CLASSIC-MS: Long-term Efficacy and Real-World Treatment Patterns for Patients with Relapsing Multiple Sclerosis who Received Cladribine Tablets in Phase III Parent Trials
Gavin Giovannoni1, Aida Aydemir2, Elisabetta Verdun Di Cantogno3, Thomas Leist4, on behalf of the CLASSIC-MS Steering Committee5
1Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 2EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, a business of Merck KGaA, Darmstadt, Germany, 3Merck KGaA, Darmstadt, Germany, 4Division of Clinical Neuroimmunology, Jefferson University, Comprehensive MS Center, 5CLASSIC-MS Steering Committee
Interim analysis of long-term outcomes for patients with relapsing multiple sclerosis (MS) originally enrolled in CLARITY with/without CLARITY Extension, as part of the CLASSIC-MS study.
CLASSIC-MS (NCT03961204) explores the long-term efficacy and durability of effect of cladribine tablets (CT; cumulative dose 3.5 mg/kg over 2 years) beyond the 2 annual treatment courses in patients enrolled to these parent trials, with the aim of informing future treatment approaches.
CLASSIC-MS is an exploratory, low-interventional, ambispective Phase IV study of patients previously enrolled into Phase III parent trials who had received ≥1 course of CT or placebo. We report an interim analysis of long-term responder rates for a small population of patients with relapsing MS who were previously enrolled in CLARITY with/without CLARITY Extension. Long-term responder status was defined as: (A) not requiring further disease-modifying drug (DMD) treatment until ≥4 years after last parent study dose (LPSD), or (B) no evidence of disease reactivation based on clinical outcomes in the 4 years following LPSD. Analyses are descriptive.
The interim population comprised 93 patients (61% female; mean EDSS score, 4.06±2.00 at CLASSIC-MS baseline), with a median time since LPSD of 10.4 (range 9.5–14.2) years; 93.5% were exposed to CT in the parent trials. Overall, 82.8% were long-term responders by definition A, and 36.6% by definition B. In addition, 68.8% of patients enrolled to CLASSIC-MS received no subsequent DMD treatment after LPSD. 45% of participating patients were actively employed at the time of CLASSIC-MS enrollment.
We report an interim analysis of a small population of patients with relapsing MS from CLARITY with/without CLARITY Extension who are participating in CLASSIC-MS. Findings show that while 3 out of 5 participating patients had disease reactivation during 4 years since LSPD, only 1 in 5 required further DMD treatment during these 4 years.