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ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis
X. Montalban, R. Gold, AJ. Thompson, S. Otero-Romero, MP. Amato, D. Chandraratna, M. Clanet, G. Comi, T. Derfuss, F. Fazekas, HP. Hartung, E. Havrdova, B. Hemmer, L. Kappos, R. Liblau, C. Lubetzki, E. Marcus, DH. Miller, T. Olsson, S. Pilling, K....
Language English Country England, Great Britain
Document type Journal Article, Research Support, Non-U.S. Gov't
- MeSH
- Immunologic Factors administration & dosage MeSH
- Immunomodulation * MeSH
- Consensus * MeSH
- Humans MeSH
- Evidence-Based Medicine standards MeSH
- Multiple Sclerosis drug therapy MeSH
- Practice Guidelines as Topic standards MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
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.
Biostatistics Unit University of Genoa Genoa Italy
Department of Neurology Medical University of Graz Graz Austria
Department of Neurology Medical University of Lodz Lodz Poland
Department of Neurology Ruhr University St Josef Hospital Bochum Germany
Department of Neurology Toulouse University Hospital Toulouse France
Department of Neurology University of Münster Münster Germany
Departments of Neurology and Biomedicine University Hospital Basel Basel Switzerland
European Multiple Sclerosis Platform Schaerbeek Belgium
Multiple Sclerosis International Federation London UK
Sorbonne Universités UPMC Univ Paris 06 UMR_S 1127 ICM GHU Pitié Salpêtrière Paris France
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- $a Montalban, Xavier $u Department of Neurology-Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain.
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- $a ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis / $c X. Montalban, R. Gold, AJ. Thompson, S. Otero-Romero, MP. Amato, D. Chandraratna, M. Clanet, G. Comi, T. Derfuss, F. Fazekas, HP. Hartung, E. Havrdova, B. Hemmer, L. Kappos, R. Liblau, C. Lubetzki, E. Marcus, DH. Miller, T. Olsson, S. Pilling, K. Selmaj, A. Siva, PS. Sorensen, MP. Sormani, C. Thalheim, H. Wiendl, F. Zipp,
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- $a 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.
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- $a Gold, Ralf $u Department of Neurology, Ruhr University, St. Josef-Hospital, Bochum, Germany.
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- $a Otero-Romero, Susana $u 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.
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- $a Amato, Maria Pia $u Department of Neurosciences, Psychology, Drugs and Child Health Area (NEUROFARBA), Section Neurosciences, University of Florence, Florence, Italy.
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- $a Kappos, Ludwig $u University Hospital Basel, Basel, Switzerland.
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- $a Liblau, Roland $u INSERM UMR U1043 - CNRS U5282, Université de Toulouse, UPS, Centre de Physiopathologie de Toulouse Purpan, Toulouse, France.
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- $a Lubetzki, Catherine $u Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1127, ICM-GHU Pitié-Salpêtrière, Paris, France.
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- $a Marcus, Elena $u Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.
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- $a Miller, David H $u NMR Research Unit and Queen Square Multiple Sclerosis Centre, University College London Institute of Neurology, London, UK.
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- $a Olsson, Tomas $u Neuroimmunology Unit, Center for Molecular Medicine, Karolinska University Hospital Solna, Stockholm, Sweden.
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- $a Pilling, Steve $u Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.
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- $a Sorensen, Per Soelberg $u Department of Neurology, Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet, Denmark.
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- $a Thalheim, Christoph $u European Multiple Sclerosis Platform (EMSP), Schaerbeek, Belgium. $7 xx0260375
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- $a Zipp, Frauke $u 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.
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