10 mg/L groups
Further findings
Baseline concomitant NSAID or SSZ use, < 5 mg/L subgroup
- More placebo-treated than TOF-treated patients received concomitant nonsteroidal antiinflammatory drugs (NSAIDs) or SSZ
Safety
Treatment-emergent adverse events (TEAEs) and all infections, incidence rates by baseline CRP
- Numerically higher for TOF vs placebo in < 5 mg/L subgroup
- Similar for TOF vs placebo in ≥ 5 mg/L subgroup
Original publication
Efficacy and Safety of Tofacitinib in Ankylosing Spondylitis by Baseline C-Reactive Protein Level: Post Hoc Analysis of Phase II and Phase III Clinical Trials. J Rheumatol. Published 1 June 2024. doi:10.
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