Spondyloarthritis & psoriatic arthritis
Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: a post-hoc analysis of phase 3 trials and long-term extension
Authors' conclusion
Tofacitinib efficacy exceeded placebo in both sexes and was comparable between sexes. Consistent with previous studies of PsA treatments, females were less likely to achieve MDA, likely due to baseline differences. Safety and time to discontinuation were generally similar between sexes.
Study context
- Population
- Patients with PsA in two phase 3 RCTs randomised to tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg every 2 weeks or placebo54.3% females
- Participants
- 816 patients
- Comparison
- Females vs males treated with tofacitinib (5 mg or 10 mg twice daily); adalimumab and placebo as comparators
- Outcome
- Impact of sex on tofacitinib efficacy (ACR20/50/70, MDA, PASI75, ΔHAQ-DI, ΔFACIT-F), safety and persistence (time to discontinuation)
- Follow-up
- Month 12 (efficacy, safety); month 42 (persistence)
Methodological detailssubgroup analysis by sex
- Subgroup analysis by sex
Pooled result
As reported in the abstract
Tofacitinib efficacy by sex · to month 12
- At month 3, tofacitinib efficacy generally exceeded placebo in both sexes
- Similar ACR20/50/70, PASI75, ΔHAQ-DI and ΔFACIT-F with tofacitinib between sexes
- Females less likely to achieve minimal disease activity (MDA)
- Persistence generally similar between sexes
- Post-hoc analysis
Safety
Serious AEs, tofacitinib 5 mg twice daily · to month 12
Serious AEs, tofacitinib 10 mg twice daily · to month 12
Treatment-emergent adverse events (AEs) with tofacitinib (both doses) · to month 12
- Similar proportions of males/females
Original publication
Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: a post-hoc analysis of phase 3 trials and long-term extension. RMD Open. Published 23 March 2023. doi:10.
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