Abstract Details

Title 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)

Topic Multiple Sclerosis

Presentation(s) P13 - Poster Session 13 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-002

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.

Authors/Disclosures
Francesco Patti, MD PRESENTER	Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Almirall. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Meyers. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson and Johnson. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. The institution of Dr. Patti has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion, Almirall, Bayer, Biogen, Bristol Meyers and Squibb Merck, Roche, Sanofi, TEVA. Dr. Patti has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for University of Catania and AISM/FISM, Fondazione Italiana Sclerosi Multipla. Dr. Patti has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers in Neurology.
	No disclosure on file
	No disclosure on file
Maria Trojano (Policlinico - Bari)	Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi_Genzyme. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi-Genzyme. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Maria Trojano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen.

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Abstract Details