Ocrelizumab Approved as an Injection to Treat Multiple Sclerosis in Adults

Introduction

Multiple sclerosis (MS) is a chronic condition affecting the brain and spinal cord, leading to a variety of symptoms such as issues with vision, movement, sensation, and balance. The severity of MS can vary, with some individuals experiencing mild symptoms while others face significant disability. The approval of ocrelizumab as an injection offers a new treatment option for adults with RMS and PPMS, potentially improving their quality of life.

Key Aspects of Ocrelizumab Treatment

Indications for Use

• RMS Patients: Ocrelizumab is approved for adults with relapsing forms of MS, characterized by flare-ups (relapses) followed by periods of remission.
• PPMS Patients: It is also approved for adults with primary progressive MS, where symptoms progressively worsen over time.

Administration and Dosage

• Previous Approval: The active ingredient ocrelizumab was first approved in the UK in 2018 as an intravenous infusion, with the initial two infusions given two weeks apart, followed by infusions every six months.
• New Formulation: The newly approved formulation allows patients to receive a 920mg dose of Ocrevus every six months via a subcutaneous injection, administered by a healthcare professional.

Mechanism of Action

• Targeting B Cells: Ocrelizumab works by binding to specific B cells, a type of white blood cell involved in MS. By targeting these cells, ocrelizumab reduces inflammation and the immune system’s attack on the myelin sheath, thereby decreasing the frequency of relapses and slowing disease progression.

Efficacy in RMS and PPMS

• RMS Benefits: In RMS patients, ocrelizumab significantly reduces relapses, slows disease progression, and increases the likelihood of patients showing no evidence of disease activity.
• PPMS Benefits: In PPMS patients, the drug helps slow disease progression and reduce deterioration in walking speed.

Clinical Trial Results

• Study Comparison: A randomized study of 236 patients with RMS or PPMS compared the injection form of ocrelizumab to the infusion form. Patients received either a single 920 mg injection or a 600 mg infusion split into two doses. Over 12 weeks, drug levels in the blood were similar between the two forms, indicating comparable efficacy.

Side Effects and Safety Monitoring

• Common Side Effects: The most common side effect of the subcutaneous injection is an injection reaction, experienced by more than 1 in 10 people. Other potential side effects include increased susceptibility to infections, such as the flu, sinus infections, bronchitis, herpes, and respiratory tract infections.
• Ongoing Monitoring: The MHRA will continue to monitor the safety and effectiveness of ocrelizumab. Patients experiencing side effects are encouraged to report them to their healthcare provider and through the MHRA Yellow Card scheme.

Conclusion

The approval of ocrelizumab as a subcutaneous injection marks a significant advancement in the treatment of multiple sclerosis, offering patients a more convenient administration option while maintaining the efficacy and safety established with the infusion form. The MHRA remains committed to ensuring the safety of this new formulation through continuous monitoring and review.

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