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Anifrolumab for the treatment of lupus

Results of the TULIP-1 and TULIP-2 trials, approval news, and discussion on lupus trial endpoints

What you need to know

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.

Regulatory approvals

Feature article

07-04-2020 | Systemic lupus erythematosus | Feature | Article

In pursuit of new lupus therapies: The importance of trial endpoints

Eric Morand explores the reasons why the TULIP-1 and TULIP-2 trials of anifrolumab found different primary results, and discusses the search for optimal endpoints in lupus trials.

Related news

23-02-2022 | Systemic lupus erythematosus | News

Anifrolumab benefits extend across multiple organ domains in SLE

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.

15-02-2022 | Lupus nephritis | News

Intensified anifrolumab regimen may warrant further investigation for lupus nephritis

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.

30-11-2020 | Systemic lupus erythematosus | News

Subcutaneous delivery feasible for anifrolumab in SLE

Phase 2 study data suggest that subcutaneous administration is a feasible option for treatment with the type I interferon receptor inhibitor anifrolumab in patients with systemic lupus erythematosus.