Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis

Jelena Vojinović, Ivan Foeldvari, Joke Dehoorne, Valda Stanevicha, Paediatric Rheumatology International Trials Organisation (PRINTO)

Research output: Contribution to journalArticlepeer-review


OBJECTIVES: CLIPPER2 was an 8-year, open-label extension of the phase 3 b, 2-year CLIPPER study on the safety and efficacy of etanercept in patients with juvenile idiopathic arthritis (JIA), categorized as extended oligoarticular arthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA).

METHODS: Participants with eoJIA (2-17 years old), ERA, or PsA (each 12-17 years old) who received ≥1 etanercept dose (0.8 mg/kg weekly; maximum 50 mg) in CLIPPER could enter CLIPPER2. Primary end point was occurrence of malignancy. Efficacy assessments included proportions achieving JIA American College of Rheumatology (ACR) 30/50/70/90/100 criteriaand ACR inactive disease criteria, and clinical remission (ACR criteria) or Juvenile Arthritis Disease Activity Score (JADAS) ≤1.

RESULTS: Overall, 109/127 (86%) CLIPPER participants entered CLIPPER2 (n = 55 eoJIA, n = 31 ERA, n = 23 PsA; 99 [78%] on active treatment); 84 (66%) completed 120 months' follow-up (32 [25%] on active treatment). One malignancy (Hodgkin's disease in 18-year-old patient with eoJIA treated with methotrexate for 8 years) was reported; there were no cases of active tuberculosis or deaths. Numbers and incidence rates [events per 100 patient-years] of TEAEs (excluding infections/ISRs) decreased from 193 [173.81] in Year 1-9 [27.15] in Year 10; TE infections and serious infections also decreased. Over 45% of participants (N = 127) achieved JIA ACR50 responses from Month 2 onwards; 42 (33%) and 17 34 (27%) participants achieved JADAS and ACR clinical remission, respectively.

CONCLUSIONS: Etanercept treatment up to 10 years was well tolerated, consistent with the known safety profile, with durable response in the participants still on active treatment. The benefit-risk assessment of etanercept in these JIA categories remains favorable.


Original languageEnglish
Publication statusE-pub ahead of print - 4 May 2023


  • TNF inhibitor
  • enthesitis-related arthritis
  • etanercept
  • extended oligoarticular arthritis
  • juvenile idiopathic arthritis
  • psoriatic arthritis

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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