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Prescribing Information, including BOXED WARNINGMedication GuideIndicationPatient SiteInformación de Prescripción Completa
SafetyImportant safety considerationsImportant safety considerations

BOXED WARNING

LTE Study Design

Pooled Safety 12+

Pooled Safety 12 to <18

Pivotal Trial Safety

CIBINQO BOXED WARNING SUMMARY1CIBINQO BOXED WARNING SUMMARY1

CIBINQO has a BOXED WARNING for serious infections, mortality, malignancies, MACE, and thrombosis.

To review the full CIBINQO BOXED WARNING below, select “Read more” to expand each box.

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.

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.

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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.

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MALIGNANCIES

Malignancies were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

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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. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

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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 thrombosis was observed when compared with TNF blockers. Avoid CIBINQO in patients at risk. If symptoms of thrombosis occur, discontinue CIBINQO and treat appropriately.

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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.

See Lab Abnormalities information.

Avoid use of live vaccines immediately prior to, during, and immediately after CIBINQO treatment.

LTE=long-term extension; TB=tuberculosis; TNF=tumor necrosis factor. Explore more Explore more Dosing & Monitoring See dosing and monitoring guidelines Go to Dosing Loading Skin Clearance ResultsSee what CIBINQO could mean for your patients See EASI-75 Data LoadingReferences:CIBINQO Package insert. Pfizer Inc; 2023.Data on file. Pfizer Inc; New York, NY.Simpson EL, Silverberg JI, Nosbaum A, et al. Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.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.Simpson EL, Silverberg JI, Nosbaum A, et al. Supplementary appendix to: Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.Cork MJ, Deleuran M, Geng B, et al. Abrocitinib treatment in patients with moderate-to-severe atopic dermatitis: safety of abrocitinib stratified by age. Poster P0189. Presented at: European Academy of Dermatology and Venereology 30th Congress; September 29-October 2, 2021.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.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.
JADE EXTEND study design2

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.

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 are the incidence of safety events and clinical abnormalities.

Primary (safety) endpoint:Primary (safety) endpoint:
  • Long-term safety
Incidence of treatment-emergent AEsIncidence of serious AEs and AEs leading to discontinuationIncidence of clinical abnormalities and change from baseline in clinical laboratory values, ECG measurements, and vital signsSecondary (efficacy) endpoints: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.Biases
  • 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 expectationVolunteer, observer, and responder/survivor effectsInitial dose of study drugStudy durationLimitations
  • Limitations include, but are not limited to
AE frequencies and incidence rates subject to change over time due to patient entry/exitDose changes or study drug interruptions influenced by both investigator and patientThe number of patients and exposure for a specific safety event possibly differing depending on the timing of censored eventsThe number of observed patients with longer exposure times becoming lowerAD=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.JADE EXTEND inclusion/exclusion criteria2Inclusion 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.2AE=adverse event. Explore more Explore more Dosing & Monitoring See dosing and monitoring guidelines Go to Dosing Loading Skin Clearance ResultsSee what CIBINQO could mean for your patients See EASI-75 Data LoadingReferences:CIBINQO Package insert. Pfizer Inc; 2023.Data on file. Pfizer Inc; New York, NY.Simpson EL, Silverberg JI, Nosbaum A, et al. Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.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.Simpson EL, Silverberg JI, Nosbaum A, et al. Supplementary appendix to: Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.Cork MJ, Deleuran M, Geng B, et al. Abrocitinib treatment in patients with moderate-to-severe atopic dermatitis: safety of abrocitinib stratified by age. Poster P0189. Presented at: European Academy of Dermatology and Venereology 30th Congress; September 29-October 2, 2021.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.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.

A long-term extension (LTE) safety study evaluating adult and pediatric patients aged 12 and older with moderate-to-severe AD who are taking CIBINQO with or without Rx topical therapies.2
See full trial design >

Well-studied safety profile with ~3800 patients representing more than 5000 patient-years of exposure3-5Well-studied safety profile with ~3800 patients representing more than 5000 patient-years of exposure3-5

AEs of special interest
These data are from an integrated safety analysis consistent-dose cohort (n=3004) of JADE EXTEND; there was also a variable-dose cohort that included safety data from an additional 798 patients. 1549 patients treated with CIBINQO had at least 48 weeks of exposure, and 944 patients had at least 96 weeks of exposure.*

AEs of special interest
These data are from an integrated safety analysis consistent-dose cohort (n=3004) of JADE EXTEND; there was also a variable-dose cohort that included safety data from an additional 798 patients. 1549 patients treated with CIBINQO had at least 48 weeks of exposure, and 944 patients had at least 96 weeks of exposure.*

Mortality:
2 deaths were reported in the CIBINQO 100 mg group (sudden death, n=1; COVID-19, n=1) and 5 in the CIBINQO 200 mg group (COVID-19, n=2; septic shock, n=1; cardiac failure, n=1; cardiorespiratory arrest, n=1).2,4**

