The U.S. Food and Drug Administration approved ocrelizumab to treat patients with either primary progressive multiple sclerosis (PPMS) or relapsing forms of the disease in March 2017, making it the first drug approved for use for PPMS in the country.
An international team of researchers will present updated safety information on the drug based on additional information from four clinical trials on October 26 at the 2017 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting in Paris (poster 676).
Syringe. (Source: Creative Commons)
The phase 3 OPERA and ORATORIO studies on which the FDA approval was based continue to track safety data for participants. OPERA included two identical studies that compared ocrelizumab to subcutaneous interferon beta-1a relapsing MS and ORATORIO evaluated the drug in PPMS compared to placebo. A phase 2 trial in RRMS compared ocrelizumab 600 mg and 2000 mg to placebo and subcutaneous interferon beta-1a on a 1:1:1:1 randomized basis. In all four trials, eligible patients were permitted to enter an ocrelizumab open-label extension phase.
As of February 17 of this year, 2,301 patients had received ocrelizumab for a total of 7,748 patient years of exposure. In aggregate, the reported rates per 100 patient years were 226 for adverse events, of which 7.18 were serious, and 71.3 for infections, of which 1.86 were serious. The malignancy rate was 0.454.
Overall, the safety profile for ocrelizumab in the all-exposure population corresponds to that seen in the controlled treatment period of the clinical trials for patients with both PPMS and remitting forms of the disease.