Amgen declares positive results from phase 3 trial of Uplizna for treatment of immunoglobulin g4-related disease

Amgen shared positive results from its phase 3 trial (NCT04540497) on Uplizna (inebilizumab-cdon) for treating immunoglobulin G4-related disease (IgG4-RD).

The study achieved its primary endpoint, showing an 87% reduction in IgG4-RD flare risk versus placebo over 52 weeks. All secondary endpoints, including remission rates, were met. Safety profiles were consistent with Uplizna's known profile.

MITIGATE, spanning 80 sites across 22 countries, is the first placebo-controlled trial offering class 1 evidence for IgG4-RD treatment. Its steroid-sparing approach could reduce treatment toxicity.

Uplizna, approved for Neuromyelitis Optica Spectrum Disorder (NMOSD), aims for regulatory approval in the US and elsewhere based on MITIGATE's findings.

The trial, enrolling 135 IgG4-RD adults, prioritized those prone to flares. Its primary endpoint measured time to first treated IgG4-RD flare, with secondary endpoints assessing remission rates.

IgG4-RD's systemic nature underscores the need for effective treatments. Uplizna's existing NMOSD approval signals its potential in addressing autoimmune disorders.