Data from the CARE-MS II clinical trial showed that Lemtrada (alemtuzumab) can lessen pre-existing disabilities in patients with relapsing-remitting multiple sclerosis (RRMS) who failed to respond adequately to previous disease-modifying therapies, according to a study of the trial’s data. The treatment was evaluated against Rebif (interferon beta-1a) therapy.
The study, “Alemtuzumab improves preexisting disability in active relapsing-remitting MS patients” was published in the journal Neurology.
A major aim of multiple sclerosis (MS) treatment is limiting patients’ disability, an outcome usually measured by the delay in confirmed disability worsening (CDW). However, interest in growing in efforts to reach confirmed disability improvement (CDI), a higher standard of therapeutic efficacy than that of slowing disability accumulation.
CDI is believed to reflect durable and clinically meaningful Expanded Disability Status Scale (EDSS) score changes. EDSS is a standard method of quantifying disability in MS.
In this study, the researchers’ objective was to characterize the effects of Lemtrada treatment on measures of disability improvement in patients with RRMS whose response to other treatments was found to be inadequate (relapsing at least once). Lemtrada is a humanized monoclonal antibody capable of remodeling the immune responses of innate immune cells in patients with RRMS.
Researchers analyzed data from the Phase 3 CARE-MS II trial (NCT00548405), which was designed to evaluate both the efficacy and safety of two different doses of Lemtrada (12 mg and 24 mg) as a treatment for RRMS compared to Rebif, another RRMS disease-modifying drug (DMT). The trial measured patient outcomes based on EDSS, the Multiple Sclerosis Functional Composite (MSFC), and Sloan low-contrast letter acuity (SLCLA). [While EDSS quantifies overall disability, MSFC is a sensitive measure of ambulation, manual dexterity and cognitive function, and SLCLA of visual acuity.]
Lemtrada-treated patients were more likely to show improvement in EDSS scores in comparison to those treated with Rebif, the researchers found. A significantly higher proportion of these patients exhibited 6-month confirmed disability improvement. Moreover, the likelihood of improved — versus stable or worsening MSFC scores — was again higher in Lemtrada-treated patients, and these patients also exhibited more favorable changes from baseline in SLCLA scores alone, and in combined MSFC plus SLCLA, relative to Rebif-treated patients.
Results showed that RRMS patients with inadequate responses to previous disease-modifying therapies had significant improvements across several disability outcomes when treated with Lemtrada, as opposed to treatment with Rebif, in the trial.
“The outcomes presented here not only support alemtuzumab’s ability to slow disability accumulation, but also demonstrate superior benefit in improving preexisting disability in patients with RRMS with an inadequate response to prior DMT,” the researchers concluded. “These data add to the body of evidence supporting a favorable benefit-risk profile of alemtuzumab in the treatment of RRMS.”