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A new drug may spare IgG4-related disease patients from steroid side effects. Data from the phase 3 INDIGO trial show that obexelimab significantly reduced glucocorticoid-associated toxicity over 52 weeks compared to placebo. Notably, only 29% of patients on obexelimab experienced significant cumulative steroid toxicity, versus 49% on placebo — roughly one in five fewer patients harmed by steroids.
A phase 3 trial shows obexelimab does more than just cut steroid doses — it actually reduces the harm steroids cause.
Presented at ACR Convergence 2026, the INDIGO trial evaluated obexelimab — a dual-function monoclonal antibody that inhibits B-cell activity by co-engaging CD19 and FcγRIIb — against placebo in patients with IgG4-related disease. All participants underwent glucocorticoid induction therapy before being randomized to weekly subcutaneous obexelimab or placebo for 52 weeks, with steroids tapered to discontinuation by week 8.
The results were clear: obexelimab outperformed placebo on the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) at both 24 and 52 weeks, with meaningful reductions in infection risk, glucocorticoid myopathy, and neuropsychiatric toxicity. Skin toxicity was similar between groups, and a small uptick in hyperlipidemia was noted in the treatment arm.
By the Numbers:
Why it matters: Steroids are the go-to treatment for IgG4-related disease, but long-term use carries serious risks and relapses are common when tapering. Obexelimab offers a path to not just reducing steroid exposure, but meaningfully protecting patients from the cumulative damage those steroids cause.
