Long-term Efficacy of Cladribine Tablets in Patients with Relapsing-Remitting or Secondary Progressive Multiple Sclerosis: Analysis of Real World Data From the Italian Multiple Sclerosis Registry (CLARINET-MS) (1511)

Objective: To assess the long-term efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive MS (SPMS). Background: Analysis of real-world data from patient registries provides insights into the long-term effectiveness of cladribine tablets, extending beyond the clinical trials. Design/Methods: CLARINET-MS was a non-interventional, retrospective investigation of data from the Italian MS Registry, which includes patients who participated in the cladribine tablets clinical development programme (ONWARD, CLARITY, CLARITY Extension and ORACLE-MS), who had received ≥1 dose of cladribine tablets and had active disease defined by relapse or attack history prior to screening. Data on the primary endpoint, time to treatment change, were previously reported. For this analysis, the observation period was from the last dose of cladribine tablets recorded in the trial, ending at the last visit or the date of the last recorded observation. Estimates of patients being event-free are based on Kaplan-Meier (KM) analysis with associated 95% confidence intervals (CI), with data presented at 12 and 36 months from last treatment. Results: This sub-analysis comprised 70 patients (RRMS, n=60; SPMS, n=10). The percentage of patients free from 3-month confirmed disability progression at 12 and 36 months for RRMS was 96.5 (95% CI 91.8–100.0%) and 72.0 (60.9–85.2%), respectively; for SPMS, 100.0 (100.0–100.0%) and 51.9 (26.7–100.0%), respectively. Percentage free from expanded disability status scale score ≥6.0 at 12 and 36 months was: RRMS, 100.0 (100.0–100.0%) and 96.1 (91.0–100.0%), respectively; SPMS, 100.0 (100.0–100.0%) and 51.9 (26.7–100.0%), respectively. Percentage free from first relapse at 12 and 36 months was: RRMS, 83.2 (74.2–93.3%) and 65.7 (54.5–79.1%), respectively; SPMS, 100.0 (100.0–100.0%) and 68.6 (44.5–100.0%), respectively. Conclusions: Cladribine tablets remain effective up to 4 years after the first dose in patients with RRMS and SPMS. Disclosure: Dr. Patti has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received personal compensation for speaking and/or advisor board activities by Almirall, Bayer, Biogen, Celgene, Merck, Myalin, Novartis, Roche, Sanofi-Genzyme and TEVA.. Dr. Patti has received research support from received grant research by MIUR (Ministero Italiano della Universita e della Ricerca Scientifica), FISM (Fondazione Italiana Sclerosi Multipla), Biogen and Merck.. Dr. Visconti has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Merck Serono S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.. Dr. Capacchione has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Merck Serono S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.. Dr. Trojano has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with scientific Advisory Boards for Biogen, Novartis, Merck Serono, Roche and Genzyme; has received speaker honoraria from Biogen Idec, Sanofi-Aventis, Merck Serono, Roche, Teva, Genzyme and Novartis; and has received research grants for her Institution from B. Dr. Trojano has received research support from Dr Trojano received research grants for her Institution from Biogen Idec, Merck Serono and Novartis..