Xavier Montalban1, Ralf Gold2, Alan J Thompson3, Susana Otero-Romero4, Maria Pia Amato5, Dhia Chandraratna6, Michel Clanet7, Giancarlo Comi8, Tobias Derfuss9, Franz Fazekas10, Hans Peter Hartung11, Eva Havrdova12, Bernhard Hemmer13, Ludwig Kappos14, Roland Liblau15, Catherine Lubetzki16, Elena Marcus17, David H Miller18, Tomas Olsson19, Steve Pilling17, Krysztof Selmaj20, Axel Siva21, Per Soelberg Sorensen22, Maria Pia Sormani23, Christoph Thalheim24, Heinz Wiendl25, Frauke Zipp26. 1. Department of Neurology-Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain. 2. Department of Neurology, Ruhr University, St. Josef-Hospital, Bochum, Germany. 3. Department of Brain Repair & Rehabilitation and Faculty of Brain Sciences, University College London Institute of Neurology, London, UK. 4. Department of Neurology-Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain/Preventive Medicine and Epidemiology Department, Vall d'Hebron University Hospital, Barcelona, Spain. 5. Department of Neurosciences, Psychology, Drugs and Child Health Area (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, Universita' 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. Multiple Sclerosis Center, Department of Neurology, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. 12. Department of Neurology and Center 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 and Munich Cluster for Systems Neurology (SyNergy), Munich, Germany. 14. University Hospital Basel, Basel, Switzerland. 15. INSERM UMR U1043 - CNRS U5282, Université de Toulouse, UPS, Centre de Physiopathologie de Toulouse Purpan, Toulouse, France. 16. Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1127, ICM-GHU Pitié-Salpêtrière, Paris, France. 17. Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational and Health Psychology, University College London, London, UK. 18. NMR Research Unit and Queen Square Multiple Sclerosis Centre, University College London Institute of Neurology, London, UK. 19. Neuroimmunology Unit, Center for Molecular Medicine, Karolinska University Hospital Solna, Stockholm, Sweden. 20. Department of Neurology, Medical University of Lodz, Lodz, Poland. 21. Clinical Neuroimmunology Unit and MS Clinic, Department of Neurology, Cerrahpasa School of Medicine, Istanbul University, Istanbul, Turkey. 22. Department of Neurology, Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet, Denmark. 23. Biostatistics Unit, University of Genoa, Genoa, Italy. 24. European Multiple Sclerosis Platform (EMSP), Schaerbeek, Belgium. 25. Department of Neurology, University of Münster, Münster, Germany. 26. Department of Neurology, Focus Program Translational Neuroscience (FTN) and Immunology (FZI), Rhine-Main Neuroscience Network (rmn2), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
Abstract
BACKGROUND: Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years. There is a need for a reference tool compiling current data to aid professionals in treatment decisions. OBJECTIVES: To develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS. METHODS: This guideline has been developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology and following the updated EAN recommendations. Clinical questions were formulated in Patients-Intervention-Comparator-Outcome (PICO) format and outcomes were prioritized. The quality of evidence was rated into four categories according to the risk of bias. The recommendations with assigned strength (strong and weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panelists was reached by use of the modified nominal group technique. RESULTS: A total of 10 questions were 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 (EMA) at the time of publication. A total of 21 recommendations were agreed by the guideline working group after three rounds of consensus. CONCLUSION: The present guideline will enable homogeneity of treatment decisions across Europe.
BACKGROUND:Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years. There is a need for a reference tool compiling current data to aid professionals in treatment decisions. OBJECTIVES: To develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS. METHODS: This guideline has been developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology and following the updated EAN recommendations. Clinical questions were formulated in Patients-Intervention-Comparator-Outcome (PICO) format and outcomes were prioritized. The quality of evidence was rated into four categories according to the risk of bias. The recommendations with assigned strength (strong and weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panelists was reached by use of the modified nominal group technique. RESULTS: A total of 10 questions were 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 (EMA) at the time of publication. A total of 21 recommendations were agreed by the guideline working group after three rounds of consensus. CONCLUSION: The present guideline will enable homogeneity of treatment decisions across Europe.
Authors: Rosa C Lucchetta; Fernanda S Tonin; Helena H L Borba; Letícia P Leonart; Vinicius L Ferreira; Aline F Bonetti; Bruno S Riveros; Jefferson Becker; Roberto Pontarolo; Fernando Fernandez-Llimós; Astrid Wiens Journal: CNS Drugs Date: 2018-09 Impact factor: 5.749
Authors: Damiano Paolicelli; Giuseppe Lucisano; Alessia Manni; Carlo Avolio; Simona Bonavita; Vincenzo Brescia Morra; Marco Capobianco; Eleonora Cocco; Antonella Conte; Giovanna De Luca; Francesca De Robertis; Claudio Gasperini; Maurizia Gatto; Paola Gazzola; Giacomo Lus; Antonio Iaffaldano; Pietro Iaffaldano; Davide Maimone; Giulia Mallucci; Giorgia T Maniscalco; Girolama A Marfia; Francesco Patti; Ilaria Pesci; Carlo Pozzilli; Marco Rovaris; Giuseppe Salemi; Marco Salvetti; Daniele Spitaleri; Rocco Totaro; Mauro Zaffaroni; Giancarlo Comi; Maria Pia Amato; Maria Trojano Journal: J Neurol Date: 2019-09-18 Impact factor: 4.849
Authors: Claire L Langrish; J Michael Bradshaw; Michelle R Francesco; Timothy D Owens; Yan Xing; Jin Shu; Jacob LaStant; Angelina Bisconte; Catherine Outerbridge; Stephen D White; Ronald J Hill; Ken A Brameld; David M Goldstein; Philip A Nunn Journal: J Immunol Date: 2021-03-05 Impact factor: 5.422
Authors: Klaus Schmierer; Thomas Campion; Audrey Sinclair; Wim van Hecke; Paul M Matthews; Mike P Wattjes Journal: Br J Radiol Date: 2019-05-14 Impact factor: 3.039