Uveitis with teclistamab and elranatamab: infection or inflammation?
In 2026, the FDA identified uveitis as a potential serious risk signal for the BCMA×CD3 bispecific antibodies teclistamab and elranatamab. Because uveitis in this setting may reflect opportunistic infection or immune-mediated inflammation—conditions requiring opposite management—the researchers sought to distinguish these causes.
They analyzed FDA Adverse Event Reporting System reports from July 2020 to June 2026, using 8,690,601 reports after deduplication, with a case-non-case design and calculated reporting odds ratios and the information component for primary-suspect reports. Comparators included belantamab mafodotin, talquetamab, and CD3 bispecific antibodies used outside myeloma. All primary-suspect uveitis reports (n = 76) were classified by a physician blinded to a rule-based algorithm as infectious, probable immune-mediated, or indeterminate.
Uveitis was reported in 18 of 2,995 teclistamab reports and 29 of 1,691 elranatamab reports, corresponding to reporting odds ratios of 4.10 (95% CI 2.58–6.52) and 11.85 (95% CI 8.21–17.12). Among these 47 cases, 20 were infectious, including 18 with cytomegalovirus chorioretinitis and a median onset of 92 days; infection-specified uveitis was disproportionately reported for both agents and for CD3 bispecifics used outside myeloma. Thirteen cases were immune-mediated, arose early (median onset 4 days), and six were co-reported with cytokine release syndrome; immune-mediated uveitis showed a signal only for elranatamab (8 cases; ROR 3.59, 95% CI 1.79–7.18), not for teclistamab or any comparator. Six of the eight elranatamab cases originated from Japan. Agreement between physician classification and the algorithm was 98.7%.
The authors conclude that the FDA uveitis signal appears to comprise a late infectious uveitis shared by most T-cell-redirecting bispecific antibodies examined and an early immune-mediated uveitis signaled only with elranatamab. These hypothesis-generating findings support prompt ophthalmological assessment of new visual symptoms and exclusion of CMV retinitis before corticosteroids are started.