Mortality:
2 deaths were reported in the CIBINQO 100 mg group (sudden death, n=1; COVID-19, n=1) and 5 in the CIBINQO 200 mg group (COVID-19, n=2; septic shock, n=1; cardiac failure, n=1; cardiorespiratory arrest, n=1).2,4**

Overall infections2:
CIBINQO 100 mg: n=553 (IR: 65.98/100 PY); CIBINQO 200 mg: n=976 (IR: 83.56/100 PY)

Overall infections2:
CIBINQO 100 mg: n=553 (IR: 65.98/100 PY); CIBINQO 200 mg: n=976 (IR: 83.56/100 PY)

Retinal detachment2:
CIBINQO 100 mg: n=2 (IR: 0.13/100 PY); CIBINQO 200 mg: n=2 (IR: 0.09/100 PY)

Retinal detachment2:
CIBINQO 100 mg: n=2 (IR: 0.13/100 PY); CIBINQO 200 mg: n=2 (IR: 0.09/100 PY)

Adverse events observed in clinical trials may not fully characterize the risks of CIBINQO. Pooled safety analyses over time may provide useful data on long-latency adverse events, but adverse rates may differ in specific populations and may change over time.

LIMITATIONS AND BIASES

Patients receiving placebo were eligible to enroll in JADE EXTEND following completion of the qualifying JADE parent study; therefore, no patients received placebo after week 16.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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 treatment and dose are known to both investigator and patient is subject to certain biases and limitations; therefore, data should be interpreted with caution.

See the study design for additional limitations and biases.

*Pooled safety from one phase 2b trial, six phase 3 trials, and one LTE trial, which is ongoing. In the consistent-dose cohort, patients received the same CIBINQO dose during the entire exposure time. In the variable-dose cohort, patients could have received different doses of CIBINQO (100 mg or 200 mg) throughout the exposure time.4†Exposure-adjusted IRs were adjusted by trial for all of the adverse reactions reported in this section. Patient-year is defined as the total follow-up time calculated up to the day of the first event for subjects with events and up to the end of the risk period for subjects without events.1,2‡Opportunistic infections were generally cases of nonserious multidermatomal herpes zoster. There was 1 event of adjudicated tuberculosis.2§Patients with a history of malignancy, except for treated NMSC and cervical carcinoma in situ, were excluded from enrolling in the trials.2llIR=0.22 events per 100 PY [95% CI: 0.07-0.52] excluding 1 event of adenocarcinoma, which occurred early in the treatment period and with symptoms being present prior to taking study treatment.2MACE was defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.1,2#One pulmonary embolism event (not adjudicated) was included.4**There was an additional death (>200 days after last dose of CIBINQO) that was previously reported that involved gastric adenocarcinoma.2AD=atopic dermatitis; AE=adverse event; PY=patient-years; IR=incidence rate; NMSC=non-melanoma skin cancer; MACE=major adverse cardiovascular event; CI=confidence interval. Serious infections in clinical trials3

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 Herpes zoster in clinical trials3

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 Malignancy (excluding NMSC) in clinical trials3,5

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

NMSC=non-melanoma skin cancer.

NMSC in clinical trials3,5

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

NMSC=non-melanoma skin cancer.

MACE in clinical trials3,5

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

MACE=major adverse cardiovascular event.

Pulmonary embolism in clinical trials3,5

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 Deep vein thrombosis in clinical trials3,5

Incidence rate per 100 patient-years (PY) measures how frequently an event occurs, taking into consideration patients’ length of exposure to therapy. One case per 100 patient-years is the same as saying 1 case was observed among 100 patients during 1 year of exposure.

 Explore more Explore more Dosing & Monitoring See dosing and monitoring guidelines Go to Dosing Loading Skin Clearance ResultsSee what CIBINQO could mean for your patients See EASI-75 Data LoadingReferences:CIBINQO Package insert. Pfizer Inc; 2023.Data on file. Pfizer Inc; New York, NY.Simpson EL, Silverberg JI, Nosbaum A, et al. Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.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.Simpson EL, Silverberg JI, Nosbaum A, et al. Supplementary appendix to: Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.Cork MJ, Deleuran M, Geng B, et al. Abrocitinib treatment in patients with moderate-to-severe atopic dermatitis: safety of abrocitinib stratified by age. Poster P0189. Presented at: European Academy of Dermatology and Venereology 30th Congress; September 29-October 2, 2021.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.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.

A long-term extension (LTE) safety study evaluating adult and pediatric patients aged 12 and older with moderate-to-severe AD who are taking CIBINQO with or without Rx topical therapies.2

See full trial design >

AEs of special interest for pediatric patients 12 to <18, with some having exposure for ~1 year2,6AEs of special interest for pediatric patients 12 to <18, with some having exposure for ~1 year2,6

AEs of special interest
These data are from an integrated safety analysis evaluating pediatric patients aged 12 to <18 (n=635) in JADE EXTEND. 150 pediatric patients treated with CIBINQO had at least 48 weeks of exposure.*

Adverse events observed in clinical trials may not fully characterize the risks of CIBINQO. Pooled safety analyses over time may provide useful data on long-latency adverse events, but adverse rates may differ in specific populations and may change over time.

