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Expert Opinion on the Use of Cladribine Tablets in Clinical Practice

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Expert Opinion on the Use of Cladribine Tablets in Clinical Practice Expert Opinion on the Use of Cladribine METHODS • The consensus program was based on a multi-step modified Delphi • A comprehensive literature review was performed for each question. The Tablets in Clinical Practice methodology, which took place between April 2018 and April 2019. level of evidence was assessed and agreed by the SC.4 • A Steering Committee (SC) of nine international MS experts led the program. • A questionnaire was developed by the SC with draft answers based on The SC in turn was supported by an extended faculty (EF, n=33) of practicing available evidence from the literature review, combined with their expert P. Soelberg Sørensen1, D. Centonze2, G. Giovannoni3, X. Montalban4,5, D. Selchen5, P. Vermersch6, H. Wiendl7, B. Yamout8, neurologists caring for MS patients. A total of 19 countries were represented opinion, where evidence was lacking. The questionnaire was completed H. Salloukh9, P. Rieckmann10 in the program. The role of the EF was to review available evidence, remotely via an on-line platform by the EF. complete a questionnaire and finally vote on draft recommendations. 1Danish Multiple Sclerosis Center, Department of Neurology, University of Copenhagen and Rigshospitalet, Copenhagen, Denmark; 2Unit of GET POSTER PDF • The results from the questionnaire were incorporated into draft clinical Neurology and Neurorehabilitation, IRCCS Neuromed, Pozzilli (IS), Italy; 3Blizard Institute, Barts and The London School of Medicine and Dentistry, Copies of this poster obtained • The SC identified practical clinical questions concerning the use of cladribine recommendations, which were then voted on by the SC and EF members. 4 Queen Mary University of London, London, UK; Department of Neurology, Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall through QR (Quick Response) tablets and prioritized the most important 11 questions to be addressed, d’Hebron University Hospital, Barcelona, Spain; 5University of Toronto, Division of Neurology, St. Michael’s Hospital, Toronto, ON, Canada; code are for personal use only categorized into six topics. • Consensus was achieved when ≥75% of respondents agreed in the range of 6University of Lille, Inserm U1172 LilNCog, CHU Lille, FHU Imminent, Lille, France; 7Department of Neurology, Institute of Translational Neurology, and may not be reproduced 7–9 (on a 9-point scale).5 University of Münster, Münster, Germany; 8Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut, Beirut, Lebanon; without written permission of 9Merck, Aubonne, Switzerland; 10Hospital for Nervous Diseases, Medical Park Loipl, Bischofswiesen, Germany. the authors RESULTS • In total, 47 recommendations were drafted by the SC and voted on. Consensus was achieved on CONCLUSION 46 of these recommendations. • The clinical questions and recommendations are provided for the following 6 topics The recommendations described here are the collective opinions of a (click on the table heading to access content): large international group of experts representing a wide geographical spread. Table 1 Table 2 Table 3 Patterns of Management of patients with They should provide practical, specific advice to all health care Definition of treatment response in evidence of disease professionals involved in the treatment and management of patients highly active activity while being disease patients treated with multiple sclerosis (MS), address gaps in existing guidance and with cladribine treated with ultimately improve care. tablets cladribine tablets INTRODUCTION OBJECTIVE Table 4 Table 5 Table 6 Management Treatment Infection risk and of pregnancy switching to and • The evolving treatment landscape in relapsing immune function planning and In order to address some of the from cladribine MS (RMS) requires physicians to have a in patients being malignancy risk tablets and unanswered questions relating treated with in patients being comprehensive understanding of the different monitoring to the use of cladribine tablets, cladribine tablets treated with disease-modifying drugs (DMDs) in order to cladribine considerations 1 offer optimal care. here we describe a consensus- tablets • Treatment labels rarely provide specific, based program led by detailed information on real-life usage. international MS experts with References: ® the aim of providing practical 1. Saposnik, G. and X. Montalban, Therapeutic Inertia in the New Landscape of Multiple Sclerosis Care. • Cladribine tablets (Mavenclad ) is a short- Front Neurol, 2018. 