Real-world efficacy of ocrelizumab in MS patients

An interim analysis of the non-interventional phase 4 CONFIDENCE study showed the efficacy of ocrelizumab in multiple sclerosis (MS) patients in a real-world setting. The majority of patients in this analysis experienced treatment success, with Expanded Disability Status Scale (EDSS) and MSIS-29 remaining constant over the first year of ocrelizumab treatment.

The safety and efficacy of ocrelizumab in MS patients have been characterised in phase 2 and phase 3 clinical trials. As of July 2020, over 170,000 patients were treated with ocrelizumab. CONFIDENCE is a non-interventional post-authorisation phase 4 safety study evaluating the safety and effectiveness of ocrelizumab in patients with relapsing MS and primary progressive MS (PPMS) in a real-world setting. This study aims to collect data for 3,000 ocrelizumab-treated patients and 1,500 patients treated with other DMTs in Germany for up to 10 years.

The 1-year interim analysis presented by young investigator Julius Eggebrecht (Roche Pharma, Germany) included data from 559 patients newly treated with ocrelizumab [1]. Of these patients, approximately 82% had relapsing MS and 18% had PPMS; 64% of patients were female (66% of relapsing MS and 55% of PPMS patients). Mean baseline EDSS was 3.3 for patients with relapsing MS and 4.5 for patients with PPMS. At baseline, patients with relapsing MS and PPMS were on average 7 and 8 years older, respectively, than those in the pivotal clinical trials. Patients with relapsing MS had a higher mean baseline EDSS score, while patients with PPMS had a slightly lower mean baseline EDSS score than patients in the pivotal trials.

Over a 1-year period, 83.6% of patients with relapsing MS and 93.2% of PPMS patients experienced treatment success. About 85.3% of patients with relapsing MS experienced no relapses. The mean change in EDSS from baseline after 1 year of treatment was 0.0 for patients with relapsing MS and 0.1 for patients with PPMS.

1. Buttmann M, et al. Assessing the real-world effectiveness of ocrelizumab in patients with MS. ECF 28^th Annual Meeting. Abstract 20.

Posted on 16 December, 202016 December, 2020