Alexander Rae-Grant1, Gregory S Day1, Ruth Ann Marrie1, Alejandro Rabinstein1, Bruce A C Cree1, Gary S Gronseth1, Michael Haboubi1, June Halper1, Jonathan P Hosey1, David E Jones1, Robert Lisak1, Daniel Pelletier1, Sonja Potrebic1, Cynthia Sitcov1, Rick Sommers1, Julie Stachowiak1, Thomas S D Getchius1, Shannon A Merillat1, Tamara Pringsheim1. 1. From the Department of Neurology (A.R.-G.), Cleveland Clinic, OH; Department of Neurology (G.S.D.), Charles F. and Joanne Knight Alzheimer Disease Research Center, Washington University in St. Louis, MO; Department of Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Neurology (A.R.), Mayo Clinic, Rochester, MN; UCSF Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), University of California, San Francisco; Department of Neurology (G.S.G.), Kansas University Medical Center, Kansas City; Department of Neurology (M.H.), School of Medicine, University of Louisville, KY; Consortium of Multiple Sclerosis Centers (J.H.), Hackensack, NJ; Department of Neuroscience (J.P.H.), St. Luke's University Health Network, Bethlehem, PA; Department of Neurology (D.E.J.), University of Virginia, Charlottesville; Consortium of Multiple Sclerosis Centers (R.L.), Hackensack, NJ; Department of Neurology (R.L.), School of Medicine, Wayne State University, Detroit, MI; Department of Neurology (D.P.), Keck School of Medicine, University of Southern California; Neurology Department (S.P.), Southern California Permanente Medical Group, Kaiser, Los Angeles; National Multiple Sclerosis Society (C.S.), Arlington, VA; National Multiple Sclerosis Society (R.S.), New York, NY; Santa Fe (J.S.), NM; Heart Rhythm Society (T.S.D.G.), Washington, DC; American Academy of Neurology (S.A.M.), Minneapolis, MN; and Department of Clinical Neurosciences, Psychiatry, Pediatrics and Community Health Sciences, Cumming School of Medicine (T.P.), University of Calgary, Alberta, Canada.
Abstract
OBJECTIVE: To develop recommendations for disease-modifying therapy (DMT) for multiple sclerosis (MS). METHODS: A multidisciplinary panel developed DMT recommendations, integrating findings from a systematic review; followed an Institute of Medicine-compliant process to ensure transparency and patient engagement; and developed modified Delphi consensus-based recommendations concerning starting, switching, and stopping DMTs pertinent to people with relapsing-remitting MS, secondary progressive MS, primary progressive MS, and clinically isolated syndromes of demyelination. Recommendations were supported by structured rationales, integrating evidence from one or more sources: systematic review, related evidence (evidence not from the systematic review), principles of care, and inference from evidence. RESULTS: Thirty recommendations were developed: 17 on starting DMTs, including recommendations on who should start them; 10 on switching DMTs if breakthrough disease develops; and 3 on stopping DMTs. Recommendations encompassed patient engagement strategies and individualization of treatment, including adherence monitoring and disease comorbidity assessment. The panel also discussed DMT risks, including counseling about progressive multifocal leukoencephalopathy risk in people with MS using natalizumab, fingolimod, rituximab, ocrelizumab, and dimethyl fumarate; and made suggestions for future research to evaluate relative merits of early treatment with higher potency DMTs vs standard stepped-care protocols, DMT comparative effectiveness, optimal switching strategies, long-term effects of DMT use, definitions of highly active MS, and effects of treatment on patient-specified priority outcomes. This guideline reflects the complexity of decision-making for starting, switching, or stopping MS DMTs. The field of MS treatment is rapidly changing; the Academy of Neurology development process includes planning for future updates.
OBJECTIVE: To develop recommendations for disease-modifying therapy (DMT) for multiple sclerosis (MS). METHODS: A multidisciplinary panel developed DMT recommendations, integrating findings from a systematic review; followed an Institute of Medicine-compliant process to ensure transparency and patient engagement; and developed modified Delphi consensus-based recommendations concerning starting, switching, and stopping DMTs pertinent to people with relapsing-remitting MS, secondary progressive MS, primary progressive MS, and clinically isolated syndromes of demyelination. Recommendations were supported by structured rationales, integrating evidence from one or more sources: systematic review, related evidence (evidence not from the systematic review), principles of care, and inference from evidence. RESULTS: Thirty recommendations were developed: 17 on starting DMTs, including recommendations on who should start them; 10 on switching DMTs if breakthrough disease develops; and 3 on stopping DMTs. Recommendations encompassed patient engagement strategies and individualization of treatment, including adherence monitoring and disease comorbidity assessment. The panel also discussed DMT risks, including counseling about progressive multifocal leukoencephalopathy risk in people with MS using natalizumab, fingolimod, rituximab, ocrelizumab, and dimethyl fumarate; and made suggestions for future research to evaluate relative merits of early treatment with higher potency DMTs vs standard stepped-care protocols, DMT comparative effectiveness, optimal switching strategies, long-term effects of DMT use, definitions of highly active MS, and effects of treatment on patient-specified priority outcomes. This guideline reflects the complexity of decision-making for starting, switching, or stopping MS DMTs. The field of MS treatment is rapidly changing; the Academy of Neurology development process includes planning for future updates.
Authors: Damiano Paolicelli; Giuseppe Lucisano; Alessia Manni; Carlo Avolio; Simona Bonavita; Vincenzo Brescia Morra; Marco Capobianco; Eleonora Cocco; Antonella Conte; Giovanna De Luca; Francesca De Robertis; Claudio Gasperini; Maurizia Gatto; Paola Gazzola; Giacomo Lus; Antonio Iaffaldano; Pietro Iaffaldano; Davide Maimone; Giulia Mallucci; Giorgia T Maniscalco; Girolama A Marfia; Francesco Patti; Ilaria Pesci; Carlo Pozzilli; Marco Rovaris; Giuseppe Salemi; Marco Salvetti; Daniele Spitaleri; Rocco Totaro; Mauro Zaffaroni; Giancarlo Comi; Maria Pia Amato; Maria Trojano Journal: J Neurol Date: 2019-09-18 Impact factor: 4.849
Authors: Natalie A Schwehr; Karen M Kuntz; Eva A Enns; Nathan D Shippee; Elaine Kingwell; Helen Tremlett; Adam F Carpenter; Mary Butler Journal: Drugs Aging Date: 2020-03 Impact factor: 3.923
Authors: Heinz Wiendl; Ralf Gold; Thomas Berger; Tobias Derfuss; Ralf Linker; Mathias Mäurer; Martin Stangel; Orhan Aktas; Karl Baum; Martin Berghoff; Stefan Bittner; Andrew Chan; Adam Czaplinski; Florian Deisenhammer; Franziska Di Pauli; Renaud Du Pasquier; Christian Enzinger; Elisabeth Fertl; Achim Gass; Klaus Gehring; Claudio Gobbi; Norbert Goebels; Michael Guger; Aiden Haghikia; Hans-Peter Hartung; Fedor Heidenreich; Olaf Hoffmann; Zoë R Hunter; Boris Kallmann; Christoph Kleinschnitz; Luisa Klotz; Verena Leussink; Fritz Leutmezer; Volker Limmroth; Jan D Lünemann; Andreas Lutterotti; Sven G Meuth; Uta Meyding-Lamadé; Michael Platten; Peter Rieckmann; Stephan Schmidt; Hayrettin Tumani; Martin S Weber; Frank Weber; Uwe K Zettl; Tjalf Ziemssen; Frauke Zipp Journal: Nervenarzt Date: 2021-07-23 Impact factor: 1.214