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    Monotherapy Trial Results

    JADE MONO-1 and MONO-2 were two identically designed double-blind pivotal phase 3 monotherapy studies that evaluated the efficacy and safety of CIBINQO without Rx topicals vs placebo.1
    See full trial design >

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    Skin Clearance Itch Reduction
    The recommended dose is CIBINQO 100 mg. If an adequate response is not achieved with 100 mg after 12 weeks, consider increasing dosage to CIBINQO 200 mg. Discontinue therapy if inadequate response is seen after dosage increase to 200 mg.
    Powerful skin clearance results without TCS1,2*

    JADE MONO-1: EASI-75 for CIBINQO 100 mg or 200 mg vs placebo (primary endpoint) 


    In only 12 weeks, CIBINQO alone achieved significantly clearer skin versus placebo.
    IGA 0/1 at week 12 (primary endpoint): 24% of patients taking CIBINQO 100 mg (P<0.01 vs placebo), 44% taking CIBINQO 200 mg (P<0.0001 vs placebo), and 8% taking placebo achieved IGA 0/1

    Similar results were observed in MONO-2.
    While subjects aged 12 to 17 years were included in MONO-1and MONO-2 trials, CIBINQO is not approved for use in pediatric subjects.

    *  Full Analysis Set (FAS) was defined as all randomized subjects who received at least one dose of study medication. All missing responses were defined as non-responders. 
    A responder was defined as achieving IGA 0 or 1 and at least a 2-point improvement from baseline.

       ∗Patients were permitted to use nonmedicated emollients during the study.

    1  TCS=topical corticosteroids; EASI-75=≥75% improvement in lesion extent and severity from baseline on the Eczema Area and Severity Index; IGA=Investigator's Global Assessment. 

    See Before and After Images See the Safety Data

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    JADE MONO-1 & MONO-2 study design1,2

    JADE MONO-1 and MONO-2 were two identically designed double-blind pivotal phase 3 monotherapy studies that evaluated the efficacy and safety of CIBINQO without Rx topicals vs placebo.

    Co-primary endpoints:

    • EASI-75 response at week 12 vs placebo
    • ​​​​​​​IGA 0/1 response with ≥2-point improvement at week 12 vs placebo

    Key secondary endpoints:

    • PP-NRS4 response at weeks 2, 4, and 12 vs placebo
    • PSAAD response at week 12 vs placebo

    While subjects aged 12 to 17 years were included in MONO-1 and MONO-2 trials, CIBINQO is not approved for use in pediatric subjects.

    In the JADE clinical trial program, EASI and IGA excluded scalp, palms, and soles from the assessment/scoring.3,4

        ‡At week 12, eligible subjects entered the long-term extension study (JADE EXTEND).
    AD=atopic dermatitis; PP-NRS4=≥4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis.


    JADE MONO-1 baseline characteristics1,5

    The baseline characteristics were similar for JADE MONO-2.

    Plus–minus values are means ± SD. Percentages may not total 100 because of rounding.
    Race was reported by the patients.
    Scores on EASI range from 0 to 72, with higher scores indicating more severe disease.
    §Scores on PP-NRS represent maximum itch severity in the previous 24 hours and range from 0 to 10, with higher scores representing more severe itch.

    SD=standard deviation; BMI=body mass index; BSA=body surface area.


    Inclusion criteria
    • ​​​​​​​≥12 years of age
    • Body weight ≥88 lbs
    • Clinically diagnosed with chronic AD for ≥1 year, confirmed by the Hanifin and Rajka criteria of AD at the screening and baseline visits
    • Have a documented history of inadequate response to previous topical therapy, or were subjects for whom topical treatments were medically inadvisable, or require systemic therapies to control their disease
    • Moderate-to-severe AD defined as BSA ≥10%, IGA ≥3, EASI ≥16, and PP-NRS ≥4 at the baseline visit
    Exclusion criteria
    • Active forms of other inflammatory skin diseases
    • Prior treatment with any JAK inhibitors
    • Vaccination with, or exposure to, a live or attenuated vaccine within 6 weeks prior to the first dose
    • Participation in other clinical studies involving investigational drug(s) within 8 weeks prior to study entry
    • Uncontrolled, clinically significant laboratory abnormality that could affect study interpretation
    • Any major psychiatric condition
    • Unwillingness to discontinue current AD medications prior to the study
    • Requiring treatment with prohibited medications during the study
    • Medical history of thrombocytopenia, coagulopathy or platelet dysfunction, or Q wave interval abnormalities
    • Presence or history of certain infections, cancers, lymphoproliferative disorders, and other medical conditions at the discretion of the investigator
    • Pregnant or breastfeeding women
    • Women of childbearing potential who are unwilling to use contraception

