Natalizumab Improves Social and Mental Health in Patients with Multiple Sclerosis

Carrie Hersh, DO, MSc

Data from a recent study suggest that natalizumab (Tysabri; Biogen) treatment improved mental and social health in patients with multiple sclerosis (MS). These findings were presented by Carrie Hersh, DO, MSc, assistant professor, neurology, Cleveland Clinic Lou Rovo Center for Brain Health, at the 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22. 

“In addition to its efficacy on traditional measures of MS disease activity, natalizumab has been associated with improvements in health-related quality of life, fatigue, depression, and cognitive function in both real-world and clinical trial settings,” Hersh said during her presentation. “Furthermore, some natalizumab-treated patients anecdotally report a feel-good effect that appears unique to this disease-modifying therapy; while it is commonly recognized, its physiological basis and clinical characterization are not well understood.”

Hersh and colleagues collected data from patients in the large, real-world MS Partners Advancing Technology and Health Solutions (MS PATHS) cohort order to assess changes on the quality of life in neurological disorders (Neuro-QoL) questionnaire after natalizumab initiation, as well as compare these scores with those after ocrelizumab (Ocrevus; Genentech) initiation. The rationale behind the study was that understanding patient-reported changes in physical, mental, and social health after MS therapy initiation is important in optimizing treatment.

The primary analysis of the MS PATHS cohort included 164 patients treated with natalizumab, all of which significantly improved in 8 of 12 Neuro-QoL domains from baseline. Patients with baseline impairments showed significant improvements in 10 of 12 domains. 

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Researchers found that a greater proportion of natalizumab-treated patients reported clinically meaningful improvements than reported worsening in all domains except lower extremity function and participation in social roles and activities (equal proportions of patients worsened and improved). Patients with higher baseline impairments saw the greatest improvements compared to the general population in most domains.

Hersh and colleagues found that the adjusted annualized rate of improvement was greater with natalizumab treatment compared with ocrelizumab treatment. These differences were significant in 3 domains: satisfaction with social roles and activities (P = .02), participation in social roles and activities (P = .0001), and emotional and behavioral dyscontrol (P = .01).

Greater proportions of natalizumab-treated patients experienced clinically meaningful improvements than ocrelizumab-treated patients in 7 domains. Proportions were equal in 3 domains. Another interesting finding that did not achieve statistical significance was that the adjusted likelihood of at least a 5-point improvement on Neuro-QoL from baseline was higher in patients impaired at baseline treated with natalizumab than those treated with ocrelizumab.

“In conclusion, natalizumab can lead to clinically meaningful improvements in aspects of mental and social health as assessed by Neuro-QoL. Improvements were more pronounced in patients with impairment at baseline, supporting the clinical relevance of these findings. The observed improvements of natalizumab are unlikely driven by expectation bias as their magnitude in certain domains exceeded improvements with another high-efficacy therapy, ocrelizumab,” Hersh concluded her presentation.

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REFERENCE

Hersh CM, Kieseier B, de Moor C, et al. Impact of natalizumab on quality of life in a real-world cohort of patients with multiple sclerosis: Results from MS Partners Advancing Technology and Health Solutions (MS PATHS). Presented at 2021 American Academy of Neurology Annual Meeting. Abstract P15 023