Is OCREVUS (ocrelizumab) the initial management for Multiple Sclerosis (MS)?

Ocrelizumab (OCREVUS) is Not the Initial Management for Most Multiple Sclerosis Patients

Ocrelizumab (OCREVUS) is not recommended as first-line therapy for most multiple sclerosis patients, but rather as an escalation therapy after failure of other disease-modifying treatments. 1, 2

Treatment Approach for Multiple Sclerosis

Initial Treatment Selection

The approach to MS treatment should follow these principles:

• FDA-approved disease-modifying therapies (DMTs) are recommended for treating multiple sclerosis 2
• Treatment selection should be based on:
  • MS subtype (relapsing or progressive)
  • Disease activity and severity
  • Patient age and comorbidities
  • Safety profile of medications

Role of Ocrelizumab in Treatment Algorithm

Ocrelizumab (OCREVUS) is FDA-approved for:

• Relapsing forms of MS (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease)
• Primary progressive MS 3

However, it is generally positioned as an escalation therapy rather than initial treatment for most patients. The European Academy of Neurology–ECTRIMS guidelines recommend ocrelizumab as a high-efficacy DMT that is more effective when used early, but typically after failure of initial therapies 1.

Evidence for Ocrelizumab Use

Efficacy Data

Ocrelizumab has demonstrated significant efficacy in clinical trials:

• 46-47% reduction in annualized relapse rate compared to interferon beta-1a
• 40% reduction in 12-week confirmed disability progression
• 94-95% reduction in gadolinium-enhancing lesions 3

Recent real-world evidence from the ENSEMBLE study showed that in early RRMS patients treated with ocrelizumab:

• 66.4% maintained no evidence of disease activity over 4 years
• 90.9% had no relapses
• 81.8% had no 24-week confirmed disability progression 4

Safety Considerations

Ocrelizumab requires careful consideration before initiation:

• Hepatitis B screening is mandatory before the first dose 2
• Monitoring of immunoglobulin levels is recommended during treatment
• Common adverse events include infusion-related reactions and infections 5

Specific Treatment Scenarios

For Newly Diagnosed MS Patients

For most newly diagnosed MS patients without markers of aggressive disease:

• Initial therapy with other DMTs is typically recommended
• Glatiramer acetate can be started immediately without hepatitis B screening 2
• Complete hepatitis B vaccination series is recommended before starting more potent MS therapies 2

For Aggressive or Highly Active MS

For patients with markers of aggressive disease (frequent relapses, incomplete recovery, high MRI activity):

• Ocrelizumab can be considered after failure of a single high-efficacy DMT 1
• In rare cases of rapidly evolving, severe MS with poor prognosis, ocrelizumab might be considered as first-line therapy, preferably within a clinical trial 1

For Progressive MS

• Ocrelizumab is indicated for primary progressive MS, being the first FDA-approved treatment for this form 3
• For secondary progressive MS, ocrelizumab is only indicated when there is evidence of active disease 1

Practical Considerations

When considering ocrelizumab:

• Vaccines should be administered 4-6 weeks before starting treatment or 4-6 months after ending treatment 2
• Confirmation of no active hepatitis B infection must be documented 2
• Treatment should be administered under the guidance of a neurologist with expertise in MS management

Conclusion

While ocrelizumab is an effective therapy for multiple sclerosis, it is typically positioned as an escalation therapy rather than initial management for most MS patients. Treatment decisions should prioritize disease activity, safety considerations, and the individual patient's clinical presentation.