Watch a brief overview of the KESIMPTA® (ofatumumab) pivotal trial results, hosted by a lead investigator.
ASCLEPIOS I & II Study Design
ASCLEPIOS I and II were 2 identical, double-blind, active comparator-controlled, parallel-group, multicenter, Phase 3 studies in patients with relapsing MS, approximately 40% of whom were DMT treatment naïve. Patients were randomized to double-dummy subcutaneous KESIMPTA (20 mg every 4 weeks) or oral Aubagio® (teriflunomide) (14 mg daily) for up to 30 months. Primary end point was ARR. Key MRI end points were number of Gd+ T1 lesions and annualized rate of new or enlarging T2 lesions. A key clinical end point was reduction in risk of 3-month CDP. Treatment duration was variable based on end of study criteria. Maximum duration 120 weeks, median duration 85 weeks.1
For your relapsing MS patients, make a difference when choosing a B‑cell treatment.1
ARR, annualized relapse rate; CDP, confirmed disability progression; DMT, disease-modifying therapy; Gd+, gadolinium-enhancing; MOA, mechanism of action; MRI, magnetic resonance imaging; MS, multiple sclerosis.