Trial participants received 600-mg doses intravenously every 24 weeks in all three trials; in OPERA I/II, they received 96 weeks of treatment with the first dose given as two 300-mg infusions split by 14 days, and, in ORATORIO, they received at least 120 weeks of treatment with all doses split, Dr. Hauser said.
In the phase 2 study, they received split doses of 600-mg or 2,000-mg infusions through week 24; then through week 96, they received either 600-mg or 1,000-mg doses; those receiving 600 mg included those who started at that dose and those who received placebo or interferon beta-1a 30 mcg, and those receiving 1,000 mg were those who started on ocrelizumab at 2,000 mg.
The comparators were placebo in the ORATORIO and phase 2 trials, and interferon beta-1a given at a dose of 44 mcg subcutaneously three times weekly (OPERA I and II) or 30 mcg intramuscularly each week in the phase 2 trial.
All patients were offered enrollment into open-label extension studies, and “there was rather massive interest in joining the open-label extension and continuing open-label extension in both trials,” he said.