To evaluate treatment discontinuation/compliance with ofatumumab and teriflunomide in the Phase 3 ASCLEPIOS trials and assess patients’ acceptance of transitioning to the ongoing open-label extension ALITHIOS study.

Ofatumumab, the first fully human anti-CD20 monoclonal antibody, administered with a monthly 20mg subcutaneous dose, demonstrated superior efficacy versus teriflunomide in ASCLEPIOS I/II in relapsing multiple sclerosis. Patients who completed the double-blind phase on study drug were eligible for transition to ALITHIOS.

In ASCLEPIOS I/II, patients were randomized (1:1) to ofatumumab 20mg (loading doses, administered at clinic: Days 1, 7, and 14; maintenance doses, administered at home: every 4 weeks from Week 4) or teriflunomide 14mg (orally once daily), for up to 30 months. We report treatment discontinuation and compliance (defined as study drug exposure [days]/on-treatment period [days]×100%) in ASCLEPIOS, and percentage of eligible patients who accepted transitioning to ALITHIOS.

In ASCLEPIOS I, 759/927 (81.9%) randomized patients (ofatumumab: 400/465 [86.0%]; teriflunomide: 359/462 [77.7%]) completed the trial on study drug. The proportion of patients discontinuing treatment were ofatumumab, 14.0%; teriflunomide, 21.2%. Most common reasons for discontinuation (>2% in any group) were patient/guardian decision (ofatumumab, 4.9%; teriflunomide, 8.2%), adverse event (5.2%; 5.0%), and physician decision (2.2%; 6.5%). In ASCLEPIOS II, 753/955 (78.8%) randomized patients (ofatumumab: 383/481 [79.6%]; teriflunomide: 370/474 [78.1%]) completed the trial on study drug. The proportion of patients discontinuing treatment were ofatumumab, 20%; teriflunomide, 21.5%; reasons for discontinuation were patient/guardian decision (ofatumumab, 7.3%; teriflunomide, 7.8%), adverse event (5.6%; 4.9%) and physician decision (5.2%; 6.8%). In both trials, compliance was high (>95% of patients falling in the ≥90% compliance category) across treatment groups. Approximately 90% of eligible patients consented to participate in ALITHIOS; compliance data will be presented.

In ASCLEPIOS, compliance with home-administered subcutaneous ofatumumab was high and fewer patients discontinued ofatumumab versus teriflunomide. The majority of eligible patients accepted transition to ALITHIOS.