Title: The efficacy and safety of abatacept in patients with non-life-threatening manifestations of SLE: Results of A 12-month exploratory study
Authors: Merrill, J T ×
Burgos-Vargas, R
Westhovens, Rene
Chalmers, A
D'Cruz, D
Wallace, D J
Bae, S C
Sigal, L
Becker, J-C
Kelly, S
Raghupathi, K
Peng, Y
Kinaszczuk, M
Nash, P #
Issue Date: Oct-2010
Publisher: John Wiley & Sons
Series Title: Arthritis and Rheumatism vol:62 issue:10 pages:3077-3087
Abstract: OBJECTIVE:: To evaluate abatacept in patients with non-life-threatening SLE polyarthritis/discoid lesions/pleuritis and/or pericarditis. METHODS:: In a 1-year, exploratory, Phase II trial, SLE patients with polyarthritis/discoid lesions/pleuritis and/or pericarditis were randomized 2:1 to abatacept ( approximately 10 mg/kg) or placebo. Prednisone (30 mg/day or equivalent) was given for 1 month, then tapered. The primary endpoint was the proportion of patients with new adjudicated BILAG A/B flare after start of steroid taper. RESULTS:: 118 patients were randomized to abatacept and 57 to placebo; baseline characteristics were similar between groups. The proportion of new BILAG A/B flare over 1 year (95% CIs) was 79.7% (72.4, 86.9) for abatacept- versus 82.5% (72.6, 92.3) for placebo-treated patients (treatment difference [95% CI] -3.5 [-15.3, 8.3]). Other prespecified flare endpoints were not met. In post-hoc analyses, the proportion of abatacept- versus placebo-treated patients with BILAG A flare was 40.7% (31.8, 49.5) versus 54.4% (41.5, 67.3), and the proportion with physician-assessed flare was 63.6% (54.9, 72.2) versus 82.5% (72.6, 92.3), respectively; treatment differences were greatest in the polyarthritis group. Prespecified exploratory patient-reported outcomes (Short-Form 36, sleep problems, fatigue) demonstrated a treatment effect with abatacept. Adverse event (AE) frequency was comparable (90.9 vs 91.5%), but serious AEs (SAEs) were higher (19.8 vs 6.8%) for abatacept. Most SAEs were single disease-related events, occurring in the first 6 months (including steroid taper period). CONCLUSION:: Although primary/secondary endpoints were not met, improvements in certain exploratory measures suggest some abatacept efficacy in patients with non-life-threatening manifestations of SLE. The increased SAE rate requires further assessment.
ISSN: 0004-3591
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Rheumatology Section (-)
× corresponding author
# (joint) last author

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