Ocrelizumab Achieved Pregnancy Safety and Reduced Disease Progression for Relapsing-Remitting Multiple Sclerosis
In phase 3b of the ENSEMBLE study (NCT03085810), participants treated with ocrelizumab (Ocrevus; Genentech, South San Francisco, CA) for early-stage relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) achieved a reduction of relapses, hospitalizations, and costs. The majority of participants (77%) with RRMS did not have prior treatment before being treated with ocrelizumab and achieved no evidence of disease activity (NEDA) at 2 years. Participants who were pregnant when being treated with ocrelizumab did not show an increased risk of adverse pregnancy and infant outcomes.
“MS often impacts young people at a time in their lives when they are starting a career or planning a family,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “These new data show that using Ocrevus as a first-line treatment brings substantial clinical and cost benefits to patients, thereby further emphasizing the efficacy that Ocrevus may bring with continued long-term use.”
The interim analysis of open label of the ENSEMBLE study observed consistent benefit over 2 years in participants treated with ocrelizumab. The majority of participants had no relapses (93%), no MRI lesion activity (89%), and no 24-week confirmed disability progression (91%).
The average annualized relapse rate (ARR) in all participants was low (0.033), equating to 1 relapse every 30 years. The mean Expanded Disability Status Scale (EDSS) score from baseline significantly improved from 1.8 to 1.67 (P<0.0001).
Newly diagnosed participants who initiated treatment with ocrelizumab had a lower rate of annualized events often associated with a relapse (0.36) compared with participants who had prior treatment before using ocrelizumab (0.51). Participants who initiated treatment with ocrelizumab also had lower hospitalization rates within 1 year when making the same comparison (0.02 vs 0.042, respectively).
“Nine-year data presented at ECTRIMS in RMS and PPMS continue to show significant efficacy against disease activity and progression with a consistent long-term safety profile, which is very encouraging for patients living with this disease and their physicians,” stated Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies and director of the Weill Institute for Neurosciences at the University of California, San Francisco. “Ocrevus has significantly changed the treatment paradigm for more than 250,000 people with MS since its approval more than 5 years ago.”
The study’s cumulative data did not suggest an increased risk of preterm birth, major congenital anomalies, or other adverse outcomes in participants who were pregnant. Of the 532 participants who were pregnant within utero, 286 had known outcomes: 79% live births, 12% therapeutic/elective abortions, 8% spontaneous abortions, 1% ectopic pregnancies, and 0.3% still births.