STELARA

What it is

STELARA contains the active ingredient ustekinumab. STELARA is a human IgG1kappa monoclonal antibody that specifically binds to the shared p40 protein subunit of the human cytokines interleukin (IL)-12 and IL-23. STELARA inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12Rbeta1 receptor protein expressed on the surface of immune cells. STELARA is available as a solution for subcutaneous injection in presentations of 45 mg/0.5 mL and 90 mg/1.0 mL in pre-filled syringes, pre-filled pens and single-use vials, and as a solution for intravenous infusion of 130 mg/26 mL in single-use vials.

Approved indications

— Treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. — Treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. — Treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological DMARD therapy has been inadequate, alone or in combination with methotrexate. — Treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. — Treatment of adult patients with moderately to severely active ulcerative colitis.

Dosing overview

For plaque psoriasis in adults, STELARA is administered by subcutaneous injection at a recommended dose of 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90 mg administered over Weeks 0 and 4, then every 12 weeks thereafter may be used in patients with a body weight greater than 100 kg. For paediatric patients aged 6 years and older with plaque psoriasis, STELARA should be administered by subcutaneous injection based on body weight at Weeks 0 and 4, then every 12 weeks thereafter. For children weighing less than 60 kg, the recommended dose is 0.75 mg/kg; for those weighing 60 to 100 kg, the dose is 45 mg; and for those weighing more than 100 kg, the dose is 90 mg. For psoriatic arthritis, STELARA is administered by subcutaneous injection at a recommended dose of 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. For Crohn's disease and ulcerative colitis, the recommended treatment regimen is to initiate STELARA with a single intravenous tiered dose based on body weight (260 mg for patients ≤55 kg, 390 mg for those >55 to ≤85 kg, and 520 mg for those >85 kg), followed by a first subcutaneous dose of 90 mg STELARA 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

Key safety warnings

STELARA is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections, with serious bacterial, fungal, and viral infections observed in clinical studies. Prior to initiating treatment, patients should be evaluated for tuberculosis infection, and STELARA should not be given to patients with active tuberculosis; treatment of latent tuberculosis infection should be initiated prior to administering STELARA. Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA, with clinical presentations including cough, dyspnoea, and interstitial infiltrates, and serious outcomes including respiratory failure and prolonged hospitalization. If diagnosis is confirmed, discontinue STELARA and institute appropriate treatment. STELARA is a selective immunosuppressant, and immunosuppressive agents have the potential to increase the risk of malignancy, with some patients in clinical studies developing cutaneous and non-cutaneous malignancies. All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer. Serious hypersensitivity reactions, including anaphylaxis and angioedema, and serious infusion-related reactions including anaphylactic reactions have been reported, and appropriate therapy should be instituted with immediate discontinuation of STELARA if such a reaction occurs. Live viral or live bacterial vaccines should not be given concurrently with STELARA; before live vaccination, treatment with STELARA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination.

Contraindications

STELARA is contraindicated in patients with severe hypersensitivity to ustekinumab or to any of the excipients. STELARA should not be given to patients with a clinically important, active infection.

PBS listing

STELARA injection 45 mg in 0.5 mL is listed on the PBS with 8 items under authority required restriction at an ex-manufacturer price of A$716.69. STELARA injection 90 mg in 1 mL single use pre-filled syringe is listed with 4 PBS items under authority required restriction at an ex-manufacturer price of A$892.04. STELARA solution for intravenous infusion 130 mg in 26 mL is listed with 6 PBS items under authority required restriction at an ex-manufacturer price of A$560.73.

Regulatory history

STELARA ustekinumab 45 mg/0.5 mL solution for injection vial was first registered on the ARTG on 28 July 2009. Pre-filled syringe presentations (45 mg/0.5 mL and 90 mg/1 mL) were registered on 19 August 2010. The intravenous infusion vial (130 mg/26 mL) was registered on 1 March 2017. Pre-filled pen presentations were registered on 9 November 2023. In November 2014, the PBAC recommended an amendment to allow treatment of patients with moderate to severe plaque psoriasis who have failed to respond to, or are intolerant of, conventional systemic therapies. The PBAC also recommended STELARA for the treatment of active psoriatic arthritis in patients who have failed to respond to, or are intolerant of, conventional systemic therapies. An AusPAR for psoriatic arthritis was approved on 9 February 2015. In November 2017, the PBAC recommended listings for severe active Crohn's disease and ulcerative colitis under authority required streamlined restrictions. This medicinal product is subject to additional monitoring in Australia due to approval of an extension of indications.