Drug Reduces MS Disease Activity
Ocrelizumab shows promise reducing symptoms of MS.
In patients with primary progressive multiple sclerosis (PPMS), researchers found that ocrelizumab (OCR) can reduce disease activity during a recent study.
The humanized monoclonal antibody can selectively target CD20+B cells in patients with multiple sclerosis.
During a double-blind placebo-controlled phase 3 study, researchers looked to evaluate the efficacy of ocrelizumab in patient subgroups that either had or did not have T1 gadolinium-enhancing (Gd+) lesions at baseline.
Researchers randomized 732 patients who were administered 600 mg of ocrelizumab or placebo (PBO) as two 300 mg intravenous infusions 14 days apart every 24 weeks for at least 120 weeks until a pre-specified number of 12 week confirmed disability progression (CDP) events occurred.
The results of the study showed that ocrelizumab significantly reduced the relative risk of CDP by 24% in 12 weeks (hazard ratio [HR], 0.76; p= 0.0321) and 25% by week 24 (HR, 0.75; p=0.0365).
In 27.5% of patients who were treated with OCR, T1 GD+ lesions were found at baseline, compared to 24.7% of the placebo group.
OCR in patients with or without T1 Gd+lesions at baseline was reduced: risk of 12 week CDP by 35% (HR, 0.65; 95% CI, 0.40-1.06; p=0.0826) and 16% (HR, 0.84; 95% CI, 0.62-1.13; p=0.2441); the risk of 24 week CDP by 33% (HR, 0.67; 95% CI, 0.40-1.14; p=0.1417) and 19% (HR, 0.81; 95% CI, 0.59-1.10; p=0.1783); and total T2 lesion volume by −3.8% (95% CI, −7.0 to −0.5) vs +12.0% with PBO (95% CI, 7.2-17.1; p<0.001) and by −3.1% (95% CI, −5.0 to −1.1) versus +6.1% with PBO (95% CI, 3.3-9.0; p<0.001).
Eligibility for the study required patients to be between the ages of 18 to 55, diagnosed with PPMS, have an expanded disability status scale score between 3.0 to 6.5, and a documentation of an elevated immunoglobulin index or oligoclonal bands in the cerebrospinal fluid.