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Monotherapy ResultsCombination Therapy ResultsCombination Therapy in Pediatric Patients 12 to <18 ResultsBefore and After Images

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Pfizer JAK InnovationHow CIBINQO WorksIdentifying PatientsAAD 2023 GuidelinesEfficacyEfficacy 

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Study DesignsSkin ClearanceEASI-75 DataIGA 0/1 & EASI-90 DataSkin Clearance at Week 96Post Hoc Analysis ResultsBefore and After PhotosItch ReductionItch Reduction Data (PP-NRS4)Absolute Change From Baseline in PP-NRSSafetySafety

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EfficacyStudy designs
  • Women of childbearing potential who are unwilling to use contraception

JADE COMPARE

JADE MONO

JADE TEEN

Combination therapy study2-4Combination therapy  study2-4JADE COMPARE was a pivotal phase 3 trial that evaluated the efficacy and safety of CIBINQO in combination with TCS 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 week 2 vs dupilumab and vs placebo
  • EASI-75 response at week 16 vs placebo
  • IGA 0/1 response with ≥2-point improvement at week 16 vs placebo

*Dupilumab was an active control except for the one head-to-head endpoint of PP-NRS4 at week 2.
Subjects used nonmedicated emollient twice a day and medicated topical therapy, such as corticosteroids, calcineurin inhibitors, or PDE4 inhibitors, per protocol guidance, to treat active lesions during the study. The majority used corticosteroids with selective use of TCI and PDE4 inhibitors.

In the JADE clinical trial program, EASI and IGA excluded scalp, palms, and soles from the assessment/scoring.
Patients randomized to dupilumab received an initial dose of 600 mg on day 1 of JADE COMPARE, followed by 300 mg Q2W.
†Dupilumab or its matching placebo was administered for 16 weeks, with the final injection planned for week 14 to facilitate the washout of dupilumab prior to eligible subjects entering the long-term extension study.5
‡At week 20, eligible subjects entered the long-term extension study (JADE EXTEND); ineligible subjects entered the 4-week off-treatment follow-up period.
AD=atopic dermatitis; 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; PP-NRS4=≥4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale; PDE4=phosphodiesterase-4; TCI=topical calcineurin inhibitors; Q2W=every 2 weeks.Baseline characteristics3,4 *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.
BMI=body mass index; IGA=Investigator’s Global Assessment; EASI=Eczema Area and Severity Index; BSA=body surface area; PP-NRS=Peak Pruritus Numerical Rating Scale; SD=standard deviation.Inclusion/exclusion criteria3Inclusion criteria
  • ≥18 years of age
  • 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 treatment with topical medications 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 systemic JAK inhibitors
  • Prior treatment with dupilumab and/or a history of hypersensitivity, intolerance, AE, or allergic reaction associated with prior exposure to the excipients of dupilumab
  • 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
*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, AD); along with ≥3 of 23 minor features specified in the criteria.6
AD=atopic dermatitis; BSA=body surface area; IGA=Investigator’s Global Assessment; EASI=Eczema Area and Severity Index; PP-NRS=Peak Pruritus Numerical Rating Scale; JAK=Janus kinase; AE=adverse event.
Explore more SafetyTake a look at the safety information for CIBINQO Go to Safety Loading Skin Clearance Results

See what CIBINQO could mean for your patients

 See EASI-75 Data Loading
Monotherapy studies2,3Monotherapy studies2,3JADE MONO-1 and MONO-2 were two identically designed double-blind, pivotal phase 3 monotherapy trials 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 change from baseline at week 12 vs placebo
In the JADE clinical trial program, EASI and IGA excluded scalp, palms, and soles from the assessment/scoring.7,8
*At week 12, eligible subjects entered the long-term extension study (JADE EXTEND); all other subjects entered the 4-week off-treatment follow-up period.
AD=atopic dermatitis; EASI-75=≥75% improvement in lesion extent and severity from baseline on the Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; PP-NRS4=≥4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis.Baseline characteristics3,9 The baseline characteristics were similar for JADE MONO-1.3,10*Plus/minus values are means ± SD. Percentages may not total 100 because of rounding.
†Race was reported by the patients.3,9
‡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; IGA=Investigator’s Global Assessment; EASI=Eczema Area and Severity Index; BSA=body surface area; PP-NRS=Peak Pruritus Numerical Rating Scale.Inclusion/exclusion criteria3

