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Abrocitinib, an oral Janus kinase (JAK) 1 inhibitor, provides an efficacious alternative for adults nonresponsive to other systemic therapies.

Atopic Dermatitis (AD) affects 1% to 3% of adults and 15% to 20% of children globally. The use of emollients and avoidance of triggers is advised for all patients.  Topical treatments, such as topical corticosteroids or calcineurin inhibitors, are used as initial treatment. Systemic medicines, including phototherapy, immunosuppressant therapies, biologic therapies, and now Janus kinase (JAK) inhibitors, are frequently employed if the response to topical treatments is inadequate.

This review, published in Annals of Pharmacotherapy, is based on clinical trials suggesting that abrocitinib, an oral JAK1 inhibitor, provides an efficacious alternative for adults nonresponsive to other systemic therapies.

 Abrocitinib Is FDA-Approved For Moderate-To-Severe AD

Abrocitinib is FDA-approved and recommended for individuals with moderate-to-severe AD who do not respond adequately to other systemic drugs or when other treatment alternatives are contraindicated. Abrocitinib is available in 50-, 100-, and 200-mg tablets. The FDA-approved starting dose is 100 mg orally once daily. If there is no improvement after 12 weeks, 200 mg once daily is suggested. Abrocitinib should be discontinued if there is no result after raising the daily dose to 200 mg. 

Abrocitinib Is Contraindicated In Multiple Conditions

Abrocitinib is not indicated for patients with severe or end-stage renal disease. The effects of abrocitinib on patients with severe hepatic impairment or hepatitis B and C are unknown, and its use in these patients is not indicated. Patients with active tuberculosis (TB) must get TB testing due to contraindications. Nursing mothers should avoid abrocitinib. Patients with platelet counts below 150,000/mm3, absolute lymphocyte counts below 500/mm3, absolute neutrophil counts below 1000/mm3, or hemoglobin levels below 8 g/dL should not administer abrocitinib.

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Abrocitinib 100 and 200 mg exhibited greater improvements compared to placebo. The short-term administration of 100 and 200 mg abrocitinib alleviated patients’ signs and symptoms of moderate-to-severe atopic dermatitis. In adolescents and adults with moderate-to-severe atopic dermatitis, abrocitinib monotherapy effectively lowers disease severity and symptoms of itching.

Adverse Effects of Abrocitinib

Most adverse effects (AEs) (94%) associated with abrocitinib are mild-to-moderate and self-limiting, with the most prevalent short-term AEs being nausea, acne, nasopharyngitis, headache, upper respiratory tract infection, vomiting, dizziness, urinary tract infection, and folliculitis. Long-term AEs include herpes simplex, herpes zoster, serious infection, and eczema herpeticum.

Patients randomized to maintenance therapy with 100 or 200 mg abrocitinib experienced relapse rates of 39.6% and 16.0%, respectively. Abrocitinib 100 mg may be effective in preventing recurrence in some patients, and more than half of patients (58.8%) who relapsed while on 100 mg abrocitinib became clear or nearly clear with abrocitinib 200 mg rescue therapy over 12 weeks.

Abrocitinib Should Be Prescribed With Caution

In patients electing to initiate abrocitinib, it is recommended to consider the black box warnings.  Patrick O. Perche, the article’s primary author, notes, “Abrocitinib carries a black box warning for increased risk of serious bacterial, fungal, viral, and opportunistic infections, mortality, malignancy, major adverse cardiac events (MACE), and thrombosis.” Before initiating abrocitinib, screening for tuberculosis, lymphopenia, thrombocytopenia, and viral hepatitis is necessary.


Perche, P. O., Cook, M. K., & Feldman, S. R. (2023). Abrocitinib: A New FDA-Approved Drug for Moderate-to-Severe Atopic Dermatitis. Annals of Pharmacotherapy, 57(1), 86-98. https://doi.org/10.1177/10600280221096713