Work

Effectiveness and Safety Outcomes After Switching from Reference Biologics to Biosimilars for Treatment of Non-Infectious Uveitis: A Systematic Review and Meta-Analysis

Year: 2026

Type: review

Study designs: Systematic Review, Meta-Analysis

Abstract: Purpose: This study aims to compare the effectiveness and safety of switch from reference biologics to their biosimilars in the treatment of non-infectious uveitis (NIU). Methods: A literature search was conducted in Ovid MEDLINE, Ovid EMBASE and Cochrane Central Register of Controlled Trials, Scopus, and Web of Science from inception until October 2024 (PROSPERO protocol #: CRD42021283386). Eligible studies involving any age groups with NIU treated with any biosimilar or reference biologic were included. Risk of bias and certainty of evidence were evaluated using ROBINS-I and GRADE, respectively, and random-effects meta-analyses were conducted using the Mantel-Haenszel method. Results: A total of 11 studies, including 343 patients with NIU, met the inclusion criteria. Most studies were retrospective before-and-after designs and were assessed as having a serious risk of bias, largely due to confounding. The relative risk of recurrence for biosimilars was 0.98 (95% CI: 0.55-1.72); final logMAR visual acuity was comparable between biosimilar and reference biologic groups (mean difference, -0.0116; -0.0983 to 0.0751). For safety outcomes, the risk ratios for ophthalmic, minor systemic, and major systemic adverse events were 1.02 (0.30-3.45), 1.24 (0.72-2.14), and 1.99 (0.67-5.87), respectively. The risk ratios for drug discontinuation due to lack of effectiveness and adverse events were 2.44 (0.80-7.45) and 1.56 (0.79-8.31), respectively. Most included studies were assessed as having a "serious" risk of bias, largely driven by confounding, and the overall certainty of evidence was graded as "low". Conclusions: Currently, the available evidence is of low quality and demonstrates insufficient support for a meaningful difference in terms of effectiveness and safety when switching patients with NIU to biosimilars from their reference biologics.

Source: Clinical ophthalmology

DOI: 10.2147/opth.s606642