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.

OBJECTIVES

The aim of this study is to investigate the efficacy of anifrolumab in disease activity and glucocorticoid (GC) tapering patterns in Japanese patients with systemic lupus erythematosus (SLE).

METHODS

We analysed disease activity and GC tapering in the Japanese subpopulation (anifrolumab, n = 24; placebo, n = 19) of the Treatment of Uncontrolled Lupus via the Interferon Pathway (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 in the placebo group [50.0% (12/24) vs 15.8% (3/19); P = .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 the observed time vs 0/19 (0.0%), and 14/24 (58.3%) vs 6/19 (31.6%) patients were classified into favourable GC tapering patterns. Anifrolumab had an acceptable tolerability profile, consistent with the overall population.

CONCLUSIONS

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