Abstract Details

Title Significant and Clinically Meaningful Health-Related Quality of Life Improvements With Alemtuzumab in RRMS Patients in Clinical Practice: Interim Results From a Prospective, Non-Interventional, Real-World Study (PROMiS)

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-098

Objective To report interim results on patient-reported health-related quality-of-life (HRQoL) outcomes, function, and degree of disability over 8 months (M) in RRMS patients receiving alemtuzumab in clinical practice.

Background Alemtuzumab significantly improved clinical, MRI, and HRQoL outcomes versus SC IFNB-1a in RRMS patients in two phase 3 clinical trials, and remained efficacious in an extension over 6-year total follow-up. Real-world data on alemtuzumab use in clinical practice are limited.

Design/Methods PROMiS is an ongoing 1-year, real-world, prospective, non-interventional, online patient-reported outcomes (PRO) survey of RRMS patients in the USA who had initiated alemtuzumab. Patients were recruited from the MS One-to-One support program. PRO questionnaires were completed at baseline and at various intervals over 1 year: Multiple Sclerosis Impact Scale (MSIS-29; scale 0-100), and Multiple Sclerosis Performance Scale (MSPS; scale 0-41), both assessed at baseline, M4, M8, M12; Patient Determined Disease Steps (PDDS; scale 0-8; assessed at baseline, M6, M12). Higher scores indicate greater disability in functional health (MSPS and PDDS) or worse HRQoL (MSIS-29). Baseline characteristics, including treatment history, were collected.

Results The interim analysis included 171 patients (mean age 44.8 years; 72.5% female); 97.7% had received another MS therapy before initiating alemtuzumab. Mean MSIS-29 scores improved at M8 after alemtuzumab versus baseline (physical impact score, 43.0 versus 53.1; psychological impact score, 36.8 versus 49.4; both P<0.0001), reaching established thresholds for clinically important changes (≥6 point reduction from baseline). Mean total MSPS was 16.6 at baseline and improved to 14.9 at M8 (P=0.0123). Mean PDDS score was 3.5 at baseline and 3.1 at M6 (P=0.0231).

Conclusions Over 8M after alemtuzumab initiation, patients reported significant and clinically meaningful HRQoL improvements while functional health remained stable. It will be important for patients to complete the full alemtuzumab regimen (2 courses) to allow further assessment of treatment benefit.

Authors/Disclosures
Bhupendra O. Khatri, MD, FAAN (Center for Neurologic Disorders/St. Francis OP Center) PRESENTER	Dr. Khatri has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Alexion. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Khatri has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for ER Squibb (Bristol Myer Squibb). Dr. Khatri has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizone. Dr. Khatri has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Khatri has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genzyne. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. Dr. Khatri has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Alexion. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Seronoe. Dr. Khatri has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for E.R. Squibb. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Khatri has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Janssen. Dr. Khatri has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutic. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genzyme. Dr. Khatri has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Khatri has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Argenx US. The institution of Dr. Khatri has received research support from Biogen.
	No disclosure on file
Luke Chung (Sanofi Genzyme)	Luke Chung has received personal compensation for serving as an employee of Sanofi Genzyme. Luke Chung has received stock or an ownership interest from Sanofi Genzyme.
Elizabeth Poole	No disclosure on file
Lobat Hashemi	No disclosure on file
	No disclosure on file

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