    JADE MONO-1 and MONO-2 inclusion/exclusion criteria1,6

    *Criteria include ≥3 of the basic features of pruritus; typical morphology and distribution, including flexural lichenification or linearity in adults and facial and extensor involvement in infants and children; chronic or chronically relapsing dermatitis; and personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis); along with ≥3 of 23 minor features specified in the criteria.
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    JAK=Janus kinase.

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    References:    
    1. Data on file. Pfizer Inc; New York, NY.
    2. CIBINQO Package insert. Pfizer Inc; 2022.
    3. Simpson EL, Sinclair R, Forman S, et al. Supplementary appendix to: Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266.
    4.  Silverberg JI, Simpson EL, Thyssen JP, et al. Supplementary appendix to: Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863-873. 
    5. Simpson EL, Sinclair R, Forman S, et al.  Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266.    
    6. Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermatovener (Stockholm). 1980;92(suppl):44-47.​​​​​​​
    Next page: Monotherapy Trial Results: Itch Reduction

    CIBINQO (abrocitinib) is indicated for the treatment of adults 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.
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    INDICATION

    Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

    WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS

    SERIOUS INFECTIONS
    Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia.


    If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection.

    Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions: 
    • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. 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.
    • Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. 
    • Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens.
    ​​​​​​​Avoid use of CIBINQO in patients with an active, serious infection, including localized infections. The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections or those who have resided or traveled in areas of endemic tuberculosis or endemic mycoses.

    Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

    Consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO. 

    Viral reactivation, including herpes virus reactivation (eg, herpes zoster, herpes simplex), was reported in clinical studies with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves. Hepatitis B virus reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C.

    MORTALITY
    In a large, randomized postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality (including sudden cardiovascular death) was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.


    MALIGNANCIES
    Malignancies, including non-melanoma skin cancer (NMSC), were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions.
    Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

    In a large, randomized postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA patients. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.


    Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

    MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)  
    Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers.
    CIBINQO is not approved for use in RA patients. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.


    Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. 

    THROMBOSIS
    Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of overall thrombosis, DVT, and PE were observed when compared with TNF blockers.
    CIBINQO is not approved for use in RA patients.

    Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and treat patients appropriately.


    CONTRAINDICATION
    CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.


    LABORATORY ABNORMALITIES
    Hematologic Abnormalities: Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation, perform a complete blood count (CBC). CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities. 

    Lipid Elevations: Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO. Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy, and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. 


    IMMUNIZATIONS
    Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations. Avoid vaccination with live vaccines immediately prior to, during, and immediately after CIBINQO therapy.


    RENAL IMPAIRMENT
    Avoid use in patients with severe renal impairment or end stage renal disease, including those on renal replacement therapy.

    HEPATIC IMPAIRMENT
    Avoid use in patients with severe hepatic impairment.

    ADVERSE REACTIONS
    Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatinine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis. 

    Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.

    Inform patients that retinal detachment has been reported in CIBINQO clinical trials. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision.

    DRUG INTERACTIONS
    Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO. See Prescribing Information for clinically relevant drug interactions.

    USE IN PREGNANCY
    Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Advise females of reproductive potential that CIBINQO may impair fertility.

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770. 

    LACTATION
    Advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose.


    Please see full Prescribing Information, including BOXED WARNING, and Medication Guide. 

    CIBINQO is indicated for the treatment of adults 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.

    Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.