The US FDA authorization of anifrolumab for systemic lupus erythematosus (SLE) in 2021 marked the first drug approval for this disease in 10 years. This approval was based on findings from the phase 3 TULIP-1 and TULIP-2 trials, which had different primary endpoints and reported apparently contradictory results.
Browse this page for perspective on this approval, a summary of the TULIP trial results, and in-depth discussion about the importance of trial endpoints.
Eric Morand gives his thoughts on the FDA approval of anifrolumab for SLE and discusses the need for additional studies to understand exactly how the drug should be used in routine clinical practice.
A post-hoc analysis of data from the TULIP-1 and TULIP-2 trials suggests that anifrolumab treatment improves disease activity across different organ systems among people with moderate-to-severe systemic lupus erythematosus.
Findings from the phase 2 TULIP-LN trial suggest that add-on treatment with an intensified regimen of anifrolumab, a type I interferon receptor inhibitor, may improve some outcomes for patients with lupus nephritis.