Effects of atacicept on disease activity in patients with moderate to severe systemic lupus erythematosus: APRIL-SLE randomized trial
© Isenberg et al.; licensee BioMed Central Ltd. 2014
Published: 18 September 2014
Atacicept is a fusion protein that inhibits B-cell stimulating factors BLyS and APRIL, which are elevated in systemic lupus erythematosus (SLE). Atacicept 150 mg (A150) was associated with reduced BILAG A and B flares in the APRIL-SLE study. We examined efficacy of atacicept in preventing flares of SLE disease activity by the BILAG organ system and modified SELENA SLEDAI flare index and assessed corticosteroid use during a previously reported trial of atacicept versus placebo (PLC).
Subjects with active SLE were treated with corticosteroid taper for 12 weeks. Subjects reaching BILAG C or D at weeks 10 and 12 were randomized at baseline 1:1:1 to receive PLC, atacicept 75 mg (A75) or A150 twice weekly every 4 weeks then weekly for 48 weeks. All patients received standard of care. Analysis was performed in the modified intention-to-treat population. BILAG and SELENA SLEDAI flares and corticosteroid usage were assessed 4 weekly.
Corticosteroid exposure post-randomization, modified intention-to-treat population
Atacicept 75 mg
Atacicept 150 mg
( n = 154)
( n = 157)
( n = 144)
Zero dose increases, n (%)
(n = 154)
(n = 157)
(n = 143)
Corticosteroids ≥20 mg/day, n (%)
Reduction of the individual BILAG system and severe SELENA SLEDAI flares and corticosteroid use was associated with A150 treatment. Analysis of potential predictive biomarkers identified a subgroup of patients with higher BLyS and APRIL levels at baseline more likely to benefit from treatment. Further studies are required to clarify safety and efficacy of atacicept in SLE patients and associations between biomarkers and clinical response to atacicept.
EudraCT: 2007-003698-13, NCT00624338
Merck Serono S.A. Geneva, Switzerland: an affiliate of Merck KGaA, Darmstadt, Germany.
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