LOS ANGELES – Patients with multiple sclerosis in the CARE-MS II study who switched from interferon beta-1a therapy to the humanized monoclonal antibody alemtuzumab experienced continued reductions in brain volume loss and lesions on MRI through 5 years, according to follow-up data from the CARE-MS II extension study known as TOPAZ.
These outcomes support core findings from the CARE-MS II study, and suggest that alemtuzumab (Lemtrada) provides a unique treatment approach for patients with prior subcutaneous interferon beta-1a (IFNB-1a) treatment, Daniel Pelletier, MD, reported in a poster discussion session at the annual meeting of the American Academy of Neurology.
In CARE-MS II, relapsing-remitting multiple sclerosis patients with inadequate response to prior therapy experienced improvements in MRI lesions and brain volume loss with two courses of alemtuzumab versus IFNB-1a through 2 years, and in a 4-year extension in which participants discontinued subcutaneous IFNB-1a and initiated alemtuzumab at 12 mg/day, they experienced durable efficacy in the absence of continuous treatment, explained Dr. Pelletier, a professor of neurology at the University of Southern California, Los Angeles.
In the extension, patients could receive alemtuzumab retreatment as needed for relapse/MRI activity or receive other disease-modifying therapies at the investigator’s discretion. Patients completing the extension could enter the 5-year TOPAZ study for further evaluation, he said.
Of 119 patients who completed TOPAZ year 1, and thus had 5 years of follow-up after initiating alemtuzumab, 78% were free of new, gadolinium-enhancing lesions in IFNB-1a year 2; this increased significantly to 92% in post-alemtuzumab year 2, and remained high at 85%-89% in years 3-5. Additionally, 48% of patients were free of new/enlarging T2 lesions in IFNB-1a year 2; this increased significantly to 81% in post-alemtuzumab year 2 and remained high in years 3-5.
Further, 47% of the TOPAZ patients were MRI disease activity–free in IFNB-1a year 2; this increased significantly to 81% in post-alemtuzumab year 2, and remained high at 67%-72% in years 3-5.