Inebilizumab shows sound efficacy in landmark research

Amgen has announced a breakthrough in the treatment of Immunoglobulin G4-related disease (IgG4-RD) with its phase 3 clinical trial of inebilizumab showing an 87% reduction in disease flares.

This significant result marks the first randomized, placebo-controlled trial to demonstrate a benefit in IgG4-RD, a rare and often devastating condition.

The trial, known as MITIGATE, met all primary and key secondary endpoints, including a reduction in the annualized flare rate and achieving flare-free, treatment-free complete remission.

The safety profile of inebilizumab remained consistent with previous findings, with no new safety concerns arising.

Jay Bradner, executive vice president of Research and Development at Amgen, expressed the importance of these findings: “MITIGATE is a landmark study with results that demonstrate an important advance in the treatment of patients with IgG4-RD. We look forward to bringing this therapy to those living with IgG4-RD.”

IgG4-RD is a chronic, systemic, immune-mediated disease that can lead to irreversible organ damage. The MITIGATE trial’s novel, steroid-sparing design offers a potential reduction in treatment toxicity.

John Stone, the principal investigator of the study, highlighted the impact of the trial: “These data mark a major milestone for the IgG4-RD community and provide substantial insight into not only how inebilizumab can help manage IgG4-RD, but also key insights into the nature of this condition.”

Uplizna (inebilizumab), currently approved for Neuromyelitis Optica Spectrum Disorder, is set to be filed for approval in the U.S. and other key markets based on the MITIGATE trial results.

This promising development could soon offer a new, approved therapy for those affected by IgG4-RD.