Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Summary

The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

Timeline

Start

2016-06-30

Primary completion

2021-12-21

Completion

2021-12-21

Publications

• Strand V, Kalunian KC, Lee KW, Seo C, Abreu G, Tummala R, Al-Mossawi H, Duncan EA, Lindholm C. Long-term effect of anifrolumab on patient-reported outcomes in systemic lupus erythematosus (TULIP-LTE): a randomised, placebo-controlled, phase 3 long-term extension trial. Lancet Rheumatol. 2025 Jul;7(7):e485-e494. doi: 10.1016/S2665-9913(25)00022-0. Epub 2025 May 2.
• Tanaka Y, Atsumi T, Okada M, Miyamura T, Ishii T, Nishiyama S, Matsumura R, Kawakami A, Hayashi N, Abreu G, Yavuz S, Lindholm C, Al-Mossawi H, Takeuchi T. The long-term safety and tolerability of anifrolumab for patients with systemic lupus erythematosus in Japan: TULIP-LTE subgroup analysis. Mod Rheumatol. 2024 Jul 6;34(4):720-731. doi: 10.1093/mr/road092.
• Kalunian KC, Furie R, Morand EF, Bruce IN, Manzi S, Tanaka Y, Winthrop K, Hupka I, Zhang LJ, Werther S, Abreu G, Hultquist M, Tummala R, Lindholm C, Al-Mossawi H. A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2023 Feb;75(2):253-265. doi: 10.1002/art.42392. Epub 2022 Nov 11.

Drugs

Indications