Inclusion criteria

  • ≥12 years of age
  • Body weight ≥88 lb
  • 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
*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, AD); along with ≥3 of 23 minor features specified in the criteria.6
AD=atopic dermatitis; BSA=body surface area; IGA=Investigator’s Global Assessment; EASI=Eczema Area and Severity Index; PP-NRS=Peak Pruritus Numerical Rating Scale; JAK=Janus kinase.Explore more SafetyTake a look at the safety information for CIBINQO Go to Safety Loading Skin Clearance Results

See what CIBINQO could mean for your patients

 See EASI-75 Data Loading
Pediatric study 12 to <182,3Pediatric study 12 to <182,3JADE TEEN was a double-blind, phase 3 trial that evaluated the efficacy and safety of CIBINQO in combination with TCS vs placebo in pediatric patients aged 12 to <18.JADE TEEN was a double-blind, phase 3 trial that evaluated the efficacy and safety of CIBINQO in combination with TCS vs placebo in pediatric patients aged 12 to <18.JADE TEEN was a double-blind, phase 3 trial that evaluated the efficacy and safety of CIBINQO in combination with TCS vs placebo in pediatric patients aged 12 to <18.JADE TEEN was a double-blind, phase 3 trial that evaluated the efficacy and safety of CIBINQO in combination with TCS vs placebo in pediatric patients aged 12 to <18. 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 change from baseline at week 12 vs placebo

Subjects used nonmedicated emollient twice a day and medicated topical therapy, such as corticosteroids or calcineurin inhibitors, per protocol guidance, to treat active lesions during the study. The majority used corticosteroids with selective use of TCI.

In the JADE clinical trial program, EASI and IGA excluded scalp, palms, and soles from the assessment/scoring.
*At week 12, eligible subjects entered the long-term extension study (JADE EXTEND); ineligible subjects entered the 4-week off-treatment follow-up period.
AD=atopic dermatitis; 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; PP-NRS4=≥4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis; TCI=topical calcineurin inhibitors.Baseline characteristics3 *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.
BMI=body mass index; IGA=Investigator’s Global Assessment; EASI=Eczema Area and Severity Index; BSA=body surface area; PP-NRS=Peak Pruritus Numerical Rating Scale.Inclusion/exclusion criteria3Inclusion criteria
  • 12 to <18 years of age
  • Body weight ≥55 lb
  • Clinically diagnosed with chronic AD, confirmed by the Hanifin and Rajka criteria of AD at the screening and baseline visits*
  • Have a documented history of inadequate response to treatment with topical medications, or had been treated with systemic therapy for AD within 6 months before screening, or were candidates for systemic therapy for AD
  • 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 systemic 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 increase risk associated with participating in the study or may have interfered with the interpretation of study results
  • Any major psychiatric condition
  • Unwillingness to discontinue current AD medications prior to the study
  • Required treatment with prohibited medications during the study
  • Medical history of thrombocytopenia, coagulopathy, or platelet dysfunction
  • Presence or history of certain infections, cancer, lymphoproliferative disorders, and other medical conditions as per protocol
  • Pregnant or breastfeeding women
  • Participants without documentation confirming prior varicella-zoster infection (chickenpox) or documented evidence
*Criteria include ≥3 of the basic features of pruritus; typical morphology and distribution, including flexural lichenification in adults and facial and extensor eruptions in infants and children; chronic or chronically relapsing dermatitis; and personal or family history of atopy (asthma, allergic rhinitis, AD); along with ≥3 of 23 minor features specified in the criteria.6
AD=atopic dermatitis; BSA=body surface area; IGA=Investigator’s Global Assessment; EASI=Eczema Area and Severity Index; PP-NRS=Peak Pruritus Numerical Rating Scale; JAK=Janus kinase.Explore more SafetyTake a look at the safety information for CIBINQO Go to Safety Loading Skin Clearance Results

