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Published on: December 9, 2015
Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous
Bianca Weinstock-Guttman1, Robert Bermel2, Gary Cutter3
1University at Buffalo, Buffalo, NY, USA.
Background:
Many patients with multiple sclerosis (MS) experience suboptimal disease control despite the use of disease-modifying therapy (DMT).
Objective:
To assess the efficacy and safety of ocrelizumab (OCR) in patients with relapsing-remitting MS (RRMS) and suboptimal response to prior DMTs.
Methods:
Patients with RRMS and suboptimal responses (one clinically reported relapse and/or lesion activity) after ⩾ 6 months on another DMT were enrolled. OCR 600 mg was given intravenously every 24 weeks. The primary outcome was no evidence of disease activity (NEDA), defined as the absence of protocol-defined relapse, confirmed disability progression (CDP), T1 Gd-enhancing lesions, and new/enlarging T2 lesions.
Results:
The intention-to-treat (ITT) population included 608 patients; NEDA was analyzed in a modified ITT (mITT) population (n = 576 (94.7%)). Over 96 weeks, 48.1% of mITT patients achieved NEDA, and most were free from protocol-defined relapse (89.6%), CDP (89.6%), and T1 Gd-enhancing lesions (95.5%); 59.5% had no new/enlarging T2 lesions. Safety observations were consistent with findings in the pivotal trials.
Conclusion:
Consistent efficacy of OCR on clinical and magnetic resonance imaging (MRI) disease activity measures and progression was shown in patients with RRMS and a suboptimal response to prior DMTs; no new safety signals were observed.
Insights
Ocrelizumab (OCR) effectively controlled disease activity in relapsing-remitting multiple sclerosis (RRMS) patients with suboptimal responses to other therapies. This treatment demonstrated consistent efficacy and safety over 96 weeks, with no new safety concerns identified.
Area of Science:
- Neurology
- Immunology
- Clinical Trials
Background:
- Many multiple sclerosis (MS) patients have suboptimal disease control despite current disease-modifying therapies (DMTs).
- Identifying effective treatments for these patients is crucial for improving outcomes.
Purpose of the Study:
- To evaluate the efficacy and safety of ocrelizumab (OCR) in patients with relapsing-remitting MS (RRMS).
- Specifically assessed patients who showed a suboptimal response to prior DMTs.
Main Methods:
- Enrolled RRMS patients with suboptimal responses (relapse and/or lesion activity) after at least 6 months on another DMT.
- Administered OCR 600 mg intravenously every 24 weeks.
- Primary outcome: No Evidence of Disease Activity (NEDA), defined by absence of relapse, disability progression, and MRI lesion activity.
Main Results:
- 48.1% of patients in the modified intention-to-treat (mITT) population achieved NEDA over 96 weeks.
- High percentages of patients were free from protocol-defined relapse (89.6%), confirmed disability progression (89.6%), and T1 Gd-enhancing lesions (95.5%).
- Safety profile was consistent with previous pivotal trial findings.
Conclusions:
- Ocrelizumab demonstrated consistent efficacy in managing both clinical and MRI-assessed disease activity in RRMS patients with prior suboptimal DMT response.
- No new safety signals were identified, supporting OCR's use in this patient population.
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