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

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.