Clinical Efficacy of Biosimilar Switch of Adalimumab and Infliximab for Noninfectious Uveitis: Systematic Review and Meta-Analysis.

Abstract

To evaluate the clinical efficacy of switching from originator tumor necrosis factor-alpha (TNF-α) inhibitors to biosimilars in the management of noninfectious uveitis. A systematic review and meta-analysis. A systematic review and meta-analysis were conducted on PubMed, Embase, and Scopus according to PRISMA guidelines and registered on PROSPERO (ID: CRD420251051301). Studies were included if they reported outcomes related to uveitis control, including flare frequency, oral corticosteroid use, or nonbiologic immunomodulatory therapy (IMT) use, before and after switching. Meta-analyses were performed to compare the incidence rate ratio (IRR) of uveitis flares, as well as the risk ratios (RR) of oral corticosteroid and nonbiological IMT use, before and after switching. A total of 6 studies were included, with publication dates ranging from 2019 to 2024. The studies included a total of 202 patients that underwent an originator to biosimilar switch. The pooled IRR of uveitis flares postswitch was 1.26 (95% CI: 0.72-2.21, P = 0.411), with significant heterogeneity (P = 0.08). Heterogeneity could be resolved through a secondary analysis excluding flares occurring within 3 months postswitch, due to early flare clustering reported in 1 study, that found an IRR of 1.20 (95% CI: 0.79-1.83, P = 0.388) without heterogeneity (P = .25). There was no significant change in the risk of oral steroid use (RR = 1.00; 95% CI: 0.88-1.12, P = 0.944) or nonbiologic IMT use (RR = 0.98; 95% CI 0.83-1.16, P = .858) postswitch. A total of 30 patients (Pooled Proportions = 0.10; 95% CI: 0.041-0.219, P = 0.022) reverted to the originator agent, most commonly due to injection-site pain or technical difficulties with the biosimilar injector. Switching from originator to biosimilar TNF-α inhibitors in noninfectious uveitis was not associated with an increase in flare rates, supporting the clinical equivalence of these biosimilars. However, a subset of patients may experience tolerability issues or early flares, warranting close monitoring in the months following a switch.