Amgen reports positive results for treatment of IgG4-RD

Amgen HQ

Amgen has reported positive topline results from its randomised, double-blind, multicentre, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of its treatment for Immunoglobulin G4-related disease (IgG4-RD).

The company’s MITIGATE study was designed to evaluate the safety and efficacy of UPLINZA compared to placebo in reducing the risk of flares in adults with IgG4-RD.

IgG4-RD is a progressive disease that affects multiple organs over time and is characterised by periods of remission and unpredictable flare-ups.

The MITIGATE study enrolled 135 adults with IgG4-RD who met criteria which included being treated with glucocorticoids at the time of screening to ensure the patient cohort were at risk of flare-ups for the primary endpoint.

The trial met its primary endpoint with 87% of the patient cohort showing a reduction in the risk of flare-ups compared to the placebo therapy. The trial also met all key secondary endpoints including annualised flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission.

A major milestone for IgG4-RD treatment

“MITIGATE is a landmark study with results that demonstrate an important advance in the treatment of patients with IgG4-RD, a devastating and rare disease that currently has no approved therapy,” said Jay Bradner, Executive Vice President, Research and Development, and Chief Scientific Officer at Amgen. “We are grateful for the partnership with patients, clinicians and patient advocacy groups critical to a successful study, and we look forward to bringing this therapy to those living with IgG4-RD.”

“IgG4-RD is a devastating, chronic, immune-mediated disease that has just begun to be fully understood over the last few decades,” said John Stone, Principal Investigator, and a Professor of Medicine at Harvard Medical School and the Edward A Fox Chair in Medicine at the Massachusetts General Hospital. “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.”

Amgen is now planning to file for approval in the US following results on the MITIGATE study.

Reece Armstrong, Editor, DDW

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