AstraZeneca initiated the Phase III IRIS trial of Saphnelo (anifrolumab) in patients with biopsy-confirmed lupus nephritis. The study will assess Saphnelo’s renal protective effects when added to standard-of-care (MMF and glucocorticoids). This development follows promising data from TULIP-LN and earlier Phase II results. With IRIS, Saphnelo becomes a direct contender to Benlysta in the renal SLE domain, potentially expanding its current label. While outcomes are pending, the initiation signals serious intent to address this high-need population. The study’s completion will be pivotal for regulatory expansion and wider clinical use in nephritis settings.

Citation: https://www.clinicaltrialsarena.com/news/astrazeneca-dosing-ln-trial

Implication: If successful, IRIS could secure label expansion for Saphnelo into lupus nephritis, challenging Benlysta’s lead.