Abstract Details

Title Real-world Comparative Effectiveness and Persistence of Cladribine Tablets and Other Oral Disease-Modifying Treatments for Multiple Sclerosis from GLIMPSE: Results from the MSBase Registry

Topic Multiple Sclerosis

Presentation(s) P12 - Poster Session 12 (5:30 PM-6:30 PM)

Poster/Presentation
Number 12-003

Background There are no clinical trials or real-world studies comparing effectiveness of CladT to other oral disease modifying therapies (DMT). The MSBase registry records demographics, DMT, Expanded Disability Status Scale (EDSS) scores and relapses in over 74000 MS patients globally.

Objective Compare treatment patterns and clinical outcomes in multiple sclerosis (MS) patients newly treated with cladribine tablets (CladT) versus fingolimod, dimethyl fumarate (DMF) and teriflunomide in real world.

Design/Methods

We described baseline demographics and outcomes for all adult (>18 years old) relapsing MS patients newly initiating CladT or oral comparators starting from January 2018 in MSBase registry. Propensity-score matching (PSM, 1:1) for three pairwise comparisons (CladT versus oral DMTs) included age, sex, EDSS, pre-baseline relapses, prior DMT initiation, and country. Outcomes included time-to-discontinuation (for CladT, switch to alternate DMT), annualised relapse rate (ARR) and time-to-first relapse. Time-to event analyses used marginal Cox models with Hazard ratio (HR) and 95% Confidence intervals (CI). ARRs were compared with a weighted negative binomial model with a cluster term for matched patient sets.

Results With PSM, cohorts were found well balanced on demographic and clinical characteristics. Median follow-up times were between 11-13 months. In the CladT versus fingolimod analysis (n=520/group), ARR was 0.09 vs 0.15 (p=0.02), HR for time-to-first relapse was 0.60 (0.41-0.88, p=0.01) and HR for time-to-discontinuation was 0.22 (0.14-0.34, p<0.001). For CladT vs DMF (n=450/group), ARR was 0.10 vs 0.15, p=0.03, HR for time-to-first relapse was 0.58 (0.37-0.90, p=0.02) and HR for time-to-discontinuation was 0.10 (0.06-0.17, p<0.001). For CladT vs teriflunomide (n=458/group), ARR was 0.09 vs 0.17, p<0.001, HR for time-to-first relapse was 0.33 (0.21-0.52, p<0.001) and HR for time-to-discontinuation was 0.10 (0.06-0.17, p<0.001).

Conclusions For all three pairwise comparisons, relapse and discontinuation outcomes significantly favoured CladT over other oral DMTs. Future analyses with longer follow-up comparing disability progression events are warranted.

Authors/Disclosures
Elisabetta Verdun Di Cantogno, MD (Merck Serono Int, SA) PRESENTER	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.
Helmut Butzkueven, MD, MBBS (Alfred Hospital)	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
Serkan Ozakbas, MD (DOKUZ EYLUL UNI. FACULTY OF MEDICINE)	Dr. Ozakbas has nothing to disclose.
Raed Alroughani, MD, FAAN	Dr. Alroughani 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, Bayer, Novartis, Merck, Roche, Sanofi. Dr. Alroughani has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bayer, Biogen, Novartis, Merck, Roche, Sanofi.
Murat Terzi, PhD (19 Mayis Universitesi)	Dr. Terzi has nothing to disclose.
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.
Guy Laureys, MD, PhD (UZ Gent)	The institution of Dr. Laureys has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Laureys has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. The institution of Dr. Laureys has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. The institution of Dr. Laureys has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Laureys has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Laureys 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. Laureys 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. Laureys 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. Laureys has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Laureys 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. Laureys has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.
Tomas Kalincik	Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 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 $5,000-$9,999 for serving as a Consultant for Novartis. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 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 $5,000-$9,999 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 vice-chair with MSBase Foundation that is relevant to AAN interests or activities.
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.
Bassem I. Yamout, MD, FAAN (Harley Street Medical Center)	Dr. Yamout 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. Yamout 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. Yamout 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. Yamout 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. Yamout has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
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.
Aysun Soysal, MD (Bakirkoy Hospital Of Mental Disorders And Neuro)	Dr. Soysal has nothing to disclose.
Jens Kuhle, MD	Dr. Kuhle has nothing to disclose.
Jose Luis Sanchez Menoyo, MD (Neurologia - Hospital Galdakao-Usansolo)	Dr. Sanchez Menoyo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Sanchez Menoyo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Sanchez Menoyo 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. Sanchez Menoyo 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. Sanchez Menoyo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis.
Yolanda Blanco Morgado, MD	Dr. Blanco Morgado has nothing to disclose.
Daniele Litterio A. Spitaleri (A.O. "S. Giuseppe Moscati")	Daniele Litterio A. Spitaleri has received research support from Novartis.
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.
Dana Horakova	Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.
Radek Ampapa, MD (Neurologicka Klinika Jihlava)	Dr. Ampapa has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzym.
Francesco Patti, MD	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.
Richard A. Macdonell, MD, FAAN (Austin Health)	Dr. Macdonell has nothing to disclose.
Abdullah Al-Asmi, MD	No disclosure on file
	No disclosure on file
Jiwon Oh, MD, FAAN (St Michael's Hospital)	Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen-Idec. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD-Serono. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon Therapeutics. Dr. Oh has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen-Idec. Dr. Oh 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. The institution of Dr. Oh has received research support from Biogen-Idec. The institution of Dr. Oh has received research support from Roche.
Ayse Altintas, MD	Dr. Altintas has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck . Dr. Altintas has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Deva. The institution of Dr. Altintas has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion.
Namita Tundia, PhD (EMD Serono)	Mrs. Tundia has received personal compensation for serving as an employee of EMD Serono.
Schiffon Wong	Schiffon Wong has received personal compensation for serving as an employee of EMD Serono.
	No disclosure on file