Multiple results regarding use of ocrelizumab (Ocrevus; Genentech, South San Francisco, CA) for treatment of patients with multiple sclerosis (MS) were presented today at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Berlin, Germany.
Approximately 89% of patients enrolled in the open-label extension of the OPERA 1 (NCT01412333) and OPERA II (NCT01247324) phase 3 trials of ocrelizumab completed all 3 years of the open-label extension period.
For those who switched from interferon ß-1a (IFN) to ocrelizumab, the adjusted annualized relapse rate (ARR) decreased from 0.20 to 0.10 after a first year of treatment with ocrelizumab (P < .001). This decrease in ARR was maintained throughout years 2 and 3 of the open-label study. Patients who had been treated with ocrelizumab during the trial and continued on ocrelizumab for the 3-year open-label extension trial maintained decreases in ARR seen during the trial.
Patients who had 5 years of treatment with ocrelizumab were less likely to have 24-week confirmed disability progression in the year before and all 3 years of the open-label extension compared to patients who had 2 years of treatment with IFN followed by 3 years of treatment with ocrelizumab (7.7%/12.0%, 10.1%/15.6%, 13.9%/18.1% and 16.1%/21.3%; P< 0.05, all difference comparisons).
Long-term reduction in brain atrophy and MS disease activity on MRI after treatment with ocrelizumab was also reported. For those who switched from IFN to ocrelizumab the number of T1 gadolinium-enhancing lesions decreased in the first year of ocrelizumab treatment from an adjusted rate of 0.48 lesions per scan to an unadjusted rate of .007 per scan or less. This decrease was maintained in years 2 and 3 of the open-label period.
Those who continued on ocrelizumab maintained a decreased number of T1 gadolinium-enhancing lesions per scan and also had lower measures of brain atrophy (P < .01) compared to those who had only 3 years of treatment with ocrelizumab.
Post-hoc analysis showed that the 72 patients of African descent treated with ocrelizumab 46% achieved no-evidence-of-disease (NEDA) status compared to 10% of this group treated with IFN (P < .002). These rates are similar to that seen in the larger trial, which is notable because patients of African descent with MS often have a faster disease progression.
In the CHORDS (NCT02637856) study, 608 patients who had a suboptimal response, or continued disease activity/progression, despite 6 or more months of treatment with another MS disease-modifying treatment were treated with ocrelizumab on an open-label basis. After 48 weeks of treatment, 96.4% had no 24-week confirmed progression of disability, 92.7% of patients had no clinical relapse, 96.4% had no new T1 gadolinium-enhancing lesions, and 65.3% had no new or enlarging T2 lesions. The mean adjusted annualized relapse rate was .047.
Hideki Garren, MD, PhD Global Head of MS & Neuroimmunology said, “We are excited to have treated over 70,000 patients with Ocrevus. As we continue to gather real-world and open-label extension data, the safety profile remains similar to that seen in trials, the benefit in slowing disease progression is maintained, and earlier treatment appears more effective.”Next Story