PHILADELPHIA – Ocrelizumab is effective and safe in patients with relapsing-remitting multiple sclerosis who had inadequate responses to previous disease-modifying treatments, said an investigator reporting interim results of a recent nonrandomized study.
The findings of the 600+ patient CHORDS study suggest a positive risk-to-benefit ratio over nearly 1 year for this anti-CD20 monoclonal antibody, said Thomas P. Leist, MD, of Thomas Jefferson University, Philadelphia, at the annual meeting of the American Academy of Neurology (AAN).
“MRI activity has been significantly attenuated in these individuals, particularly, in the period from 24 to 48 weeks, and the overall safety that has been observed to date has been in line with what has been observed in clinical trials with this medication,” Dr. Leist said in a podium presentation.
While previous investigations demonstrated superiority to treatment with interferon in patients with relapsing multiple sclerosis, this phase IIIb study was needed to further clarify the effects of the treatment following suboptimal response to several disease modifying treatments, according to Dr. Leist and his co-investigators.
The intention-to-treat population of CHORDS consisted of 608 patients who received disease-modifying therapy for 6 or more months and discontinued it due to suboptimal response, which was defined as one or more clinically reported relapses, one or more T1 gadolinium-enhancing lesions, or two or more enlarging T2 lesions. They all received a 600 mg dose of ocrelizumab every 24 weeks for as many as 96 weeks.
With 48 weeks of follow-up, the majority of patients had no relapses, no enhancing T1 lesions, no new or enlarging T2 lesions, and no confirmed progression of disability. In all, 54.5% of the patients experienced none of those events, according to Dr. Leist.
The adjusted annualized relapse rate in this cohort was 0.065, he reported.
New MRI activity included 48 new T1 gadolinium-enhancing lesions in 1,174 MRI scans, for an adjusted rate of 0.023, he also reported, while there were 679 new or enlarging T2 lesions on 1,175 scans, for an adjusted rate of 0.581.
The safety in this population was comparable to the overall safety profile of ocrelizumab seen in other studies, according to Dr. Leist. A total of 25 patients, or 4.1%, experienced a serious adverse event, though none led to treatment withdrawal and only one led to a dose modification or interruption, the data show.
Dr. Leist reported disclosures related to Alkermes, Bayer, Biogen, EMD Serono, Genentech, Inc., Novartis, Sanofi Genzyme, Sun Pharma, and Teva Neuroscience.
SOURCE: Leist TP, et al. Presented at the 2019 American Academy of Neurology (AAN) Annual Meeting, May 4-10, 2019. Philadelphia. Presentation S56.007.