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.

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The comparative safety and benefit-risk profiles of moderate-to-severe psoriasis treatments have not been well studied.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.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).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.The results may not be generalizable to real world populations.Anti-IL-23 agents were associated with low rates of safety events. Risankizumab had the most favorable benefit-risk profile in the long term.


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Authors: Neil H Shear, Keith A Betts, Ahmed M Soliman, Avani Joshi, Yan Wang, Jing Zhao, Paolo Gisondi, Ranjeeta Sinvhal, April W Armstrong

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