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dc.contributor.author Foeldvari, Ivan
dc.contributor.author Constantin, Tamàs
dc.contributor.author Vojinović, Jelena
dc.contributor.author Horneff, Gerd
dc.contributor.author Chasnyk, Vyacheslav
dc.contributor.author Dehoorne, Joke
dc.contributor.author Panaviene, Violeta
dc.contributor.author Sušić, Gordana
dc.contributor.author Stanevicha, Valda
dc.contributor.author Kobusinska, Katarzyna
dc.contributor.author Zuber, Zbigniew
dc.contributor.author Dobrzyniecka, Bogna
dc.contributor.author Nikishina, Irina
dc.contributor.author Bader-Meunier, Brigitte
dc.contributor.author Breda, Luciana
dc.contributor.author Doležalová, Pavla
dc.contributor.author Job-Deslandre, Chantal
dc.contributor.author Rumba-Rozenfelde, Ingrida
dc.contributor.author Wulffraat, Nico
dc.contributor.author Pedersen, Ronald D
dc.contributor.author Bukowski, Jack F
dc.contributor.author Vlahos, Bonnie
dc.contributor.author Martini, Alberto
dc.contributor.author Ruperto, Nicolino
dc.contributor.author Paediatric Rheumatology International Trials Organisation (PRINTO)
dc.date.accessioned 2020-03-26T08:02:35Z
dc.date.available 2020-03-26T08:02:35Z
dc.date.issued 2019
dc.identifier.citation journalVolume=21;journalIssueNumber=1;journalTitle=ARTHRITIS RESEARCH & THERAPY;pagination=125, pages: 10;;journalAbbreviatedTitle=ARTHRITIS RES THER;
dc.identifier.uri http://repo.lib.semmelweis.hu//handle/123456789/8107
dc.identifier.uri doi:10.1186/s13075-019-1916-9
dc.description.abstract To describe the 6-year safety and efficacy of etanercept (ETN) in children with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitis-related arthritis (ERA), and psoriatic arthritis (PsA) METHODS: Patients who completed the 2-year, open-label, phase III CLinical Study In Pediatric Patients of Etanercept for Treatment of ERA, PsA, and Extended Oligoarthritis (CLIPPER) were allowed to enroll in its 8-year long-term extension (CLIPPER2). Children received ETN at a once-weekly dose of 0.8 mg/kg, up to a maximum dose of 50 mg/week. Efficacy assessments included the JIA core set of outcomes, the JIA American College of Rheumatology response criteria (JIA-ACR), and the Juvenile Arthritis Disease Activity Score (JADAS). Efficacy data are reported as responder analyses using a hybrid method for missing data imputation and as observed cases. Safety assessments included treatment-emergent adverse events (TEAEs).Out of 127 patients originally enrolled in CLIPPER, 109 (86%) entered CLIPPER2. After 6 years of trial participation (2 years in CLIPPER and 4 years in CLIPPER2), 41 (32%) patients were still taking ETN, 13 (11%) entered the treatment withdrawal phase after achieving low/inactive disease (of whom 7 had to restart ETN), 36 (28%) discontinued treatment for other reasons but are still being observed, and 37 (29%) discontinued treatment permanently. According to the hybrid imputation analysis, proportions of patients achieving JIA ACR90, JIA ACR100, and JADAS inactive disease after the initial 2 years of treatment were 58%, 48%, and 32%, respectively. After the additional 4 years, those proportions in patients who remained in the trial were 46%, 35%, and 24%. Most frequently reported TEAEs [n (%), events per 100 patient-years] were headache [28 (22%), 5.3], arthralgia [24 (19%), 4.6], and pyrexia [20 (16%), 3.8]. Number and frequency of TEAEs, excluding infections and injection site reactions, decreased over the 6-year period from 193 and 173.8, respectively, during year 1 to 37 and 61.3 during year 6. A single case of malignancy (Hodgkin's lymphoma) and no cases of active tuberculosis, demyelinating disorders, or deaths were reported.Open-label etanercept treatment for up to 6 years was safe, well tolerated, and effective in patients with eoJIA, ERA, and PsA.ClinicalTrials.gov: CLIPPER, NCT00962741 , registered 20 August, 2009, CLIPPER2, NCT01421069 , registered 22 August, 2011.
dc.relation.ispartof urn:issn:1478-6354
dc.title Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis
dc.type Journal Article
dc.date.updated 2020-01-08T14:37:06Z
dc.language.rfc3066 en
dc.rights.holder NULL
dc.identifier.mtmt 31044219
dc.identifier.pubmed 31122296
dc.contributor.department SE/AOK/K/II. Sz. Gyermekgyógyászati Klinika
dc.contributor.institution Semmelweis Egyetem


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