Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis: part 1 (week 12) of the CLIPPER study

Abstract

ObjectiveTo investigate the efficacy and safety of etanercept (ETN) in paediatric subjects with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA).MethodsCLIPPER is an ongoing, Phase 3b, open-label, multicentre study; the 12-week (Part 1) data are reported here. Subjects with eoJIA (2–17 years), ERA (12–17 years), or PsA (12–17 years) received ETN 0.8 mg/kg once weekly (maximum 50 mg). Primary endpoint was the percentage of subjects achieving JIA American College of Rheumatology (ACR) 30 criteria at week 12; secondary outcomes included JIA ACR 50/70/90 and inactive disease.Results122/127 (96.1%) subjects completed the study (mean age 11.7 years). JIA ACR 30 (95% CI) was achieved by 88.6% (81.6% to 93.6%) of subjects overall; 89.7% (78.8% to 96.1%) with eoJIA, 83.3% (67.2% to 93.6%) with ERA and 93.1% (77.2% to 99.2%) with PsA. For eoJIA, ERA, or PsA categories, the ORs of ETN vs the historical placebo data were 26.2, 15.1 and 40.7, respectively. Overall JIA ACR 50, 70, 90 and inactive disease were achieved by 81.1, 61.5, 29.8 and 12.1%, respectively. Treatment-emergent adverse events (AEs), infections, and serious AEs, were reported in 45 (35.4%), 58 (45.7%), and 4 (3.1%), subjects, respectively. Serious AEs were one case each of abdominal pain, bronchopneumonia, gastroenteritis and pyelocystitis. One subject reported herpes zoster and another varicella. No differences in safety were observed across the JIA categories.ConclusionsETN treatment for 12 weeks was effective and well tolerated in paediatric subjects with eoJIA, ERA and PsA, with no unexpected safety findings.

The clinical effectiveness and cost-effectiveness of abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis: a systematic review and economic evaluation

“…42 Of the remaining four studies, three were not relevant, as they were single-arm studies, and a fourth was a RCT reported in a conference abstract 98 with only limited detail available. However, one of the single-arm studies -the CLIPPER study 99 -is noteworthy as it focuses specifically on the JIA subtypes that were absent from the pivotal Lovell and colleagues trial, 42 namely EO JIA, ERA and PA. Details are presented in Additional supporting evidence.…”

“…99 This is a single-arm, Phase-IIIb open-label, multicentre interventional study funded by Wyeth (subsequently acquired by Pfizer Inc.). The study was designed to assess the safety and efficacy of etanercept in children and adolescents with three JIA subtypes classified using the ILAR criteria: EO, ERA and PA.…”

“…104 This study formed part of the evidence base supporting the licence extension for etanercept across the JIA subtypes in 2012. The assessment group has extracted 12-week data from the published paper 99 on ACR Pedi response rates and inactive disease, change in CHAQ score, PGA of pain, number of active joints, number of joints with LOM and JIA category-specific assessments (data at week 12 compared with historical placebo data, historical active control data and data from a meta-analysis have not been data extracted). Data from the conference poster 104 on ACR Pedi response rates and inactive disease have also been extracted and this summary is supplemented with some data presented in the Pfizer CS.…”

Etanercept Treatment Results in Children With Non-Systemic Juvenile Idiopathic Arthritis: Remission, Recrudescence, and Adverse Events. Retrospective Cohort Study

“…Так, в 2007 г. было опубликовано 23 статьи, а спустя 10 лет, в 2017 г., -22 статьи в рецен-зируемых иностранных журналах в сети PubMed (ключе-вые слова: etanercept, JIA) [19]. Помимо крупных много-летних многоцентровых исследований, направленных на изучение отдаленной эффективности и безопасности [20,21], ежегодно детские ревматологи разных стран публикуют данные как локальных регистров, так и реги-стров, охватывающих пациентов целого государства [6,22]. Интерес ревматологов к результатам, полученным из реальной клинической практики, связан с тем, что в большие многоцентровые клинические исследования включаются далеко не все пациенты.…”

A Randomized, Double‐Blind, Placebo‐Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis‐Related Arthritis

“…In addition to nonsteroidal antiinflammatory drugs (NSAIDs), children with ERA are often treated with sulfasalazine (SSZ) 9, methotrexate (MTX), and glucocorticoids. Several studies suggest that biologic agents, specifically tumor necrosis factor (TNF) inhibitors, improve ERA symptoms 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22.…”