AMGN•AMGN•Phase 3 MITIGATE open-label data show UPLIZNA produced 0% flares and 71.4% glucocorticoid-free remission at year one in 56 IgG4-RD patients, while 5.9% of the 51 placebo-switched patients flared and 41.2% achieved remission. Real-world TAVNEOS use in 159 ANCA vasculitis patients enabled shorter steroid tapering with resolved hepatic events.
Data from the Phase 3 MITIGATE open-label extension show that none of the 56 patients who continued UPLIZNA experienced disease flares over one year, with 71.4% achieving glucocorticoid-free complete remission. Among 51 patients switching from placebo, 5.9% flared and 41.2% reached complete remission, with safety events consistent with the established profile, including COVID-19 and upper respiratory infections.
An analysis of 159 ANCA-associated vasculitis patients treated with TAVNEOS demonstrated maintained disease control alongside rapid glucocorticoid tapering, with many patients reducing to minimal or no steroid use within two months. Hepatic abnormalities resolved in all cases and overall safety outcomes aligned with clinical trial experience, supporting potential for shorter steroid regimens.
Natural history assessment within MITIGATE identified CD19+ B-cell rises as the first biomarker signal preceding flares, followed by increases in total IgG and IgG subsets within 30 days of flare onset. Dynamic patterns of new organ involvement underscored the chronic, unpredictable nature of IgG4-related disease and the need for early intervention.
