ERELZI

What it is

ERELZI is etanercept , a tumour necrosis factor (TNF) antagonist. It is available as a 50 mg solution for injection in auto-injector and pre-filled syringe presentations, and as a 25 mg solution for injection in pre-filled syringe .

Approved indications

ERELZI is indicated for active, adult rheumatoid arthritis in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs . It is also indicated for severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease . ERELZI treats the signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate . It is indicated for adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy . ERELZI treats the signs and symptoms of active ankylosing spondylitis in adults . It is indicated for treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein and/or MRI change who have had an inadequate response to NSAIDs . ERELZI treats active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more DMARDs . It treats active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate . ERELZI treats active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy . It treats active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate . ERELZI is indicated for chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies .

Dosing overview

For rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis in adults, the recommended dose is 50 mg per week, given as a subcutaneous injection either once weekly as a single 50 mg injection or twice weekly as two separate 25 mg injections given 3–4 days apart . For plaque psoriasis, the recommended dose is 50 mg per week, given once weekly or twice weekly as a subcutaneous injection. Higher responses may be achieved from initial treatment for up to 12 weeks with a dose of 50 mg given twice weekly, after which the dose should be reduced to the standard dose of 50 mg per week . For juvenile idiopathic arthritis in children aged 2–17 years, the recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly as a subcutaneous injection, or 0.4 mg/kg (up to a maximum of 25 mg) given twice weekly with an interval of 3–4 days between doses . For paediatric plaque psoriasis in children aged 4 years and above, the recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly as a subcutaneous injection for up to 24 weeks .

Key safety warnings

Serious infections including sepsis and tuberculosis have been reported with the use of ERELZI, and some of these infections have been fatal . Opportunistic infections have also been reported, including listeriosis, legionellosis and invasive fungal infections . Patients who develop a new infection while undergoing treatment with ERELZI should be monitored closely, and administration should be discontinued if a patient develops a serious infection or sepsis . Tuberculosis, including disseminated or extrapulmonary presentation, has been observed in patients receiving ERELZI, and may be due to reactivation of latent TB infection or to new infection . Prophylaxis of latent TB infection should be initiated prior to therapy with ERELZI . Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus and had received ERELZI has been reported, and in some instances HBV reactivation occurring in conjunction with ERELZI therapy has been fatal . Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with ERELZI . Post-marketing reports of worsening of congestive heart failure, with and without identifiable precipitating factors, and rare reports of new onset congestive heart failure have been received . Post-marketing reports of interstitial lung disease, including pneumonitis and pulmonary fibrosis, some of which had fatal outcomes, have been received .

Contraindications

Known hypersensitivity to etanercept or to any of its excipients is a contraindication . Patients with, or at risk of, sepsis should not receive ERELZI . Treatment should not be initiated in patients with serious, active infection including chronic or localised infections . Concurrent treatment with Interleukin-1 antagonists is contraindicated .

PBS listing

ERELZI 50 mg in 1 mL single-use pre-filled syringes and 50 mg in 1 mL single-use auto-injectors are listed on the PBS with streamlined and authority required restrictions. The ex-manufacturer price is A$743.60 .

Regulatory history

ERELZI was first registered on the ARTG on 30 November 2017, with three presentations registered: 50 mg auto-injector, 25 mg pre-filled syringe, and 50 mg pre-filled syringe . In March 2018, the PBAC recommended ERELZI for listing for rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, juvenile idiopathic arthritis and paediatric plaque psoriasis as a biosimilar with the same indications as the reference biologic .