See what CIBINQO could mean for your patients

 See EASI-75 Data Loading

JADE EXTEND

Long-term extension safety study3JADE EXTEND is a long-term extension (LTE) safety study evaluating adult and pediatric patients 12 years of age and older with moderate-to-severe AD who are taking CIBINQO with or without Rx topical therapies. No patients received placebo in JADE EXTEND. The Long-Term Extension trial (JADE EXTEND) is an ongoing safety study for eligible subjects taking CIBINQO who have completed a qualifying JADE parent study. The primary endpoints in JADE EXTEND included the incidence of safety events and clinical abnormalities.Primary (safety) endpoint:
  • Long-term safety
    • Incidence of treatment-emergent AEs
    • Incidence of serious AEs and AEs leading to discontinuation
    • Incidence of clinical abnormalities and change from baseline in clinical laboratory values, ECG measurements, and vital signs
Secondary (efficacy) endpoints:
  • EASI-75 response at all scheduled time points
  • IGA 0/1 response with ≥2-point improvement at all scheduled time points
  • PP-NRS4 response at all scheduled time points
*Subjects who completed week 92 and remained eligible could enroll in an open-label treatment period of variable length. Subjects could continue to receive CIBINQO in the LTE trial until availability of commercial CIBINQO or until the study was terminated in their respective country.
AD=atopic dermatitis; TCS=topical corticosteroids; AE=adverse event; ECG=electrocardiogram; EASI-75=≥75% improvement in lesion extent and severity from baseline on the Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; PP-NRS4=≥4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale.Biases and limitationsBiases and limitationsBiases
  • LTE studies may provide useful data on low-frequency, long-latency AEs, risk factor analysis, and trends over exposure time. However, conduct of LTE studies in which both treatment and dose are known to both investigator and patient is subject to certain biases and limitations; therefore, data should be interpreted with caution
  • Biases include, but are not limited to
    • Patient selection (patient willingness or ineligibility to enroll, which may be due to prior serious AEs)
    • Prior treatment and investigator/patient expectation
    • Volunteer, observer, and responder/survivor effects
    • Initial dose of study drug
    • Study duration
Limitations
  • Limitations include, but are not limited to
    • AE frequencies and incidence rates subject to change over time due to patient entry/exit
    • Dose changes or study drug interruptions influenced by both investigator and patient
    • The number of patients and exposure for a specific safety event possibly differing depending on the timing of censored events
    • The number of observed patients with longer exposure times becoming lower
Inclusion/exclusion criteria3Inclusion criteria
  • ≥12 years of age*
  • Body weight ≥88 lb if applicable from a qualifying parent study
  • Completed the full treatment or full rescue treatment of a qualifying parent study or completed the full open-label run-in of JADE REGIMEN but did not meet response criteria
Exclusion criteria
  • Active forms of other inflammatory skin diseases
  • Presence of other medical conditions at the discretion of the investigator
  • Pregnant or breastfeeding women
  • Women of childbearing potential who are unwilling to use contraception
  • Discontinued from treatment (or rescue treatment) early in a qualifying parent study
  • Ongoing AE in a qualifying parent study
*Adolescent subjects under the age of 18 years old (or country-specific age of majority) will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years (or country-specific age of majority) and older will be enrolled.
AE=adverse event.Explore more SafetyTake a look at the safety information for CIBINQO Go to Safety Loading Skin Clearance ResultsSee skin clearance results at week 96 See Week 96 Data Loading
SafetyTake a look at the safety information for CIBINQO Go to Safety Loading Skin Clearance Results

See what CIBINQO could mean for your patients

 See EASI-75 Data LoadingReferences:Simpson EL, Silverberg JI, Nosbaum A, et al. Safety of abrocitinib in 3582 patients with moderate-to-severe atopic dermatitis with over 900 patients exposed for almost 2 years. Poster P0362. Presented at: European Academy of Dermatology and Venereology Hybrid Congress; September 7–10, 2022.CIBINQO Package insert. Pfizer Inc; 2023.Data on file. Pfizer Inc; New York, NY.Bieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Bieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Supplementary appendix to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112. Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermatovener (Stockholm). 1980;92(suppl):44-47.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, randomized, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266.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.Silverberg JI, Simpson EL, Thyssen JP, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863-873.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, randomized, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266.Efficacy Ready to Start Your Patients on CIBINQO?

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

Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
Important Safety Information 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 in accordance with clinical guidelines before starting therapy and monitor for reactivation 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 venous 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% with CIBINQO 100 mg) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, and dermatitis contact.Most common adverse reactions (≥1% with CIBINQO 200 mg and greater than CIBINQO 100 mg) are nausea, headache, herpes simplex, increased blood creatine kinase, dizziness, urinary tract infection, acne, vomiting, gastroenteritis, 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 patients who can become pregnant 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 or visit CIBINQOPregnancyRegistry.com. LACTATION
Advise patients 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. INDICATIONCIBINQO is indicated for the treatment of adults and pediatric 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.Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.