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Skin clearance from the pivotal trials: CIBINQO IMPROVED RASH AND LESIONS
EASI-75
IGA 0/1
Tab Number 3
Tab Number 4
Tab Number 5
+TCS: ADULTS
+TCS: PEDIATRICS
WITHOUT TCS
~6 out of 10 PATIENTS ACHIEVED ≥75% CLEARER SKIN with CIBINQO 100 mg in ONLY 12 WEEKS1,2
JADE COMPARE was a pivotal phase 3 trial that evaluated the efficacy and safety of CIBINQO in combination with TCS vs placebo.2-4 Dupilumab was included as an active control for EASI-75 and IGA 0/1. Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between CIBINQO and dupilumab. See the JADE COMPARE study design to learn more.
EASI-75 in JADE COMPARE (co-primary endpoint) | +TCS1,2
RECOMMENDED DOSE: CIBINQO 100 mg2 If response to 100 mg is inadequate, consider increasing to 200 mg. Discontinue if inadequate response is seen after dose increase.
EASI-75 at Week 16 (key secondary endpoint)1 58% with CIBINQO 100 mg (P<0.0001 vs placebo); 69% with CIBINQO 200 mg (P<0.0001 vs placebo); 29% with placebo; and 63% with dupilumab.
Consider CIBINQO for patients 12+ with refractory, moderate-to-severe AD when other systemics are inadequate or inadvisable.2
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.1 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; TCS=topical corticosteroids.
64% of PEDIATRIC PATIENTS (ages 12 to <18) ACHIEVED ≥75% CLEARER SKIN with CIBINQO 100 mg in ONLY 12 WEEKS2
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 years.1,5
EASI-75 in JADE TEEN (co-primary endpoint) | +TCS1,2
RECOMMENDED DOSE: CIBINQO 100 mg2 If response to 100 mg is inadequate, consider increasing to 200 mg. Discontinue if inadequate response is seen after dose increase.
Consider CIBINQO for patients 12+ with refractory, moderate-to-severe AD when other systemics are inadequate or inadvisable.2
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.1 AD=atopic dermatitis; EASI-75=≥75% improvement in lesion extent and severity from baseline on the Eczema Area and Severity Index; TCS=topical corticosteroids.
>4x IMPROVEMENT vs PLACEBO for CIBINQO 100 mg as MONOTHERAPY in ONLY 12 WEEKS1,2
JADE MONO-1 and JADE 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.1,2,6,7
EASI-75 in JADE MONO-2 (co-primary endpoint) | Without TCS1,2*
RECOMMENDED DOSE: CIBINQO 100 mg2 If response to 100 mg is inadequate, consider increasing to 200 mg. Discontinue if inadequate response is seen after dose increase.
Similar results were observed in JADE MONO-1.1,2
Consider CIBINQO for patients 12+ with refractory, moderate-to-severe AD when other systemics are inadequate or inadvisable.2
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.1 *Patients were permitted to use nonmedicated emollients during the study.6 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; TCS=topical corticosteroids.
+TCS: ADULTS
+TCS: PEDIATRICS
WITHOUT TCS
>1/3 of PATIENTS ACHIEVED CLEAR OR ALMOST CLEAR SKIN (IGA 0/1) with CIBINQO 100 mg in 12 WEEKS1-3
JADE COMPARE was a pivotal phase 3 trial that evaluated the efficacy and safety of CIBINQO in combination with TCS vs placebo.2-4
Dupilumab was included as an active control for EASI-75 and IGA 0/1.Results are not to be interpreted as evidence of superiority, noninferiority, or similarity between CIBINQO and dupilumab.
IGA 0/1 in JADE COMPARE (co-primary endpoint) | +TCS1-3
RECOMMENDED DOSE: CIBINQO 100 mg2 If response to 100 mg is inadequate, consider increasing to 200 mg. Discontinue if inadequate response is seen after dose increase.
IGA 0/1 at Week 16 (key secondary endpoint)1,3 34% with CIBINQO 100 mg (P<0.0001 vs placebo); 46% with CIBINQO 200 mg (P<0.0001 vs placebo); 12% with placebo; and 37% with dupilumab.
