Trial design and patients
The methods of ASCLEPIOS I/II, APLIOS, and APOLITOS have been reported previously.Analysis sets and time periods.*The “newly switched ofatumumab group” comprised patients randomized to teriflunomide in ASCLEPIOS I/II (those who completed treatment were eligible to enter ALITHIOS and be switched to ofatumumab); the “continuous ofatumumab group” comprised patients randomized to ofatumumab in ASCLEPIOS I/II (those who completed treatment were eligible to enter ALITHIOS). All patients who completed study treatment in the core period were eligible to enter ALITHIOS but could withdraw prior to treatment. The efficacy analysis set comprised all patients randomized to ofatumumab or teriflunomide in ASCLEPIOS I/II, regardless of whether they completed/discontinued study treatment. The safety analysis set comprised patients who received ≥1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS, or ALITHIOS. Percentages based on the number of randomized patients. The open-label extension period was defined as following the first dose of ofatumumab in ALITHIOS (below the dashed line); the core period is prior to the open-label extension (above the dashed line). Reasons for the discontinuation of study treatment are presented in 