Merck’s Mavenclad branded cladribine tablets for the treatment of highly active relapsing multiple sclerosis has demonstrated the medication a achieve sustained control of the disease over four years with a maximum of only 20 days of oral treatment.
“Today’s publication further strengthens the evidence for the use of cladribine tablets in MS, demonstrating significant, durable benefits in patients not receiving active treatment after the two short courses,” said Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and chair of Neurology, Barts and The London School of Medicine and Dentistry. “The data from this publication and other recent articles suggest that cladribine tablets selectively targets the adaptive immune system, particularly the B-cell compartment, and therefore allows the immune system to reconstitute while still preventing MS disease activity in the majority of treated patients.”
In August, the European Commission (EC) granted Marketing Authorization for cladribine tablets for the treatment of adults with highly active relapsing MS in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein, and Iceland. Merck plans additional filings for regulatory approval in other countries, including the United States.
The trial, an extension of the Phase III CLARITY study, included 806 patients out of 1,184 patients who completed the CLARITY study. The study assessed several clinical efficacy endpoints including annualized relapse rate (ARR) and confirmed three-month Expanded Disability Status Scale (EDSS) progression.
The proportion of patients who remained relapse-free at the end of four years was similar to the patients who received cladribine tablets 3.5 mg/kg in CLARITY followed by placebo in CLARITY Extension (75.6 per cent), and those who received cladribine tablets 3.5 mg/kg in both studies (81.2 per cent). The proportion of patients who remained free of three-month EDSS progression was also similar between the treatment groups (72.4 per cent vs. 77.4 per cent).
“The enduring benefits in patients who did not receive active treatment after the two short courses alleviate some safety concerns normally associated with continuous immunosuppression seen with other treatment options,” said Dr. Mark S. Freedman, director, Multiple Sclerosis Research Unit at the Ottawa Hospital, and senior scientist at The Ottawa Hospital Research Institute and investigator for the CLARITY study.
The safety outcomes were comparable to those seen in CLARITY; adverse event rates were similar in patients who received cladribine tablets in CLARITY followed by placebo in CLARITY Extension, and those who received cladribine tablets in both studies.
“Today’s data add to the growing evidence for the use of cladribine tablets in patients with relapsing MS,” said Luciano Rossetti, head of global R&D for the biopharma business of Merck.