From the Guidelines
Abrocitinib is recommended for adults with moderate to severe atopic dermatitis who have failed other systemic therapies or when use of those therapies is inadvisable, at a dose of 100mg or 200mg PO daily. This recommendation is based on the guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies, which suggest a strong recommendation for the use of abrocitinib 1. The medication works by selectively inhibiting Janus kinase 1 (JAK1), which blocks multiple inflammatory cytokine pathways involved in atopic dermatitis, reducing inflammation and itch.
Key Considerations
- Abrocitinib is approved by the FDA for use in adults with moderate to severe atopic dermatitis who have failed other systemic therapies or when use of those therapies is inadvisable 1.
- The recommended dosage is typically 100mg once daily, though some patients may require 200mg daily 2.
- Treatment should be initiated under the supervision of a healthcare provider experienced in treating atopic dermatitis.
- Before starting abrocitinib, patients should undergo screening for tuberculosis and other infections, as JAK inhibitors can increase infection risk.
- Common side effects include nausea, headache, acne, and upper respiratory infections.
- Blood monitoring is necessary during treatment to check for decreases in platelets, lymphocytes, and hemoglobin 3.
Monitoring and Contraindications
- Consider treatment interruption and dose adjustment if a patient’s haemoglobin decreases below 8 g dL (5 mmol L–1), and their absolute lymphocyte count is < 0.5 × 10^9 cells L–1 or their absolute neutrophil count is < 1 × 10^9 cells L–1 3.
- Abrocitinib is not recommended in patients with a platelet count < 150 × 10^9 cells L–1 and should be stopped if a person’s platelet count falls below 50 × 10^9 cells L–1 3.
- This medication should not be used with other JAK inhibitors, biologic therapies, or strong immunosuppressants, and is contraindicated during pregnancy or in patients with severe hepatic impairment.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Abrocitinib Overview
- Abrocitinib is a Janus kinase (JAK) 1-selective inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD) 4, 5, 6, 7, 8
- It is an oral medication, with a recommended starting and maintenance dose of 100 mg once daily 4
Efficacy and Safety
- Abrocitinib has been shown to be effective in treating moderate-to-severe AD, with significant improvements in disease severity and itch response 5, 6, 7
- The medication has a good safety profile, with most adverse events being mild and self-limited 5, 6, 7
- Clinical trials have demonstrated the efficacy and safety of abrocitinib in adults and adolescents aged 12 years and older 5, 6, 7
Regulatory Approvals
- Abrocitinib was approved in the UK and Japan in 2021 for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older 8
- It has also received a positive CHMP opinion in the EU for the treatment of moderate-to-severe atopic dermatitis in adults 8
- Regulatory applications for the drug have been submitted for review to several other countries, including the USA and Australia 8
Clinical Use
- The decision to use abrocitinib for the treatment of AD should take into account individual patient factors, such as age, comorbidities, previous therapy, quality of life, and treatment tolerability 4
- Abrocitinib is an important additional tool for the treatment of moderate-to-severe forms of AD, with the advantage of being an orally administered medication 6