Efficacy of anifrolumab on systemic lupus erythematosus patients with serological manifestations: A post hoc analysis of the Japan subgroup of the TULIP-2 Trial

Abstract Objectives To describe the efficacy of anifrolumab vs. placebo in Japanese systemic lupus erythematosus (SLE) patients with low complement (C3 or C4) and/or who are positive for anti-double stranded DNA (anti-dsDNA) antibodies. Methods This was a descriptive post hoc analysis of Japanese SLE patients with serological manifestations in the TULIP-2 trial who received either anifrolumab or placebo. Results Of the 43 patients enrolled, 79.2% (19/24) and 73.7% (14/19) had low C3, low C4, and/or were positive for anti-dsDNA antibodies at baseline in the anifrolumab and placebo groups, respectively. At week 52, 52.6% (10/19) and 7.1% (1/14) patients in the anifrolumab and placebo groups, respectively, achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response. The proportion of patients who tapered their glucocorticoid (GC) dose throughout the study, without increasing their dose, or who sustained baseline GC doses of ≤7.5 mg/day was numerically higher in the anifrolumab group (78.9% [15/19]) than in the placebo group (50.0% [7/14]). Conclusions In line with the clinical profile of anifrolumab in the TULIP-2 study, the efficacy of anifrolumab was shown in Japanese SLE patients with serological manifestations achieving a BICLA response, and with tapered GC dose or sustained GC doses of ≤7.5 mg/day.