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About CIBINQOEfficacyEfficacyOverviewEfficacy of CIBINQO + Medicated TopicalsEfficacy of CIBINQO Without Medicated TopicalsReduction in Risk of FlaresLong-term Efficacy ResultsBefore and After PhotosGlossarySafetySafetySafety ProfileSafety ConsiderationsLab AbnormalitiesDosing & MonitoringDosing &
MonitoringDosingLab Monitoring

Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
Safety Profile
CIBINQO▼ should only be used if no suitable treatment alternatives are available in patients:
-65 years of age and older;
-patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
-patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

Adverse reactions in
placebo-controlled
trials

Adverse events of 
special interest*

Adverse events
with variable dosing
​​​​​​​(JADE REGIMEN)

Header
Consistent safety profile with CIBINQO in clinical trials¹

Most common adverse reactions observed in 5 placebo-controlled phase 2 and 3 trials up to 16 weeks, with CIBINQO in adults and adolescents

• The most common adverse reactions were dose-dependent2
• The majority of adverse reactions were mild or moderate in severity2
• The most frequent serious adverse reactions were infections (0.3%)3
• In clinical studies, CIBINQO was administered without regard to food3

Title
Most cases of nausea were mild to moderate in severity, typically resolved in ~2 weeks, and infrequently led to discontinuation (0.4%). Taking CIBINQO with food may improve nausea³
Includes pooled results from a phase 2b, placebo-controlled, dose-ranging study and phase 3, placebo-controlled trials, including JADE MONO-1, JADE MONO-2, JADE COMPARE, and JADE TEEN.1,3*Creatine kinase (U/L) >5x ULN.
  ULN=upper limit of normal.

Please refer to the CIBINQO Summary of Product Characteristics for complete safety information.

Explore more
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Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.

References:Data on file. Pfizer Inc.; New York, NY.
Simpson EL, Silverberg JI, Nosbaum A, et al. Integrated safety analysis of abrocitinib for the treatment of moderate-to-severe atopic dermatitis from the phase II and phase III clinical trial program. Am J Clin Dermatol. 2021;22(5):693-707.CIBINQO Summary of Product CharacteristicsSimpson 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. 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.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.
CIBINQO has demonstrated a consistent safety profile across 7 clinical trials, with  patients having exposure to CIBINQO for ~2 years1 Adverse events of special interest observed during ~2 years1-3*

This analysis includes patients treated with CIBINQO, including pooled phase 2b and 3 studies and an analysis of the ongoing long-term extension study (N=2784).†

In the consistent-dose cohort, 1451 patients taking CIBINQO had at least 48 weeks of constant exposure and 554 patients had at least 96 weeks of exposure.1

These data include a safety analysis of patients who received the same dose of CIBINQO during the parent studies and JADE EXTEND (consistent dose cohort). The data cutoff was 16 April 2021.

All opportunistic infections, excluding tuberculosis, were cases of herpes zoster. Most cases were multidermatomal cutaneous herpes zoster, and the majority were mild or moderate.


No patients received placebo after completing the parent study. Patients taking placebo or dupilumab in the parent studies were initiated with either dose of CIBINQO following the completion of the parent trial as per study protocol  
  • Incidence rates are used to express safety data over time, taking into account the length of exposure of each patient while on treatment 
  • An assessment of long-term risk of malignancy requires longer periods of surveillance, which is ongoing  
Long-term safety data also included patients with more than 96 weeks of exposure.Includes pooled results from a phase 2b,dose-ranging study and phase 3 trials,including JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE TEEN, non-responders in the open-label period of JADE REGIMEN, JADE DARE, and interim safety analysis of JADE EXTEND, with a data cutoff of 16 April 2021.      QD=once a day; MACE=major adverse cardiovascular event

Please refer to the CIBINQO Summary of Product Characteristics for complete safety information.

