Autoinflammatory & rare systemic diseases
Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial
Authors' conclusion
All patients except for one had clinical responses to obexelimab treatment.
Study context
- Population
- Patients aged 18–80 years with active IgG4-RD (IgG4-RD responder index score ≥3), Massachusetts General Hospital, Boston, MA, USA
- Participants
- 15 patients
- Outcome
- Proportion of patients with a decrease of ≥2 from baseline in the IgG4-RD responder index (primary responders)
- Follow-up
- Day 169
Methodological detailsopen-label, single-arm, single centre, Enrolled Feb 24, 2016, to Dec 21, 2016
- Open-label
- Single-arm
- Single centre
- Enrolled Feb 24, 2016, to Dec 21, 2016
Main finding
As reported in the abstract
Primary responders (decrease ≥2 from baseline in IgG4-RD responder index)
Patients achieving the primary endpoint
12 (80%) of 15
Further findings
Responders (decrease ≥2 in IgG4-RD responder index at any visit)
- Patients defined as responders
- 14 (93%)
Serum B cells and plasmablasts
- Reductions from baseline in serum B cells and plasmablasts following obexelimab
- In most patients with follow-up data, serum B cells recovered to 75% of baseline within 42 days of the final dose
Safety
Adverse events
- Patients reporting AEs
- 13 (87%) of 15
- AE (infusion reaction) resulting in treatment discontinuation
- 1
Original publication
Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial. Lancet Rheumatol. Published 24 July 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →