The efficacy and safety of anifrolumab in Japanese patients with systemic lupus erythematosus: TULIP-2 subanalysis.

Abstract

OBJECTIVES:

Evaluate the efficacy and safety of anifrolumab in the subpopulation of Japanese patients with systemic lupus erythematosus (SLE) in phase 3 TULIP-2 trial.

METHODS:

TULIP-2 was a 52-week randomized placebo-controlled trial (N = 362) that evaluated efficacy and safety of anifrolumab 300 mg IV every 4 weeks vs. placebo in patients with moderate to severe SLE who were receiving standard therapy. We performed a post hoc analysis of the primary and key secondary endpoints, and safety, of TULIP-2 in the Japanese subpopulation.

RESULTS:

In the Japanese subpopulation (anifrolumab, n = 24; placebo, n = 19), the proportion of patients who achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment response at Week 52 (primary endpoint) was greater in the anifrolumab group vs. placebo [50.0% (12/24) vs. 15.8% (3/19); treatment difference: 34.2%, 95% confidence interval 6.9, 61.5; nominal p = .014]. Improvement in skin activity and flare rates (key secondary endpoints) were favourable for anifrolumab vs. placebo. Consistent with the overall population, anifrolumab had an acceptable safety and tolerability profile.

CONCLUSIONS:

The efficacy and safety of anifrolumab 300 mg in Japanese patients with SLE was consistent with the demonstrated clinical profile of anifrolumab for the overall TULIP-2 population.

• Authors: Yoshiya Tanaka, Tatsuya Atsumi, Masato Okada, Tomoya Miyamura, Tomonori Ishii, Susumu Nishiyama, Ryutaro Matsumura, Nobuya Hayashi, Gabriel Abreu, Raj Tummala, Eric F Morand, Tsutomu Takeuchi
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 33 Issue 1 Pg. 134-144 (Jan 03 2023) ISSN: 1439-7609 [Electronic] England
• PMID: 35134970 (Publication Type: Randomized Controlled Trial, Journal Article)
• Copyright: © Japan College of Rheumatology 2022. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• anifrolumab
• Antibodies, Monoclonal, Humanized

Topics

• Humans
• Tulipa
• East Asian People
• Antibodies, Monoclonal, Humanized (adverse effects)
• Lupus Erythematosus, Systemic (drug therapy)
• Treatment Outcome
• Double-Blind Method