Universität zu Köln

Foeldvari, Ivan, Constantin, Tamas, Vojinovic, Jelena ORCID: 0000-0002-6701-3370, Horneff, Gerd, Chasnyk, Vyacheslav, Dehoorne, Joke, Panaviene, Violeta, Susic, Gordana, Stanevicha, Valda, Kobusinska, Katarzyna, Zuber, Zbigniew, Dobrzyniecka, Bogna, Nikishina, Irina, Bader-Meunier, Brigitte, Breda, Luciana, Dolezalova, Pavla, Job-Deslandre, Chantal, Rumba-Rozenfelde, Ingrida, Wulffraat, Nico, Pedersen, Ronald D., Bukowski, Jack F., Vlahos, Bonnie, Martini, Alberto and Ruperto, Nicolino ORCID: 0000-0001-8407-7782 (2019). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res. Ther., 21. LONDON: BMC. ISSN 1478-6362

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Abstract

BackgroundTo 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)MethodsPatients 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 0.8mg/kg, up to a maximum dose of 50mg/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).ResultsOut of 127 patients originally enrolled in CLIPPER, 109 (86%) entered CLIPPER2. After 6years of trial participation (2years in CLIPPER and 4years 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 2years of treatment were 58%, 48%, and 32%, respectively. After the additional 4years, 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.ConclusionsOpen-label etanercept treatment for up to 6years was safe, well tolerated, and effective in patients with eoJIA, ERA, and PsA.Trial registrationClinicalTrials.gov: CLIPPER, NCT00962741, registered 20 August, 2009, CLIPPER2, NCT01421069, registered 22 August, 2011.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Foeldvari, Ivan UNSPECIFIED UNSPECIFIED UNSPECIFIED Constantin, Tamas UNSPECIFIED UNSPECIFIED UNSPECIFIED Vojinovic, Jelena UNSPECIFIED orcid.org/0000-0002-6701-3370 UNSPECIFIED Horneff, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Chasnyk, Vyacheslav UNSPECIFIED UNSPECIFIED UNSPECIFIED Dehoorne, Joke UNSPECIFIED UNSPECIFIED UNSPECIFIED Panaviene, Violeta UNSPECIFIED UNSPECIFIED UNSPECIFIED Susic, Gordana UNSPECIFIED UNSPECIFIED UNSPECIFIED Stanevicha, Valda UNSPECIFIED UNSPECIFIED UNSPECIFIED Kobusinska, Katarzyna UNSPECIFIED UNSPECIFIED UNSPECIFIED Zuber, Zbigniew UNSPECIFIED UNSPECIFIED UNSPECIFIED Dobrzyniecka, Bogna UNSPECIFIED UNSPECIFIED UNSPECIFIED Nikishina, Irina UNSPECIFIED UNSPECIFIED UNSPECIFIED Bader-Meunier, Brigitte UNSPECIFIED UNSPECIFIED UNSPECIFIED Breda, Luciana UNSPECIFIED UNSPECIFIED UNSPECIFIED Dolezalova, Pavla UNSPECIFIED UNSPECIFIED UNSPECIFIED Job-Deslandre, Chantal UNSPECIFIED UNSPECIFIED UNSPECIFIED Rumba-Rozenfelde, Ingrida UNSPECIFIED UNSPECIFIED UNSPECIFIED Wulffraat, Nico UNSPECIFIED UNSPECIFIED UNSPECIFIED Pedersen, Ronald D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bukowski, Jack F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vlahos, Bonnie UNSPECIFIED UNSPECIFIED UNSPECIFIED Martini, Alberto UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruperto, Nicolino UNSPECIFIED orcid.org/0000-0001-8407-7782 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-147936
DOI:	10.1186/s13075-019-1916-9
Journal or Publication Title:	Arthritis Res. Ther.
Volume:	21
Date:	2019
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1478-6362
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DISEASE-ACTIVITY; NECROSIS-FACTOR; PEDIATRIC-PATIENTS; DEFINING CRITERIA; DOUBLE-BLIND; CHILDREN; METHOTREXATE; CATEGORIES; ADALIMUMAB; INITIATION Multiple languages Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14793