The Food and Drug Administration (FDA) has approved Cibinqo (abrocitinib), an oral Janus kinase 1 (JAK1) inhibitor, for the treatment of refractory, moderate to severe atopic dermatitis in adults whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
The approval was based on data from the phase 3 JADE clinical trial program consisting of JADE MONO-1 (ClinicalTrials.gov Identifier: NCT03349060) and JADE MONO-2 (ClinicalTrials.gov Identifier: NCT03575871), which compared abrocitinib 100mg and 200mg once daily to placebo in patients aged 12 years and older with moderate to severe atopic dermatitis. The program also included the JADE COMPARE (ClinicalTrials.gov Identifier: NCT03720470) trial, which compared abrocitinib 100mg and 200mg once daily to subcutaneous dupilumab 300mg every 2 weeks or placebo in combination with background topical corticosteroids in patients aged 18 years and older.
The coprimary endpoints across all 3 trials included the Investigator’s Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of at least 2 points; and 75% improvement from baseline on the Eczema Area and Severity Index (EASI) at week 12.
Results showed a significantly greater proportion of patients treated with abrocitinib met the coprimary endpoints at week 12 compared with placebo.
IGA response rate in the abrocitinib 100mg, 200mg and placebo arms, respectively:
- JADE MONO-1: 24%, 44%, 8%;
- JADE MONO-2: 28%, 38%, 9%;
- JADE COMPARE: 36%, 47%, 14%.
EASI-75 response rate in the abrocitinib 100mg, 200mg, and placebo arms, respectively:
- JADE MONO-1: 40%, 62%,12%;
- JADE MONO-2: 44%, 61%, 10%;
- JADE COMPARE: 58%, 68%, 27%.
Additionally, abrocitinib was associated with a statistically significant reduction in pruritus as early as week 2 with at least a 4-point improvement as measured by the pruritus numerical rating scale (secondary endpoint).
Dupilumab also demonstrated superiority to placebo at week 12. Findings from JADE COMPARE showed that treatment with abrocitinib 200mg led to a statistically superior reduction in itch by week 2 compared with dupilumab.
The most common adverse reactions with abrocitinib included nasopharyngitis, nausea, headache, herpes simplex, increased blood creatinine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis. Impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia have also been reported.
Cibinqo carries a Boxed Warning regarding the potential for serious infection, malignancy, major adverse cardiovascular events, thrombosis, and death associated with JAK inhibitors. The treatment is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Cibinqo is supplied as 50mg, 100mg, and 200mg tablets in 30-count bottles. The product is expected to be available in the coming weeks.
- US FDA approves Pfizer’s Cibinqo® (abrocitinib) for adults with moderate-to-severe atopic dermatitis. News release. Pfizer, Inc. Accessed January 18, 2022. https://www.businesswire.com/news/home/20220114005394/en/U.S.-FDA-Approves-Pfizer%E2%80%99s-CIBINQO%C2%AE-abrocitinib-for-Adults-with-Moderate-to-Severe-Atopic-Dermatitis.
- Cibinqo. Package insert. Pfizer; 2021. Accessed January 18, 2022. https://cdn.pfizer.com/pfizercom/USPI_Med_Guide_CIBINQO_Abrocitinib_tablet.pdf.