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.
Eriksen, S., van Exel, J., Frederiksen, J.L., Nielsen, H.H., Torkildsen, O., Rini, A., et al. (2020). 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. NEUROLOGY, 94(15s), 143-143 [10.1212/WNL.94.15_supplement.143].
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
Lugaresi, AWriting – Review & Editing
;
2020
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
