Relationship of anifrolumab pharmacokinetics with efficacy and safety in patients with systemic lupus erythematosus.

ABSTRACT:

Objectives

To characterize the relationship of anifrolumab pharmacokinetics with efficacy and safety in patients with moderate to severe SLE despite standard therapy, using pooled data from two phase 3 trials.

Methods

TULIP-1 and TULIP-2 were randomized, placebo-controlled, 52-week trials of intravenous anifrolumab (every 4 weeks for 48 weeks). For the exposure-response analysis, BILAG-based Composite Lupus Assessment (BICLA) or SLE Responder Index [SRI(4)] response rates at week 52 in each quartile/tertile of average anifrolumab serum concentration (Cave) were compared for anifrolumab and placebo in all-comers, patients who completed treatment, and IFN gene signature (IFNGS)-high patients who completed treatment, using average marginal effect logistic regression. Relationsh

SUBMITTER: Chia YL 

PROVIDER: S-EPMC9071514 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature