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

Centre for Outcomes Research and Effectiveness Research Department of Clinical Educational and Health Psychology University College London London UK

Clinical Neuroimmunology Unit and MS Clinic Department of Neurology Cerrahpasa School of Medicine Istanbul University Istanbul Turkey

Department of Brain Repair and Rehabilitation and Faculty of Brain Sciences University College London Institute of Neurology London UK

Department of Neurology and Center of Clinical Neuroscience 1st Faculty of Medicine and General University Hospital Charles University Prague Czech Republic

Department of Neurology Danish Multiple Sclerosis Center Copenhagen University Hospital Rigshospitalet Denmark

Department of Neurology Focus Program Translational Neuroscience University Medical Center of the Johannes Gutenberg University Mainz Mainz Germany

Department of Neurology Klinikum Rechts der Isar Technische Universität München and Munich Cluster for Systems Neurology Munich Germany

Department of Neurology Medical University of Graz Graz Austria

Department of Neurology Medical University of Lodz Lodz Poland

Department of Neurology Neuroimmunology Multiple Sclerosis Centre of Catalonia Vall d'Hebron University Hospital Barcelona Spain

Department of Neurology Neuroimmunology Multiple Sclerosis Centre of Catalonia Vall d'Hebron University Hospital Barcelona Spain Preventive Medicine and Epidemiology Department Vall d'Hebron University Hospital Barcelona Spain

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

Department of Neurosciences Psychology Drugs and Child Health Area Section Neurosciences University of Florence Florence Italy

Departments of Neurology and Biomedicine University Hospital Basel Basel Switzerland

European Multiple Sclerosis Platform Schaerbeek Belgium

INSERM UMR U1043 CNRS U5282 Université de Toulouse UPS Centre de Physiopathologie de Toulouse Purpan Toulouse France

Multiple Sclerosis Center Department of Neurology Medical Faculty Heinrich Heine University Düsseldorf Düsseldorf Germany

Multiple Sclerosis International Federation London UK

Neuroimmunology Unit Center for Molecular Medicine Karolinska University Hospital Solna Stockholm Sweden

Neurological Department Institute of Experimental Neurology Scientific Institute Hospital San Raffaele Universita' Vita Salute San Raffaele Milan Italy

NMR Research Unit and Queen Square Multiple Sclerosis Centre University College London Institute of Neurology London UK

Sorbonne Universités UPMC Univ Paris 06 UMR_S 1127 ICM GHU Pitié Salpêtrière Paris France

University Hospital Basel Basel Switzerland

Erratum In

Mult Scler. 2020 Apr;26(4):517. doi: 10.1177/1352458520906383. PubMed

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