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

Objectives To describe the efficacy of anifrolumab versus placebo in Japanese systemic lupus erythematosus (SLE) patients with low complement (C3 or C4) and/or who are positive for anti-double stranded DNA antibodies.Methods This was a descriptive post hoc analysis of Japanese SLE patients with serological manifestations in the Treatment of Uncontrolled Lupus via the Interferon Pathway-2 (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-double stranded DNA 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.