The efficacy and safety of abatacept in patients with non–life‐threatening manifestations of systemic lupus erythematosus: Results of a twelve‐month, multicenter, exploratory, phase IIb, randomized, double‐blind, placebo‐controlled trial

摘要: Objective. To evaluate abatacept therapy in patients with non-life-threatening systemic lupus erythematosus (SLE) and polyarthritis, discoid lesions, or pleuritis and/or pericarditis. Methods. In a 12-month, multicenter, exploratory, phase IIb randomized, double-blind, placebo-controlled trial, SLE pericarditis were randomized at ratio of 2:1 to receive (∼10 mg/kg body weight) placebo. Prednisone (30 mg/day equivalent) was given for 1 month, then the dosage tapered. The primary end point proportion new flare (adjudicated) according score A/B on British Isles Lupus Assessment Group (BILAG) index after start steroid taper. Results. A total 118 57 baseline characteristics similar 2 groups. BILAG flares over 12 months 79.7% (95% confidence interval [95% CI] 72.4, 86.9) group 82.5% CI 72.6, 92.3) placebo (treatment difference -3.5 -15.3, 8.3]). Other prespecified points not met. post hoc analyses, proportions abatacept-treated placebo-treated 40.7% 31.8, 49.5) versus 54.4% 41.5, 67.3), physician-assessed 63.6% 54.9, 72.2) 92.3), respectively; treatment differences greatest polyarthritis group. Prespecified exploratory patient-reported outcomes (Short Form 36 health survey, sleep problems, fatigue) demonstrated effect abatacept. frequency adverse events (AEs) comparable groups (90.9% 91.5%), but serious AEs (SAEs) higher (19.8 6.8%). Most SAEs single, disease-related occurring during first 6 study (including taper period). Conclusion. Although primary/secondary met this study, improvements certain measures suggest some efficacy manifestations SLE. increased rate requires further assessment.