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.
The first phase III trial of anifrolumab has failed to show a significant overall benefit for patients with systemic lupus erythematosus when taken in addition to standard care, but does demonstrate some clinical response improvements that the researchers say deserve further investigation.