Evaluating Patient-Reported Outcomes in a Real-World Setting with Alemtuzumab in Relapsing MS Patients Discontinuing a Prior Dmt: PRO-ACT Study Design

Background: Alemtuzumab, approved in over 60 countries for the treatment of relapsing forms of MS, demonstrated greater clinical and MRI efficacy versus SC IFNB-1a over 2 years in one phase 2 and two phase 3 studies. Further, improvements on both disease-specific and general measures of quality of life were significantly greater with alemtuzumab than with SC IFNB-1a. Efficacy was durable through 6 years in an extension study, with a consistent safety profile, in the absence of continuous treatment. Patients’ satisfaction with treatment and the impact of treatment on quality of life are essential to the overall assessment of drug effectiveness, and confirm the clinical meaningfulness of improvements in symptoms. Patient perspectives in the real-world setting may also help guide treatment decisions.

Objectives: To describe PRO-ACT, a real-world study designed to assess patients’ satisfaction with alemtuzumab treatment and its effects on quality of life, fatigue, disease progression, and work productivity.

Methods: PRO-ACT is a 24-month, prospective, multicenter, non-interventional, single-arm, observational study enrolling a total of 200 adults with relapsing MS who have discontinued a prior disease-modifying therapy (DMT) and have been prescribed alemtuzumab in routine clinical practice in the United States and Canada.  Alemtuzumab 12 mg/day IV is administered per approved labeling as 2 courses (Course 1: 5 consecutive days at baseline; Course 2: 3 consecutive days 12 months later). Primary endpoint: change from baseline at 24 months in the Treatment Satisfaction Questionnaire for Medication score. Secondary endpoints: change from baseline at 24 months in score on the MS Impact Scale 29, Modified Fatigue Impact Scale, Patient-Determined Disease Steps scale, and Health- Related Productivity Questionnaire; as well as adverse events and lymphocyte repopulation over 24 months. Tertiary endpoint: to describe methods for switching from prior DMT to alemtuzumab (eg, washout periods and steroid use). Patient-reported outcomes will be evaluated at baseline, and at Months 6, 12 (before second treatment course), 18, and 24. Data will be recorded using a computer-based portal.

Results: PRO-ACT is currently enrolling patients.

Conclusions: PRO-ACT will provide real-world insights into treatment satisfaction with alemtuzumab and its impact in clinical practice on multiple aspects of quality of life in patients switching from a prior DMT.