General Information

Cibinqo (abrocitinib) is a Janus kinase (JAK) inhibitor.

Cibinqo is specifically indicated for the treatment of patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Cibinqo is supplied as tablets for oral administration. Perform the following tests and evaluations prior to Cibinqo initiation:

Tuberculosis (TB) infection evaluation – Cibinqo is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of Cibinqo.

Viral hepatitis screening in accordance with clinical guidelines: Cibinqo is not recommended in patients with active hepatitis B or hepatitis C

A complete blood count (CBC): Cibinqo is not recommended in patients with a platelet count <150,000/mm3 , an absolute lymphocyte count <500/mm3 , an absolute neutrophil count <1,000/mm3 , or a hemoglobin value <8 g/dL.

Complete any necessary immunizations, including herpes zoster vaccinations, in agreement with current immunization guidelines prior to Cibinqo initiation

The recommended dose of Cibinqo is 100mg orally once daily. If an adequate response is not achieved with Cibinqo 100 mg orally daily after 12 weeks, consider increasing dosage to 200 mg orally once daily. Discontinue therapy if inadequate response is seen after dosage increase to 200 mg once daily. Cibinqo can be used with or without topical corticosteroids. If a dose is missed, administer the dose as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose. Thereafter, resume dosing at the regular scheduled time.

Mechanism of Action

Cibinqo (abrocitinib) reversibly inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site. In a cell-free isolated enzyme assay, abrocitinib was selective for JAK1 over JAK2 (28-fold), JAK3 (>340-fold), and tyrosine kinase (TYK) 2 (43-fold), as well as the broader kinome. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. Both the parent compound and the active metabolites inhibit JAK1 activity in vitro with similar levels of selectivity.

Side Effects

Adverse effects associated with the use of Cibinqo may include, but are not limited to, the following:

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

The Cibinqo drug label comes with the following Black Box Warning: Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with Cibinqo if serious or opportunistic infection occurs. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. Higher rate of all-cause mortality, including sudden cardiovascular death, with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. Cibinqo is not approved for use in RA patients. Malignancies have occurred with Cibinqo. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. MACE has occurred with Cibinqo. Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. Thrombosis has occurred with Cibinqo. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.

Clinical Trial Results

The safety and efficacy of Cibinqo was evaluated in three Phase 3, randomized, placebo-controlled clinical trials. The trials evaluated measures of improvements in skin clearance, itch, disease extent, and severity, including the Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), and Peak Pruritus Numerical Ratings Scale (PP-NRS). In each of the trials, over 40% of patients had prior exposure to a systemic therapy:

JADE MONO-1 and JADE MONO-2: A pair of randomized, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy in 778 patients 12 years of age and older with moderate-to-severe AD. The trials assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12.

JADE COMPARE: A randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo in 837 adult patients with moderate-to-severe AD on background topical medicated therapy. The trial also included an active control arm with dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo. The trial assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12.

Select findings for Cibinqo 100 mg, 200 mg, and placebo:

JADE MONO-1: