X Montalban1, R Gold2, A J Thompson3, S Otero-Romero1,4, M P Amato5, D Chandraratna6, M Clanet7, G Comi8, T Derfuss9, F Fazekas10, H P Hartung11, E Havrdova12, B Hemmer13,14, L Kappos15, R Liblau16, C Lubetzki17, E Marcus18, D H Miller19, T Olsson20, S Pilling18, K Selmaj21, A Siva22, P S Sorensen23, M P Sormani24, C Thalheim25, H Wiendl26, F Zipp27. 1. Multiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology-Neuroimmunology, Vall d'Hebron University Hospital, Barcelona, Spain. 2. Department of Neurology, Ruhr University, St Josef-Hospital, Bochum, Germany. 3. Department of Brain Repair and Rehabilitation, Faculty of Brain Sciences, University College London Institute of Neurology, London, UK. 4. Preventive Medicine and Epidemiology Department, Vall d'Hebron University Hospital, Barcelona, Spain. 5. Department NEUROFARBA, Section Neurosciences, University of Florence, Florence, Italy. 6. Multiple Sclerosis International Federation, London, UK. 7. Department of Neurology, Toulouse University Hospital, Toulouse, France. 8. Neurological Department, Institute of Experimental Neurology (INSPE), Scientific Institute Hospital San Raffaele, University Vita-Salute San Raffaele, Milan, Italy. 9. Departments of Neurology and Biomedicine, University Hospital Basel, Basel, Switzerland. 10. Department of Neurology, Medical University of Graz, Graz, Austria. 11. Department of Neurology, Medical Faculty, Multiple Sclerosis, Heinrich-Heine-University, Düsseldorf, Germany. 12. Department of Neurology and Centre of Clinical Neuroscience, First Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic. 13. Department of Neurology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany. 14. Munich Cluster for Systems Neurology (SyNergy), Munich, Germany. 15. University Hospital Basel, Basel, Switzerland. 16. INSERM UMR U1043 - CNRS U5282, Centre de Physiopathologie de Toulouse Purpan, Université de Toulouse, UPS, Toulouse, France. 17. ICM-GHU Pitié-Salpêtrière, Sorbonne Universités UPMC Univ Paris 06, UMR_S 1127, Paris, France. 18. Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational and Health Psychology, University College London, London, UK. 19. NMR Research Unit, Queen Square Multiple Sclerosis Centre, University College London (UCL) Institute of Neurology, London, UK. 20. Neuroimmunology Unit, Centre for Molecular Medicine, L8:04, Karolinska University Hospital (Solna), Stockholm, Sweden. 21. Department of Neurology, Medical University of Lodz, Lodz, Poland. 22. Clinical Neuroimmunology Unit and MS Clinic, Department of Neurology, Cerrahpasa School of Medicine, Istanbul University, Istanbul, Turkey. 23. Danish Multiple Sclerosis Centre, Department of Neurology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. 24. Biostatistics Unit, University of Genoa, Genoa, Italy. 25. European Multiple Sclerosis Platform (EMSP), Schaerbeek/Brussels, Belgium. 26. Department of Neurology, University of Münster, Münster, Germany. 27. Department of Neurology, Focus Program Translational Neuroscience (FTN) and Immunology (FZI), Rhine-Main Neuroscience Network (rmn2), University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
Abstract
BACKGROUND AND PURPOSE: Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process. METHODS: This guideline has been developed using the GRADE methodology and following the recently updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. An exhaustive literature search up to December 2016 was performed for each question and the evidence is presented narratively and, when possible, combined in a meta-analysis using a random-effects model. The quality of evidence for each outcome was rated into four categories - very high, high, low and very low - according to the risk of bias. GRADE evidence profiles were created using GRADEprofiler (GRADEpro) software (Version 3.6). The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panellists was reached by use of the modified nominal group technique. RESULTS: A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 20 recommendations were agreed by the guideline working group members after three rounds of consensus.
BACKGROUND AND PURPOSE:Multiple sclerosis (MS) is a complex disease of the central nervous system. As new drugs are becoming available, knowledge on diagnosis and treatment must continuously evolve. There is therefore a need for a reference tool compiling current data on benefit and safety, to aid professionals in treatment decisions and use of resources across Europe. The European Committee of Treatment and Research in Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) have joined forces to meet this need. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS to guide healthcare professionals in the decision-making process. METHODS: This guideline has been developed using the GRADE methodology and following the recently updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. An exhaustive literature search up to December 2016 was performed for each question and the evidence is presented narratively and, when possible, combined in a meta-analysis using a random-effects model. The quality of evidence for each outcome was rated into four categories - very high, high, low and very low - according to the risk of bias. GRADE evidence profiles were created using GRADEprofiler (GRADEpro) software (Version 3.6). The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panellists was reached by use of the modified nominal group technique. RESULTS: A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 20 recommendations were agreed by the guideline working group members after three rounds of consensus.
Authors: Heinz Wiendl; Ralf Gold; Thomas Berger; Tobias Derfuss; Ralf Linker; Mathias Mäurer; Martin Stangel; Orhan Aktas; Karl Baum; Martin Berghoff; Stefan Bittner; Andrew Chan; Adam Czaplinski; Florian Deisenhammer; Franziska Di Pauli; Renaud Du Pasquier; Christian Enzinger; Elisabeth Fertl; Achim Gass; Klaus Gehring; Claudio Gobbi; Norbert Goebels; Michael Guger; Aiden Haghikia; Hans-Peter Hartung; Fedor Heidenreich; Olaf Hoffmann; Zoë R Hunter; Boris Kallmann; Christoph Kleinschnitz; Luisa Klotz; Verena Leussink; Fritz Leutmezer; Volker Limmroth; Jan D Lünemann; Andreas Lutterotti; Sven G Meuth; Uta Meyding-Lamadé; Michael Platten; Peter Rieckmann; Stephan Schmidt; Hayrettin Tumani; Martin S Weber; Frank Weber; Uwe K Zettl; Tjalf Ziemssen; Frauke Zipp Journal: Nervenarzt Date: 2021-07-23 Impact factor: 1.214
Authors: Giancarlo Comi; Amit Bar-Or; Hans Lassmann; Antonio Uccelli; Hans-Peter Hartung; Xavier Montalban; Per Solberg Sørensen; Reinhard Hohlfeld; Stephen L Hauser Journal: Ann Neurol Date: 2020-11-04 Impact factor: 10.422
Authors: Boris A Kallmann; Stefan Ries; Jennifer S Kullmann; Laura M Quint; Ulrich Engelmann; Andrew Chan Journal: Ther Adv Neurol Disord Date: 2021-05-18 Impact factor: 6.570