Please use this identifier to cite or link to this item:
10.1093/rheumatology/kead183
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DC Field | Value | Language |
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dc.contributor.author | Vojinović, Jelena | - |
dc.contributor.author | Foeldvari, Ivan | - |
dc.contributor.author | Dehoorne, Joke | - |
dc.contributor.author | Stanevicha, Valda | - |
dc.contributor.author | Paediatric Rheumatology International Trials Organisation (PRINTO) | - |
dc.date.accessioned | 2024-01-09T12:00:01Z | - |
dc.date.available | 2024-01-09T12:00:01Z | - |
dc.date.issued | 2024-01-01 | - |
dc.identifier.citation | Vojinović , J , Foeldvari , I , Dehoorne , J , Stanevicha , V & Paediatric Rheumatology International Trials Organisation (PRINTO) 2024 , ' Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis ' , Rheumatology , vol. 63 , no. 1 , pp. 140-148 . https://doi.org/10.1093/rheumatology/kead183 | - |
dc.identifier.issn | 1462-0324 | - |
dc.identifier.other | unpaywall: 10.1093/rheumatology/kead183 | - |
dc.identifier.other | Mendeley: f127f65a-98e1-3847-92d6-4b9e317f7b6c | - |
dc.identifier.uri | https://dspace.rsu.lv/jspui/handle/123456789/15093 | - |
dc.description | Publisher Copyright: © 2023 The Author(s). Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. | - |
dc.description.abstract | Objectives: CLIPPER2 was an 8-year, open-label extension of the phase 3b, 2-year CLIPPER study on the safety and efficacy of etanercept in patients with JIA, categorized as extended oligoarticular arthritis (eoJIA), enthesitis-related arthritis (ERA) or PsA. Methods: Participants with eoJIA (2-17 years old), ERA or PsA (each 12-17 years old) who received ≥1 etanercept dose (0.8 mg/kg weekly; maximum 50 mg) in CLIPPER could enter CLIPPER2. Primary end point was occurrence of malignancy. Efficacy assessments included proportions achieving JIA ACR 30/50/70/90/100 criteria and ACR inactive disease criteria, and clinical remission (ACR criteria) or Juvenile Arthritis DAS (JADAS) ≤1. Results: Overall, 109/127 (86%) CLIPPER participants entered CLIPPER2 [n = 55 eoJIA, n = 31 ERA, n = 23 PsA; 99 (78%) on active treatment]; 84 (66%) completed 120 months' follow-up [32 (25%) on active treatment]. One malignancy (Hodgkin's disease in 18-year-old patient with eoJIA treated with methotrexate for 8 years) was reported; there were no cases of active tuberculosis or deaths. Numbers and incidence rates (events per 100 patient-years) of TEAEs (excluding infections/ISRs) decreased from 193 (173.81) in Year 1 to 9 (27.15) in Year 10; TE infections and serious infections also decreased. Over 45% of participants (n = 127) achieved JIA ACR50 responses from Month 2 onwards; 42 (33%) and 34 (27%) participants achieved JADAS and ACR clinical remission, respectively. Conclusions: Etanercept treatment up to 10 years was well tolerated, consistent with the known safety profile, with durable response in the participants still on active treatment. The benefit-risk assessment of etanercept in these JIA categories remains favourable. Trial registration: ClinicalTrials.gov | en |
dc.format.extent | 9 | - |
dc.format.extent | 589162 | - |
dc.language.iso | eng | - |
dc.relation.ispartof | Rheumatology | - |
dc.rights | info:eu-repo/semantics/openAccess | - |
dc.subject | TNF inhibitor | - |
dc.subject | enthesitis-related arthritis | - |
dc.subject | etanercept | - |
dc.subject | extended oligoarticular arthritis | - |
dc.subject | juvenile idiopathic arthritis | - |
dc.subject | psoriatic arthritis | - |
dc.subject | 3.2 Clinical medicine | - |
dc.subject | 1.1. Scientific article indexed in Web of Science and/or Scopus database | - |
dc.subject | SDG 3 - Good Health and Well-being | - |
dc.title | Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis | en |
dc.type | /dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article | - |
dc.identifier.doi | 10.1093/rheumatology/kead183 | - |
dc.contributor.institution | Rīga Stradiņš University | - |
dc.identifier.url | http://www.scopus.com/inward/record.url?scp=85181760823&partnerID=8YFLogxK | - |
dc.description.status | Peer reviewed | - |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
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Ten-year_safety_and_clinical_benefit_from_open-label.pdf | 575.35 kB | Adobe PDF | View/Open |
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