Satisfaction with alemtuzumab in relapsing multiple sclerosis patients: Results from the real-world PRO-ACT study

Abstract

Background Patient-reported outcomes are increasingly used in the management of patients with multiple sclerosis to understand the patient's perspective of disease and treatment. These measures provide insights into important factors including treatment satisfaction, physical and psychological function, and quality of life. Objective To present results from the real-world PRO-ACT study in patients with multiple sclerosis who switched to alemtuzumab from another disease-modifying therapy. Methods This 24-month, prospective, multicenter, observational study had a primary endpoint of change in overall satisfaction, measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4. Secondary endpoints included the Multiple Sclerosis Impact Scale-29 (MSIS-29), Modified Fatigue Impact Scale-5 (MFIS-5), and the Patient-Determined Disease Steps (PDDS). Safety was monitored with adverse events (AEs). Results Of 199 enrolled patients, improvements were observed in mean TSQM scores for overall satisfaction (baseline, 50.3; year 2, + 13.2; p  < 0.0001), effectiveness (49.3 and + 12.2; p  < 0.0001), and side effects (77.6 and + 4.5; p  = 0.04). Improvements were also observed in MSIS-29 physical (52.4 and −6.0; p  < 0.0001), MSIS-29 psychological (53.4 and −7.0; p  = 0.0003), and MFIS-5 (12.8 and −1.7; p  < 0.0001). Most (95.0%) patients experienced ≥ 1 AE (88.4% mild, 67.8% moderate). Conclusions The primary endpoint was met; the safety of alemtuzumab was consistent with pivotal studies.