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Standardized Definition of Progression Independent of Relapse Activity (PIRA) in Relapsing-Remitting Multiple Sclerosis
J. Müller, S. Sharmin, J. Lorscheider, S. Ozakbas, R. Karabudak, D. Horakova, B. Weinstock-Guttman, V. Shaygannejad, M. Etemadifar, R. Alroughani, F. Patti, S. Eichau, A. Prat, A. Lugaresi, V. Tomassini, AG. Kermode, MP. Amato, R. Turkoglu, A....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, multicentrická studie
- MeSH
- dospělí MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- posuzování pracovní neschopnosti MeSH
- progrese nemoci * MeSH
- recidiva MeSH
- registrace MeSH
- relabující-remitující roztroušená skleróza * diagnóza patofyziologie MeSH
- retrospektivní studie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
IMPORTANCE: Progression independent of relapse activity (PIRA) is a significant contributor to long-term disability accumulation in relapsing-remitting multiple sclerosis (MS). Prior studies have used varying PIRA definitions, hampering the comparability of study results. OBJECTIVE: To compare various definitions of PIRA. DESIGN, SETTING, AND PARTICIPANTS: This cohort study involved a retrospective analysis of prospectively collected data from the MSBase registry from July 2004 to July 2023. The participants were patients with MS from 186 centers across 43 countries who had clinically definite relapsing-remitting MS, a complete minimal dataset, and 3 or more documented Expanded Disability Status Scale (EDSS) assessments. EXPOSURE: Three-hundred sixty definitions of PIRA as combinations of the following criteria: baseline disability (fixed baseline with re-baselining after PIRA, or plus re-baselining after relapses, or plus re-baselining after improvements), minimum confirmation period (6, 12, or 24 months), confirmation magnitude (EDSS score at/above worsening score or at/above threshold compared with baseline), freedom from relapse at EDSS score worsening (90 days prior, 90 days prior and 30 days after, 180 days prior and after, since previous EDSS assessment, or since baseline), and freedom from relapse at confirmation (30 days prior, 90 days prior, 30 days before and after, or between worsening and confirmation). MAIN OUTCOME AND MEASURE: For each definition, we quantified PIRA incidence and persistence (ie, absence of a 3-month confirmed EDSS improvement over ≥5 years). RESULTS: Among 87 239 patients with MS, 33 303 patients fulfilled the inclusion criteria; 24 152 (72.5%) were female and 9151 (27.5%) were male. At the first visits, the mean (SD) age was 36.4 (10.9) years; 28 052 patients (84.2%) had relapsing-remitting MS, and the median (IQR) EDSS score was 2.0 (1.0-3.0). Participants had a mean (SD) 15.1 (11.9) visits over 8.9 (5.2) years. PIRA incidence ranged from 0.141 to 0.658 events per decade and persistence from 0.753 to 0.919, depending on the definition. In particular, the baseline and confirmation period influenced PIRA detection. The following definition yielded balanced incidence and persistence: a significant disability worsening compared with a baseline (reset after each PIRA event, relapse, and EDSS score improvement), in absence of relapses since the last EDSS assessment, confirmed with EDSS scores (not preceded by relapses within 30 days) that remained above the worsening threshold for at least 12 months. CONCLUSION AND RELEVANCE: Incidence and persistence of PIRA are determined by the definition used. The proposed standardized definition aims to enhance comparability among studies.
Aarhus University Hospital Arhus C Aarhus Denmark
AUSL Romagna Department of Diagnostic Imaging S Maria delle Croci Hospital of Ravenna Ravenna Italy
Austin Health Melbourne Victoria Australia
AZ Alma Ziekenhuis Sijsele Damme Belgium
Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino Avellino Italy
Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases Istanbul Turkey
Brain and Mind Centre Sydney New South Wales Australia
Center of Neuroimmunology Service of Neurology Hospital Clinic de Barcelona Barcelona Spain
Centro Sclerosi Multipla UOC Neurologia Azienda Ospedaliera per l'Emergenza Cannizzaro Catania Italy
CHUM MS Center and Universite de Montreal Montreal Quebec Canada
College of Medicine and Public Health Flinders University Adelaide South Australia Australia
CORe Department of Medicine University of Melbourne Melbourne Victoria Australia
CSSS Saint Jérôme Saint Jerome Canada
Department NEUROFARBA University of Florence Florence Italy
Department of Medical and Surgical Sciences and Advanced Technologies GF Ingrassia Catania Italy
Department of Medicine and Surgery University Hospital Reina Sofia Cordoba Spain
Department of Medicine School of Clinical Sciences Monash University Melbourne Victoria Australia
Department of Neurology Antwerp University Hospital Edegem Belgium
Department of Neurology ASL3 Genovese Genova Italy
Department of Neurology Booalisina Hospital Sari Iran
Department of Neurology Centro Hospitalar Universitario de Sao Joao Porto Portugal
Department of Neurology Cliniques Universitaires Saint Luc UCLouvain Brussels Belgium
Department of Neurology Concord Repatriation General Hospital Sydney New South Wales Australia
Department of Neurology Faculty of Medicine AHEPA University Hospital Thessaloniki Greece
Department of Neurology Faculty of Medicine University of Debrecen Debrecen Hungary
Department of Neurology Haydarpasa Numune Training and Research Hospital Istanbul Turkey
Department of Neurology Hospital Clínico Universitario San Carlos IdISSC Madrid Spain
