Real-life evaluation of the 2017 McDonald criteria for relapsing-remitting multiple sclerosis after a clinically isolated syndrome confirms a gain in time-to-diagnosis.
Clinically isolated syndrome
Diagnosis
McDonald criteria
Multiple sclerosis
Oligoclonal bands
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
31 Aug 2023
31 Aug 2023
Historique:
received:
25
05
2023
accepted:
25
07
2023
revised:
25
07
2023
medline:
31
8
2023
pubmed:
31
8
2023
entrez:
31
8
2023
Statut:
aheadofprint
Résumé
Previous cohort studies evaluating the performances of the McDonald criteria suffered from bias regarding real-life conditions. We aimed to evaluate the probability of diagnosing relapsing-remitting multiple sclerosis (MS) at several timepoints from the first medical evaluation and the gain in time-to-diagnosis with the 2017 McDonald criteria compared with the 2001, 2005 and 2010 versions in real life. Patients with a first demyelinating event suggestive of MS between 2002 and 2020 were included in the ReLSEP, an exhaustive and prospectively incremented registry of MS patients in North-Eastern France. We estimated the probability of being positive at the first medical evaluation and at five timepoints according to the four versions of criteria using Kaplan-Meier estimators and Cox models. A total of 2220 patients were followed up for a median of 7.1 years. At baseline, 31.7%, 32.1%, 36.6% and 54.0% of patients, respectively, fulfilled the 2001, 2005, 2010 and 2017 McDonald criteria. Using the 2017 criteria, the gain in time-to-diagnosis was 3.7 months compared with the 2010 criteria. The presence of intrathecal synthesis of immunoglobulin G in the McDonald 2017 criteria led to a 1.8-month reduction in median time-to-diagnosis compared to a version of McDonald 2017 without this criteria. In real-life, the 2017 McDonald criteria revision undoubtedly shortened time-to-diagnosis.
Sections du résumé
BACKGROUND
BACKGROUND
Previous cohort studies evaluating the performances of the McDonald criteria suffered from bias regarding real-life conditions. We aimed to evaluate the probability of diagnosing relapsing-remitting multiple sclerosis (MS) at several timepoints from the first medical evaluation and the gain in time-to-diagnosis with the 2017 McDonald criteria compared with the 2001, 2005 and 2010 versions in real life.
METHODS
METHODS
Patients with a first demyelinating event suggestive of MS between 2002 and 2020 were included in the ReLSEP, an exhaustive and prospectively incremented registry of MS patients in North-Eastern France. We estimated the probability of being positive at the first medical evaluation and at five timepoints according to the four versions of criteria using Kaplan-Meier estimators and Cox models.
RESULTS
RESULTS
A total of 2220 patients were followed up for a median of 7.1 years. At baseline, 31.7%, 32.1%, 36.6% and 54.0% of patients, respectively, fulfilled the 2001, 2005, 2010 and 2017 McDonald criteria. Using the 2017 criteria, the gain in time-to-diagnosis was 3.7 months compared with the 2010 criteria. The presence of intrathecal synthesis of immunoglobulin G in the McDonald 2017 criteria led to a 1.8-month reduction in median time-to-diagnosis compared to a version of McDonald 2017 without this criteria.
CONCLUSIONS
CONCLUSIONS
In real-life, the 2017 McDonald criteria revision undoubtedly shortened time-to-diagnosis.
