Disease activity and glucocorticoid tapering patterns in Japanese patients with systemic lupus erythematosus treated with anifrolumab: post hoc analysis of the Japanese subpopulation of the TULIP-2 study.

Abstract

Objectives: To investigate the efficacy of anifrolumab on disease activity and glucocorticoid tapering patterns in Japanese patients with systemic lupus erythematosus (SLE).

Methods: We analysed disease activity and glucocorticoid tapering in the Japanese subpopulation (anifrolumab, n = 24; placebo, n = 19) of the TULIP-2 trial, which showed the efficacy and safety of anifrolumab in patients with moderate-to-severe active SLE.

Results: The percentage of patients who achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment response at Week 52 was greater in the anifrolumab group than placebo [50.0% (12/24) vs. 15.8% (3/19); p = 0.014]. Lupus low disease activity state (LLDAS) was achieved at Week 52 by 9/24 (37.5%) and 3/19 (15.8%) patients receiving anifrolumab and placebo, respectively. During the 52-week study period, in the anifrolumab vs. placebo groups, 5/24 (20.8%) patients were in LLDAS ≥50% of observed time vs. 0/19 (0.0%), and 14/24 (58.3%) vs. 6/19 (31.6%) patients were classified into favourable glucocorticoids tapering pattern. Anifrolumab had an acceptable tolerability profile, consistent with the overall population.

Conclusions: In the Japanese subpopulation of the TULIP-2 trial, anifrolumab resulted in an improvements in disease activity to those reported for the overall population, suggesting a beneficial effect for disease control.