9: p. 174. course oral DMD for use in MS, that recommendations to support its 2. Mavenclad SmPC. Mar 2020; Available from: https://www.medicines.org.uk/emc/product/8435/smpc. 2,3 3. Deeks, E.D., Cladribine Tablets: A Review in Relapsing MS. CNS Drugs, 2018. 32(8): p. 785–796. preferentially reduces lymphocytes. use in real-life clinical practice. 4. Balshem, H., et al., GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol, 2011. 64(4): p. 401–406. 5. Boguniewicz, M., et al., Expert Perspectives on Management of Moderate-to-Severe Atopic Dermatitis: A Multidisciplinary GET ADDITIONAL Consensus Addressing Current and Emerging Therapies. J Allergy Clin Immunol Pract, 2017. 5(6): p. 1519–1531. CONTENT PSS has served on advisory boards for Biogen, MedDay, GSK, Merck KGaA, Novartis, and Teva; on steering committees or independent data monitoring boards in trials sponsored by GSK, Merck KGaA, Novartis, and Teva; has received speaker honoraria from Biogen Idec, Celgene, Genzyme, Merck KGaA, Novartis, Sanofi-Aventis, and Teva. His department has received research support from Biogen, Genzyme, Merck KGaA, Novartis, Roche, and Teva. DC is an advisory board member of Almirall, Bayer Schering, Biogen, GW Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva, and received honoraria for speaking or consultation fees from Almirall, Bayer Schering, Biogen, GW Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva. He is also the principal investigator in clinical trials for Bayer Schering, Biogen, Merck Serono, Mitsubishi, Novartis, Roche, Sanofi-Genzyme, and Teva. His preclinical and clinical research was supported by grants from Bayer Schering, Biogen Idec, Celgene, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva. GG has received speaker honoraria and consulting fees from Abbvie, Actelion, Atara Bio, Almirall, Bayer Schering, Biogen Idec, FivePrime, GSK, GW Pharma, Ironwood, Merck & Co., Merck KGaA, Novartis, Pfizer Inc., Protein Discovery Laboratories, Sanofi-Genzyme, Teva, UCB, and Vertex Pharmaceuticals; and has received research support unrelated to this study from Biogen Idec, Ironwood, Merc k & Co. , and Novartis. XM has received speaking honoraria and travel expenses for participation in scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in the past years with Actelion, Bayer, Biogen, Celgene, Excemed, Genzyme, Merck, MSIF, NMSS, Novartis, Roche, Sanofi-Genzyme, and Teva. DS has received grants and/or personal fees from Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva. PV has received honoraria or consulting fees from Almirall, Bayer, Biogen, Celgene, Merck KGaA, Novartis, Roche, and Sanofi-Genzyme; and research support from Bayer, Biogen, Merck KGaA, and Sanofi-Genzyme. HW is a member of Scientific Advisory Boards/Steering Committees for Bayer HealthCare, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi-Genzyme, and Teva. He received speaker honoraria and travel support from Bayer Vital GmbH, Bayer Schering AG, Biogen, CSL Behring, EMD Serono, Fresenius Medical Care, Genzyme, Merck Serono, O mniamed, Novartis, Sanofi-Aventis, and Teva. He received compensation as a consultant from Biogen Idec, Merck Serono, Novartis, Omniamed, Roche, and Sanofi-Genzyme. He has received research support from Bayer HealthCare, Bayer Vital, Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme, Sanofi US, and Teva as well as German Ministry for Education and Research (BMBF), German Research Foundat ion (DFG), Else Kröner Fresenius Foundation, Fresenius Foundation, Hertie Foundation, Merck Serono, Novartis, NRW Ministry of Education and Research, Interdisciplinary Center for Clinical Studies (ISKF) Münster, and RE Children’s Foundation. BY has received honoraria for lectures and advisory boards from Bayer, Biogen, Genpharm, Genzyme, Merck Serono, and Novartis; and has received research grants from Bayer, Biogen, Merck Serono, Novartis, and Pfizer. HS is an employee of Merck, Aubonne, Switzerland, a division of Merck KGaA, Darmstadt, Germany. PR has received honoraria for lectures/steering committee meetings from Bayer Schering, Biogen Idec, Boehringer Ingelheim, Genzyme, Merck, Novartis, Sanofi-Aventis, Serono Symposia International Foundation, and Teva. Editorial support for preparation of this poster was provided by Steve Winter of inScience Communications, Springer Healthcare Ltd, UK, and was funded by Merck KGaA, Darmstadt, Germany. The SC would also like to acknowledge the EF members who contributed by completing the questionnaire and voting on the draft recommendations. Presented at the American Academy of Neurology (AAN) 2020 Virtual Congress | 25 April – 1 May This work was supported by Merck KGaA, Darmstadt, Germany, who provided funding for the project.
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