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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▼ + Medicated Topicals

JADE COMPARE was a randomised, double-blind, double-dummy, placebo-controlled pivotal phase 3 clinical trial that evaluated the efficacy and safety of CIBINQO in combination with TCS vs placebo + TCS in 837 adult patients with moderate-to-severe AD, with a direct head-to-head comparison vs dupilumab for itch relief, as measured by PP-NRS4, at week 2.1

Skin Clearance

Itch Relief

Patient-reported Outcomes

See full trial design >

Rapid and significant skin clearance results with CIBINQO + TCS1

Data limitations
EASI-75 response for CIBINQO vs placebo at week 12 was a prespecified, multiplicity-controlled primary endpoint and at week 16 was a prespecified multiplicity-controlled key secondary 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. This study was not designed to evaluate CIBINQO vs dupilumab with respect to EASI-75 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

EASI-75 response is defined as at least 75% improvement in EASI score from baseline. 
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required. 
AD=atopic dermatitis; PP-NRS=Peak Pruritus Numerical Rating Scale; EASI=Eczema Area and Severity Index; QD=once a day; Q2W=every 2 weeks.Fast and significant clear or almost-clear skin results achieved with both doses of CIBINQO + TCS1

Data limitations
IGA 0/1 response for CIBINQO vs placebo at week 12 was a prespecified, multiplicity-controlled primary endpoint and at week 16 was a prespecified, multiplicity-controlled key secondary 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. This study was not designed to evaluate CIBINQO vs dupilumab with respect to IGA 0/1 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.
IGA=Investigator’s Global Assessment.A proportion of patients achieved EASI-90, a higher threshold for skin clearance, with either dose of CIBINQO + TCS2,3

A nominal difference was seen as early as week 2 vs placebo2

Data limitations
EASI-90 response was a prespecified secondary endpoint not controlled for multiplicity. Therefore, treatment differences could represent chance findings and no conclusions regarding any comparisons can be made. The study was not designed to evaluate CIBINQO vs dupilumab with respect to EASI-90 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

EASI-90 response is defined as at least 90% improvement in EASI score from baseline.
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.1

Skin clearance you can see1,2
Results seen by week 2 and sustained through week 16, with CIBINQO + TCS 
Images of patients with moderate-to-severe AD from clinical trials. Not everyone will respond to treatment with CIBINQO. Individual results may vary.

Face
SEX: Male CLINICAL TRIAL: JADE COMPARE
AGE: 21 IGA AT BASELINE: Severe
DOSAGE: 200 mg QD IGA AT WEEK 2: Moderate
USE OF MEDICATED TOPICALS: Yes IGA AT WEEK 12: Clear
  IGA AT WEEK 16: Clear
TCS includes low- to medium-potency topical corticosteroids and other medicated topicals.2
See Additional Before and After Photos LoadingJADE COMPARE Study Design

Coprimary endpoints:

  • EASI-75 response at week 12 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline 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 response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 16 vs placebo
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 low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.Patients randomised to dupilumab received a loading dose of 600 mg.At week 16, patients taking placebo were randomised to CIBINQO 200 mg + TCS or CIBINQO 100 mg + TCS.
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.
At week 20, 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.SC=subcutaneous. Explore more About CIBINQO About CIBINQO Loading Rapid and Significant Itch Relief for Patients1,5 See Results Loading

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

References: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.Data on file. Pfizer Inc.; New York, NY.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.Bieber T, Simpson EL, Silverberg JI, et al. Supplementary protocol to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Ständer S, Kwatra SG, Silverberg JI et al. Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial. Am J Clin Dermatol 2023;24:97–107.

See full trial design >

Rapid and superior itch relief vs dupilumab 300 mg + TCS at week 2 with CIBINQO 200 mg + TCS1-3

Data limitations4,5
PP-NRS4 response for CIBINQO vs dupilumab and vs placebo at week 2 was a prespecified key secondary endpoint controlled for multiplicity. The onset of pruritus relief was assessed through a step-down approach, day by day, from week 2 to earlier time points once statistical significance was demonstrated at week 2, at the 5% level of significance. Any hypotheses made after the last day for which the comparison was significant was not considered statistically significant. P values at day 4 and day 9 are controlled for multiplicity for the family of PP-NRS4 comparisons. 

PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS. 
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.CIBINQO was compared to dupilumab in a key secondary head-to-head endpoint at week 2. This endpoint was further analysed as a prespecified, multiplicity-controlled analysis and CIBINQO 200 mg + TCS showed superiority vs dupilumab down to day 4. The difference in PP-NRS4 between CIBINQO 100 mg + TCS and dupilumab + TCS was not statistically significant at week 2.
AD=atopic dermatitis; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day; Q2W=every 2 weeks.JADE COMPARE Study Design

Coprimary endpoints:

  • EASI-75 response at week 12 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline 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 response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 16 vs placebo
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 low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.Patients randomised to dupilumab received a loading dose of 600 mg.At week 16, patients taking placebo were randomised to CIBINQO 200 mg + TCS or CIBINQO 100 mg + TCS.
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.
At week 20, 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.
SC=subcutaneous; EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment.Explore more About CIBINQO About CIBINQO Loading Quality of Life Improvements With CIBINQO + Medicated Topicals4,6,7 See Results Loading

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

References: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.Ständer S, Kwatra SG, Silverberg JI et al. Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial. Am J Clin Dermatol 2023;24:97–107.Data on file. Pfizer Inc.; New York, NY.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.Bieber T, Simpson EL, Silverberg JI, et al. Supplementary protocol to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.CIBINQO Summary of Product CharacteristicsThyssen JP, Yosipovitch G, Paul C, et al. Supplementary appendix to: Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis [published online ahead of print, 2021 Nov 15]. J Eur Acad Dermatol Venereol. 2021;10.1111/jdv.17813. doi:10.1111/jdv.17813

See full trial design >

In a post hoc analysis, 

Patients reported improvement in the severity of AD symptoms by week 12 with CIBINQO + TCS vs placebo + TCS²

POEM is a patient-reported outcome used to evaluate AD severity by measuring frequency of symptoms in AD over a week’s duration, including itch, sleep disturbance, bleeding skin, weeping/oozing skin, cracked skin, flaking skin, and dry/rough skin, from the patient’s perspective.3 

At baseline, the mean value for POEM total score was 21.1 for all groups, which represents severe AD symptoms. The graph above represents percentage of patients who achieved clear or almost-clear AD symptoms.1,4

Data limitations
POEM total score 0-2 (clear/almost-clear response) was a post hoc analysis and the P values are nominal. The study was not designed to evaluate CIBINQO vs dupilumab with respect to POEM. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

POEM is the copyright of the University of Nottingham.
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.
A POEM score of 0-2 is defined as clear or almost-clear AD symptoms.4,5Analysis included the subset of patients with ≥3 points in POEM at baseline.AD=atopic dermatitis; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day; Q2W=every 2 weeks.

In a post hoc analysis,

~9/10 patients reported a clinically meaningful improvement in QoL with CIBINQO 200 mg + TCS at week 122,6

DLQI is designed to measure the health-related quality of life in patients with dermatologic conditions. An improvement of ≥4-point reduction in DLQI score is considered clinically meaningful.1,6

Data limitations
DLQI improvement ≥4 points was a post hoc analysis and the P values are nominal.
The study was not designed to evaluate CIBINQO vs dupilumab with respect to DLQI. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.
QoL=quality of life.

In a post hoc analysis,

Patients reported rapid improvement in sleep loss related to AD with CIBINQO + TCS at week 122,7

SCORAD is a clinical tool used to assess the extent and severity of AD. This tool takes into account body area, AD intensity, and subjective symptoms, such as itch and sleep, for the past 3 nights. SCORAD VAS sleep loss is one domain of the composite SCORAD.1,8

Data limitations
SCORAD VAS sleep loss <2 response was a post hoc analysis and the P values are nominal. 
The study was not designed to evaluate CIBINQO vs dupilumab with respect to SCORAD VAS sleep loss subscale. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.1 A SCORAD sleep loss score of <2 is defined as minimal or no sleep loss.7VAS=visual analog scale.JADE COMPARE Study Design

Coprimary endpoints:

  • EASI-75 response at week 12 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline 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 response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 16 vs placebo
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 low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.
Patients randomised to dupilumab received a loading dose of 600 mg.At week 16, patients taking placebo were randomised to CIBINQO 200 mg + TCS or CIBINQO 100 mg + TCS.
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.
At week 20, 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.
SC=subcutaneous; EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment.Explore moreAbout CIBINQO About CIBINQO Loading Skin Clearance With CIBINQO as Monotherapy11,12 See Results Loading

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

References: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.Thyssen JP, Yosipovitch G, Paul C, et al. Supplementary appendix to: Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis [published online ahead of print, 2021 Nov 15]. J Eur Acad Dermatol Venereol. 2021;10.1111/jdv.17813. doi:10.1111/jdv.17813Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients’ perspective. Arch Dermatol. 2004;140(12):1513-1519.Charman CR, Venn AJ, Ravenscroft JC, Williams HC. Translating Patient-Oriented Eczema Measure (POEM) scores into clinical practice by suggesting severity strata derived using anchor-based methods. Br J Dermatol. 2013;169(6):1326-1332.The University of Nottingham. POEM – Patient-oriented eczema measure. Accessed 10 June 2021. https://www.nottingham.ac.uk/research/groups/cebd/documents/methodological-resources/poem-for-self-completion-or-proxy-completion.pdfBasra MKA, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.Simpson EL, Bieber T, Eckert L, et al. Patient burden of moderate to severe atopic dermatitis (AD): insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. 2016;74(3):491-498.European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Dermatology. 1993;186(1):23-31.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.Bieber T, Simpson EL, Silverberg JI, et al. Supplementary protocol to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.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.
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
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PP-CIB-IRL-0087 June 2023

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