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AboutTherapeutic IndicationsRheumatoid arthritisJuvenile idiopathic arthritisPsoriatic arthritisAxial spondyloarthritisPlaque psoriasis & Paediatric plaque psoriasisMechanism of actionMechanism of actionDosingDosingRheumatoid arthritis, psoriatic arthritis & axial spondyloarthritisJuvenile idiopathic arthritisPlaque psoriasisPaediatric plaque psoriasisAdministration & storageAdministrationMYCLIC®StorageEfficacy & SafetyEfficacy & SafetyRheumatoid arthritisAxial spondyloarthritisPsoriatic arthritisPlaque psoriasisJuvenile idiopathic arthritisSupport & ResourcesMaterials
Enbrel for Juvenile Idiopathic ArthritisJIA Indication for Enbrel

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, methotrexate.1

Enbrel is also indicated for the treatment of PsA in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.1

Enbrel is also indicated for the 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 dosingThe 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.
​​​​​​​
The 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25kg.​​​​​​​1
No formal clinical trials have been conducted in children aged 2 to 3 years. However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously.

There is generally no applicable use of Enbrel in children aged below 2 years in the indication JIA.1

Patients treated with Enbrel should be given the Patient Card.
Clinical efficacy in JIAThe safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular-course JIA who had a variety of JIA onset types (polyarthritis, pauciarthritis, systemic onset). Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled. 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. Disease flare was defined as a ≥ 30% worsening in three of six JRA core set criteria and ≥ 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.1

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 placebo.1

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.1

Please refer to the Enbrel Summary of Product Characteristics for additional efficacy data.​​​​​​​
​​​​​​​
Summary of the safety profile in patients with JIAIn 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

Before prescribing Enbrel refer to the full Summary of Product Characteristics which is linked below.
ACR PedI:American College of Rheumatology Paediatric; JIA:juvenile idiopathic arthritis; JRA:juvenile rheumatoid arthritis; PsA:psoriatic arthritis; RA:rheumatoid arthritis.

Please refer to the ENBREL Summary of Product Characteristics for full prescribing information

Reference:Enbrel Summary of Product Characteristics.

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