Inebilizumab demonstrates proven efficacy in groundbreaking study
Amgen announced a breakthrough in the treatment of immunoglobulin G4-related disease (IgG4-RD) after a Phase 3 clinical trial of inebilizumab showed an 87% reduction in disease recurrence.
These important results represent the first randomized, placebo-controlled trial to demonstrate benefit in IgG4-RD, a rare and often devastating condition.
The trial, called MITIGATE, met all primary and key secondary endpoints, including reducing annual relapse rates and achieving relapse-free, treatment-free complete remission.
The safety profile of inebilizumab was consistent with previous findings, and no new safety concerns were raised.
Jay Bradner, Amgen’s executive vice president of research and development, spoke about the importance of these study findings: “MITIGATE is a groundbreaking study with results that demonstrate an important advance in the treatment of patients with IgG4-RD. We look forward to offering this therapy to patients with IgG4-RD.”
IgG4-RD is a chronic, systemic immune-mediated disease that can lead to irreversible organ damage, and the novel steroid-sparing design of the MITIGATE trial promises to reduce treatment toxicity.
John Stone, lead investigator of the study, highlighted the impact of the trial: “These data mark a major milestone for the IgG4-RD community, providing important insights not only into how inebilizumab may help manage IgG4-RD, but also into the nature of the disease.”
Uplizna (inebilizumab), currently approved for the treatment of neuromyelitis optica spectrum disorder, is expected to be submitted for regulatory submission in the U.S. and other major markets based on the results of the MITIGATE trial.
This promising development may soon provide a new approved treatment for people living with IgG4-RD.
