ASCLEPIOS I & II
(2020)Objective
To compare the efficacy and safety of subcutaneous ofatumumab versus oral teriflunomide in patients with relapsing multiple sclerosis
Study Summary
• Ofatumumab reduced ARR by 51-58% compared to teriflunomide (0.11 vs 0.22 in trial 1; 0.10 vs 0.25 in trial 2, P<0.001)
• Ofatumumab reduced 3-month confirmed disability worsening by 34% (HR 0.66, P=0.002)
• Ofatumumab dramatically reduced Gd+ lesions by 94-97% vs teriflunomide
• Ofatumumab reduced 3-month confirmed disability worsening by 34% (HR 0.66, P=0.002)
• Ofatumumab dramatically reduced Gd+ lesions by 94-97% vs teriflunomide
Intervention
Ofatumumab 20 mg SC every 4 weeks (after loading doses on days 1, 7, 14) vs Teriflunomide 14 mg oral daily
Inclusion Criteria
Age 18-55 years, relapsing-remitting or active secondary progressive MS per 2010 McDonald criteria, EDSS 0-5.5, ≥1 relapse in prior year or ≥2 relapses in prior 2 years or ≥1 Gd+ lesion in prior year, neurologically stable ≥1 month
Study Design
Arms: Ofatumumab 20 mg SC every 4 weeks, Teriflunomide 14 mg oral daily (double-dummy design)
Patients per Arm: 946 ofatumumab, 936 teriflunomide (pooled)
Outcome
• Primary ARR: 0.11 vs 0.22 (trial 1) and 0.10 vs 0.25 (trial 2), both P<0.001
• 3-month CDP: 10.9% vs 15.0% (HR 0.66, P=0.002)
• 6-month CDP: 8.1% vs 12.0% (HR 0.68, P=0.01)
• Gd+ lesions: 97% and 94% reduction vs teriflunomide
• 3-month CDP: 10.9% vs 15.0% (HR 0.66, P=0.002)
• 6-month CDP: 8.1% vs 12.0% (HR 0.68, P=0.01)
• Gd+ lesions: 97% and 94% reduction vs teriflunomide