ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis

Author:

Montalban Xavier1,Gold Ralf2,Thompson Alan J3,Otero-Romero Susana4,Amato Maria Pia5,Chandraratna Dhia6,Clanet Michel7,Comi Giancarlo8,Derfuss Tobias9,Fazekas Franz10,Hartung Hans Peter11,Havrdova Eva12,Hemmer Bernhard13,Kappos Ludwig14,Liblau Roland15,Lubetzki Catherine16,Marcus Elena17,Miller David H18,Olsson Tomas19,Pilling Steve17,Selmaj Krysztof20,Siva Aksel21,Sorensen Per Soelberg22,Sormani Maria Pia23,Thalheim Christoph24,Wiendl Heinz25,Zipp Frauke26

Affiliation:

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.

Publisher

SAGE Publications

Subject

Neurology (clinical),Neurology

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