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

Alberto Martini, Bogna Dobrzyniecka, Bonnie Vlahos, Brigitte Bader-Meunier, Chantal Job-Deslandre, Gerd Horneff, Gordana Susic, Ingrīda Rumba-Rozenfelde, Irina Nikishina, Ivan Foeldvari, Jack F. Bukowski, Jelena Vojinovic, Joke Dehoorne, Katarzyna Kobusinska, Luciana Breda, Nico Wulffraat, Nicolino Ruperto, Pavla Dolezalova, Ronald D. Pedersen, Tamas ConstantinValda Staņēviča, Violeta Panaviene, Vyacheslav Chasnyk, Zbigniew Zuber

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
Article number125
JournalArthritis research & therapy
Volume21
Issue number1
DOIs
Publication statusPublished - 2019

Field of Science

  • 3.2 Clinical medicine

Publication Type

  • 1.1. Scientific article indexed in Web of Science and/or Scopus database

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