Optimizing premedications for multiple sclerosis patients treated with ocrelizumab: A randomized controlled trial

Area of Science:

• Neurology
• Pharmacology

Background:

• Multiple sclerosis (MS) management involves disease-modifying therapies (DMTs) that can cause infusion-related reactions (INRRs).
• Corticosteroids are used to prevent INRRs but carry long-term health risks.
• Optimizing safety requires balancing INRR prevention with minimizing corticosteroid exposure during DMTs like ocrelizumab (Xacrel).

Purpose of the Study:

• To compare the effectiveness of standard versus adjusted low-dose corticosteroid premedication for reducing INRRs in MS patients receiving ocrelizumab.
• To evaluate safety and minimize corticosteroid exposure.

Main Methods:

• A single-blind, randomized clinical trial involving 200 adult MS patients previously treated with ocrelizumab.
• Two groups: standard (100 mg IV methylprednisolone) and adjusted (8 mg IV dexamethasone) premedication.
• Monitoring of INRRs incidence and severity up to 24 hours post-infusion; statistical analysis using Chi-square and logistic regression.

Main Results:

• The standard regimen significantly reduced INRRs occurrence (40.6%) compared to the adjusted regimen (78.8%, p<0.01).
• Itching and throat irritation were more frequent in the adjusted group (p<0.01).
• No significant difference in severe INRRs; a history of INRRs strongly predicted future reactions (OR 6.27).

Conclusions:

• Standard corticosteroid premedication is more effective in preventing INRRs during ocrelizumab infusions for MS.
• A reduced corticosteroid regimen may be considered for select patients, given no significant difference in severe reactions.
• Patient history of INRRs is a critical factor in risk management.