Spondyloarthritis & psoriatic arthritis

Sex-related differences in patient characteristics, and efficacy and safety of advanced therapies in randomised clinical trials in psoriatic arthritis: a systematic literature review and meta-analysis

Lancet RheumatolPublished Systematic review and meta-analysis of randomised trials

Authors' conclusion

Biological sex of patients with psoriatic arthritis influences their response to advanced therapies, but the effect varies by drug class.

Study context

Population
Participants in RCTs assessing the efficacy of advanced therapies (biological and targeted synthetic) in PsA
Participants
22,621 participants54 trials
Comparison
Male vs female patients with PsA in RCTs of advanced therapies, by drug class
  • Malen = 11,107
  • Femalen = 11,514reference
Outcome
ACR20, ACR50 and minimal disease activity (MDA) response in male vs female patients by drug class
Methodological detailsrandom-effects models, Risk of bias was low for most studies
  • Random-effects models
  • Risk of bias was low for most studies

Pooled result

As reported in the abstract

ACR20 response, male vs female, by drug class
Male vs FemaleOdds ratio (95% CI)
IL-17 inhibitors
1.70(1.38–2.11)
IL-23 inhibitor
1.46(1.20–1.78)
IL-12 and IL-23 inhibitor
2.67(1.39–5.09)
TNF inhibitors
1.55(1.11–2.18)
JAK and TYK2 inhibitors; no difference
1.10(0.87–1.38)

Further pooled results

OutcomeOR (95% CI)
ACR50 response, male vs female, by drug classMalevs FemaleTNF inhibitors2.17 (1.62–2.90)
ACR50 response, male vs female, by drug classMalevs FemaleIL-17 inhibitors1.93 (1.56–2.38)
ACR50 response, male vs female, by drug classMalevs FemaleIL-23 inhibitor1.71 (1.25–2.34)
ACR50 response, male vs female, by drug classMalevs FemaleIL-12 and 23 inhibitor2.43 (1.14–5.20)
ACR50 response, male vs female, by drug classMalevs FemaleJAK and TYK2 inhibitors1.09 (0.73–1.62)
MDA, male vs female, by drug classMalevs FemaleIL-17 inhibitors1.99 (1.50–2.63)
MDA, male vs female, by drug classMalevs FemaleIL-23 inhibitors1.79 (1.29–2.50)
MDA, male vs female, by drug classMalevs FemaleTNF inhibitors2.62 (1.54–4.44)
MDA, male vs female, by drug classMalevs FemaleJAK and TYK2 inhibitors1.77 (1.15–2.73)
OutcomeMean difference (95% CI)
Baseline characteristics, male vs femaleMalevs FemaleTender joint count−3.01 (−3.83 to −2.18)
Baseline characteristics, male vs femaleMalevs FemaleHAQ scores−0.28 (−0.33 to −0.24)
Baseline characteristics, male vs femaleMalevs FemalePain scores−4.58 (−6.86 to −2.30)
Baseline characteristics, male vs femaleMalevs FemalePGA (patient)−3.22 (−5.27 to −1.17)
Baseline characteristics, male vs femaleMalevs FemalePhysician global assessment−1.34 (−2.08 to −0.08)
Baseline characteristics, male vs femaleMalevs FemalePASI scores1.95 (0.78–3.11)
Baseline characteristics, male vs femaleMalevs FemaleCRP concentrations2.57 (0.40–4.74)

Sex-disaggregated reporting

Baseline characteristics reported by sex
nine [17%] of 54
Efficacy reported by sex
18 [33%]
Safety endpoints reported by sex
two [4%]

Original publication

Sex-related differences in patient characteristics, and efficacy and safety of advanced therapies in randomised clinical trials in psoriatic arthritis: a systematic literature review and meta-analysis. Lancet Rheumatol. Published 14 November 2023. doi:10.1016/s2665-9913(23)00264-3

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