The drug’s approval was based on the results of 3 clinical trials.
On January 14, 2022, the FDA approved abrocitinib (Cibinqo) for the treatment of adults with refractory, moderate to severe atopic dermatitis (AD) inadequately controlled with other systemic drugs, including biologics, or for patients in whom the use of such therapies is inadvisable.1 Abrocitinib is a Janus kinase inhibitor and is not recommended for use in combination with other Janus kinase inhibitors, biological immunomodulators or other immunosuppressants. Abrocitinib is approved in doses of 50 mg, 100 mg and 200 mg.
Abrocitinib was approved based on the results of 3 randomized, double-blind, placebo-controlled studies: Trial-AD-1 (NCT03349060; n = 387; abrocitinib alone), Trial-AD-2 (NCT03575871; n = 391, monotherapy) and Trial-AD-3 (NCT03720470; n = 837; combination therapy). In the 2 monotherapy studies, participants 12 years of age and older were randomly assigned to placebo, 100 mg, or 200 mg groups. In the combination therapy study, adult participants were randomly assigned to receive oral or injectable placebo, abrocitinib 100 mg or 200 mg, or dupilumab (Dupixent) 300 mg. The efficacy of abrocitinib was compared with dupilumab in terms of itch relief at 2 weeks. All participants in this study also received basic topical corticosteroids.2
Across all 3 studies, the 12-week co-primary outcome measures were the proportion of participants who achieved a clear (0) or nearly clear (1) investigator global assessment response (IGA) and a reduction greater than or equal to 2 points from baseline and the percentage of participants who achieve an Eczema Area response and Severity Index of improvement greater than or equal to 75%. At the end of the 12-week period, both abrocitinib doses reached the IGA end point (IGA, 0 or 1) relative to placebo.1
The most common adverse events reported in greater than or equal to 5% of patients in the abrocitinib 100 mg, abrocitinib 200 mg and placebo groups, respectively, included nasopharyngitis (12.4%, 8.7%, 7.9%), nausea ( 6%, 14.5%, 2.1%) and headache (6%, 7.8%, 3.5%).2
The abrocitinib prescribing information contains boxed warnings for an increased risk of serious bacterial, fungal, viral, or opportunistic infections, including tuberculosis, leading to hospitalization or death. In addition, major adverse cardiac events, malignancies and thrombosis have occurred in clinical trials for AD with abrocitinib therapy.2
The recommended dose of abrocitinib is 100 mg once daily, administered orally. In patients unresponsive to the 100 mg dose, the dose can be increased to 200 mg once daily. A 50 mg dose is approved for patients with moderate renal impairment (estimated glomerular filtration rate, 30-59 mL / min), for patients who are known or suspected poor metabolisers of cytochrome P450 (CYP) 2C19, or for patients receiving CYP2C19 inhibitors.2
Hooman Kashi is a PharmD candidate in the class of 2022 University of Connecticut School of Pharmacy, as well as UConn Pharmacy Ambassador and UConn Leader Scholarship. Kevin Ho is a PharmD candidate in the University of Connecticut School of Pharmacy Class of 2022, as well as a UConn Leading Track Scholar.
- The US FDA approves Pfizer’s Cibinqo (abrocitinib) for adults with moderate to severe atopic dermatitis. Press release. Pfizer Inc. January 14, 2022. Accessed April 13, 2022. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-cibinqor-abrocitinib-adults
- Cibinqo. Prescribing Information. Pfizer Inc; 2022. Accessed April 13, 2022. https://cdn.pfizer.com/pfizercom/USPI_Med_Guide_CIBINQO_Abrocitinib_tablet.pdf