Abstract Details

Title Baseline Patient and Caregiver Characteristics From a Prospective, Noninterventional, Real-World Study (REALITY) on the Effect of Alemtuzumab on Fatigue and Other Patient- and Caregiver-Reported Quality-of-Life Outcomes in Patients With RRMS

Topic Multiple Sclerosis

Presentation(s) P13 - Poster Session 13 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-009

Objective Assess the burden of MS on patient and caregiver quality of life (QoL) at baseline before starting alemtuzumab.

Background Alemtuzumab significantly improved clinical, MRI, and QoL outcomes versus subcutaneous interferon beta-1a in patients with RRMS in clinical trials. Little is known about real-world QoL in alemtuzumab-treated patients and their caregivers.

Design/Methods REALITY is a 3-year prospective, multicenter, noninterventional, observational, real-world study of alemtuzumab-treated RRMS patients conducted in Denmark, Italy, and Norway. Included patients had a baseline Fatigue Scale for Motor and Cognitive Functions (FSMC) total score ≥43. Patient QoL was assessed using FSMC and Multiple Sclerosis Impact Scale (MSIS)-29, and caregiver QoL using 36-Item Short-Form (SF-36) Health Survey physical component summary (PCS) and mental component summary (MCS).

Results Baseline characteristics were available for 87 (100%) patients and 55 caregivers. Patients were 81% female, mean (SD) age 36.4 (8.4) years, MS duration 7.8 (6.1) years, EDSS score 3.1 (1.6), and number of previous MS therapies 2.9 (1.5). Caregivers were 62% male, mean age 44.8 (11.7) years; 85% had been a caregiver for >1 year, 64% were employed full-time, and 75% had children living at home. Before alemtuzumab initiation, mean patient-reported FSMC total score (n=67) was 66.4 (15.6). Patients’ MSIS-29 physical and psychological impact scores at baseline (n=46) were 42.3 (24.6) and 51.7 (28.7), respectively, whereas matched caregivers’ estimates (blinded to patients’ responses) were 36.5 (22.2) and 49.8 (25.9). Caregivers reported mean baseline SF-36 PCS and MCS scores of 48.5 (10.6) and 44.3 (9.9), respectively (lower than general population norm-based score of 50 [10]).

Conclusions Before alemtuzumab initiation, caregivers’ perceptions of patient QoL trended better than patients’ own QoL evaluations and caregivers experienced lower QoL versus the general population on SF-36. The ongoing REALITY study will assess the effect of alemtuzumab treatment on these measures.

Authors/Disclosures
PRESENTER	No disclosure on file
	No disclosure on file
Vladana Markovic	No disclosure on file
Helle Hvilsted Nielsen, MD, PhD (Odense University Hospital)	No disclosure on file
Oivind Torkildsen	No disclosure on file
Augusto Rini, MD	No disclosure on file
Luca Massacesi (Osp. Policlinico Careggi)	The institution of Luca Massacesi has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck-Serono. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson and Johnson. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Horizon. The institution of Luca Massacesi has received research support from Tuscan Region Government. The institution of Luca Massacesi has received research support from Sanofi. The institution of Luca Massacesi has received research support from Roche. Luca Massacesi has received research support from Merck-Serono.
Margaret Mondino	No disclosure on file
Massimiliano Mirabella, MD	Dr. Mirabella has nothing to disclose.
Alessandra Lugaresi, MD (Istituto delle Scienze Neurologiche di Bologna)	Dr. Lugaresi has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck Serono. Dr. Lugaresi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis Pharma. Dr. Lugaresi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Lugaresi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Lugaresi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Lugaresi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Lugaresi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan. Dr. Lugaresi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Sqibb. Dr. Lugaresi has a non-compensated relationship as a Speaker at meetings, participant in trials with Fondazione Italiana Sclerosi Multipla that is relevant to �鶹��ýӳ�� interests or activities.
Giacomo Lus (Policlinico di Napoli)	Giacomo Lus has nothing to disclose.
Damiano Paolicelli	Damiano Paolicelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck Serono. Damiano Paolicelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi.
	No disclosure on file
	No disclosure on file
Elio A. Scarpini, MD (University of Milan)	No disclosure on file

�鶹��ýӳ��

�鶹��ýӳ��