CIBINQO

What it is

CIBINQO contains abrocitinib and is supplied as film-coated tablets in strengths of 50 mg, 100 mg, or 200 mg. Abrocitinib is a Janus kinase (JAK) 1 inhibitor. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

Dosing overview

CIBINQO treatment should be initiated and supervised by a dermatologist or physician specialising in treatment of atopic dermatitis. The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics, with a starting dose of 100 mg once daily recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy. A dose of 200 mg once daily may be appropriate for patients with high disease burden who are not at higher risk of VTE, MACE and malignancy or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks. For patients taking strong inhibitors of cytochrome P450 (CYP) 2C19 (e.g., fluvoxamine, fluconazole), 50 mg once daily is the recommended dose. For patients with moderate (eGFR 30 to < 60 mL/min) or severe (eGFR < 30 mL/min) renal impairment, 50 mg once daily is the recommended dose. The recommended starting dose for patients aged 65 years or older is 100 mg once daily.

Key safety warnings

In a large randomised post-marketing safety study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients aged 50 years and older with at least one additional cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with tofacitinib compared to TNF inhibitors, with mortality mainly due to cardiovascular events, infections and malignancies. In patients 65 years of age and older, patients who are current or past long-time smokers, and patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, CIBINQO should only be used if no suitable treatment alternatives are available. Serious and sometimes fatal events of thrombosis, including deep venous thrombosis (DVT), arterial thrombosis and pulmonary embolism (PE) have occurred in patients treated with JAK inhibitors including CIBINQO. A higher rate of VTE was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including CIBINQO. In clinical studies with CIBINQO, a higher rate of malignancy (excluding non-melanoma skin cancer, NMSC) was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. Serious infections have been reported in patients receiving CIBINQO, with the most frequent serious infections in clinical studies being herpes simplex, herpes zoster, and pneumonia. Patients should be screened for TB before starting CIBINQO therapy. Viral reactivation, including herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical studies, with the rate of herpes zoster infections higher in patients treated with 200 mg, aged 65 years and older, with a medical history of herpes zoster, with a confirmed ALC < 1 × 10³/mm³ prior to the event and patients with severe atopic dermatitis at baseline. Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO compared to placebo.

Contraindications

CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (< 81 mg daily), during the first 3 months of treatment. CIBINQO must not be used in combination with biological disease-modifying anti-rheumatic drugs (bDMARDs). CIBINQO is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. CIBINQO is contraindicated in patients with active serious systemic infections, including tuberculosis (TB). CIBINQO must not be used in patients with severe (Child-Pugh C) hepatic impairment. CIBINQO is contraindicated during pregnancy. CIBINQO is contraindicated during breastfeeding.

PBS listing

In November 2024, CIBINQO was recommended for General Schedule (Authority Required) listing for adult patients with chronic severe atopic dermatitis. The 200 mg dose was recommended on a cost-minimisation basis to dupilumab, the 100 mg dose on a cost-utility analysis compared to dupilumab, and the 50 mg dose at the same price per mg as 100 mg for patients with moderate to severe renal impairment or taking strong CYP2C19 inhibitors.

Regulatory history

CIBINQO 50 mg, 100 mg, and 200 mg tablets were first listed on the ARTG on 16 April 2024. PBAC first considered CIBINQO in November 2021 for atopic dermatitis, with a recommendation to be considered at a future PBAC meeting. In November 2024, PBAC recommended CIBINQO for General Schedule (Authority Required) listing for adult patients with chronic severe atopic dermatitis.