Show simple item record Foeldvari, Ivan Constantin, Tamàs Vojinović, Jelena Horneff, Gerd Chasnyk, Vyacheslav Dehoorne, Joke Panaviene, Violeta Sušić, Gordana Stanevicha, Valda Kobusinska, Katarzyna Zuber, Zbigniew Dobrzyniecka, Bogna Nikishina, Irina Bader-Meunier, Brigitte Breda, Luciana Doležalová, Pavla Job-Deslandre, Chantal Rumba-Rozenfelde, Ingrida Wulffraat, Nico Pedersen, Ronald D Bukowski, Jack F Vlahos, Bonnie Martini, Alberto Ruperto, Nicolino Paediatric Rheumatology International Trials Organisation (PRINTO) 2020-03-26T08:02:35Z 2020-03-26T08:02:35Z 2019
dc.identifier.citation journalVolume=21;journalIssueNumber=1;journalTitle=ARTHRITIS RESEARCH & THERAPY;pagination=125, pages: 10;;journalAbbreviatedTitle=ARTHRITIS RES THER;
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 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 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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