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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.
Efficacy of CIBINQO▼ Without Medicated Topicals

JADE MONO-1 and MONO-2 were two identically designed, randomised, double-blind, placebo-controlled pivotal phase 3 clinical trials that evaluated the efficacy and safety of CIBINQO as monotherapy vs placebo in 387 and 391 patients with moderate-to-severe atopic dermatitis (AD).1,2

Although this clinical trial included adolescents, please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

Skin Clearance

Itch Relief

See full trial design >

Significant skin clearance you can see, without use of TCS1-3

Data limitations
EASI-75 response at week 12 was a prespecified, multiplicity-controlled primary endpoint. All other time points were prespecified, non–multiplicity-controlled secondary endpoints. Therefore, treatment differences could represent chance findings and no conclusions regarding other comparisons can be made.

EASI-75 response is defined as at least 75% improvement in EASI score from baseline. 
Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.
AD=atopic dermatitis; EASI=Eczema Area and Severity Index; QD=once a day.Skin clearance you can see1-3
Results seen by week 12, without TCS 

Images of patients with moderate-to-severe AD from clinical trials. Not everyone will respond to treatment with CIBINQO. Individual results may vary. 

Legs
SEX: Female CLINICAL TRIAL: JADE MONO-2
AGE: 43 IGA AT BASELINE: Severe
DOSAGE: 200 mg QD IGA AT WEEK 12: Moderate
USE OF MEDICATED TOPICALS: No
Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.1,2
TCS=topical corticosteroids; IGA=Investigator's Global Assessment.
 See Additional Before and After Photos LoadingJADE MONO Study Design

Study design1,2

    •     In JADE MONO-1 and MONO-2, a total of 124 adolescents were studied.

Please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. 

Coprimary endpoints:

  • EASI-75 response at week 12 
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 12 
Key secondary endpoints:
  • PP-NRS4 response at weeks 2, 4, and 12
  • PSAAD change from baseline at week 12
Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.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.At week 12, eligible subjects had the option to enter JADE EXTEND, the long-term extension study; all other subjects entered the 4-week, off-treatment, follow-up period.4,5
PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis.Explore moreAbout CIBINQO About CIBINQO LoadingRapid and Significant Itch Relief for Patients2,5 See Results Loading

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

References: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.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.Data on file. Pfizer Inc.; New York, NY.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.

See full trial design >

Rapid and significant itch relief through week 12 without TCS1-3

Data limitations
Only PP-NRS4 responses at weeks 2, 4, and 12 were prespecified key secondary endpoints controlled for multiplicity.

Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.
PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.
AD=atopic dermatitis; TCS=topical corticosteroids; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day.JADE MONO Study Design

Study design1,2
  • In JADE MONO-1 and MONO-2, a total of 124 adolescents were studied. Please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. 

Coprimary endpoints:

  • EASI-75 response at week 12 
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 12 

Key secondary endpoints:

  • PP-NRS4 response at weeks 2, 4, and 12
  • PSAAD change from baseline at week 12
Patients in JADE MONO-1 and MONO-2 did not receive topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, and rescue treatment was not permitted during the trials.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. At week 12, eligible subjects had the option to enter JADE EXTEND, the long-term extension study; all other subjects entered the 4-week, off-treatment, follow-up period.3,4PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis.Explore more About CIBINQO About CIBINQO LoadingDosing Find out more Loading

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

References: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.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.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.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.
Efficacy
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-0087 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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