Abstract Details

Title Real-world evaluation of effectiveness and safety of cladribine tablets and patient reported outcomes in suboptimally controlled patients previously taking oral or intravenous disease-modifying drugs for relapsing forms of multiple sclerosis (MASTER-2)

Topic Multiple Sclerosis

Presentation(s) P9 - Poster Session 9 (12:00 PM-1:00 PM)

Poster/Presentation
Number 9-016

Objective This real-world study evaluates cladribine tablets (CT) in patients with relapsing forms of multiple sclerosis (RMS). The primary objective is to estimate annualized relapse rate over 24 months (ARR-24). Secondary objectives are to assess patient reported outcomes (PROs), treatment adherence and satisfaction, physicians’ treatment patterns, safety, and to estimate ARR-24 prior to CT initiation.

Background Efficacy and safety for CT 3.5 mg/kg have been reported in RMS, including active disease, from the ORACLE-MS, CLARITY, and CLARITY Extension Phase 3 studies; however, real-world data for CT are limited.

Design/Methods This is a prospective, single arm, observational, 30-month, Phase 4 study in the United States (US). Eligible patients are adults with a relapsing-remitting MS or active secondary progressive MS diagnosis, who had suboptimal response to an oral or intravenous disease-modifying drug (DMD), and satisfied criteria for CT per US Prescribing Information (USPI). Patients will receive CT 3.5 mg/kg (cumulative dose over 2 years), per the USPI. Approximately 200 patients across 50 sites are planned for inclusion, with an estimated 160 with evaluable data for the primary study outcome. Study began in July 2019 and will end by May 2023.

Results ARR-24 will be assessed in patients transitioning to CT. Changes from baseline at Months 6, 12, and 24 for PROs will be assessed using six different questionnaires/surveys at baseline. Data for treatment adherence will be collected at baseline (to prior DMD) and at the end of Months 1, 2, 13, and 14 to CT. Other data to be collected include proportion of patients with relapse, previous treatment for MS, and frequency of CT discontinuation and adverse events.

Conclusions MASTER-2 will describe the effectiveness and safety of cladribine tablets, as well as PROs, in patients with RMS with suboptimal response to prior oral or intravenous DMDs in a real-world setting.

Authors/Disclosures
Edward Fox, MD, PhD, F�鶹��ýӳ�� PRESENTER	Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Fox 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. Dr. Fox 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. Dr. Fox 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. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Fox has received research support from Biogen. The institution of Dr. Fox has received research support from Genentech. The institution of Dr. Fox has received research support from Celgene - BMS. The institution of Dr. Fox has received research support from Chugai. The institution of Dr. Fox has received research support from Novartis. The institution of Dr. Fox has received research support from EMD-Serono. The institution of Dr. Fox has received research support from TG Therapeutics. The institution of Dr. Fox has received research support from AbbVie. The institution of Dr. Fox has received research support from Sanofi Genzyme. The institution of Dr. Fox has received research support from AbbVie.
Ann D. Bass, MD (Lone Star Neurology - San Antonio)	Dr. Bass has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion, Amgen, Bristol-Myers-Squibb, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. Dr. Bass has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen, Alexion, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. Dr. Bass has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Alexion, Amgen, Bristol-Myers-Squibb, EMD Serono, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. The institution of Dr. Bass has received research support from Bristol-Myers-Squibb, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics.
Brooke Hayward, SM, MBA (EMD Serono, Inc.)	Brooke Hayward, SM, MBA has received personal compensation for serving as an employee of EMD Serono, Inc., Rockland, MA USA, an affiliate of Merck KGaA, Darmstadt, Germany.
John Walsh	No disclosure on file
Lori Lebson, PhD	No disclosure on file
Derrick Robertson, MD	Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Greenwich Biosciences. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mallinckrodt. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Robertson has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Robertson has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Genentech. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for PRIME CME. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Janssen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for McVeigh. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Mccumber. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Goodis. The institution of Dr. Robertson has received research support from Biogen. The institution of Dr. Robertson has received research support from EMD Serono. The institution of Dr. Robertson has received research support from Jansenn. The institution of Dr. Robertson has received research support from Genentech. The institution of Dr. Robertson has received research support from Patient-Centered Outcomes Research Institute. The institution of Dr. Robertson has received research support from Novartis. The institution of Dr. Robertson has received research support from Sanofi Genzyme. The institution of Dr. Robertson has received research support from TG Therapeutics. The institution of Dr. Robertson has received research support from Prime. The institution of Dr. Robertson has received research support from Greenwich Biosciences. The institution of Dr. Robertson has received research support from Atara Biotherapeutics. The institution of Dr. Robertson has received research support from CorEvitas. The institution of Dr. Robertson has received research support from Anokion. The institution of Dr. Robertson has received research support from UCB Biosciences. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Consortium of Multiple Sclerosis Centers. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Multiple Sclerosis Association of America.

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