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First Patients Dosed in IRIS Phase III Trial Evaluating Anifrolumab in Lupus Nephritis

Anifrolumab is a first-in-class type I interferon receptor antibody

The first patients have been dosed in the IRIS Phase III clinical trial of anifrolumab in lupus nephritis (LN).

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Up to 60% of patients with lupus develop kidney involvement. In more severe cases, this can develop into LN.1 LN is characterized by kidney inflammation and is one of the most common severe organ manifestations in systemic lupus erythematosus (SLE),2 a chronic and complex autoimmune disease in which the immune system attacks healthy tissue in the body.3 Patients with LN are at a substantial increased risk of dialysis and early mortality.4-6 Patients with LN have been shown to have elevated levels of type I interferons in the blood and kidneys.7,8

Eduardo Mysler, Medical Director and Rheumatologist at the Organización Médica de Investigación, Buenos Aires, Argentina, and the international coordinating investigator in the anifrolumab clinical development program for LN, said, “The Phase II results of anifrolumab in lupus nephritis provided important evidence suggesting that blocking type I interferons is a potentially promising strategy for the treatment of lupus nephritis. I look forward to contributing to the next phase of anifrolumab’s development in this severe and often debilitating complication of lupus where new therapeutic options are needed.”

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Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Lupus nephritis continues to represent a significant burden to patients worldwide. Following the approval of anifrolumab as the first new treatment for systemic lupus erythematosus in over a decade, the start of our IRIS Phase III trial in lupus nephritis is another important step forward in our ambition to bring anifrolumab to more patients with diseases where type I interferon is a central driver.”

Results from the TULIP-LN1 Phase II proof of concept, dose-finding trial of anifrolumab were published in Annals of the Rheumatic Diseases in February 2022.9 The primary endpoint was the change in a measure of kidney function (baseline 24-hour urine protein creatinine ratio) at week 52 for combined anifrolumab versus placebo groups. Although the trial’s primary endpoint was not met (69% versus 70%, p=0.905), the higher dose tested showed clinically meaningful numeric improvements across multiple secondary and exploratory endpoints versus placebo (with all patients also receiving standard therapy).9 The adverse events that were more common (≥5% difference) in the combined anifrolumab versus placebo groups were herpes zoster, urinary tract infection, and influenza.9

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