Abstract
Purpose :
Systemic immunosuppression is core to the management of non-infectious uveitis (NIU). Often, clinicians use targeted 'biologic' therapies - molecules (antibodies or their fragments) isolated from living organisms (or their cells) that target specific components of the immunologic pathway and prevent downstream immunogenic signaling. Though highly effective, biologics often carry significant patient and health-system costs and thus may not be easily accessible. To reduce barriers to care, there exist 'biosimilar' medications - molecules that are analogous to their reference biologic, though produced by a different manufacturer than the originator medication. Although biosimilars are assumed to be equivalent to their reference biologics, their utility in the management of NIU remains unclear. This study comprehensively examines the safety and efficacy of biosimilars in comparison to their reference biologics in the treatment of NIU.
Methods :
We conducted a systematic review and meta-analysis. We searched 16 electronic databases, from inception until December 2, 2023, for studies examining patients crossing-over from any type of reference biologic therapy to biosimilar therapy, for NIU. Our search was done without study type or language restrictions and was supplemented with searching of the grey literature and manual-review of references. Our primary outcome was the number of NIU flares. We summarized our analyses by calculating unilateral weighted pooled means, as well as weighted mean differences for continuous outcomes and relative risks for dichotomous outcomes, with associated 95% confidence intervals.
Results :
10 observational studies, (422 eyes) were eligible. The number of flares did not differ significantly between biosimilar (7.0) and reference (11.2) therapy. Central macular thickness was similar following the switch from reference biologic (303.73μm) to biosimilar (290.35μm) treatment. Patients spent a mean of 38-months on reference therapy prior to switching, and remained on their biosimilar for a mean of 26.8-months.
Conclusions :
Our work suggests that biosimilars have equivalent safety and efficacy to their reference medications in the management of NIU. Given that all available evidence is drawn from observational studies, further research, in the form of rigorous randomized trials, is required to generalize these findings.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.