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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.

approvalsWatch

FDA approves anifrolumab for moderate-to-severe SLE

The US FDA has approved anifrolumab-fnia for the treatment of adult patients with moderate-to-severe SLE who are receiving standard therapy.

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

11-11-2019 | Systemic lupus erythematosus | ACR/ARP 2019 | News

TULIP-1 results fail to support phase II findings for anifrolumab in SLE

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.

13-11-2019 | Systemic lupus erythematosus | ACR/ARP 2019 | News

TULIP-2 meets primary endpoint for anifrolumab efficacy in SLE

Anifrolumab has shown clinical efficacy in systemic lupus erythematosus, based on BICLA response as the primary outcome, TULIP-2 results show.

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.

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