DX07
Durable Clinical Improvements with Alemtuzumab in RRMS Patients in the Absence of Continuous Treatment: 7-Year Follow-up of Care-MS II (TOPAZ Study)
Objectives: To evaluate efficacy/safety of alemtuzumab over 7 y (2 y of core study plus 4 y of extension and Y1 of TOPAZ) in patients initially randomized to alemtuzumab in CARE-MS II.
Methods: In TOPAZ, patients can receive alemtuzumab (12 mg/day on 3 consecutive days) retreatment ≥12 months apart or other DMTs at any time. MRI scans are performed annually. Assessments: annualized relapse rate (ARR); 6-month confirmed disability worsening (CDW); 6-month confirmed disability improvement (CDI); EDSS scores; no evidence of disease activity (NEDA; absence of clinical disease activity [relapses and 6-month CDW] and MRI disease activity [new Gd-enhancing T1 and new/enlarging T2 hyperintense lesions]); and AEs.
Results: Of the 336 patients who entered TOPAZ, 317 (94%) completed Y1 (Y7 after initiating alemtuzumab). ARR remained low (Y7: 0.14); 51% were relapse-free in Y3–7. The percentage of patients with improved/stable EDSS scores versus baseline remained high at Y7 (73% [improved, 22%; stable, 51%]). The mean change in EDSS score from baseline to Y7 was 0.17. At Y7, 69% were free of 6-month CDW; 44% achieved 6-month CDI. The majority of patients achieved NEDA each year (Y7: 60%). 47% received neither alemtuzumab retreatment nor other DMT, and 88% did not receive another DMT after the initial 2 courses. Overall AE incidence decreased over time. Thyroid AE incidence peaked in Y3 (17%) and then declined.
Conclusions: Alemtuzumab efficacy was maintained for 7 y in patients who were initially randomized to alemtuzumab in CARE-MS II, despite 47% receiving no additional treatment since the initial 2 courses. 44% showed improvement in disability. Alemtuzumab safety profile remained consistent, with a decreased AE incidence over time. Alemtuzumab provides a unique treatment approach for RRMS patients, offering durable efficacy without continuous treatment.
Study Support: Sanofi and Bayer HealthCare Pharmaceuticals.