Abstract Details

Title Treatment Sequencing and Satisfaction With Alemtuzumab in Relapsing Multiple Sclerosis Patients: Interim Results of the Real-world PRO-ACT Study

Topic Multiple Sclerosis

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

Poster/Presentation
Number 15-097

Objective Assess interim results on treatment sequencing and satisfaction in RRMS patients switching to alemtuzumab in the PRO-ACT study.

Background The PRO-ACT study assesses patient-reported outcomes, safety, and sequencing paradigms in RRMS patients after transitioning to alemtuzumab in routine clinical practice.

Design/Methods PRO-ACT is a 24-month (M), prospective, multicenter, single-arm, observational study. Primary endpoint: change from baseline to M24 in Global Satisfaction score of the Treatment Satisfaction Questionnaire for Medication (TSQM; scale 0-100 in each domain; higher scores indicate greater satisfaction). This interim analysis assessed change in TSQM score from baseline to M12.

Results The target sample size was met with 201 patients enrolling in PRO-ACT; 75.6% were female, mean (SD) age was 43.7 (10.6) years, mean disease duration was 10.1 (7.5) years. Mean (SD) EDSS score (n=66) was 3.6 (1.9). Most common prior disease-modifying therapies (DMTs) were natalizumab (36.8%), fingolimod (14.4%), dimethyl fumarate (13.4%), teriflunomide (12.4%), IFNB (11.4%), and glatiramer acetate (7.5%). Mean (SD) duration on most recent prior DMT was 2.5 (2.7) years and mean time since discontinuation was 0.3 (0.7) years. Most frequent reasons for switching were lack of efficacy (75.1%), safety (14.9%), and tolerability (6.5%). Mean TSQM Global Satisfaction score at baseline was 50.1, increasing to 64.9 at M12 after alemtuzumab. Mean Effectiveness score increased from 49.8 to 60.1. Mean Side Effects and Convenience scores decreased (Side Effects: 77.7 [baseline] to 76.7 [M12]; Convenience: 70.1 to 66.2).

Conclusions In this interim analysis, improvements in 2 of 4 TSQM domains were observed in patients with available data at baseline and 12M after alemtuzumab initiation in real-world clinical settings. Treatment satisfaction will be further evaluated after completion of the 2-course alemtuzumab regimen. Natalizumab was the most common prior therapy, although many patients transitioned from oral therapies and IFNB/glatiramer acetate, mainly due to lack of efficacy.

Authors/Disclosures
Sibyl E. Wray, MD (Hope Neurology) PRESENTER	Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb/Celgene. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche/Genentech. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi/Genzyme. The institution of Dr. Wray has received research support from Biogen. The institution of Dr. Wray has received research support from Atara Biotherapeutics. The institution of Dr. Wray has received research support from Bristol Myers Squibb/Celgene. The institution of Dr. Wray has received research support from Novartis. The institution of Dr. Wray has received research support from Roche/Genentech. The institution of Dr. Wray has received research support from Sanofi/Genzyme. The institution of Dr. Wray has received research support from TG Therapeutics. The institution of Dr. Wray has received research support from EMD Serono. The institution of Dr. Wray has received research support from Pharmaceuticals Corp..
Francois H. Jacques, MD (Clinique Neuro-Outaouais)	No disclosure on file
Tamara Miller, MD (Advanced Neurology of Colorado LLC)	Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics Therapeutics, Abbvie, Genentech. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono, TG Therapeutics, Biogen, Abbvie, Genentech, Lundbeck. The institution of Dr. Miller has received research support from Abbvie, Ipsen, Alexion, Pfizer, BMS, Genentech, ThermoFisher Scientific.
Jacqueline A. Nicholas, MD (OhioHealth Riverside Methodist Hospital)	Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squib. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Greenwich Biosciences. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Vielo Bio. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Nicholas has received research support from Novartis. The institution of Dr. Nicholas has received research support from Biogen. The institution of Dr. Nicholas has received research support from Genentech. The institution of Dr. Nicholas has received research support from PCORI. Dr. Nicholas has a non-compensated relationship as a Physician with National MS Society that is relevant to AAN interests or activities. Dr. Nicholas has a non-compensated relationship as a Physician with Siegal Rare Neuroimmune Association that is relevant to AAN interests or activities.
Susan Mozzicato, MD	No disclosure on file
Mary-Jean Fanelli, MD	No disclosure on file
Houari Korideck, MD (Sanofi)	Dr. Korideck has nothing to disclose.
	No disclosure on file
	No disclosure on file
Colin Mitchell, PhD (Sanofi Genzyme)	No disclosure on file
Samuel F. Hunter, MD, PhD (Advanced Neurosciences Institute)	The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbview. The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMDSerono. The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. The institution of Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Osmotica. Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMDSerono. Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Hunter has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sanofi. The institution of Dr. Hunter has received research support from Biogen. The institution of Dr. Hunter has received research support from Abbvie. The institution of Dr. Hunter has received research support from Genentech/Roche. The institution of Dr. Hunter has received research support from Janssen. The institution of Dr. Hunter has received research support from Novartis. The institution of Dr. Hunter has received research support from Osmotica. The institution of Dr. Hunter has received research support from Sanofi. Dr. Hunter has received intellectual property interests from a discovery or technology relating to health care. Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with MS Views and News. Dr. Hunter has a non-compensated relationship as a CEO - Volunteer with NeuroNexes/Novel Pharmaceutics Institute that is relevant to AAN interests or activities. Dr. Hunter has a non-compensated relationship as a Writing support with Novartis Pharmaceuticals that is relevant to AAN interests or activities. Dr. Hunter has a non-compensated relationship as a Writing Support with Osmotica that is relevant to AAN interests or activities. Dr. Hunter has a non-compensated relationship as a Writing support with Mallinckrodt that is relevant to AAN interests or activities. Dr. Hunter has a non-compensated relationship as a Writing Support with Sanofi that is relevant to AAN interests or activities.

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