Vojinović, JelenaFoeldvari, IvanDehoorne, JokeStanevicha, ValdaPaediatric Rheumatology International Trials Organisation (PRINTO)2024-01-092024-01-092024-01-01Vojinović, 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/kead1831462-0324unpaywall: 10.1093/rheumatology/kead183Mendeley: f127f65a-98e1-3847-92d6-4b9e317f7b6chttps://dspace.rsu.lv/jspui/handle/123456789/15093Publisher Copyright: © 2023 The Author(s). Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved.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.gov9589162enginfo:eu-repo/semantics/openAccessTNF inhibitorenthesitis-related arthritisetanerceptextended oligoarticular arthritisjuvenile idiopathic arthritispsoriatic arthritis3.2 Clinical medicine1.1. Scientific article indexed in Web of Science and/or Scopus databaseSDG 3 - Good Health and Well-being/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article10.1093/rheumatology/kead183http://www.scopus.com/inward/record.url?scp=85181760823&partnerID=8YFLogxK