Abstract
BACKGROUND: Multiple sclerosis (MS), a chronic neurological disease, is typically managed with disease-modifying therapies (DMTs) to reduce relapse rates and slow disease progression. Some of these DMTs can cause infusion-related reactions (INRRs), which range from mild symptoms to severe allergic reactions. Corticosteroids are commonly used in premedication regimens to mitigate INRRs. However, long-term use of corticosteroids carries health risks. This study aims to compare the effectiveness of a standard corticosteroid regimen with an adjusted, low-dose regimen in reducing INRRs among people living with MS, receiving ocrelizumab (Xacrel), with the goal of optimizing safety while minimizing corticosteroid exposure. METHODS: In a single-blind, randomized, parallel-group clinical trial conducted at Sina Hospital, 200 adult patients with MS who had previously received ocrelizumab were recruited and randomly assigned to either a standard or adjusted premedication regimen groups. The standard regimen group (n = 101) received 100 mg intravenous (IV) methylprednisolone, along with cetirizine and acetaminophen tablets as premedication, while the adjusted regimen group (n = 99) received a reduced dose of 8 mg IV dexamethasone. The incidence of INRRs and their severity was monitored up to 1-hour post-infusion and 24-h post-infusion. Statistical analyses, including Chi-square tests and logistic regression, were used to evaluate the frequency of INRRs, characterize symptom profiles, and identify potential predictive factors for INRRs occurrence. RESULTS: Overall, the standard premedication demonstrated more efficacy in reducing the occurrence of INRRs, while the adjusted regimen group showed a significantly higher incidence of INRRs compared to the standard regimen group (78.8% vs. 40.6%, p-value <0.01). Specific INRRs symptoms, such as itching (29.3% in the adjusted group vs. 8.3% in the standard group, p-value <0.01) and throat irritation (65.7% vs. 31.7%, p-value <0.01), were notably more frequent in the adjusted regimen group. Most INRRs were mild to moderate in severity in both groups. There was no statistically significant difference in the occurrence of severe reactions between the two groups. Notably, a history of INRRs from previous infusions was identified as a strong predictor of INRRs in the current study, with an odds ratio of 6.27 (95% CI: 3.36-11.70), highlighting the importance of patients' history in managing INRRs risk. CONCLUSIONS: The standard premedication regimen was more effective in reducing INRRs in people living with MS, receiving Xacrel compared to the reduced corticosteroid regimen. However, the findings suggest that a lower corticosteroid regimen may be beneficial for some patients, as there was no significant difference in the incidence of severe INRRs between the two groups.