Efficacy and Safety of Switching from Adalimumab Originator to SB5 Biosimilar in Noninfectious Uveitis: Early Clinical Outcomes.
Ji Hun Song, Chungwoon Kim, Yoo-Ri Chung, Hae Rang Kim
Abstract
Open AccessBackground/Objectives: To evaluate the real-world efficacy and safety of switching from adalimumab originator (Humira®, AbbVie) to SB5 biosimilar (Adalloce®, Samsung Bioepis) in patients with noninfectious uveitis. Methods: This retrospective study included 18 patients (32 eyes) who switched from adalimumab originator to SB5 for nonmedical reasons with at least 6 months follow-up. Clinical outcomes-best-corrected visual acuity (BCVA), intraocular pressure (IOP), anterior chamber (AC) cell grade, vitreous haze grade, central macular thickness (CMT), and macular volume (MV)-were assessed at baseline and 2, 4, and 6 months post-switch. Ultra-widefield fluorescein angiography (UWFA) findings were compared at approximately 4 months. Pre- versus post-switch comparisons employed Wilcoxon signed-rank tests. Results: Mean patient age was 45.7 ± 13.4 years, with mean follow-up of 16.8 ± 5.9 (range, 9-29) months. No significant changes were observed in BCVA, IOP, AC cell grade, vitreous haze grade, CMT, or MV at any timepoint versus baseline (all p > 0.05). No uveitis recurrence occurred based on predefined criteria including AC cell grade, vitreous haze grade, BCVA, and UWFA findings. Five patients (28%) re-switched to the originator after a mean of 24 (range, 4-64) weeks due to injection-site discomfort (n = 2) or extremity rashes (n = 3). No other adverse events were observed. Conclusions: Switching from adalimumab originator to SB5 biosimilar maintained clinical stability with comparable efficacy and safety in patients with noninfectious uveitis, supporting its use as a cost-effective alternative.