COSENTYX

What it is

Cosentyx is a solution for injection or powder for injection containing secukinumab, a recombinant fully human monoclonal antibody selective for interleukin-17A. Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary cells. Secukinumab is a fully human IgG1 antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin-17A (IL-17A).

Approved indications

— Moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy. — Active psoriatic arthritis in adult patients, including axial manifestations, when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. — Active ankylosing spondylitis in adult patients. — Active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation (elevated C-reactive protein and/or MRI change) who have had inadequate response to, or are intolerant to, NSAIDs. — Active enthesitis-related arthritis in patients 4 years and older who have had inadequate response or were intolerant to at least one NSAID and at least one DMARD. — Active juvenile psoriatic arthritis in patients 2 years and older who have had inadequate response or were intolerant to at least one NSAID and at least one DMARD. — Active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with inadequate response to conventional systemic hidradenitis suppurativa therapy.

Dosing overview

For plaque psoriasis in adult patients, the recommended dose is 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3, and 4 followed by the same dose every month. Some patients weighing 90 kg or more may derive additional benefit from receiving 300 mg every 2 weeks. For paediatric patients with plaque psoriasis, the recommended dose is based on body weight and administered by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3, and 4 followed by the same dose every month, with dosing of 75 mg for patients under 25 kg, 75 mg for patients 25 to under 50 kg (which may be increased to 150 mg), and 150 mg for patients 50 kg or more (which may be increased to 300 mg).

Key safety warnings

Cosentyx has the potential to increase the risk of infections, with infections observed in clinical studies, though most were mild or moderate. Non-serious mucocutaneous candida infections were more frequently reported for secukinumab than placebo in psoriasis clinical studies. Caution should be exercised when considering Cosentyx in patients with chronic infection or a history of recurrent infection; patients should be instructed to seek medical advice if signs or symptoms of infection occur; and if a patient develops a serious infection, Cosentyx should not be administered until the infection resolves. Tuberculosis (active and latent reactivation) can occur in patients treated with Cosentyx, and patients should be evaluated for tuberculosis infection prior to initiating treatment; Cosentyx should not be given to patients with active tuberculosis. Initiation of treatment for latent tuberculosis should be considered prior to administering Cosentyx, and anti-tuberculosis therapy should be considered prior to initiation in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Hepatitis B virus reactivation can occur in patients treated with Cosentyx, and testing for HBV infection is to be considered before initiating treatment; Cosentyx should not be given to patients with active hepatitis B. Caution should be exercised when prescribing Cosentyx to patients with inflammatory bowel disease, as exacerbations, in some cases serious, occurred in Cosentyx-treated patients during clinical trials. New onset inflammatory bowel disease cases occurred in clinical trials and have been reported with post-marketing use. Rare cases of anaphylactic reactions and angioedema have been observed in patients receiving Cosentyx in clinical studies, and angioedema cases have also been reported in the post-marketing setting. In post-marketing reports, severe eczematous eruptions, including dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving Cosentyx, with some cases resulting in hospitalisation; the onset was variable, ranging from days to months after the first dose.

Contraindications

Cosentyx is contraindicated in patients with severe hypersensitivity reactions to the active substance or to any of the excipients. Cosentyx is contraindicated in patients with clinically important, active infections.

PBS listing

Cosentyx 150 mg in 1 mL pre-filled pen is listed on the PBS with 19 items under authority required restriction at an ex-manufacturer price of A$625.37. Cosentyx 300 mg in 2 mL pre-filled pen is listed on the PBS with 13 items under authority required restriction at an ex-manufacturer price of A$1250.73.

Regulatory history

Cosentyx secukinumab 150 mg powder for injection vial and 150 mg solution for injection in prefilled syringe and prefilled pen were first listed on the ARTG on 2015-01-12. In November 2014, the PBAC recommended Cosentyx for the treatment of moderate to severe plaque psoriasis in patients who have failed to respond to, or are intolerant of, conventional systemic therapies. In March 2016, the PBAC recommended General Schedule Authority Required listing of secukinumab for the treatment of severe active psoriatic arthritis and ankylosing spondylitis on a cost-minimisation basis. In November 2017, the PBAC recommended an amendment to allow secukinumab to be used as a first-line biological disease-modifying anti-rheumatic drug for psoriatic arthritis. In November 2017, streamlined authority required listings were recommended for severe chronic plaque psoriasis, severe active psoriatic arthritis, and severe active ankylosing spondylitis. In November 2021, the PBAC recommended paediatric psoriasis. In February 2022, Cosentyx 75 mg/0.5 mL solution for injection pre-filled syringe and 300 mg/2 mL solution for injection pre-filled syringe and pen were first listed on the ARTG. In November 2023, the PBAC recommended listing for moderate to severe hidradenitis suppurativa, and an AusPAR approval dated 2022-05-03 was published covering treatment of moderate to severe plaque psoriasis in patients 6 years and older, active psoriatic arthritis in adults, active ankylosing spondylitis in adults, and active non-radiographic axial spondyloarthritis in adults with objective signs of inflammation. Cosentyx is subject to additional monitoring in Australia due to approval of an extension of indications, which allows quick identification of new safety information.