Abstract Details

Title Real-world Experience with Cladribine Tablets in the MSBase Registry

Topic Multiple Sclerosis

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

Poster/Presentation
Number 056

Objective We analysed the cladribine treatment experience in the MSBase registry. We described baseline characteristics, treatment pathways, and relapse and discontinuation outcomes in patients with ≥6 months follow-up data from cladribine initiation.

Background Cladribine tablets are approved for treatment of multiple sclerosis (MS) in many jurisdictions. Real-world outcomes data is very limited.

Design/Methods We performed a secondary data analysis using MSBase Registry data of patients with a confirmed diagnosis of MS and newly treated with cladribine tablets after regulatory approval. Descriptive statistics were used to analyse baseline patient characteristics recorded within 3 months prior to cladribine tablets initiation, including demographics, disease course and duration, prior disease modifying drugs (DMD), and Expanded Disability Status Scale (EDSS).

Results

As of the 4th June 2020, MSBase included 660 patients treated with cladribine from 9 countries, mainly from Australia and Europe. A total of 576 met all inclusion criteria.

These included 496 relapsing-remitting MS (RRMS) patients. In these, median age at cladribine tablets start was 45 years and median disease duration since clinically isolated syndrome was 12.6 years. Median EDSS at cladribine tablets start was 2.5. Around 13% of all RRMS patients initiated cladribine tablets as first line therapy. Of all RRMS patients switching to cladribine tablets with a treatment gap of <6 months, the most common immediate prior DMDs were fingolimod (17%), followed by natalizumab, teriflunomide and dimethylfumarate (all appx. 10%). Total follow-up time was 340 patient-years. Annualised relapse rate (ARR) on cladribine tablets was 0.12 (95%CI 0.09-0.17), compared to a pre-cladribine ARR of 0.38. Treatment persistence was 95% after 12 months (95%CI 91-98%), and 92% after 24 months (95%CI 87-96%).

Conclusions This study characterizes RRMS patients treated with cladribine tablets in a real-world clinic setting. First-line use was uncommon. ARR was low, consistent with clinical trial data, and early discontinuations were very rare.

Authors/Disclosures
Helmut Butzkueven, MD, MBBS PRESENTER	Dr. Butzkueven has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Oxford Health Policy Forum. The institution of Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. The institution of Dr. Butzkueven has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. The institution of Dr. Butzkueven has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for MSBase . The institution of Dr. Butzkueven has received research support from NHMRC. The institution of Dr. Butzkueven has received research support from Biogen. The institution of Dr. Butzkueven has received research support from Roche. The institution of Dr. Butzkueven has received research support from Novartis.
Timothy Spelman	No disclosure on file
Suzanne J. Hodgkinson, MD, MBBS, PhD, FRACP	The institution of Dr. Hodgkinson has received research support from MERCK. The institution of Dr. Hodgkinson has received research support from Atara. The institution of Dr. Hodgkinson has received research support from Biogen . The institution of Dr. Hodgkinson has received research support from Genzyme. The institution of Dr. Hodgkinson has received research support from ROCHE. The institution of Dr. Hodgkinson has received research support from Novartis.
Tomas Kalincik	Tomas Kalincik has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi Genzyme. Tomas Kalincik has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Tomas Kalincik has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving as a Consultant for National Health and Medical Research Council. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MS Research Australia. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Tomas Kalincik has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for WebMD Global. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi Genzyme. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for BioCSL. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. The institution of Tomas Kalincik has received research support from Biogen. The institution of Tomas Kalincik has received research support from Novartis. The institution of Tomas Kalincik has received research support from Genzyme. The institution of Tomas Kalincik has received research support from Roche. The institution of Tomas Kalincik has received research support from Celgene. The institution of Tomas Kalincik has received research support from Merck. The institution of Tomas Kalincik has received research support from MSBase Foundation. The institution of Tomas Kalincik has received research support from ARSEP and EDMUS Foundations. The institution of Tomas Kalincik has received research support from MS Research Australia. The institution of Tomas Kalincik has received research support from National Health and Medical Research Council. The institution of Tomas Kalincik has received research support from Australian Research Council. The institution of Tomas Kalincik has received research support from MS Society. The institution of Tomas Kalincik has received research support from Trish Foundation. Tomas Kalincik has a non-compensated relationship as a scientific leadership group chair with MSBase Foundation that is relevant to AAN interests or activities.
Katherine Buzzard, MBBS, PhD, FRACP (Eastern Health, Dept Neuroscience)	Dr. Buzzard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Buzzard has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Buzzard has received personal compensation in the range of $5,000-$9,999 for serving as a support to attend educational conference with Roche.
	No disclosure on file
	No disclosure on file
Guillermo Izquierdo Ayuso, MD (Servicio De Neurologia)	Dr. Izquierdo Ayuso has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer, Biogen Idec, Novartis, Sanofi, Merck Serono, Roche, Actelion and Celgene. Dr. Izquierdo Ayuso has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme, Novartis, Sanofi Aventis, Alexion.
Anneke Van Der Walt, MD (Alfred Health)	Dr. Van Der Walt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Van Der Walt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Van Der Walt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Van Der Walt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Van Der Walt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Van Der Walt has received research support from NHMRC Australia. The institution of Dr. Van Der Walt has received research support from MSRA. The institution of Dr. Van Der Walt has received research support from Roche.
Francois Grand-Maison, MD (Francois Grand'Maison MD INC)	Dr. Grand-Maison has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Grand-Maison has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Grand-Maison has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Serono. Dr. Grand-Maison has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Grand-Maison has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis .
Ernest G. Butler, MD, PhD, FRACP	Dr. Butler has nothing to disclose.
Julie Prevost, MD (Neurologie des Laurentides)	No disclosure on file
Pamela A. McCombe, MD (Dr PA McCombe Medical Pty Ltd)	Dr. McCombe 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. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. The institution of Dr. McCombe has received research support from Motor Neurone Disease Resaerch Institute of Australia.
Mariana Espinosa-Polanco	No disclosure on file
Richard A. Macdonell, MD, FAAN (Austin Health)	Dr. Macdonell has nothing to disclose.
Jeannette Lechner-Scott, MD, PhD, FRACP (HNEAH)	The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for elsevier. The institution of Prof. Lechner-Scott has received research support from Merck. The institution of Prof. Lechner-Scott has received research support from Biogen.
Vincent Van Pesch, MD, PhD (Cliniques Universitaires Saint-Luc)	Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Vincent Van Pesch, MD, PhD has received research support from Biogen.
Pierre Duquette, MD	The institution of Dr. Duquette has received research support from Biogen and Genzyme.
Alexandre Prat, MD (CHUM Hopital Norte Dame/ Dept of Neurology)	The institution of Dr. Prat has received research support from CIHR and MSSC.
J M. Girard, MD	Dr. Girard has nothing to disclose.
Allan G. Kermode, MD, MBBS, FRACP (SJOG Clinic, Suite 314)	Dr. Kermode has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Kermode has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche.
Jessica Fabris	Jessica Fabris has nothing to disclose.

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