Comparison of highly effective treatments shows mental health advantages

When it comes to the mental and social health of multiple sclerosis patients, treatment with the highly effective agent natalizumab appears to have better outcomes than ocrelizumab, researchers reported.

In the MS Partners Advancing Technology and Health Solutions (MS PATHS) study, treatment with natalizumab among 164 patients was associated with significant improvements from baseline in 8 to 12 neuro-quality of life domains, reported Carrie Hersh, DO, assistant professor of medicine at the Cleveland Clinic Nevada Lou Ruvo Center for Brain Health in Las Vegas.

“Patients with baseline impairment exhibited significant improvements in 10 domains and higher rates of improvement than the overall cohort (P<0.05),” Hersh reported in her poster abstract at the 2021 virtual annual meeting of the American Academy of Neurology.

In this subgroup, Hersh reported that the domains with the highest proportion of patients with at least a five-point improvement were:

  • Sleep disturbance: 32% achieved improvement.
  • Anxiety: 27% achieved at least afive5-point improvement.
  • Behavioral dyscontrol: 26% achieved at least a five-point improvement.

In scrutinizing results based on the annualized improvement rates and utilizing propensity matching methodology, the 145 patients in this subgroup who were treated with natalizumab appeared to have better outcomes than the 520 patients treated with ocrelizumab. These differences, reported Hersh, reached statistical significance in the positive affect and well-being area (P=0.02), the sleep disturbance domain (P=0.003) and in satisfaction with social roles and activities domain (P=0.03).

When patients were stratified for impaired baseline neuro-quality of life, natalizumab was associated with significantly higher rates of improvement than ocrelizumab in the emotional/behavioral dyscontrol domain (P=0.01), participation in social roles and activities domain (P=0.0001), and satisfaction with social roles and activities (P=0.02).

The percentage of patients with at least a five-point improvement was numerically higher with natalizumab than with ocrelizumab for seven neuro-quality of life domains and the same for three domains.

“Understanding patient-reported changes in physical, mental, and social health after multiple sclerosis therapy initiation is important in optimizing treatment,” Hersh said, adding that this was the underlying focus of the subgroup analysis.

To conduct the study, she and colleagues obtained the T-scores of 12 neuro-quality of life domains that were assessed at routine visits in MS PATHS. Neuro-quality of life scores from visits post-natalizumab initiation were compared with baseline neuro-quality of life scores to calculate the annualized rate of change and the likelihood of clinically meaningful change—defined as at least a five-point change in scores. Comparisons with ocrelizumab-treated patients were conducted after propensity-score weighting and adjustment for relevant co-medications, year, and drug-year interaction. In discussing the report, Asaff Harel, MD, assistant professor of neurology at Lenox Hill Hospital, Northwell Health, New York City, told BreakingMED, “You have to take these results with caution, given that the study was sponsored by the company that makes natalizumab. They have looked at quality of life with natalizumab compared with ocrelizumab.

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“What they found was that both groups improved compared to baseline, which is what we would expect,” Harel explained. “A person starts taking these medications usually after experiencing a relapse, so they are not feeling well when having the relapse, so taking a highly-active medication is likely to make them feel better. So the finding that treatment with natalizumab improves quality of life makes sense.

“I am not sure why people who started with natalizumab would feel better than people who started with ocrelizumab,” he said. “It may be because the patients receive monthly treatments with natalizumab, and those extra visits to the clinic could give relief from anxiety and get some extra reassurance every month, while the patients on ocrelizumab only have to see their doctor once every six months.”

He also noted limitations in the study. “The numbers are so small in this study,” he said. “It is also possible that the results that show a benefit over ocrelizumab might have just happened by chance. Both these treatments are highly efficacious, so I think we need to see more information to determine why there is this difference in quality of life measurements. I don’t think this has been fully explained.”

  1. Treatment with natalizumab appears to improve certain quality of life measurements in patients with multiple sclerosis, according to resuts from the MS PATHS study.
  2. This study was presented as an abstract at a medical meeting, and the findings should be viewed with caution until publication in a peer-reviewed journal.

Edward Susman, Contributing Writer, BreakingMED™

The trial was sponsored by Biogen.

Harel disclosed no relevant relationships with industry.

Hersh disclosed relationships with Biogen and Novartis.

 

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