SKYRIZI

What it is

SKYRIZI (risankizumab) is an interleukin-23 blocker, a humanised immunoglobin G1 (IgG1) monoclonal antibody. Risankizumab selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor complex. SKYRIZI is available as a solution for injection in a pre-filled syringe or pre-filled pen.

Approved indications

— Moderate to severe plaque psoriasis in adults (18 years or older) who are candidates for phototherapy or systemic therapy. — Active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). — Moderate to severe Crohn's disease in adult patients who have an inadequate response, a lost response, an intolerance or a contra-indication to either conventional or biologic therapy. — Moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologic therapy.

Dosing overview

For psoriasis and psoriatic arthritis, the recommended dose is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Patients may self-inject SKYRIZI after training in subcutaneous injection technique.

Key safety warnings

**Infections.** SKYRIZI may increase the risk of infections, and in patients with a chronic infection or a history of recurrent infection, the risks and benefits should be considered prior to prescribing SKYRIZI. Patients should be instructed to seek medical advice if signs or symptoms of clinically important infection occur. **Tuberculosis.** Prior to initiating treatment with SKYRIZI, patients should be evaluated for TB infection, and SKYRIZI must not be given to patients with active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. **Hypersensitivity.** Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of risankizumab, and if a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated. **Hepatotoxicity in inflammatory bowel disease.** A serious adverse reaction of drug-induced liver injury was reported in a patient with Crohn's disease following two intravenous doses of SKYRIZI, which resolved following administration of steroids and subsequent discontinuation of SKYRIZI. For the treatment of Crohn's disease and ulcerative colitis, liver enzymes and bilirubin should be evaluated at baseline and during induction at least up to 12 weeks of treatment, with monitoring thereafter according to routine patient management.

Contraindications

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, and in patients with clinically important active infections.

PBS listing

SKYRIZI 150 mg in 1 mL pre-filled pen is listed on the PBS with authority required restriction at an ex-manufacturer price of A$4977.33.

Regulatory history

SKYRIZI risankizumab 150 mg/mL solution for injection pre-filled syringe was first registered on the ARTG on 18 August 2021, followed by the pre-filled pen on 19 August 2021. The 600 mg/10 mL intravenous concentrate solution for infusion vial was registered on 5 October 2022, and the 360 mg/2.4 mL pre-filled cartridge with on-body delivery system on 4 October 2022. The 180 mg/1.2 mL pre-filled cartridge with on-body delivery system was registered on 15 November 2024. PBAC recommended SKYRIZI for severe chronic plaque psoriasis in July 2019 on a cost-minimisation basis with the least costly biologic currently listed on the PBS. In November 2021, a previous recommendation was rescinded and a new recommendation issued for severe chronic plaque psoriasis. In March 2022, PBAC recommended SKYRIZI for severe psoriatic arthritis. PBAC deferred consideration for Crohn's disease in July 2022, then recommended SKYRIZI for severe Crohn's disease and complex refractory fistulising Crohn's disease in November 2022. In November 2023, PBAC recommended SKYRIZI for chronic plaque psoriasis as a cost-effective option when cost-minimised to the least costly alternative therapy.