Uplizna reduces IgG4 related disease flare risk by 87% in MITIGATE trial
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Key takeaways:
- Uplizna met all primary and secondary endpoints for treatment of IgG4 related disease.
- MITIGATE was the first placebo-controlled trial to show benefit in IgG4 related disease.
The monoclonal antibody Uplizna met key endpoints in a phase 3 trial for the treatment of IgG4-related disease, marking the first time a placebo-controlled study has shown benefit in the condition, according to a press release from Amgen.
Topline results from the double-blind, randomized trial, called MITIGATE, demonstrated an 87% reduced risk for IgG4-related disease (IgG4-RD) flare in patients who received Uplizna (inebilizumab-cdon, Amgen) vs. placebo, and yielded no new safety signals for the drug. The trial also met all key secondary endpoints, including annualized flare rate; flare-free and treatment-free complete remission; and flare-free, corticosteroid-free complete remission.
“The results are incredibly exciting for the IgG4-RD community,” study investigator Zachary Wallace, MD, MSc, an associate professor of medicine at Massachusetts General Hospital, told Healio.
“Today, for the first time, we know that there is an effective therapy to treat patients living with IgG4-RD,” he added. “These topline results give tremendous hope to patients with IgG4-RD, as well as their caregivers and clinicians. Besides demonstrating inebilizumab’s efficacy for IgG4-RD, these data will be key to teaching us more about this disease and its natural history.”
MITIGATE is the first placebo-controlled trial to provide class 1 evidence in the treatment of IgG4-RD, according to the release. The double-blind, parallel-group trial was conducted at 80 sites across 22 countries and enrolled 135 adults with IgG4-RD. Its “novel, steroid-sparing study design paves the way for a reduced toxicity treatment approach,” Amgen said in the release.
No therapy is currently approved for IgG4-RD, Jay Bradner, MD, executive vice president of research and development, and chief scientific officer at Amgen, said in the release. Amgen stated it plans to file for approval in the United States and other markets based on the MITIGATE results.
The FDA previously approved inebilizumab-cdon for neuromyelitis optica spectrum disorder.
“We are grateful for the partnership with patients, clinicians and patient advocacy groups critical to a successful study,” Bradner said. “We look forward to bringing this therapy to those living with IgG4-RD.”
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