Abrocitinib

What is abrocitinib?

Abrocitinib (Cibinqo®) is a selective oral Janus kinase 1 (JAK 1) inhibitor used for the treatment of moderate-to-severe atopic dermatitis (eczema).

What is abrocitinib used for?

Abrocitinib received FDA approval in 2022 for the treatment of adults and patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Approval for adults has also been given by the European Medicines Agency.

• Abrocitinib can be used as a monotherapy or with topical corticosteroids.
• It is not recommended for use with other JAK inhibitors, systemic immunosuppressants, or biologic immunomodulators.

There are case reports of abrocitinib being trialled for alopecia areata and contact dermatitis.

How does abrocitinib work?

The JAK-STAT (signal transducer and activator of transcription) pathway has been shown to play a contributory role in the pathogenesis of multiple inflammatory and/or immune-mediated conditions including atopic dermatitis.

JAK inhibitors work by blocking downstream inflammatory cytokine signalling pathways in cells (including IL-4, IL-13, IL-31 and interferon γ), many of which are inappropriately upregulated in atopic dermatitis. This results in effective immunosuppressive and antiproliferative outcomes in patients.

What are the precautions and contraindications with abrocitinib?

Precautions

• Use with caution in patients over the age of 65 years and those with a history of cardiovascular disease and thrombosis, including current or previous long-term smokers, or those who are at increased risk of cancer.
• There are a number of possible drug interactions.
• Efficacy in children under 12 years of age has not yet been established.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients in the formulation.
• Active serious systemic infections, including tuberculosis.
• Severe liver disease/hepatic impairment.
• Pregnancy and breastfeeding.

Abrocitinib administration and monitoring

Administration

• Abrocitinib is an oral medication taken once daily.
• The recommended starting dose is often 100–200mg daily (depending on the clinical context).
• In patients who experience nausea, taking tablets with food may improve this.

Monitoring

• Blood tests are recommended prior to starting, including tuberculosis testing, hepatitis screening, full blood count, liver function, renal function, and lipid profile.
  • Dose adjustments are required in patients with moderate to severe renal impairment.
• Repeat blood tests should be considered 4 weeks after starting treatment as clinically indicated, including a full blood count.
• Check and update vaccination status before starting treatment. Avoid live, attenuated vaccines just before or during treatment. See: Immunisation in immunosuppressed dermatology patients.
• Consider discontinuing treatment if no evidence of therapeutic benefit after 24 weeks.

What are the benefits of abrocitinib?

Abrocitinib is an effective systemic therapy, easy to administer as an oral medication that can be taken with or without food, and usually well tolerated. In clinical trials, it reduces the severity of atopic eczema with significant clearing of the skin and rapid improvement of itch (pruritus) when compared to placebo.

What are the side effects and risks of abrocitinib?

Common side effects:

• Nausea/vomiting
• Headache
• Upper respiratory tract infection/nasopharyngitis
• Acne
• Herpes simplex infection/reactivation
• Blood creatine phosphokinase increase
• Dizziness
• Upper abdominal pain.

Less common adverse events:

• Serious viral, bacterial, or fungal infections
• Thrombocytopaenia, lymphopaenia
• Hyperlipidaemia
• Venous thromboembolism.

Janus kinase inhibitors may potentially increase the risk of malignancy (eg, lymphoma).

Approved datasheets are the official source of information for medicines, including approved uses, doses, and safety information. Check the individual datasheet in your country for information about medicines.

We suggest you refer to your national drug approval agency such as the Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration (FDA), UK Medicines and Healthcare products regulatory agency (MHRA) / emc, and NZ Medsafe, or a national or state-approved formulary eg, the New Zealand Formulary (NZF) and New Zealand Formulary for Children (NZFC) and the British National Formulary (BNF) and British National Formulary for Children (BNFC).