DALLAS — Alemtuzumab (Lemtrada) continued to show benefits in clinical outcomes, lesion load, and brain volume loss in relapsing-remitting multiple sclerosis (MS) for 8 years, an extension study of patients from the CARE-MS II trial found.
In years 3 through 8, alemtuzumab-treated patients had a cumulative annualized relapse rate (ARR) of 0.19 (95% CI 0.17-0.22), reported Barry Singer, MD, of Missouri Baptist Medical Center in St. Louis, and colleagues at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum.
At year 8, 70% had improved or stable disability scores compared with baseline. Over years 2 through 8, 66% to 76% of patients were free of MRI disease activity each year. The median cumulative brain volume loss over 8 years was -1.06%, with brain volume loss -0.19% or less annually in years 3-8.
“We’re seeing very low rates of brain volume loss,” Singer told MedPage Today. “Patients are preserving brain tissue.”
Alemtuzumab is a humanized monoclonal antibody that targets the CD52 molecule on the surface of T and B cells. The drug originally was approved in 2001 with a brand name of Campath to treat B-cell chronic lymphocytic leukemia.
The FDA approved alemtuzumab for relapsing-remitting MS in 2014 based on two 2-year trials: CARE-MS I, which studied alemtuzumab in drug-naive patients, and CARE-MS II, which looked at alemtuzumab in patients who relapsed while treated with interferon beta-1a (Rebif) or glatiramer acetate (Copaxone).
In a 4-year extension of CARE-MS II, patients could receive additional courses of alemtuzumab (12 mg/day on 3 consecutive days; ≥12 months apart) as needed for disease activity, or other disease-modifying therapy, at any time point. After that 4-year extension, patients could continue in TOPAZ, an additional 5-year extension study.
Of 435 alemtuzumab-treated patients in CARE-MS II, 300 (69%) completed 8-year total follow-up. In total, 44% of CARE-MS II patients received neither additional courses of alemtuzumab nor another disease-modifying treatment through year 8. About half (51%) of CARE-MS II patients who entered the extension received one or more courses of alemtuzumab over 8 years, with 29% receiving just one additional course.
“This is an example of effective induction therapy and discontinuous treatment,” said Aaron Boster, MD, of OhioHealth Neuroscience in Columbus, who was an investigator in the CARE-MS trials.
“When people require a repeat dose, the data supports that they fare very well,” Boster told MedPage Today. “I find this to be reassuring as I talk to patients, because we now have 8 years of solid prospectively collected data of people with that amount of time in front of us. We can look at their outcomes for efficacy and safety to guide us.”
Although there was extensive reporting about adverse effects including serious infections, thyroid abnormalities, and immune thrombocytopenia in the CARE-MS trials, “the safety profile was consistent through year 8 and there were no new signals,” Singer said.
The incidence of adverse events was reduced in years 3-8 compared with the core CARE-MS study (years 1 and 2). No immune thrombocytopenia events occurred after the 48-month monitoring period from the last alemtuzumab dose. The incidence of infections declined from years 4 through 8, and the incidence of serious infections was 3.3% per year or less through 8 years.
Ten malignancy cases were reported over 8 years, Singer and colleagues noted. Two deaths occurred in year 7 (one suicide and one unknown cause) and four deaths occurred in year 8, which were assessed as not related to alemtuzumab, they added.