Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2014 Jun;73(6):1114-22.
doi: 10.1136/annrheumdis-2012-203046. Epub 2013 May 21.

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

Collaborators, Affiliations
Free PMC article
Clinical Trial

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

Gerd Horneff et al. Ann Rheum Dis. .
Free PMC article

Abstract

Objective: To 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).

Methods: CLIPPER 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.

Results: 122/127 (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.

Conclusions: ETN treatment for 12 weeks was effective and well tolerated in paediatric subjects with eoJIA, ERA and PsA, with no unexpected safety findings.

Keywords: Ankylosing Spondylitis; Arthritis; DMARDs (biologic); Juvenile Idiopathic Arthritis; Spondyloarthritis.

Figures

Figure 1
Figure 1
Subject disposition. Adverse events include infections. All subjects who discontinued ETN continued to be monitored for safety. *One PsA subject withdrew early but had assessment data for Week 12; therefore, analyses were performed on n = 29 subjects.
Figure 2
Figure 2
Juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) response 30, 50, 70, 90 and inactive disease status. (A) JIA ACR 30 response rates by JIA category over 12 weeks. Data are compared with historical placebo data and historical active control. *JIA ACR 30 historical placebo rate = 28.9% (95% CI 24.0 to 34.2; n = 323). JIA ACR 30 historical placebo rate = 42.8% (95% CI 16.9 to 68.8; n=14). JIA ACR 30 historical active-control response rate at Week 12 = 73.9% (95% CI 63.6 to 84.3; n=69).17 (B) OR (95% CI) of JIA ACR 30 response rates at week 12 vs historical placebo data. Observed cases, mITT population. Log scale used for horizontal axis. *JIA ACR 30 historical placebo rate = 28.9% (95% CI 24.0, 34.2; n = 323). Six historical studies treated individually in the logistic regression model (adjusted). **JIA ACR 30 historical placebo rate = 42.8% (95% CI 16.9, 68.8; n = 14). (C) OR (95% CI) of JIA ACR 30 response rates at week 12 vs historical active control. Observed cases, mITT population. Log scale used for horizontal axis. Historical active control data taken from; JIA ACR 30 response rate at Week 12 = 73.9% (95% CI 63.6 to 84.3; n = 69).
Figure 3
Figure 3
Juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 50, 70, 90 responses and inactive disease at week 12. (A) JIA ACR 50, 70, 90 responses and inactive disease status (secondary outcomes) according to JIA category at week 12. (B) JIA ACR 30, 50, 70, 90 responses and inactive disease according to age groups in eoJIA at week 12. Observed cases, mITT population. Error bars represent 95% CI.

Similar articles

See all similar articles

Cited by 33 articles

See all "Cited by" articles

References

    1. Oen KG, Cheang M. Epidemiology of chronic arthritis in childhood. Semin Arthritis Rheum 1996;26:575–91 - PubMed
    1. Gare BA. Epidemiology. Baillière's Clin Rheumatol 1998;12:191–208 - PubMed
    1. Sacks JJ, Helmick CG, Luo YH, et al. Prevalence of and annual ambulatory health care visits for pediatric arthritis and other rheumatologic conditions in the United States in 2001–2004. Arthritis Rheum 2007;57:1439–45 - PubMed
    1. Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet 2007;369:767–78 - PubMed
    1. Petty RE, Southwood TR, Manners P, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol 2004;31:390–2 - PubMed

Publication types

Feedback