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

Ivan Foeldvari, Tamàs Constantin, Jelena Vojinović, Gerd Horneff, Vyacheslav Chasnyk, Joke Dehoorne, Violeta Panaviene, Gordana Sušić, Valda Stanevicha, Katarzyna Kobusinska, Zbigniew Zuber, Bogna Dobrzyniecka, Irina Nikishina, Brigitte Bader-Meunier, Luciana Breda, Pavla Doležalová, Chantal Job-Deslandre, Ingrida Rumba-Rozenfelde, Nico Wulffraat, Ronald D. PedersenJack F. Bukowski, Bonnie Vlahos, Alberto Martini, Nicolino Ruperto

Research output: Article

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Abstract

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.

Original languageEnglish
Article number125
JournalArthritis Research and Therapy
Volume21
Issue number1
DOIs
Publication statusPublished - máj. 23 2019

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

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    Foeldvari, I., Constantin, T., Vojinović, J., Horneff, G., Chasnyk, V., Dehoorne, J., Panaviene, V., Sušić, G., Stanevicha, V., Kobusinska, K., Zuber, Z., Dobrzyniecka, B., Nikishina, I., Bader-Meunier, B., Breda, L., Doležalová, P., Job-Deslandre, C., Rumba-Rozenfelde, I., Wulffraat, N., ... Ruperto, N. (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 Research and Therapy, 21(1), [125]. https://doi.org/10.1186/s13075-019-1916-9