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.

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

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

Department NEUROFARBA Section Neurosciences University of Florence Florence Italy

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

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

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

Department of Neurology Klinikum Rechts der Isar Technische Universität München Munich Germany

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

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 Brussels Belgium

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

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

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

Multiple Sclerosis International Federation London UK

Munich Cluster for Systems Neurology Munich Germany

Neuroimmunology Unit Centre for Molecular Medicine L8 04 Karolinska University Hospital Stockholm Sweden

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

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

Preventive Medicine and Epidemiology Department Vall d'Hebron University Hospital Barcelona Spain

University Hospital Basel Basel Switzerland

Erratum In

Eur J Neurol. 2018 Mar;25(3):605. doi: 10.1111/ene.13590. PubMed

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