Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Methods: ATLAS is a phase II, placebo controlled, double blind, RCT to determine whether the addition of BIIB023 (3 mg/kg or 20 mg/kg q4wk) to MMF and steroids could increase the 52-week complete or partial renal response (RR) rates in patients with proliferative lupus nephritis. Patients had centrally verified biopsies demonstrating ISN/RPS class III or IV LN and urine protein creatinine ratio (UPCR) >1 mg/mg. All patients were induced with MMF and steroids during the run-in period, but only patients with persistent UPCR >0.5 mg/mg at week 12 were eligible for the addition of BIIB023 or placebo to SOC.
Results: The study enrolled 276 subjects and randomized 188 subjects. 38 (14%) subjects completed run-in but did not qualify for randomization. The trial was prematurely terminated with 145 completing BIIB023/placebo infusions through wk 44. This group was designated the modified-ITT group, with 48 patients on placebo, 49 patients on 3 mg/kg and 48 patients on 20 mg/kg. At wk 52, complete and partial RR were: placebo: 25% (95% CI 15-35); BIIB023 3 mg/kg: 16% (8-25), and BIIB023 20 mg/kg: 31% (20-42). There were no differences between placebo and BIIB023 in time to RR or duration of RR. Dose-dependent reductions of serum and urinary TWEAK were observed. Treatment emergent adverse events were reported in 76% and 85% of placebo and BIIB023-treated subjects respectively. Serious adverse events were reported in 11% and 17% of placebo and BIIB023-treated patients, respectively.
To cite this abstract in AMA style:Furie R, Malvar A, Navarra SV, Smirnakis K, Kong J, Franchimont N, Shih F. Evaluation of the Efficacy, Safety, and Tolerability of BIIB023 As an Adjunct to Standard of Care in Subjects with Lupus Nephritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/evaluation-of-the-efficacy-safety-and-tolerability-of-biib023-as-an-adjunct-to-standard-of-care-in-subjects-with-lupus-nephritis/. Accessed December 2, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/evaluation-of-the-efficacy-safety-and-tolerability-of-biib023-as-an-adjunct-to-standard-of-care-in-subjects-with-lupus-nephritis/