Cladribine Extension Trial and Post Hoc Analysis Shows 10-Year Safety and Efficacy
In data presented at the European Committee on Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Berlin, Germany Oct. 10-12, real-world follow up and post-hoc analysis of cladribine (EMD Serono, Rockland, MA) for treatment of patients with highly-active multiple sclerosis (MS) were presented and showed continued long-term safety and efficacy. Cladribine is an oral tablet taken for a maximum of 20 days over a 2 year period that is marketed in Europe, Canada and other countries as Mavenclad, and is not yet approved for use in the US.
Integrated analysis of data from patients enrolled in the CLARITY (NCT00213135), CLARITY EXT (NCT00641537), and ORACLE-MS (NCT00725985) trials, and the 2-year update of the long-term PREMIERE Registry, confirmed the safety profile of cladribine with no new treatment-emergent adverse events occurring. The integrated analysis included 923 patients who received cladribine tablets 3.5 mg/kg and 641 patients who received placebo. Review of post-approval safety data since EU approval on August 2017 to July 2018 also showed no new safety or tolerability signals for cladribine tablets.
The adjusted adverse event incidences per 100 patient-years for those experiencing ≥ 1 serious adverse event were 3.88 for cladribine tablets and 3.24 for placebo in the two-year update, similar to the 4.00 and 3.57, respectively that were reported previously. No new adverse events, including serious lymphopenia, serious infection and infestations, serious herpes zoster, serious neoplasm, benign, malignant or unspecified have occurred.
Post hoc analyses of data from CLARITY EXT show that after 20 days of treatment with cladribine years 1 and 2, the annual no evidence of disease activity (NEDA-3) remained for patients treated cladribine for 2 to 4 years. Efficacy of cladribine does not appear to be affected by age as measured clinically or by the number of new T1 gadolinium-enhancing or T2 lesions.
The clinical development program of cladribine tablets in MS comprises close to 12,000 patient years of data with over 2,700 patients and up to 10 years of follow-up in some patients.
The data presented at ECTRIMS 2018 highlight our commitment to continuing to best understand the benefit-risk profile of cladribine tablets,” said John Walsh, MD, Vice President, Neurology & Immunology, US Medical Affairs. “We believe in the potential of investigational cladribine tablets and are committed to collecting more data and conducting more comprehensive analyses on the safety and efficacy of the drug.”