Identifiants
pubmed: 37650895
doi: 10.1007/s00415-023-11905-w
pii: 10.1007/s00415-023-11905-w
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
Références
Jacobs LD, Beck RW, Simon JH et al (2000) Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med 343:898–904. https://doi.org/10.1056/NEJM200009283431301
doi: 10.1056/NEJM200009283431301
pubmed: 11006365
Comi G, Filippi M, Barkhof F et al (2001) Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet Lond Engl 357:1576–1582
doi: 10.1016/S0140-6736(00)04725-5
PRISMS Study Group and the University of British Columbia MS/MRI Analysis Group (2001) PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS. Neurology 56:1628–1636. https://doi.org/10.1212/wnl.56.12.1628
doi: 10.1212/wnl.56.12.1628
Comi G, Martinelli V, Rodegher M et al (2009) Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet Lond Engl 374:1503–1511. https://doi.org/10.1016/S0140-6736(09)61259-9
doi: 10.1016/S0140-6736(09)61259-9
Trojano M, Pellegrini F, Paolicelli D et al (2009) Real-life impact of early interferon beta therapy in relapsing multiple sclerosis. Ann Neurol 66:513–520. https://doi.org/10.1002/ana.21757
doi: 10.1002/ana.21757
pubmed: 19847899
Kinkel RP, Dontchev M, Kollman C et al (2012) Association between immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome and long-term outcomes: a 10-year follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance. Arch Neurol 69:183–190. https://doi.org/10.1001/archneurol.2011.1426
doi: 10.1001/archneurol.2011.1426
pubmed: 21987393
Cocco E, Sardu C, Spinicci G et al (2015) Influence of treatments in multiple sclerosis disability: a cohort study. Mult Scler Houndmills Basingstoke Engl 21:433–441. https://doi.org/10.1177/1352458514546788
doi: 10.1177/1352458514546788
Kappos L, Edan G, Freedman MS et al (2016) The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology 87:978–987. https://doi.org/10.1212/WNL.0000000000003078
doi: 10.1212/WNL.0000000000003078
pubmed: 27511182
pmcid: 5027814
Kavaliunas A, Manouchehrinia A, Stawiarz L et al (2017) Importance of early treatment initiation in the clinical course of multiple sclerosis. Mult Scler Houndmills Basingstoke Engl 23:1233–1240. https://doi.org/10.1177/1352458516675039
doi: 10.1177/1352458516675039
McDonald WI, Compston A, Edan G et al (2001) Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol 50:121–127
doi: 10.1002/ana.1032
pubmed: 11456302
Polman CH, Reingold SC, Edan G et al (2005) Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria.” Ann Neurol 58:840–846. https://doi.org/10.1002/ana.20703
doi: 10.1002/ana.20703
pubmed: 16283615
Polman CH, Reingold SC, Banwell B et al (2011) Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 69:292–302. https://doi.org/10.1002/ana.22366
doi: 10.1002/ana.22366
pubmed: 21387374
pmcid: 3084507
Thompson AJ, Banwell BL, Barkhof F et al (2017) Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. https://doi.org/10.1016/S1474-4422(17)30470-2
doi: 10.1016/S1474-4422(17)30470-2
pubmed: 29275977
Gamraoui S, Mathey G, Debouverie M et al (2019) High performance of cerebrospinal fluid immunoglobulin G analysis for diagnosis of multiple sclerosis. J Neurol 266:902–909. https://doi.org/10.1007/s00415-019-09212-4
doi: 10.1007/s00415-019-09212-4
pubmed: 30707357
Gobbin F, Zanoni M, Marangi A et al (2019) 2017 McDonald criteria for multiple sclerosis: Earlier diagnosis with reduced specificity? Mult Scler Relat Disord 29:23–25. https://doi.org/10.1016/j.msard.2019.01.008
doi: 10.1016/j.msard.2019.01.008
pubmed: 30658260
van der Vries RMV, Mescheriakova JY, Wong YYM et al (2018) Application of the 2017 Revised McDonald criteria for multiple sclerosis to patients with a typical clinically isolated syndrome. JAMA Neurol 75:1392. https://doi.org/10.1001/jamaneurol.2018.2160
doi: 10.1001/jamaneurol.2018.2160
Habek M, Pavičić T, Ruška B et al (2018) Establishing the diagnosis of multiple sclerosis in Croatian patients with clinically isolated syndrome: 2010 versus 2017 McDonald criteria. Mult Scler Relat Disord 25:99–103. https://doi.org/10.1016/j.msard.2018.07.035
doi: 10.1016/j.msard.2018.07.035
pubmed: 30059896
Hyun J-W, Kim W, Huh S-Y et al (2019) Application of the 2017 McDonald diagnostic criteria for multiple sclerosis in Korean patients with clinically isolated syndrome. Mult Scler Houndmills Basingstoke Engl 25:1488–1495. https://doi.org/10.1177/1352458518790702
doi: 10.1177/1352458518790702
