A study of relapsing-remitting multiple sclerosis (RRMS) patients who had one or more relapses on earlier treatment, showed that alemtuzumab (Lemtrada) improved disability progression over five years, even though most patients received treatment only during the first two years.
The study showed that alemtuzumab is a viable option for long-term treatment of patients with a history of poor treatment response.
The results were recently presented at the Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual Meeting, in National Harbor, Md. Dozens of worldwide researchers, neurologists, clinicians, patients and support organizations attended the June 1-4 event.
The sessions titled Disease Management, Imaging, and Therapeutics featured an array of updates on best practices that help keep MS in check. The study, “Patients with Active Relapsing-Remitting Multiple Sclerosis and Inadequate Response to Therapy at Baseline Show Durable Disability Improvement over 5 Years with Alemtuzumab: CARE-MS II,”was no exception.
The study explored disability outcomes, measured by Expanded Disability Status Scale (EDSS) scores, in patients enrolled in the CARE-MS II trial. These patients were treated with either alemtuzumab or subcutaneous interferon beta-1a (Rebif) for two years, with alemtuzumab being administered once per year.
Eligible patients could then enter an extension study, where they were treated with alemtuzumab only in case of a relapse or if magnetic resonance imaging (MRI) showed evidence of new or expanding lesions. Patients were offered an option to receive other disease-modifying drugs at the investigator’s discretion.
Almost all patients participating in the first study, 93% or 393 individuals, enrolled in the extension trial.
North Central Neurology Associates, which performed the study with support from Genzyme and Bayer HealthCare Pharmaceuticals, reported that throughout the period of five years, 91% of the patients remained in the study. Of them, 60% received no further alemtuzumab after the initial two courses, and 92% received no other disease modifying treatment.
The average yearly change in EDSS score over five years was +0.06 — and 75% of the patients did not show evidence of disease progression at six months.
Scientists also measured sustained reduction in preexisting disability, defined as one or more point EDSS decrease from baseline in patients with baseline EDSS of 2.0 or more.
At three, six, and 12 month intervals, sustained reduction in pre-existing disability averaged 48%, 43%, and 33%, respectively, over five years. A majority of patients who achieved 6-month disability reduction were also free from confirmed disability progression at this time point.
At year five, 77% of patients had either improved or were stable in terms of disability progression across all functional domains.
Among the 93 patients who improved during the first two years, most were stable during the following three years. Among the 189 patients who were stable from study start through two years, 81% either improved or remained stable during the following years.
Dr. Christopher LaGanke, who presented the data at CMSC 2016, hypothesized that the mechanism of action of alemtuzumab may explain its effect durability.
“Immunomodulation linked to lymphocyte repopulation may contribute to durability of the effect – a shift from a pro-inflammatory to anti-inflammatory profile,” said LaGanke.
The researcher concluded on his presentation: “Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continuous treatment for RRMS patients.”