Relationship of anifrolumab pharmacokinetics with efficacy and safety in patients with systemic lupus erythematosus
Rheumatology Sep 20, 2021
Chia YL, Zhang J, Tummala R, et al. - In the TULIP trials, a consistent positive advantage favouring anifrolumab 300 mg vs placebo was reported in BILAG-based Composite Lupus Assessment (BICLA) and SLE Responder Index (SRI[4]) responses across average anifrolumab serum concentration (C ave) subgroups, despite the fact that higher C ave indicated better efficacy.
TULIP-1/TULIP-2 patients that received anifrolumab (150 mg [n = 91], 300 mg [n = 356]) or placebo (n = 366) completed treatment, with 470 having IFNGS high.
BICLA and SRI(4) treatment differences favoring anifrolumab 300 mg vs placebo were evident across C ave subgroups and all analysis populations in the exposure–efficacy analyses.
C ave was revealed as a significant covariate for anticipated BICLA response using logistic regression, with higher anifrolumab C ave predicting greater efficacy.
Through week 52, there was no evidence of an exposure-driven incidence of key safety events in patients receiving anifrolumab 150 or 300 mg.
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