New real-world data show MAVENCLAD (cladribine tablets) had lower annualised relapse rates and longer time to first relapse and time to switch than fingolimod, dimethyl fumarate and teriflunomide in relapsing multiple sclerosis patients
DARMSTADT, Germany -- (BUSINESS WIRE) -- Merck, a leading science and technology company, today announced new real-world data from the MSBase Registry demonstrating MAVENCLAD® (cladribine tablets) had more favourable relapse outcomes and longer time to switch to another disease modifying therapy (DMT) compared to the oral DMTs fingolimod, dimethyl fumarate (DMF) and teriflunomide in relapsing multiple sclerosis (RMS) patients. A second study, analysing real-world follow up of clinical trial patients with a first attack suggestive of MS, showed those treated with MAVENCLAD had a lower rate of conversion to clinically definite multiple sclerosis (CDMS), defined by further relapse or disability progression, and lower risk of relapse than those not exposed to MAVENCLAD. These data will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2022, taking place 24-26 February 2022. In this first analysis of its size from the Generating Learnings In MultiPle SclErosis (GLIMPSE) study, data from 633 patients prescribed MAVENCLAD in the MSBase Registry was matched using propensity scores to patients receiving fingolimod (n=1195), DMF (n=912) or teriflunomide (n=735). Results showed the annualised relapse rate (ARR) for patients treated with MAVENCLAD was 0.09 compared to 0.15, 0.15 and 0.17 for fingolimod, DMF and teriflunomide, respectively. Time-to-first relapse in MAVENCLAD-treated patients was 40%, 42% and 67% lower than in patients treated with fingolimod, DMF and teriflunomide, respectively. The time to switch rate in patients treated with MAVENCLAD was 4, 7 and 6.5 times lower than fingolimod, DMF and teriflunomide, respectively. The GLIMPSE study was a longitudinal, retrospective analysis of adult patients identified with RMS from the MSBase Registry, an international online registry for neurologists studying MS and other neuro-immunological diseases. “It is important in a lifelong disease like MS to continue assessing the efficacy and safety of available treatment options in the real world,” said Helmut Butzkueven, MBBS, FRACP, PhD, Department of Neuroscience, Central Clinical School, Monash University, Melbourne. “This is where the MSBase Registry, using standardised data records from over 79,000 people with MS around the world, can provide information that is not possible to obtain in a randomised clinical trial. This information showed us that in GLIMPSE, MAVENCLAD had better relapse outcomes and longer treatment persistence compared to other oral DMTs, including fingolimod.” Also being presented are new data from an exploratory Phase IV CLASSIC-MS follow-up of patients (n=227) from the Phase III ORACLE-MS study which suggest early use of cladribine tablets reduced the risk of further relapse or disability progression (CDMS) in patients who experienced a first episode of neurologic attack with characteristics that put them at high risk of CDMS. Over half the patients (53.2%) treated with cladribine tablets remained relapse free compared to 28.2% of those who did not receive cladribine tablets. In patients who received cladribine tablets, 42.9% were diagnosed with CDMS in the median of 9.5 years since their last dose. In patients never treated with cladribine tablets, 70.4% were diagnosed with CDMS. In ORACLE-MS, patients with a first clinical demyelinating event were randomised to receive cladribine tablets 3.5 mg/kg, cladribine tablets 5.25 mg/kg or placebo. This analysis at the ACTRIMS Forum 2022 investigated the long-term efficacy in patients from the ORACLE-MS trial who had received at least one course of cladribine tablets (68.7%) or placebo (31.3%). Cladribine tablets (5.25 mg/kg) are not approved for any use in any region. About MAVENCLAD® MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been approved in over 80 countries, including Canada, Australia and the U.S. Refer to the respective prescribing information for further details. The clinical development programme for cladribine tablets includes:
In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.
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About Merck Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Electronics. View source version on businesswire.com: https://www.businesswire.com/news/home/20220223006102/en/ CONTACT:
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