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Abstract Details

Disease activity after cladribine immune reconstitution therapy: To repeat or to retreat?
Multiple Sclerosis
P9 - Poster Session 9 (5:30 PM-6:30 PM)
12-002

Cladribine immune reconstitution therapy (Clad-IRT) is an effective disease modifying treatment (DMT) in people with relapsing MS (pwRMS). However, disease activity may resume after variable delay. Characteristics of pwRMS that develop disease breakthrough after Clad-IRT remain unknown.

To describe characteristics of patients from our real world cohort (RWC) of >250 pwMS who underwent a third course of cladribine immune reconstitution therapy (Clad-IRT).

RWC observation. Patient demographics, clinical and magnetic resonance imaging (MRI) variables were extracted from medical records.

Nine pwMS (seven women, two men) received a third course of Clad-IRT a mean of 33 months (range 16-43) after completing their second course. Mean age was 46 years (range 33-68), disease duration 14 years (5-29). Median EDSS was 4 (0-7.5). The decision for administering a third course was based on MRI-evidence of disease activity only in six (6 new T2 lesions, 2 new Gd+ lesions), clinical relapse in one, and both in two (including 1 new T2 lesion and 3 Gd+ lesions). In four/9 patients, the third course of cladribine was administered via subcutaneous injection, 5/9 received cladribine tablets (Mavenclad). DMTs prior to initial Clad-IRT included dimethyl-fumarate (n=2 patients), fingolimod (2), mitoxantrone (1), interferon beta-1a (2), glatiramer acetate (1) and none (4). Reviewing cladribine doses administered during the initial 2 treatment courses, only 5/9 had received the full dose of Clad-IRT for their first, and 4/9 for their second course.  Mean total lymphocyte count at baseline and 20 weeks was 1.6x10^9/L (0.8-3) and 1x10^9/L (0.6-1.6), respectively.

Similar to pwMS experiencing breakthrough activity on alemtuzumab, pwMS may benefit from a third treatment course of Clad-IRT. In this sample from our RWC, dose adjustment during initial Clad-IRT course(s) may have contributed to resuming disease activity. Clinical monitoring and mechanistic studies continue to address this question.

Authors/Disclosures
Kimberley Allen-Philbey, MSc (The Blizard Institute (Neuroscience and Trauma))
PRESENTER
Miss Allen-Philbey has nothing to disclose.
Monica Marta Monica Calado-Marta has nothing to disclose.
Sharmilee Gnanapavan, MB (Institute of Neurology) Dr. Gnanapavan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. The institution of Dr. Gnanapavan has received research support from NIHR.
David Baker No disclosure on file
Klaus Schmierer, MD, PhD (The Blizard Institute, Centre for Neuroscience, Surgery & Trauma) Dr. Schmierer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AXDEV. Dr. Schmierer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MedScape. Dr. Schmierer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDiem. Dr. Schmierer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurology Academy. Dr. Schmierer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck KGaA. Dr. Schmierer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Merck KGaA. Dr. Schmierer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for F. Hoffmann-La Roche AG. Dr. Schmierer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Dr. Schmierer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva.