Risk of Serious Infections in Patients with Psoriasis on Biologic Therapies: An Updated Systematic Review and Meta-Analysis

ABSTRACT Background The increase in the number of available biologic agents for psoriasis has led to an urgent need to evaluate their associated risk of serious infections to help inform clinical decisions. Methodology We systematically searched PubMed, Medline, Embase, and Cochrane databases for biologics targeting TNF (adalimumab, etanercept, infliximab, certolizumab pegol), interleukin (IL)-12/23 (ustekinumab), IL-17A (secukinumab, ixekizumab), IL-17RA (brodalumab) and IL-23p19 (guselkumab, risankizumab, and tildrakizumab) for the primary outcome serious infections, at 10– 16 weeks, 1 year and 3 years. Peto’s method (fixed effect model) was used to estimate the pooled odds ratio (OR) in meta-analyses comparing biologics with one another, methotrexate, or placebo. Results Forty-three publications (49 trials) consisting of 29,724 participants met our inclusion criteria. Serious infections across all studies were low (n=97) at 10–16 weeks and did not show an increased risk with biologic therapies compared with placebo. Seven head-to-head RCTs were identified, most of which showed no significant difference in the risk of serious infections at 10–16 weeks and at 1 year. Adalimumab was not associated with a significant increased risk of serious infections compared with methotrexate in children at 10–16 weeks. Conclusions Biologics for psoriasis were not associated with an increased risk of serious infections compared with placebo or one another at 10–16 weeks. Longer-term, real-world data with larger sample sizes are warranted.