Consider CIBINQO for patients 12+ with refractory, moderate-to-severe AD when other systemics are inadequate or inadvisable.2
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.1 A responder was defined as achieving IGA 0 or 1 and at least a 2-point improvement from baseline.2 AD=atopic dermatitis; IGA=Investigator’s Global Assessment; TCS=topical corticosteroids.
~4 in 10 PEDIATRIC PATIENTS (ages 12 to <18) achieved CLEAR or ALMOST CLEAR SKIN with CIBINQO 100 mg1,2,5
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 years.1,5
IGA 0/1 in JADE TEEN (co-primary endpoint) | +TCS1,2,5
RECOMMENDED DOSE: CIBINQO 100 mg2 If response to 100 mg is inadequate, consider increasing to 200 mg. Discontinue if inadequate response is seen after dose increase.
Consider CIBINQO for patients 12+ with refractory, moderate-to-severe AD when other systemics are inadequate or inadvisable.2
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.1 A responder was defined as achieving IGA 0 or 1 and at least a 2-point improvement from baseline.2 AD=atopic dermatitis; IGA=Investigator’s Global Assessment; TCS=topical corticosteroids.
WITHOUT TCS
>1 in 4 PATIENTS ACHIEVED CLEAR OR ALMOST CLEAR SKIN (IGA 0/1) with CIBINQO 100 mg as MONOTHERAPY in 12 WEEKS1,2,6,8
JADE MONO-1 and JADE 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.1,2,6,7
IGA 0/1 in JADE MONO-2 (co-primary endpoint) | Without TCS1,2,6,8*
RECOMMENDED DOSE: CIBINQO 100 mg2 If response to 100 mg is inadequate, consider increasing to 200 mg. Discontinue if inadequate response is seen after dose increase.
Similar results were observed in JADE MONO-1.1,2,7,9
Consider CIBINQO for patients 12+ with refractory, moderate-to-severe AD when other systemics are inadequate or inadvisable.2
Full analysis set (FAS) was defined as all randomized subjects who received at least 1 dose of study medication. All missing responses were defined as non-responders.1
A responder was defined as achieving IGA 0 or 1 and at least a 2-point improvement from baseline.2
*Patients were permitted to use nonmedicated emollients during the study.6
AD=atopic dermatitis; IGA=Investigator’s Global Assessment; TCS=topical corticosteroids.
See what’s next Supportive Skin Clearance Data
See higher threshold and long-term skin clearance data
Go to Supportive Skin Clearance Data
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See itch reduction data from the pivotal trials
Go to PP-NRS Results
Loading Safety Take a look at the safety information for CIBINQO Go to Safety Loading Skin Clearance Results See results from a long-term extension study See Long-term Data Loading Safety Take a look at the safety information for CIBINQO Go to Safety Loading Skin Clearance Results See results from a long-term extension study See Long-term Data LoadingReferences:Data on file. Pfizer Inc; New York, NY.CIBINQO Package insert. Pfizer Inc; 2023.Bieber T, Simpson EL, Silverberg JI, et al; JADE COMPARE Investigators. Abrocitinib versus placebo or dupilumab for atopic dermatitis.N Engl J Med. 2021;384(12):1101-1112.Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy (JADE Compare). ClinicalTrials.gov Identifier: NCT03720470. Updated January 19, 2021. Accessed May 28, 2025. https://clinicaltrials.gov/study/NCT03720470Eichenfield LF, Flohr C, Sidbury R, et al. Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial.JAMA Dermatol. 2021;157(10):1165-1173.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, randomised, placebo-controlled, phase 3 trial.Lancet. 2020;396(10246):255-266.Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (JADE Mono-2). ClinicalTrials.gov Identifier: NCT03575871. Updated April 21, 2020. Accessed May 28, 2025. https://clinicaltrials.gov/study/NCT03575871Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (JADE Mono-1). CinicalTrials.gov Identifier: NCT03349060. Updated December 10, 2019. Accessed May 29, 2025. https://www.clinicaltrials.gov/study/NCT03349060Efficacy
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PP-CIB-USA-0156
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 InformationWARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSISSERIOUS INFECTIONSPatients 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 fullPrescribing Information, includingBOXED WARNING, andMedication 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.