Abstract Details

Title 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

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 079

Objective 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.

Background 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.

Design/Methods 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.

Results 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.

Conclusions 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.

Authors/Disclosures
Gavin Giovannoni, MD (QMUL) PRESENTER	Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche-Genentech. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape.
	No disclosure on file
Elisabetta Verdun Di Cantogno, MD (Merck Serono Int, SA)	Dr. Verdun Di Cantogno has received personal compensation for serving as an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA. Dr. Verdun Di Cantogno has stock in EMD Serono Research & Development Institute, Inc., Billerica, MA, USA.
Thomas Leist, MD, PhD, FAAN (Thomas Jefferson University)	Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Leist has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Seono. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Expert Wittness with DHHS HRSA.
	No disclosure on file

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