As published in The New England Journal of Medicine (NEJM), the ASCLEPIOS 1 (NCT02792218) and 2 (NCT02792231) studies of ofatumumab (OMB157) show a significant reduction in annualized relapse rate (ARR), gadolinium enhancing (Gd+) T1 lesions, and neuroaxonal damage.
The studies compared treatment with ofatumumab (20 mg/month subcutaneously ) vs teriflunomide (14 mg/day orally) in adults with relapsing forms of multiple sclerosis (MS). Results from the ASCLEPIOS 1 and 2 studies showed that compared with teriflunomide, ofatumumab:
• Significantly reduced the ARR by 51% (0.11 vs 0.22) and 58% (0.10 vs 0.25) in ASCLEPIOS 1 and 2 (P<.001 in both studies)
• Was associated with a relative risk reduction of 34% (P=.002) in 3-month confirmed disability worsening (CDW) and 32% (P=.01) in 6-month CDW
• Significantly reduced both gadolinium enhancing (Gd+) T1 lesions (97% and 94% relative reduction in ASCLEPIOS 1 and 2, respectively; P<.001), and new or enlarging T2 lesions ( 82% and 85% relative reduction, respectively; P<.001).
• higher reductions of neurofilament light chain (NfL) serum concentrations suggesting prevention of axonal damage ,a major determinant of irreversible neurologic disability in MS
• Injection-related reactions, including nasopharyngitis, headache, injection-site reaction, upper respiratory tract infection and urinary tract infection were the most commonly observed adverse events with ofatumumab, occurring in ≥10% of participants.
The ASCLEPIOS 1 and 2 studies are twin, identical design flexible duration (up to 30 months) double-blind randomized, multicenter phase 3 studies evaluating the safety and efficacy of ofatumumab (20 mg/month subcutaneously) injections vs teriflunomide (14 mg/day orally). The ASCLEPIOS 1 and 2 studies enrolled 1,882 participants with MS, between the ages of 18 and 55 years who had expanded disability status scale (EDSS) scores between 0 and 5.5.
F. Stephen Benesh, MD, and Shruti P. Agnihotri, MD
Bettina Balint, MD
Shailee S. Shah, MD, and Andrew McKeon, MD