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

• Published in: Arthritis research & therapy 2019-05, Vol.21 (1), p.125-125, Article 125
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Adolescent; Antirheumatic Agents - therapeutic use; Arthralgia; Arthritis; Arthritis, Juvenile - drug therapy; Back pain; Child; Child health; Child, Preschool; Clinical trials; Dosage and administration; Drug dosages; Drug therapy; Enthesitis-related arthritis; Enthesitis-related arthritis (ERA); Etanercept; Etanercept - therapeutic use; Extended oligoarticular juvenile idiopathic arthritis (eoJIA); Female; Fever; Headache; Humans; Juvenile arthritis; Juvenile idiopathic arthritis; Labels; Lymphomas; Male; Medical research; Patient outcomes; Patients; Pediatrics; Psoriasis; Psoriatic arthritis; Psoriatic arthritis (PsA); Rheumatology; TNF inhibitors; Treatment Outcome; Tuberculosis; Tumor necrosis factor-TNF; Tumors
• ISSN: 1478-6362; 1478-6354; 1478-6362
• DOI: 10.1186/s13075-019-1916-9

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 PsA. ClinicalTrials.gov: CLIPPER, NCT00962741 , registered 20 August, 2009, CLIPPER2, NCT01421069 , registered 22 August, 2011.