Miclea A, Salmen A, Wiest R et al (2019) Prediction of conversion to multiple sclerosis using the 2017 McDonald and 2016 MAGNIMS criteria in patients with clinically isolated syndrome: a retrospective single-center study. Ther Adv Neurol Disord 12:1756286419835652. https://doi.org/10.1177/1756286419835652
doi: 10.1177/1756286419835652
pubmed: 30956685
pmcid: 6444400
Gaetani L, Prosperini L, Mancini A et al (2018) 2017 revisions of McDonald criteria shorten the time to diagnosis of multiple sclerosis in clinically isolated syndromes. J Neurol 265:2684–2687. https://doi.org/10.1007/s00415-018-9048-8
doi: 10.1007/s00415-018-9048-8
pubmed: 30196327
Lee D-H, Peschke M, Utz KS, Linker RA (2019) Diagnostic value of the 2017 McDonald criteria in patients with a first demyelinating event suggestive of relapsing-remitting multiple sclerosis. Eur J Neurol 26:540–545. https://doi.org/10.1111/ene.13853
doi: 10.1111/ene.13853
pubmed: 30362206
McNicholas N, Lockhart A, Yap SM et al (2018) New versus old: Implications of evolving diagnostic criteria for relapsing-remitting multiple sclerosis. Mult Scler Houndmills Basingstoke Engl. https://doi.org/10.1177/1352458518770088
doi: 10.1177/1352458518770088
Beesley R, Anderson V, Harding KE et al (2018) Impact of the 2017 revisions to McDonald criteria on the diagnosis of multiple sclerosis. Mult Scler Houndmills Basingstoke Engl 24:1786–1787. https://doi.org/10.1177/1352458518778007
doi: 10.1177/1352458518778007
Schwenkenbecher P, Wurster U, Sühs K-W et al (2018) Applying the 2017 McDonald diagnostic criteria for multiple sclerosis. Lancet Neurol 17:498. https://doi.org/10.1016/S1474-4422(18)30160-1
doi: 10.1016/S1474-4422(18)30160-1
pubmed: 29778358
Zhang K, Zhao Y, Liang Z et al (2020) Validity of the McDonald criteria in predicting second events in multiple sclerosis. Mult Scler Relat Disord 43:102223. https://doi.org/10.1016/j.msard.2020.102223
doi: 10.1016/j.msard.2020.102223
pubmed: 32480348
Pagani Cassará F, Curbelo MC, Vazquez G et al (2020) Application of the 2017 McDonald criteria for the diagnosis of multiple sclerosis after a first demyelinating event in patients from Argentina. Mult Scler Relat Disord 41:102043. https://doi.org/10.1016/j.msard.2020.102043
doi: 10.1016/j.msard.2020.102043
pubmed: 32200341
Zheng Y, Shen C-H, Wang S et al (2020) Application of the 2017 McDonald criteria in a Chinese population with clinically isolated syndrome. Ther Adv Neurol Disord 13:1756286419898083. https://doi.org/10.1177/1756286419898083
doi: 10.1177/1756286419898083
pubmed: 32010225
pmcid: 6971959
Hacohen Y, Brownlee W, Mankad K et al (2020) Improved performance of the 2017 McDonald criteria for diagnosis of multiple sclerosis in children in a real-life cohort. Mult Scler Houndmills Basingstoke Engl 26:1372–1380. https://doi.org/10.1177/1352458519863781
doi: 10.1177/1352458519863781
Filippi M, Preziosa P, Meani A et al (2022) Performance of the 2017 and 2010 revised McDonald criteria in predicting MS diagnosis after a clinically isolated syndrome: a MAGNIMS study. Neurology 98:e1–e14. https://doi.org/10.1212/WNL.0000000000013016
doi: 10.1212/WNL.0000000000013016
pubmed: 34716250
Gout O, Lebrun-Frenay C, Labauge P et al (2011) Prior suggestive symptoms in one-third of patients consulting for a “first” demyelinating event. J Neurol Neurosurg Psychiatry 82:323–325. https://doi.org/10.1136/jnnp.2008.166421
doi: 10.1136/jnnp.2008.166421
pubmed: 21097550
Debouverie M, Pittion-Vouyovitch S, Louis S et al (2008) Natural history of multiple sclerosis in a population-based cohort. Eur J Neurol 15:916–921. https://doi.org/10.1111/j.1468-1331.2008.02241.x
doi: 10.1111/j.1468-1331.2008.02241.x
pubmed: 18637953
Confavreux C, Compston DA, Hommes OR et al (1992) EDMUS, a European database for multiple sclerosis. J Neurol Neurosurg Psychiatry 55:671–676
doi: 10.1136/jnnp.55.8.671
pubmed: 1527537
pmcid: 489202
Mathey G, Ferrand M, Epstein J, Soudant M (2022) An algorithm to determine the date when the McDonald criteria are met for the diagnosis of relapsing-remitting multiple sclerosis. Rev Neurol (Paris). https://doi.org/10.1016/j.neurol.2022.07.005
doi: 10.1016/j.neurol.2022.07.005
pubmed: 36496270
Debouverie M, Laforest L, Van Ganse E et al (2009) Earlier disability of the patients followed in Multiple Sclerosis centers compared to out-patients. Mult Scler Houndmills Basingstoke Engl 15:251–257. https://doi.org/10.1177/1352458508097919
doi: 10.1177/1352458508097919
Kappos L, Polman CH, Freedman MS et al (2006) Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology 67:1242–1249. https://doi.org/10.1212/01.wnl.0000237641.33768.8d
doi: 10.1212/01.wnl.0000237641.33768.8d
pubmed: 16914693