Cibinqo From Pfizer Inc

Pharmacy Times, May 2022, Volume 88, Issue 5

The FDA has approved abrocitinib tablets to treat adults with moderate-to-severe, refractory atopic dermatitis.

The FDA has approved abrocitinib tablets (Cibinqo; Pfizer) to treat adults with moderate-to-severe, refractory atopic dermatitis (AD) whose disease is not controlled with other systemic medications, including biologics,
or when use of those treatments is not advised.

The approval carries the limitation that treatment with Cibinqo is not recommended in combination with other biologic immunomodulators, immunosuppressants, or Janus kinase (JAK) inhibitors.1

Pharmacology and Pharmacokinetics

Cibinqo is a JAK inhibitor that reaches peak plasma concentrations within 1 hour of oral administration. Cibinqo and its 2 active metabolites display mean elimination half-lives of 3 to 5 hours.1

Dosage and Administration

The recommended dose of Cibinqo is 100 mg orally once daily, which may be increased to 200 mg once daily if an adequate response is not achieved after 12 weeks. Patients who are CYP2C19 poor metabolizers, use strong inhibitors of CYP2C19, or have moderate renal impairment should begin treatment with 50 mg orally once daily and may increase that to 100 mg once daily if needed after 12 weeks. Cibinqo should not be used concomitantly with moderate to strong CYP2C9 and CYP2C19 inhibitors or with strong CYP2C9 or CYP2C19 inducers.1

Clinical Trials

The efficacy of Cibinqo as monotherapy and in combination with background topical corticosteroids was evaluated in 3 double-blind, placebo-controlled, randomized phase 3 trials of patients with moderate to severe AD. JADE MONO-1 (NCT03349060) and JADE MONO-2 (NCT03575871) randomly assigned patients 12 years and older to receive Cibinqo 100 mg once daily, Cibinqo 200 mg once daily, or a placebo. JADE COMPARE (NCT03720470) randomly assigned adults 18 years and older to receive Cibinqo 100 mg once daily, Cibinqo 200 mg once daily, or a placebo while concomitantly using topical corticosteroids. An active control arm was also included in JADE COMPARE, which consisted of topical corticosteroid therapy with either dupilumab (Dupixent) or a placebo. The coprimary end points of all 3 trials were the Eczema Area and Severity Index and Investigator’s Global Assessment responses at week 12. Each trial found significant improvement with both doses of Cibinqo compared with the placebo.1,2

Contraindications, Warnings, and Precautions

Cibinqo carries a boxed warning stating that patients using Cibinqo may be at an increased risk for serious bacterial, fungal, opportunistic, and viral infections, including tuberculosis, which may lead to death or hospitalization. Patients should be tested for tuberculosis before and during treatment. The warning states that a higher rate of all-cause mortality, including sudden cardiovascular death, has been observed in patients also using another JAK inhibitor. The warning states that major adverse cardiovascular events, malignancies, and thrombosis have occurred in patients using Cibinqo and that the drug is not approved for the treatment of rheumatoid arthritis.

The use of Cibinqo is contraindicated in patients using antiplatelet therapies, except for aspirin 81 mg daily or lower, during the first 3 months of treatment.

Complete blood count and lipids should be monitored in patients using Cibinqo. Live vaccines should be avoided prior to, during, and immediately after treatment with Cibinqo. When used in combination with a P-glycoprotein (P-gp) substrate where small concentration changes may lead to life-threatening or serious toxicities, the dose of the P-gp substrate should be monitored or titrated. Cibinqo should not be used in patients with end-stage renal disease or severe hepatic or renal impairment. It should not be used by patients who
are breastfeeding.

The most common adverse reactions include acne, dizziness, fatigue, gastroenteritis, headaches, herpes simplex, increased blood creatine phosphokinase, influenza, nasopharyngitis, nausea, oropharyngeal pain, urinary tract infection, and vomiting. The most common adverse reactions in patients taking either the 100-mg or the 200-mg dose also include contact dermatitis, herpes zoster, hypertension, impetigo, thrombocytopenia, and upper abdominal pain.1

About The Author

Monica Holmberg, PharmD, BCPS, is a pharmacist in Phoenix, Arizona, and Pharmacy Times® contributor.

References

1. Cibinqo. Prescribing information. PfizerInc. 2022. Accessed March 21, 2022. https://labeling.pfizer.com/ShowLabeling.aspx?id=16652

2. U.S. FDA approves Pfizer’s Cibinqo (abrocitinib)for adults with moderate-to-severe atopic dermatitis. Pfizer Inc. January 14, 2022. Accessed March 21, 2022. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-cibinqor-abrocitinib-adults