Abstract Details

Title 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)

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 023

Objective Assess changes in the Quality of Life in Neurological Disorders (Neuro-QoL) questionnaire after natalizumab initiation and compare to another high efficacy therapy, ocrelizumab.

Background Understanding patient-reported changes in physical, mental, and social health after multiple sclerosis therapy initiation is important in optimizing treatment.

Design/Methods T-scores of 12 Neuro-QoL domains were obtained at routine visits in MS PATHS. Neuro-QoL scores from visits post natalizumab initiation were compared with baseline Neuro-QoL scores to calculate the annualized rate of change and the likelihood of clinically meaningful (≥5-point) change. Comparisons with ocrelizumab-treated patients were conducted after propensity-score weighting and adjustment for relevant co-medications, year, and drug-year interaction.

Results In 164 natalizumab-treated patients, significant improvements from baseline were seen in 8 of 12 Neuro-QoL domains. Patients with baseline impairment exhibited significant improvements in 10 domains and higher rates of improvement than the overall cohort (P<0.05). In this subgroup, the domains with the highest proportion of patients with ≥5-point improvement were sleep disturbance (32%), anxiety (27%), and emotional and behavioral dyscontrol (EBD; 26%). In the natalizumab (n=145) and ocrelizumab (n=520) subgroups, annualized improvement rates were higher with natalizumab than with ocrelizumab, reaching statistical significance for positive affect and well-being (P=0.02), sleep disturbances (P=0.003), and satisfaction with social roles and activities (SRA; P=0.03). In patients with impaired baseline Neuro-QoL, significantly higher rates of improvement were seen with natalizumab than with ocrelizumab for EBD (P=0.01), participation in SRA (P=0.0001), and satisfaction with SRA (P=0.02). The percentage of patients with ≥5-point improvement was numerically higher with natalizumab than with ocrelizumab for 7 Neuro-QoL domains and was the same for 3 domains.

Conclusions Natalizumab can lead to clinically meaningful improvements in mental and social health. As the magnitude of these improvements exceeded those with another high-efficacy therapy (ocrelizumab), they are unlikely to be driven primarily by expectation bias.

Authors/Disclosures
Carrie M. Hersh, DO, MSc, FAAN (Cleveland Clinic Lou Ruvo Center for Brain Health) PRESENTER	Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech_GN41791. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol-Myers Squibb . Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Hersh has received research support from Biogen. The institution of Dr. Hersh has received research support from Novartis. The institution of Dr. Hersh has received research support from Genentech_GN41791. The institution of Dr. Hersh has received research support from PCORI. The institution of Dr. Hersh has received research support from Bristol Myers Squibb.
Bernd C. Kieseier, MD (Novartis)	Dr. Kieseier has received personal compensation for serving as an employee of Novartis. Dr. Kieseier has stock in Novartis.
Carl DeMoor	Carl DeMoor has received personal compensation for serving as an employee of Biogen. Carl DeMoor has received stock or an ownership interest from Biogen. An immediate family member of Carl DeMoor has received personal compensation in the range of $100,000-$499,999 for serving as a Program Director with NIH.
Deborah M. Miller, PhD (Cleveland Clinic Foundation)	Dr. Miller has received intellectual property interests from a discovery or technology relating to health care.
Denise I. Campagnolo, MD, MS	Dr. Campagnolo has received personal compensation for serving as an employee of Biogen. Dr. Campagnolo has received stock or an ownership interest from Biogen.
James R. Williams III, PhD	Dr. Williams has received personal compensation for serving as an employee of Biogen. Dr. Williams has received stock or an ownership interest from Biogen.
Kathryn Fitzgerald, PhD (Johns Hopkins University)	Dr. Fitzgerald has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Setpoint Medical. The institution of Dr. Fitzgerald has received research support from NIH. The institution of Dr. Fitzgerald has received research support from National MS Society.
	No disclosure on file
Marisa P. McGinley, DO (Cleveland Clinic)	Dr. McGinley has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. McGinley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. The institution of Dr. McGinley has received research support from Biogen. The institution of Dr. McGinley has received research support from Genentech. The institution of Dr. McGinley has received research support from NIH. The institution of Dr. McGinley has received research support from AHRQ. The institution of Dr. McGinley has received research support from EMD Serono.
Megan Hyland, MD (University of Rochester)	The institution of Dr. Hyland has received research support from Biogen. The institution of Dr. Hyland has received research support from PCORI.
Richard A. Rudick, MD, FAAN (Optimal Brain Health Consultants)	Dr. Rudick has received personal compensation for serving as an employee of Biogen. Dr. Rudick has received stock or an ownership interest from Biogen. Dr. Rudick has received publishing royalties from a publication relating to health care.
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden)	Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS . Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Dresden Internation University. The institution of Dr. Ziemssen has received research support from Novartis. The institution of Dr. Ziemssen has received research support from Merck. The institution of Dr. Ziemssen has received research support from Sanofi. The institution of Dr. Ziemssen has received research support from BMS. The institution of Dr. Ziemssen has received research support from Roche.
Irene Koulinska	Irene Koulinska has received personal compensation for serving as an employee of Biogen.

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