LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials.

Objectives: To investigate the long-term impact of anifrolumab versus placebo on lupus low disease activity state (LLDAS) and definition of remission in systemic lupus erythematosus (DORIS) attainment in patients with systemic lupus erythematosus (SLE).

Methods: This post hoc analysis included patients with moderate to severe SLE who were randomly assigned to receive intravenous anifrolumab 300 mg or placebo (once every 4 weeks) in the 52-week, phase 3 TULIP-1/TULIP-2 trials and continued with the same treatment in the 3-year long-term extension. LLDAS/DORIS rates over time were analysed using a stratified Cochran-Mantel-Haenszel approach and logistic regression. Time to first LLDAS/DORIS was estimated using Cox regression. Cumulative time and percentage of time in LLDAS/DORIS were assessed using an analysis of covariance. All P values are nominal.

Results: This analysis included 369 patients (anifrolumab n = 257, placebo n = 112). After 4 years of treatment (at Week 208), 36.9% of anifrolumab-treated patients versus 17.1% of placebo-treated patients were in LLDAS (odds ratio [OR], 2.7; 95% CI, 1.3-5.5; P = .0081); 30.3% versus 18.3% were in DORIS (OR, 1.9; 95% CI, 1.0-3.9; P = .0663). Time to first LLDAS and DORIS favoured anifrolumab versus placebo (LLDAS: hazard ratio, 1.56; 95% CI, 1.18-2.09; P = .0024; DORIS: hazard ratio, 1.50; 95% CI, 1.04-2.22; P = .0373). Cumulative time in LLDAS and DORIS was greater with anifrolumab than that with placebo (P = .0004 and P = .0032, respectively).

Conclusions: LLDAS and DORIS remission, which are associated with favourable outcomes such as reduced damage and mortality in patients with SLE, are attainable and sustainable treatment targets with long-term anifrolumab treatment.