LIMITATIONS AND BIASES

Patients receiving placebo were eligible to enroll in JADE EXTEND following completion of the qualifying JADE parent study; therefore, no patients received placebo after week 12.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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 treatment and dose are known to both investigator and patient is subject to certain biases and limitations; therefore, data should be interpreted with caution.

See the study design for additional limitations and biases.

‡Confidence intervals (Cls) reflect the uncertainty around an estimated number; therefore, the upper limit (UL) is nonzero. For adverse events with no instances reported, IR could be greater than zero with a 2.5% chance (due to 95% Cl) to be >2.33 in the CIBINQO 100 mg group and >1.33 in the 200 mg group. The depiction above is not intended to imply zero risk.

*Pooled safety from four phase 3 trials and one LTE trial, which is ongoing.†Exposure-adjusted IRs were adjusted by trial for all of the adverse reactions reported in this section. Patient-year is defined as the aggregate total follow-up time calculated for each event, censored at the time of first event for any given patient, subject to a risk period of up to 28 days beyond the last dose or to the data cutoff date.AD=atopic dermatitis; AE=adverse event; PY=patient-years; IR=incidence rate; NMSC=non-melanoma skin cancer; MACE=major adverse cardiovascular event. Explore more Explore more Dosing & Monitoring See dosing and monitoring guidelines Go to Dosing Loading Skin Clearance ResultsSee what CIBINQO could mean for your patients See EASI-75 Data LoadingEASI-75=≥75% improvement in lesion extent and severity from baseline on the Eczema Area and Severity Index.References:CIBINQO Package insert. Pfizer Inc; 2023.Data on file. Pfizer Inc; New York, NY.Simpson EL, Silverberg JI, Nosbaum A, et al. Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.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.Simpson EL, Silverberg JI, Nosbaum A, et al. Supplementary appendix to: Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.Cork MJ, Deleuran M, Geng B, et al. Abrocitinib treatment in patients with moderate-to-severe atopic dermatitis: safety of abrocitinib stratified by age. Poster P0189. Presented at: European Academy of Dermatology and Venereology 30th Congress; September 29-October 2, 2021.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.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.
Evaluated in placebo-controlled pivotal trials, up to 16 weeks1,2

AEs of special interest

Adverse events observed in clinical trials may not fully characterize the risks of CIBINQO. Pooled safety analyses over time may provide useful data on long-latency adverse events, but adverse rates may differ in specific populations and may change over time.

LIMITATIONS AND BIASES

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The size of the control groups and duration of treatment do not permit precise comparative assessments for AEs with low frequency or long latency. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk. The zeros listed here indicate that no AEs were observed during the reporting period. This should not be interpreted as zero risk for that AE.

Data shown include one phase 2b and three phase 3 trials. *Exposure-adjusted IRs were adjusted by trial for all of the adverse reactions reported in this section. Patient-year is defined as the aggregate total follow-up time calculated for each event, censored at the time of first event for any given patient, subject to a risk period of up to 28 days beyond the last dose or to the data cutoff date.2 †Opportunistic infections were generally cases of multidermatomal cutaneous herpes zoster.1‡Patients with a history of malignancy, except for treated NMSC and cervical carcinoma in situ, were excluded from enrolling in the trials.1,7,8§MACE was defined as cardiovascular death, myocardial infarction, and stroke.1AE=adverse event; PY=patient-years; IR=incidence rate; NMSC=non-melanoma skin cancer; MACE=major adverse cardiovascular event; EASI-75=≥75% improvement in lesion extent and severity from baseline on the Eczema Area and Severity Index. Explore more Explore more Dosing & Monitoring See dosing and monitoring guidelines Go to Dosing Loading Skin Clearance ResultsSee what CIBINQO could mean for your patients See EASI-75 Data LoadingEASI-75=≥75% improvement in lesion extent and severity from baseline on the Eczema Area and Severity Index.References:CIBINQO Package insert. Pfizer Inc; 2023.Data on file. Pfizer Inc; New York, NY.Simpson EL, Silverberg JI, Nosbaum A, et al. Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.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.Simpson EL, Silverberg JI, Nosbaum A, et al. Supplementary appendix to: Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patient-years of exposure. Presented at: AAD Annual Meeting; March 17-21, 2023; New Orleans, LA.Cork MJ, Deleuran M, Geng B, et al. Abrocitinib treatment in patients with moderate-to-severe atopic dermatitis: safety of abrocitinib stratified by age. Poster P0189. Presented at: European Academy of Dermatology and Venereology 30th Congress; September 29-October 2, 2021.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.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.
Safety Aaron Farberg, MD on CIBINQO Safety

Learn more about the safety profile from the clinical studies of CIBINQO

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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 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.