JADE EXTEND Study Design

Long-term extension study design2,3

An ongoing long-term extension trial with a 92-week primary treatment period followed by an open-label, variable duration treatment period to evaluate the safety and efficacy of CIBINQO, with or without TCS,* in adult and adolescent patients with moderate-to-severe AD who have previously participated in a qualifying parent clinical trial.
  • JADE EXTEND is currently ongoing3
  • Qualifying parent studies that transition to the long-term extension trial include: JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE DARE,† JADE TEEN, and JADE REGIMEN§1
  • Patients studied in JADE EXTEND were allowed to use nonmedicated and medicated topical therapies as needed3
Primary endpoint:4
  • Long-term safety
Secondary endpoints:4
  • EASI-75 at all scheduled time points
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at all scheduled time points
  • PP-NRS4 at all scheduled time points
EASI-75 response is defined as at least 75% improvement in EASI score from baseline. PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.+/- TCS includes any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors and were permitted throughout JADE EXTEND, per the treating physician’s usual practice. Nonmedicated topicals were also permitted. Other systemic therapies for AD (eg, systemic corticosteroids, traditional immunosuppressive therapies, or biologics) were prohibited during JADE EXTEND.2,3All subjects enrolling from JADE DARE received CIBINQO 200 mg open-label in JADE EXTEND, including all patients from the dupilumab arm.2Subjects continue to receive CIBINQO in the long-term extension trial until availability of commercial CIBINQO or until the study is terminated in their respective country.4Subjects enrolling from the open-label period of JADE REGIMEN who were nonresponders continued receiving CIBINQO 200 mg open label in JADE EXTEND.4AD=atopic dermatitis; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; PP-NRS=Peak Pruritus Numerical Rating Scale.
Explore more Have Any Questions About CIBINQO Safety? Request an eRep Call Loading Adverse events with variable dosing (JADE REGIMEN) See Data Loading
Take On Moderate-to-Severe AD With CIBINQO
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Take On Moderate-to-Severe AD With CIBINQO

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Dosing Find out moreLoading

Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.

References: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; 7–10 September 2022.Data on file. Pfizer Inc.; New York, NY.Reich K, Silverberg JI, Papp K, et al. Long-term management of moderate-to-severe atopic dermatitis with abrocitinib: a phase 3 extension study (JADE EXTEND). Presented at: Revolutionizing Atopic Dermatitis Virtual Conference; 13 June 2021.
ClinicalTrials.gov identifier: NCT03422822. Study to evaluate efficacy and safety of PF-04965842 with or without topical medications in subjects aged 12 years and older with moderate to severe atopic dermatitis (JADE EXTEND). Updated 14 May 2021. Accessed 9 June 2021. https://www.clinicaltrials.gov/ct2/show/NCT03422822
Adverse events with variable dosing (JADE REGIMEN)
  • One nonfatal serious event of retinal vein thrombosis occurred, leading to discontinuation of CIBINQO 100 mg during the maintenance period²
In the randomised period of JADE REGIMEN, patients had different times of exposure to placebo or CIBINQO, depending on two factors: 1) if the patients flared or not during this 40-week period and 2) for those patients who flared, and when they flared during the treatment period. Given these different exposures, safety comparisons between the treatment arms cannot be directly made.²Please refer to the CIBINQO Summary of Product Characteristics for complete safety information.TEAE=treatment-emergent adverse event; OL=open label; URTI=upper respiratory tract infection.JADE REGIMEN Study Design
 Primary endpoint:
  • Loss of response or protocol-defined flare requiring rescue treatment 
Key secondary endpoint:
  • Loss of IGA 0/1 response
Eligible subjects had the option to enter JADE EXTEND, a long-term extension study. Patients who did not meet the responder criteria at the end of the induction period, as well as eligible patients who completed the maintenance period or the rescue period, had the option to enter JADE EXTEND.2,3TCS in the rescue period of JADE REGIMEN included any potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, used per investigator’s usual practice in JADE REGIMEN.2,4EASI-75 response is defined as at least 75% improvement in EASI score from baseline.AD=atopic dermatitis; IGA=Investigator’s Global Assessment; EASI=Eczema Area and Severity Index; QD=once a day.
Explore more Have Any Questions About CIBINQO Safety? Request an eRep Call Loading
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Safety Considerations Learn More Loading
Take On Moderate-to-Severe AD With CIBINQO
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Take On Moderate-to-Severe AD With CIBINQO

Discover the efficacy of CIBINQO

 See Efficacy Overview Loading
Dosing Find out moreLoading

Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.

References:Blauvelt A, Silverberg JI, Lynde CW, et al. Supplementary appendix to: Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial. J Am Acad Dermatol. 2022;86(1):104-112. 
Blauvelt A, Silverberg JI, Lynde CW, et al. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial. J Am Acad Dermatol. 2022;86(1):104-112.
ClinicalTrials.gov. Study to investigate efficacy and safety of PF-04965842 in subjects aged 12 years and over with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects. ClinicalTrials.gov identifier: NCT03627767. Updated 20 January 2021. Accessed 9 June 2021. https://www.clinicaltrials.gov/ct2/show/NCT03627767Data on file. Pfizer Inc.; New York, NY.
Safety
Take On Moderate-to-Severe AD With CIBINQO

Discover the efficacy of CIBINQO

 See Efficacy OverviewLoading

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Legal Category: S1A
Further information is available upon request

PP-CIB-IRL-0093 June 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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