Please use this identifier to cite or link to this item:
10.1093/rheumatology/keae025
Title: | Safety and effectiveness of abatacept in juvenile idiopathic arthritis : results from the PRINTO/PRCSG registry |
Authors: | Lovell, Daniel J Tzaribachev, Nikolay Henrickson, Michael Simonini, Gabriele Griffin, Thomas A Alexeeva, Ekaterina Bohnsack, John F Zeft, Andrew Horneff, Gerd Vehe, Richard K Staņēviča, Valda Tarvin, Stacey Trachana, Maria Del Río, Ana Quintero Huber, Adam M Kietz, Daniel Orbán, Ilonka Dare, Jason Foeldvari, Ivan Quartier, Pierre Dominique, Alyssa Simon, Teresa A Martini, Alberto Brunner, Hermine I Ruperto, Nicolino Rīga Stradiņš University |
Keywords: | adolescent rheumatology;biological therapies;DMARDs;juvenile idiopathic arthritis;paediatric/juvenile rheumatology;3.2 Clinical medicine;1.1. Scientific article indexed in Web of Science and/or Scopus database |
Issue Date: | 1-Sep-2024 |
Citation: | Lovell , D J , Tzaribachev , N , Henrickson , M , Simonini , G , Griffin , T A , Alexeeva , E , Bohnsack , J F , Zeft , A , Horneff , G , Vehe , R K , Staņēviča , V , Tarvin , S , Trachana , M , Del Río , A Q , Huber , A M , Kietz , D , Orbán , I , Dare , J , Foeldvari , I , Quartier , P , Dominique , A , Simon , T A , Martini , A , Brunner , H I & Ruperto , N 2024 , ' Safety and effectiveness of abatacept in juvenile idiopathic arthritis : results from the PRINTO/PRCSG registry ' , Rheumatology , vol. 63 , no. SI2 , pp. SI195-SI206 . https://doi.org/10.1093/rheumatology/keae025 |
Abstract: | OBJECTIVE: The aim of this study was to report the interim 5-year safety and effectiveness of abatacept in patients with JIA in the PRINTO/PRCSG registry. METHODS: The Abatacept JIA Registry (NCT01357668) is an ongoing observational study of children with JIA receiving abatacept; enrolment started in January 2013. Clinical sites enrolled patients with JIA starting or currently receiving abatacept. Eligible patients were assessed for safety (primary end point) and effectiveness over 10 years. Effectiveness was measured by clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10) in patients with JIA over 5 years. As-observed analysis is presented according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. RESULTS: As of 31 March 2020, 587 patients were enrolled; 569 are included in this analysis (including 134 new users) with 1214.6 patient-years of safety data available. Over 5 years, the incidence rate (IR) per 100 patient-years of follow-up of serious adverse events was 5.52 (95% CI: 4.27, 7.01) and of events of special interest was 3.62 (95% CI: 2.63, 4.86), with 18 serious infections [IR 1.48 (95% CI: 0.88, 2.34)]. As early as month 3, 55.9% of patients achieved cJADAS10 low disease activity and inactive disease (20.3%, 72/354 and 35.6%, 126/354, respectively), sustained over 5 years. Disease activity measures improvement over 5 years across JIA categories. CONCLUSION: Abatacept was well tolerated in patients with JIA, with no new safety signals identified and with well-controlled disease activity, including some patients achieving inactive disease or remission. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01357668. |
Description: | © The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com. |
DOI: | 10.1093/rheumatology/keae025 |
ISSN: | 1462-0324 |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
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