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

Multiple Sclerosis Journal - Tập 24 Số 2 - Trang 96-120 - 2018
Xavier Montalbán1, Ralf Gold2, Alan J. Thompson3, Susana Otero-Romero Otero-Romero4, Maria Pia Amato5, Dhia Chandraratna6, M. Clanet7, Carlo Pozzilli8, Tobias Derfuß9, Franz Fazekas10, Hans-Peter Hartung11, Eva Havrdová12, Bernhard Hemmer13, Ludwig Kappos14, Roland Liblau15, Catherine Lubetzki16, Elena Marcus17, David H. Miller18, Tomas Olsson19, Steve Pilling17, Krzysztof Selmaj20, Aksel Sıva21, Per Soelberg Sørensen22, Maria Pia Sormani23, Christoph Thalheim24, Heinz Wiendl25, Frauke Zipp26
1Department of Neurology-Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d’Hebron University Hospital, Barcelona, Spain
2Department of Neurology, Ruhr University, St. Josef-Hospital, Bochum, Germany
3Department of Brain Repair & Rehabilitation and Faculty of Brain Sciences, University College London Institute of Neurology, London, UK
4Department 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
5Department of Neurosciences, Psychology, Drugs and Child Health Area (NEUROFARBA), Section Neurosciences, University of Florence, Florence, Italy
6Multiple Sclerosis International Federation, London, UK
7Department of Neurology, Toulouse University Hospital, Toulouse, France
8Neurological Department, Institute of Experimental Neurology (INSPE), Scientific Institute Hospital San Raffaele, Universita’ Vita-Salute San Raffaele, Milan, Italy
9Departments of Neurology and Biomedicine, University Hospital Basel, Basel, Switzerland
10Department of Neurology, Medical University of Graz, Graz, Austria
11Multiple Sclerosis Center, Department of Neurology, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany
12Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic
13Department of Neurology, Klinikum rechts der Isar, Technische Universität München and Munich Cluster for Systems, Neurology (SyNergy), Munich, Germany
14University Hospital Basel, Basel, Switzerland
15INSERM UMR U1043 - CNRS U5282, Université de Toulouse, UPS, Centre de Physiopathologie de Toulouse Purpan, Toulouse, France
16Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1127, ICM-GHU Pitié-Salpêtrière, Paris, France
17Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical Educational and Health Psychology, University College London, London, UK
18NMR Research Unit and Queen Square Multiple Sclerosis Centre, University College London Institute of Neurology, London, UK
19Neuroimmunology Unit, Center for Molecular Medicine, Karolinska University Hospital Solna, Stockholm, Sweden
20Department of Neurology, Medical University of Lodz, Lodz, Poland
21Clinical Neuroimmunology Unit and MS Clinic, Department of Neurology, Cerrahpasa School of Medicine, Istanbul University, Istanbul, Turkey
22Department of Neurology, Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet, Denmark
23Biostatistics Unit, University of Genoa, Genoa, Italy
24European Multiple Sclerosis Platform (EMSP), Schaerbeek, Belgium
25Department of Neurology, University of Münster, Münster, Germany
26Department 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

Tóm tắt

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.

Từ khóa


Tài liệu tham khảo

10.1056/NEJM200009283431307

10.1007/s00415-015-7842-0

Grytten N, 2016, J Neurol Neurosurg Psychiatry, 87, 100

10.1212/WNL.0000000000000768

10.1177/1352458517694432

10.1586/14737167.2015.1067141

10.1093/brain/awl007

10.1093/brain/112.1.133

10.1016/S1474-4422(07)70243-0

10.1093/brain/120.6.1085

10.1038/nrneurol.2016.21

10.1007/s40263-015-0277-4

10.1002/ana.1032

10.1002/ana.22366

10.1002/ana.20703

Thompson AJ, 2017, Lancet Neurol

10.1212/WNL.0000000000000560

10.1093/brain/awv105

10.1002/ana.24682

10.1038/nrneurol.2009.178

10.1016/j.jocn.2014.01.018

10.1016/j.jns.2014.02.017

National Clinical Guideline, 2014, National Institute for Health and Care Excellence: Clinical Guidelines. Multiple Sclerosis: Management of multiple sclerosis in primary and secondary care

10.1185/03007995.2015.1047750

10.1212/WNL.46.4.907

10.1177/1352458511430704

10.1212/WNL.0000000000002880

10.1177/1352458513484547

10.1212/WNL.0000000000002877

10.1016/j.jclinepi.2010.04.026

10.1111/ene.12818

10.1002/9780470712184

10.1136/bmj.i4919

10.1136/bmj.39489.470347.AD

10.1186/s12874-016-0210-7

10.3310/hta2030

10.1016/S1474-4422(11)70262-9

10.1016/S0140-6736(09)61259-9

10.1056/NEJM200009283431301

10.1212/01.wnl.0000237641.33768.8d

10.1016/S1474-4422(14)70191-7

10.1177/1352458512469695

10.1212/WNL.0000000000003078

10.1212/01.wnl.0000200778.65597.ae

10.1136/jnnp-2013-306222

10.1016/S0140-6736(07)61194-5

10.1016/S1474-4422(09)70237-6

10.1016/S1474-4422(14)70068-7

10.1007/s00415-014-7264-4

10.1212/WNL.43.4.655

Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis, 1998, Lancet, 352, 1498, 10.1016/S0140-6736(98)03334-0

