Comparative Safety and Benefit-Risk Profile of Biologics and Oral Treatments for Moderate-to-Severe Plaque Psoriasis: a Network Meta-Analysis of Clinical Trial Data

Abstract Background The comparative safety and benefit-risk profiles of moderate-to-severe psoriasis treatments have not been well studied. Objective To compare the short-term (12-16 weeks) and long-term (48-56 weeks) safety and benefit-risk profiles of moderate-to-severe psoriasis treatments. Methods A systematic literature review of Phase II-IV randomized controlled trials (RCTs) of moderate-to-severe psoriasis treatments was conducted (cut-off: 07/01/2020). Any adverse events (AE), any serious AE (SAE), and AEs leading to treatment discontinuation were compared with Bayesian network meta-analyses (NMAs). Results 52 and 7 RCTs were included in the short- and long-term NMAs. In the short term, the rates of any AEs were lowest for tildrakizumab (posterior median: 46.0%), certolizumab (46.2%), and etanercept (49.1%). The rates of any SAE were lowest for certolizumab (0.8%), risankizumab (1.2%), and etanercept (1.6%). The rates of AEs leading to treatment discontinuation were lowest for risankizumab (0.5%), tildrakizumab (1.0%), and guselkumab (1.5%). In the long term, risankizumab had the lowest rates of all three outcomes (67.5%, 4.4% and 1.0%, respectively) and the most favorable benefit-risk profile. Limitations The results may not be generalizable to real world populations. Conclusions Anti-IL-23 agents were associated with low rates of safety events. Risankizumab had the most favorable benefit-risk profile in the long term.