Autoinflammatory & rare systemic diseases
Obexelimab for the Treatment of IgG4-Related Disease
Primary result · Time to first disease flare requiring rescue therapyResult — go to the resultHazard ratio 0.44 95% CI 0.28–0.71Authors' conclusion
Among patients with active IgG4-related disease, weekly obexelimab treatment led to a significantly lower risk of disease flare and significantly less glucocorticoid exposure than placebo.
Study context
- Population
- Patients with active IgG4-RD
- Participants
- 194 patients
- Comparison
- Subcutaneous obexelimab 250 mg once weekly vs placebo for 52 weeks, with GC tapered to discontinuation at week 8
- Obexelimabn = 97
- Placebon = 97reference
- Primary endpoint
- Time to first IgG4-RD flare requiring rescue therapy, as determined by both the investigator and the independent adjudication committee
Methodological detailsphase 3, double-blind, placebo-controlled, January 2023 through November 2024
- Phase 3
- Double-blind
- Placebo-controlled
- January 2023 through November 2024
Primary result
As reported in the abstract
Time to first disease flare requiring rescue therapy
Hazard ratio
0.44
95% CI 0.28–0.71
P < 0.001
Events by treatment group
Obexelimabvs Placebo
HR 0.44 (95% CI 0.28–0.71); P < 0.001
Secondary outcomes
Complete remission (key secondary) · week 52
P = 0.005
Cumulative dose of GC rescue therapy (key secondary) · through week 52
P = 0.004
Safety
Arthralgias
Hypersensitivity
Diarrhea
Serious adverse events
Original publication
Obexelimab for the Treatment of IgG4-Related Disease. N Engl J Med. Published 2 June 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →