42621 Biosimilars in the treatment of psoriasis – A systematic review of evidence from randomized controlled trials and real-world data

Abstract

Background: Biosimilars can be approved to treat psoriasis based on extrapolated evidence from other diseases, raising concerns about their use for psoriasis treatment. Method(s): This systematic review compares the efficacy/effectiveness, safety, and drug survival of biosimilars with originator biologics for the treatment of plaque psoriasis using data from randomized controlled trials and cohort studies. MEDLINE, EMBASE, Cochrane library, and ClinicalTrials.gov were searched. Eligible studies were appraised using the Cochrane Risk of Bias 2 and ROBINS-I tools. Result(s): Thirteen trials (10 adalimumab, 2 etanercept, 1 infliximab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) were included. Eleven trials and 9 trials compared biosimilars with originators in originator- naive patients (initiators) and switching from originator to biosimilar (switchers) with continuous originator treatment, respectively. No trial showed significant difference in 75% improvement in Psoriasis Area and Severity Index and adverse events (AE) at week 16 (initiators) and week 52 (switchers) between the comparators. Two cohort studies showed no difference in effectiveness and safety outcomes between originators and biosimilars, while 1 study reported more AEs in the biosimilar adalimumab group (switchers) at 12 months. There was a moderate risk of bias in the majority (10/13) of included trials and a moderate to high risk of bias in all cohort studies. Conclusion(s): The majority of available evidence suggests similarities between biosimilars and originators. However, one real-world study found a higher risk of AEs with adalimumab biosimilars. Future pharmacovigilance studies are needed to evaluate the long-term, real-world use of biosimilars for psoriasis treatment.Copyright © 2023