Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis

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dc.contributor.authorVojinović, Jelena
dc.contributor.authorFoeldvari, Ivan
dc.contributor.authorDehoorne, Joke
dc.contributor.authorStanevicha, Valda
dc.contributor.authorPaediatric Rheumatology International Trials Organisation (PRINTO)
dc.contributor.institutionRīga Stradiņš University
dc.date.accessioned2024-01-09T12:00:01Z
dc.date.available2024-01-09T12:00:01Z
dc.date.issued2024-01-01
dc.descriptionPublisher Copyright: © 2023 The Author(s). Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved.
dc.description.abstractObjectives: 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.goven
dc.description.statusPeer reviewed
dc.format.extent9
dc.format.extent589162
dc.identifier.citationVojinović, 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.doi10.1093/rheumatology/kead183
dc.identifier.issn1462-0324
dc.identifier.otherunpaywall: 10.1093/rheumatology/kead183
dc.identifier.otherMendeley: f127f65a-98e1-3847-92d6-4b9e317f7b6c
dc.identifier.urihttps://dspace.rsu.lv/jspui/handle/123456789/15093
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85181760823&partnerID=8YFLogxK
dc.language.isoeng
dc.relation.ispartofRheumatology
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectTNF inhibitor
dc.subjectenthesitis-related arthritis
dc.subjectetanercept
dc.subjectextended oligoarticular arthritis
dc.subjectjuvenile idiopathic arthritis
dc.subjectpsoriatic arthritis
dc.subject3.2 Clinical medicine
dc.subject1.1. Scientific article indexed in Web of Science and/or Scopus database
dc.subjectSDG 3 - Good Health and Well-being
dc.titleTen-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritisen
dc.type/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article

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