O24 Flare assessments in patients with active systemic lupus erythematosus (SLE) treated with anifrolumab in 2 phase 3 trials

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Background Anifrolumab treatment improved BICLA response rates in patients with SLE in the phase 3 TULIP-2 and TULIP-1 trials (Morand et al, 2020; Furie et al, 2019). In addition, annualized flare rates were lower with anifrolumab vs placebo. TULIP-2 and TULIP-1 data were analyzed to assess effects of anifrolumab on the number of flares and time to first flare during 52 weeks of treatment. Methods The randomized, double-blind, placebo-controlled TULIP-2 and TULIP-1 trials evaluated efficacy and safety of intravenous anifrolumab (300 mg Q4W) over 52 weeks in patients with moderate to severe SLE despite standard-of-care treatment. Flares were defined as ≥1 new BILAG-2004 A or ≥2 new (worsening) BILAG-2004 B domain scores compared with the prior month’s visit. Number of flares, time to first flare, and annualized flare rate were assessed. Results In TULIP-2 (anifrolumab, n=180; placebo, n=182) and TULIP-1 (anifrolumab, n=180; placebo, n=184), fewer anifrolumab-treated patients experienced ≥1 flare (TULIP-2: 31.1%, n=56; TULIP-1: 36.1%, n=65) vs placebo-treated patients (TULIP-2: 42.3%, n=77; TULIP-1: 43.5%, n=80). Results favoring anifrolumab were observed in time to first flare (TULIP-2: hazard ratio [HR]=0.65, 95% confidence interval [CI] 0.46–0.91; TULIP-1: HR=0.76, 95% CI 0.55–1.06; figure 1) and annualized flare rates (TULIP-2: adjusted rate ratio=0.67, 95% CI 0.48–0.94; TULIP-1: rate ratio=0.83, 95% CI 0.60–1.14). Conclusions Across 2 phase 3 trials, we observed reduced total number of flares and annualized flare rates, as well as prolongation of time to first flare with anifrolumab treatment vs placebo. These results support the potential of anifrolumab to reduce disease activity and reduce flares, benefiting patients with SLE.

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