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Nearly 87% of patients enrolled in the phase 3b CASTING study had no evidence of disease activity following treatment with ocrelizumab after having an inadequate response to prior DMTs.
Gavin Giovannoni, MBBCh, PhD
Results of an interim analysis of 1-year data from the phase 3b CASTING study (NCT02637856) revealed that 87% of patients who switched to treatment with ocrelizumab after having a suboptimal response to 1 to 2 other disease-modifying therapies (DMTs) for multiple sclerosis (MS) showed no evidence of disease activity (NEDA) at 48 weeks.
The findings, which were presented at ECTRIMS 2019, September 11-13 in Stockholm, Sweden, support the growing argument to initiate patients with MS on treatment with highly-effective DMTs rather than a more stepped-up approach to therapy.
“The Ocrevus data at ECTRIMS highlight that the benefit of delaying, and possibly preventing, disability progression is greater when the treatment is used earlier in the disease course for both relapsing and primary progressive forms of MS,” said Professor Gavin Giovannoni, MBBCh, PhD, of Barts and the London School of Medicine and Dentistry, in a statement.
The prospective, multicenter, single-arm study included 680 patients with relapsing-remitting MS with an Expanded Disability Status Scale [EDSS] score of ≤4; disease duration of ≤10 years; and discontinued use of prior DMT of ≥6 months' duration due to suboptimal disease control. Patients who received 1 prior DMT (n=411) or 2 DMTs (n=265) were started on treatment with ocrelizumab as an initial dose of 2 300-mg intravenous infusions 14 days apart followed by 1 600-mg infusion for a max of 4 doses over 96 weeks. The primary end point was percentage of patients without any protocol-defined event during the treatment period, including relapse or T1 gadolinium-enhanced lesion, new or enlarging T2 lesion, or confirmed disability progression at 24 weeks.
At week 48, 86.9% of patients showed NEDA. Rates of 24-week confirmed disability progression were 4.8%, while rates of protocol-defined relapses were 4.2%, T1 gadolinium-enhancing lesions were 2.8%, and new/enlarging T2 lesions were 6.2%. Overall, the adjusted annualized relapse rate was 0.048.
In terms of safety, 86.9% of patients experience at least 1 adverse event, and 5% of patients experienced at least 1 serious adverse event, which included infusion-related reactions.
The humanized monoclonal antibody that selectively targets CD20-positive B cells is currently approved for the treatment of relapsing forms of MS, including secondary progressive MS, and primary progressive MS.
For more coverage of ECTRIMS 2019, click here.
1. Vermersch P, Eralinna JP, Nicholas R, et al. Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with a suboptimal response to previous disease-modifying therapies (1-year interim results). Presented at: ECTRIMS 2019. September 11-13, 2019; Stockholm, Sweden. Abstract P690.
2. Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis [news release]. Basel, Switzerland: Roche. September 13, 2019. https://www.roche.com/media/releases/med-cor-2019-09-13b.htm. Accessed September 13, 2019.