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Anifrolumab meets endpoint in phase 2 study of patients with SLE
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Anifrolumab met its primary endpoint of reduced disease activity in a greater proportion of patients with systemic lupus erythematosus compared to placebo, according to a study presented at the American College of Rheumatology Annual Meeting.
In the phase 2, randomized, double-blind, placebo-controlled study, researchers studied data from 305 patients with moderate-to-severe systemic lupus erythematosus (SLE). Patients were randomized to receive IV 300-mg or 1,000-mg anifrolumab, a type 1 interferon inhibitor, or placebo every 4 weeks for 48 weeks.
At day 169, they found that 34.3% of patients who received 300-mg anifrolumab and 28.8% of patients who received 1,000-mg anifrolumab met the primary endpoint of a sustained reduction in oral corticosteroid use to less than 10 mg per day, no more than one maintained between days 85 and 169 and SLE Responder Index (SRI) response compared to 17.6% of patients who received placebo.
A secondary endpoint of an improvement of the SRI and a sustained reduction of oral corticosteroids to 7.5 mg or less per day at day 365 in patients who received 10 mg or more was met by 56.4% of patients who received 300-mg anifrolumab, 31.7% of patients who received 1,000-mg anifrolumab and by 26.6% pf patients who received placebo.
Multiple global and organ-specific benefits were associated with treatment with anifrolumab, including a 50% reduction of the 28-joint count scores and a 50% reduction of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score. Lower rates of British Isles Lupus Assessment Group (BILAG) 2004-defined moderate or severe flares were observed in patients in the treatment groups. – by Shirley Pulawski
Reference:
Furie RA, et al. Paper #3223. Presented at: American College of Rheumatology Annual Meeting; Nov. 7-11, 2015; San Francisco.
Disclosure: Furie reports the receipt of funding from MedImmune. Please see the full study for a list of all other authors’ relevant financial disclosures.