Standardized Definition of Progression Independent of Relapse Activity (PIRA) in Relapsing-Remitting Multiple Sclerosis.
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Müller Jannis, Sharmin Sifat, Lorscheider Johannes, Ozakbas Serkan, Karabudak Rana, Horakova Dana, Weinstock-Guttman Bianca, Shaygannejad Vahid, Etemadifar Masoud, Alroughani Raed, Patti Francesco, Eichau Sara, Prat Alexandre, Lugaresi Alessandra, Tomassini Valentina, Kermode Allan G, Amato Maria Pia, Turkoglu Recai, Altintas Ayse, Buzzard Katherine, Soysal Aysun, van der Walt Anneke, Butzkueven Helmut, Blanco Yolanda, Gerlach Oliver, Khoury Samia J, Barnett Michael, John Nevin, Lechner-Scott Jeannette, Foschi Matteo, Surcinelli Andrea, van Pesch Vincent, Prevost Julie, Sa Maria Jose, Maimone Davide, D'hooghe Marie, Hughes Stella, Hodgkinson Suzanne, McGuigan Chris, Cartechini Elisabetta, Taylor Bruce, Spitaleri Daniele, Slee Mark, McCombe Pamela, Yamout Bassem, Benkert Pascal, Kuhle Jens, Kappos Ludwig, Roos Izanne, Kalincik Tomas, MSBase Study Group, Havrdova Eva Kubala, Girard Marc, Duquette Pierre, Fabis-Pedrini Marzena, Carroll William M, Skibina Olga, Gouider Riadh, Mrabet Saloua, Ramo-Tello Cristina, Solaro Claudio, Habek Mario, Van Wijmeersch Bart, Ampapa Radek, Macdonell Richard, Oreja-Guevara Celia, de Gans Koen, Laureys Guy, Oh Jiwon, Garber Justin, Gray Orla, Agüera-Morales Eduardo, Sanchez-Menoyo Jose Luis, Castillo-Triviño Tamara, Grigoriadis Nikolaos, Petersen Thor, Hardy Todd A, Vucic Steve, Reddel Stephen, Ramanathan Sudarshini, Al-Asmi Abdullah, Simu Mihaela, Baghbanian Seyed Mohammad, Poehlau Dieter, Al-Harbi Talal, Rojas Juan Ignacio, Deri Norma, Lalive Patrice, Cambron Melissa, Csepany Tunde, Shuey Neil, Willekens Barbara, Shaw Cameron, Decoo Danny, Massey Jennifer, Yaldizli Özgür, Derfuss Tobias, Granziera Cristina
Аннотация
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.