Department of Neurology Hospital de Galdakao Usansolo Galdakao Spain
Department of Neurology Hospital Fernandez Capital Federal Argentina
Department of Neurology Hospital Universitario Virgen Macarena Sevilla Spain
Department of Neurology Jacobs MS Center for Treatment and Research Buffalo New York
Department of Neurology Monash Health Clayton Australia
Department of Neurology Nationaal MS Centrum Melsbroek Belgium
Department of Neurology The Alfred Hospital Melbourne Victoria Australia
Department of Neurology Timisoara Romania
Department of Neurology University Hospital Ghent Ghent Belgium
Department of Neurology University of Queensland Brisbane Queensland Australia
Department of Neurology Westmead Hospital Sydney New South Wales Australia
Department of Neuroscience Barwon Health Geelong Australia
Department of Neuroscience Hospital Germans Trias i Pujol Badalona Spain
Department of Neurosciences Box Hill Hospital Melbourne Victoria Australia
Dipartimento di Scienze Biomediche e Neuromotorie Università di Bologna Bologna Italy
Division of Neurology Department of Medicine Amiri Hospital Sharq Kuwait
Eastern Health Clinical School Monash University Box Hill Melbourne Victoria Australia
Groene Hart Ziekenhuis Gouda the Netherlands
Hospital Universitario de CEMIC Buenos Aires Argentina
Hospital Universitario Donostia San Sebastián Spain
Hunter Medical Research Institute University Newcastle Newcastle Australia
IRCCS Fondazione Don Carlo Gnocchi Florence Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna Bologna Italia
Isfahan University of Medical Sciences Isfahan Iran
Izmir University of Economics Medical Point Hospital Konak Izmir Turkey
Multiple Sclerosis Centre Kamillus Klinik Asbach Germany
Multiple Sclerosis Research Association Izmir Turkey
Nemocnice Jihlava Jihlava Czech Republic
Neuroimmunology Centre Department of Neurology Royal Melbourne Hospital Melbourne Victoria Australia
Neurology Az Sint Jan Brugge Bruges Belgium
Neurology Department King Fahad Specialist Hospital Dammam Khobar Saudi Arabia
Neurology Dr Etemadifar MS Institute Isfahan Iran
Neurology Institute Harley Street Medical Center Abu Dhabi United Arab Emirates
Neurology Unit P O Unico Macerata ast Macerata Macerata Italy
Royal Hobart Hospital Hobart Australia
Royal Victoria Hospital Belfast United Kingdom
South Eastern HSC Trust Belfast United Kingdom
St Michael's Hospital Toronto Ontario Canada
St Vincent's Hospital Fitzroy Melbourne Victoria Australia
St Vincent's Hospital Sydney Sydney New South Wales Australia
St Vincent's University Hospital Dublin Ireland
UOS Sclerosi Multipla AOU Policlinico G Rodolico San Marco Catania Italy
Citace poskytuje Crossref.org
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- $a IMPORTANCE: Progression independent of relapse activity (PIRA) is a significant contributor to long-term disability accumulation in relapsing-remitting multiple sclerosis (MS). Prior studies have used varying PIRA definitions, hampering the comparability of study results. OBJECTIVE: To compare various definitions of PIRA. DESIGN, SETTING, AND PARTICIPANTS: This cohort study involved a retrospective analysis of prospectively collected data from the MSBase registry from July 2004 to July 2023. The participants were patients with MS from 186 centers across 43 countries who had clinically definite relapsing-remitting MS, a complete minimal dataset, and 3 or more documented Expanded Disability Status Scale (EDSS) assessments. EXPOSURE: Three-hundred sixty definitions of PIRA as combinations of the following criteria: baseline disability (fixed baseline with re-baselining after PIRA, or plus re-baselining after relapses, or plus re-baselining after improvements), minimum confirmation period (6, 12, or 24 months), confirmation magnitude (EDSS score at/above worsening score or at/above threshold compared with baseline), freedom from relapse at EDSS score worsening (90 days prior, 90 days prior and 30 days after, 180 days prior and after, since previous EDSS assessment, or since baseline), and freedom from relapse at confirmation (30 days prior, 90 days prior, 30 days before and after, or between worsening and confirmation). MAIN OUTCOME AND MEASURE: For each definition, we quantified PIRA incidence and persistence (ie, absence of a 3-month confirmed EDSS improvement over ≥5 years). RESULTS: Among 87 239 patients with MS, 33 303 patients fulfilled the inclusion criteria; 24 152 (72.5%) were female and 9151 (27.5%) were male. At the first visits, the mean (SD) age was 36.4 (10.9) years; 28 052 patients (84.2%) had relapsing-remitting MS, and the median (IQR) EDSS score was 2.0 (1.0-3.0). Participants had a mean (SD) 15.1 (11.9) visits over 8.9 (5.2) years. PIRA incidence ranged from 0.141 to 0.658 events per decade and persistence from 0.753 to 0.919, depending on the definition. In particular, the baseline and confirmation period influenced PIRA detection. The following definition yielded balanced incidence and persistence: a significant disability worsening compared with a baseline (reset after each PIRA event, relapse, and EDSS score improvement), in absence of relapses since the last EDSS assessment, confirmed with EDSS scores (not preceded by relapses within 30 days) that remained above the worsening threshold for at least 12 months. CONCLUSION AND RELEVANCE: Incidence and persistence of PIRA are determined by the definition used. The proposed standardized definition aims to enhance comparability among studies.
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- 856 41
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