10.1002/ana.410390304

10.1212/WNL.56.12.1628

10.1177/1352458514557986

10.1212/01.wnl.0000237994.95410.ce

10.1136/jnnp.2009.204123

10.1056/NEJMoa1206328

10.1212/WNL.45.7.1268

10.1002/ana.23938

10.1177/135245850000600407

10.1016/S1474-4422(13)70308-9

10.1056/NEJMoa1014656

10.1212/WNL.0000000000002441

10.1056/NEJMoa1114287

10.1177/1352458516649037

10.1016/S1474-4422(14)70049-3

10.1056/NEJMoa0909494

10.1212/WNL.0000000000001462

10.1056/NEJMoa044397

10.1016/S0140-6736(12)62190-4

10.1016/S1474-4422(14)70039-0

10.1056/NEJMoa0902533

10.1212/01.wnl.0000345970.73354.17

10.1177/1352458510394702

10.1016/S1474-4422(08)70200-X

10.1016/S1474-4422(09)70226-1

10.1177/1352458513507821

10.1056/NEJMoa0907839

10.1016/S1474-4422(11)70099-0

10.1136/jnnp-2015-310597

10.1056/NEJMoa1501481

10.1016/S0140-6736(12)61769-3

10.1056/NEJMoa0802670

10.1016/S0140-6736(12)61768-1

10.1056/NEJMoa1601277

Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis, 1998, Lancet, 352, 1491, 10.1016/S0140-6736(98)10039-9

10.1212/WNL.56.11.1496

10.1136/jnnp.2003.010090

10.1212/01.WNL.0000146958.77317.3E

10.1177/1352458515594440

10.1016/S0140-6736(02)12023-X

10.1212/WNL.60.1.44

10.1016/S0140-6736(15)01314-8

Montalban X., 2004, Mult Scler, 10, S62

10.1056/NEJMoa1606468

10.1002/ana.21079

10.1001/archneurol.2011.241

Evidence of interferon beta-1a dose response in relapsing-remitting MS: The OWIMS Study, 1999, Neurology, 53, 679, 10.1212/WNL.53.4.679

10.1016/j.jns.2015.12.043

10.1212/WNL.0000000000002830

10.1111/ene.12695

10.1371/journal.pone.0129243

10.1177/1352458513502399

Rio J, 2016, Rev Neurol, 63, 145

10.1001/jamaneurol.2014.3537

10.1111/j.1468-1331.2009.02708.x

10.1177/1352458512460605

Simon JH, 2006, AJNR Am J Neuroradiol, 27, 455

10.7224/1537-2073-14.3.105

10.1038/nrneurol.2015.157

10.1007/s00415-013-6932-0

10.1016/j.msard.2014.06.005

10.1371/journal.pone.0088472

10.1007/s00415-015-7970-6

10.1001/jamaneurol.2014.4147

10.1111/j.1468-1331.2011.03648.x

10.1002/acn3.180

10.1177/1352458511417481

10.1136/jnnp-2015-312221

10.1111/j.1468-1331.2011.03577.x

10.1177/1352458510392098

10.1001/jamaneurol.2014.1200

10.1001/jamaneurol.2013.6240

10.3109/00207454.2015.1127919

10.1136/jnnp-2014-307591

10.1001/jamaneurol.2016.0826

10.1007/s00415-011-6019-8

10.1001/archneurol.2010.257

10.1111/cns.12282

10.1016/j.msard.2014.04.003

10.1002/ana.22163

10.1007/s00415-012-6808-8

10.1007/s40120-015-0038-9

10.1007/s10072-013-1527-1

10.1177/1352458512464282

10.1111/ane.12250

10.1177/1352458514549401

10.1002/ana.24651

10.1093/brain/awv260

10.1212/WNL.0000000000000355

10.1136/jnnp-2016-313760

10.1212/WNL.0b013e3182698c64

10.1212/WNL.0b013e3181fd62bb

10.1212/01.wnl.0000180575.77021.c4

10.1136/bmjopen-2013-004536

10.1177/1352458507077896

10.1136/bmjopen-2016-011210

10.1177/1352458509102366

10.1016/j.clineuro.2012.04.024

10.1186/1471-2377-12-124

10.1177/1756285612453192

10.1177/1352458515623366

10.1177/1352458511422244

10.1007/s00415-008-0909-4

10.1136/jnnp-2014-308113

10.1111/cen3.12231

10.1177/1352458509106543

10.1177/1352458514546790

10.1186/s12883-016-0674-4

10.1177/1352458511401944

10.1007/s40120-015-0033-1

10.1007/s40120-014-0020-y

10.1212/WNL.0000000000000137

10.1177/1352458516634872

Thông tin
Thông tin xuất bản

Multiple Sclerosis Journal

Tập 24 Số 2

96-120

Thông tin tác giả