John Stone, MD, MPH: Continuing Progress With IgG4-Related Disease Research

Inebilizumab was well-tolerated in people with IgG4-related disease and reduced the risk of flares by 87% compared to placebo by CD19-targeted B cell depletion.

These findings, from the phase 3 MITIGATE study, were presented by primary investigator John Stone, MD, MPH, director, clinical rheumatology at Mass General Hospital, and Professor of Medicine at Harvard Medical School, and founder and executive chairman at The IgG4ward! Foundation, at the American College of Rheumatology (ACR) Convergence 2024, held November 14-19 in Washington, DC.

The MITIGATE study met its primary endpoint, with the inebilizumab group having a hazard ratio of flares of 0.13 (95% CI, 0.06-0.28; P <.0001) compared to placebo. The inebilizumab group had an infusion related reaction rate of 4.4% (n = 3) and an opportunistic infection rate of 8.8% (n = 6), compared to the placebo group’s 7.5% (n = 5) and 3.0% (n = 2), respectively.

“Basic epidemiology and basic demographics are important [to understand]. The disease only got its own ICD-10 code about a year ago, so now, armed with that ICD010 code, we can really begin to understand the epidemiology better,” Stone told HCPLive® during the meeting.

Stone discussed the recent progress of research for IgG4 and questions that remain to be answered about the disease. He touched on the potential of cell therapies to also target B-cells for treating IgG4. Lastly, he noted that The IgG4ward! Foundation which he founded last year recently had its first patient jamboree, which importantly brought together patients with this rare disease.

“There are still many questions about the disease, but we have gone from patients to beginning to understanding their disease to having an understanding that's sufficient enough to develop a new therapy and then demonstrating that that therapy works in a clinical trial. So, it's a really exciting time for people living with IgG4-related disease,” Stone said.

Relevant disclosure for Stone include Amgen, Argenx, Bristol-Myers Squibb, Novartis, Sanofi, and Zenas.

REFERENCE

Stone J, Culver E, Khosroshahi A, et al. A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab in IgG4-Related Disease (MITIGATE): Primary Efficacy and Safety Findings. Presented at: ACR Convergence 2024, November 14-19; Washington, DC.