Seattle – , according to a pooled analysis presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Patients who achieved this outcome had improvement in several functional systems, regardless of their baseline EDSS scores. “These results suggest a broad and prolonged effect of alemtuzumab on disability improvement and a potential for changing the MS disease course,” said Samuel F. Hunter, MD, a neurologist and psychiatrist at the Advanced Neurosciences Institute in Franklin, Tenn., and colleagues.
The researchers’ findings come from their analysis of pooled data from the CARE-MS I and CARE-MS II trials. Those studies indicated that alemtuzumab improved clinical and MRI outcomes over 2 years in relapsing-remitting MS, compared with interferon beta-1a. In a 4-year extension, alemtuzumab’s efficacy was maintained, and 81% of participants continued in the study until year 6. In addition, 34% of alemtuzumab-treated patients in CARE-MS I and 43% of alemtuzumab-treated patients in CARE-MS II achieved 6-month confirmed disability improvement. The relationship between baseline disability levels and the achievement of disability improvement is not well understood, however.
Dr. Hunter and colleagues conducted a pooled analysis of CARE-MS I and CARE-MS II data to evaluate how baseline disability affects improvements in each functional system in patients treated with alemtuzumab over 6 years. In those studies, patients received two 12-mg/day courses of alemtuzumab: a 5-day course at baseline and a 3-day course 12 months later. Additional treatment with alemtuzumab or other disease-modifying therapies was provided as needed during the extension study.
The investigators defined confirmed disability improvement as a decrease of 1 or more points in EDSS score confirmed over 6 months among patients with a baseline EDSS score of 2 or higher. Improvement (i.e., a decrease of 1 or more points) or stability (i.e., no change) in each of the functional system scores was assessed in patients with confirmed disability improvement, stratified by baseline EDSS scores. Patients were grouped according to whether their baseline EDSS scores were 2.0-2.5, 3.0-3.5, 4.0-4.5, 5.0-5.5, or 6.0-6.5.
A total of 208 of 565 patients (37%) achieved 6-month confirmed disability improvement through year 6. This outcome was achieved by the highest percentages of patients with baseline EDSS scores of 4.0-4.5 (57%) and 3.0-3.5 (44%), followed by those with baseline EDSS scores of 5.0-5.5 (28%) and 2.0-2.5 (27%). No patients with baseline EDSS scores of 6.0-6.5 achieved confirmed disability improvement.
At 6 months after onset of confirmed disability improvement, patients within each baseline EDSS group showed stability or improvement in each individual functional system. The proportion of stable or improved patients was 94% or greater in the 2.0-2.5 group, 92% or greater in the 3.0-3.5 group, 88% or greater in the 4.0-4.5 group, and 75% or greater in the 5.0-5.5 group. Between 67% and 76% of patients achieved improvements in two or more functional systems. Improvements were most frequent in the pyramidal (13% to 50%), sensory (42% to 50%), and cerebellar (13% to 55%) functional systems.
Sanofi, Bayer HealthCare Pharmaceuticals supported the study. Dr. Hunter received grants and financial support from AbbVie, Actelion, Acorda, Adamas, Alkermes, Avanir, Bayer HealthCare, Biogen, Novartis, Osmotica, Questcor, Roche, Sanofi, Synthon, and Teva.
SOURCE: Hunter SF et al. CMSC 2019. Abstract DXT08.