Efficacy and safety of biologics for hidradenitis suppurativa: A network meta-analysis of phase III trials.

Abstract

Background: Phase III clinical trials are designed to evaluate the therapeutic effect of drugs and their superiority over other treatment methods, but biologics for hidradenitis suppurativa (HS) have not been compared head-to-head in phase III studies.

Objective: To evaluate the relative efficacy and safety of biologics for HS in a network meta-analysis including available data from phase III trials.

Methods: MEDLINE and Embase were searched for phase III trials investigating the efficacy and/or safety of at least one biologic for moderate-to-severe HS. The odds ratios for reaching an HS Clinical Response 50 (HiSCR50) and for the occurrence of adverse events after 12-16 weeks were compared between treatments.

Results: PIONEER I and II (adalimumab 40 mg weekly vs. placebo), SUNSHINE and SUNRISE (secukinumab 300 mg every 2 vs. 4 weeks vs. placebo) as well as BE HEARD I and II (bimekizumab 320 mg every 2 vs. 4 weeks vs. placebo) with 2731 patients were included. Adalimumab weekly was ranked most effective in reaching a HiSCR50 with significant superiority over secukinumab every 2 weeks (OR = 1.74; 95% confidence interval [CI]: 1.11-2.73) and 4 weeks (OR = 1.72; 95% CI: 1.09-2.7) and insignificant superiority over bimekizumab every 2 weeks (OR = 1.23; 95% CI: 0.74-2.06) and 4 weeks (OR = 1.25; 95% CI: 0.73-2.14). Adalimumab showed the fewest adverse events with significant superiority over bimekizumab every 2 weeks (OR = 0.52; 95% CI: 0.32-0.86) and insignificant superiority over bimekizumab every 4 weeks (OR = 0.79; 95% CI: 0.47-1.33) and secukinumab every 2 weeks (OR = 0.69; 95% CI: 0.45-1.07) and 4 weeks (OR = 0.71; 95% CI: 0.46-1.1).

Conclusions: Among currently approved biologic agents for moderate-to-severe HS, adalimumab demonstrated the highest efficacy and safety in the first 12-16 weeks of treatment.