AstraZeneca has announced positive topline data from the phase 3 TULIP 2 trial of anifrolumab for the treatment of systemic lupus erythematosus (SLE).

Anifrolumab is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor and blocking all type I IFNs including IFN-alpha, IFN-beta and IFN-omega.

The TULIP 2 trial is a multicenter, double-blind, placebo-controlled study that evaluated the efficacy and safety of anifrolumab in 373 adult patients with moderately to severely active SLE. Patients were randomized 1:1 to receive a fixed-dose intravenous (IV) infusion of anifrolumab 300mg or placebo every 4 weeks for a total of 13 doses. The primary end point was the number of patients who achieved a reduction in disease activity at Week 52, as measured by the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA); BICLA requires improvement in all organs with disease activity with no new flares.

Results showed that anifrolumab had a statistically significant and clinically-meaningful reduction in disease activity with a positive BICLA response compared to placebo. BICLA was also used as a pre-specified end point in the previous phase 3 TULIP 1 trial and were consistent with the positive BICLA response observed in the TULIP 2 trial. 

Full detailed data from TULIP 1 and TULIP 2 will be submitted for presentation at a future medical meeting.

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“We look forward to seeing the full results of the study and further progress in evaluating anifrolumab as a potential therapy,” said Lupus Research Alliance President and CEO Kenneth M. Farber.

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