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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

I. Foeldvari, T. Constantin, J. Vojinović, G. Horneff, V. Chasnyk, J. Dehoorne, V. Panaviene, G. Sušić, V. Stanevicha, K. Kobusinska, Z. Zuber, B. Dobrzyniecka, I. Nikishina, B. Bader-Meunier, L. Breda, P. Doležalová, C. Job-Deslandre, I....

. 2019 ; 21 (1) : 125. [pub] 20190523

Language English Country Great Britain

Document type Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc20023938

BACKGROUND: 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). RESULTS: 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. CONCLUSIONS: Open-label etanercept treatment for up to 6 years was safe, well tolerated, and effective in patients with eoJIA, ERA, and PsA. TRIAL REGISTRATION: ClinicalTrials.gov: CLIPPER, NCT00962741 , registered 20 August, 2009, CLIPPER2, NCT01421069 , registered 22 August, 2011.

Andrzej Frycz Modrzewski Krakow University Krakow Poland

Children's Hospital Affiliate of Vilnius University Hospital Santaros Clinic Vilnius Lithuania Clinic of Children's Diseases Vilnius University Vilnius Lithuania

Clinic of Pediatrics Clinical Center Niš Faculty of Medicine University of Niš Niš Serbia

Clinica Pediatrica e Reumatologia IRCCS Istituto Giannina Gaslini EULAR Centre of Excellence in Rheumatology 2008 2023 Paediatric Rheumatology International Trials Organisation Via Gaslini 5 16147 Genoa Italy

Department of General Paediatrics Asklepios Clinic Sankt Augustin Sankt Augustin Germany Department of Paediatric and Adolescents Medicine Medical Faculty University Hospital of Cologne Cologne Germany

Department of Pediatric Immunology and Rheumatology Wilhelmina Children's Hospital Utrecht The Netherlands

Department of Pediatric Rheumatology Ghent University Hospital Ghent Belgium

Department of Pediatrics and Adolescent Medicine General University Hospital and 1st Faculty of Medicine Charles University Prague Prague Czech Republic

Department of Pediatrics Riga Stradins University Children University Hospital Riga Latvia

Dipartimento di Neuroscienze Riabilitazione Oftalmologia Genetica e Scienze Materno Infantili Università degli Studi di Genova Genoa Italy

Dipartimento di Pediatria Ospedale Policlinico Università degli Studi di Chieti Chieti Italy

Division of Pediatric Rheumatology Institute of Rheumatology Belgrade Serbia

Faculty of Medicine University of Latvia Riga Latvia University Children Hospital Riga Latvia

Hamburg Centre for Pediatric and Adolescent Rheumatology Hamburg Germany

Hôpital Universitaire Cochin Centre de Reference National pour les Arthrites Juveniles Site Patients Adultes Service Rhumatologie A Paris France

IMAGINE Institute Hôpital Necker Enfants Malades Centre de Référence National pour les Rhumatismes Inflammatoires et les Maladies Auto Immunes Sytémiques rares de l'enfant Unité d'Immunologie Hématologie et Rhumatologie Pediatrique Paris France

Pediatric Department 5 A Nasonova Research Institute of Rheumatology Moscow Russian Federation

Pfizer Collegeville PA USA

Provincial Children's Hospital J Brudzińskiego Bydgoszcz Poland

Saint Petersburg State Pediatric Medical University Saint Petersburg Russian Federation

Szpital Specjalistyczny im A Falkiewicza Szpital Specjalistyczny Wroclaw Poland

Unit of Pediatric Rheumatology Immunology 2nd Department of Pediatrics Semmelweis University Budapest Hungary

References provided by Crossref.org

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$a BACKGROUND: 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). RESULTS: 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. CONCLUSIONS: Open-label etanercept treatment for up to 6 years was safe, well tolerated, and effective in patients with eoJIA, ERA, and PsA. TRIAL REGISTRATION: ClinicalTrials.gov: CLIPPER, NCT00962741 , registered 20 August, 2009, CLIPPER2, NCT01421069 , registered 22 August, 2011.
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