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Information on how to access Enbrel® (etanercept) prescribing information and adverse event reporting can be found at the bottom of the page.

Juvenile Idiopathic Arthritis

Indication

Enbrel is indicated for the treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, MTX.1

Treatment of PsA in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, MTX.1

Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.1

Enbrel has not been studied in children aged less than 2 years.1

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients1
  • Sepsis or risk of sepsis1
  • Treatment with Enbrel should not be initiated in patients with active infections, including chronic or localised infections1

JIA dosing

The recommended dose of Enbrel is 0.4 mg/kg (up to a maximum of 25 mg per dose) given twice weekly as a subcutaneous injection with an interval of 3–4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.1

Discontinuation of treatment should be considered in patients who show no response after 4 months.1

No formal clinical trials have been conducted in children aged 2–3 years. There is generally no applicable use of Enbrel in children aged below 2 years in the indication JIA.1

Clinical efficacy

The safety and efficacy of Enbrel were assessed in a two-part study in 69 children aged 4–17 years with polyarticular-course JIA who had a variety of JIA onset types (polyarthritis, pauciarthritis, systemic onset). Patients remained on a stable dose of a single nonsteroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum). In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) Enbrel subcutaneously twice weekly. In part 2, patients with a clinical response at day 90 were randomised to remain on Enbrel or receive placebo for four months and assessed for disease flare. Responses were measured using the ACR Pedi 30, defined as ≥ 30% improvement in at least three of six and ≥ 30% worsening in no more than one of six JRA core set criteria.2

In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2. In part 2, 6 of 25 (24%) patients remaining on Enbrel experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007). From the start of part 2, the median time to flare was ≥ 116 days for patients who received Enbrel and 28 days for patients who received.2

Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on Enbrel continued to improve from month 3 through month 7, while those who received placebo did not improve.2

See the RA tab for more information about Enbrel efficacy in adult RA patients.

Summary of the safety profile in patients with JIA

​​​​​​​In general, the adverse events in paediatric patients with JIA were similar in frequency and type to those seen in adult patients (see the RA page for undesirable effects in adults). Differences from adults and other special considerations are covered below.1

The types of infections seen in clinical trials in JIA patients aged 2–18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations. Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae, appendicitis, gastroenteritis, depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.1

Several adverse events were reported more commonly in JIA patients receiving 3 months of Enbrel treatment compared to adult RA patients. These included headache, nausea, abdominal pain, and vomiting.1

There were 4 reports of macrophage activation syndrome in JIA clinical trials.1

There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with Enbrel from post-marketing sources, including a very small number of cases indicating a positive rechallenge.1

Before prescribing Enbrel refer to the full Summary of Product Characteristics.

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ACR PedI=American College of Rheumatology Paediatric; JIA=juvenile idiopathic arthritis; JRA=juvenile rheumatoid arthritis; MTX=methotrexate; PsA=psoriatic arthritis; RA=rheumatoid arthritis.

References
  1. Enbrel (etanercept) SmPC. Enbrel 10 mg powder and solvent for solution for injection for paediatric use.
  2. Lovell DJ, et al. NEJM. 2000; 342:763–769.
PP-ENB-GBR-0979. March 2021

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PP-PFE-GBR-2688. December 2020

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