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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.
Overview

JADE Clinical Program Overview

Efficacy Overview

The JADE clinical program evaluated >3580 patients with moderate-to-severe AD1-7

Key endpoints and objectives studied in clinical trials:

 JADE MONO-1 and MONO-2

Studied CIBINQO vs placebo as monotherapy in 654 adult patients2,3

  • Skin clearance (EASI-75 and IGA 0/1) at week 12 
  • Itch relief (PP-NRS4) at weeks 2, 4, and 12
 See full trial design & results Loading JADE COMPARE

Studied CIBINQO vs placebo and vs dupilumab as a combination therapy with TCS in 837 adult patients1

  • Skin clearance (EASI-75 and IGA 0/1) vs placebo at weeks 12 and 16
  • Head-to-head vs dupilumab in itch relief (PP-NRS4) at week 2
 See full trial design & results Loading JADE REGIMEN

Studied CIBINQO as monotherapy in 987 adults and 246 adolescents aged  ≥12 years (N=1233)4

Responders* (n=798) were identified after 12-week OL treatment with CIBINQO 200 mg and randomised to CIBINQO 200 mg, CIBINQO 100 mg, or placebo during a 40-week maintenance period to assess: 

  • Loss of response (risk and probability of flare)† requiring rescue medication during the maintenance period and proportion of patients who recaptured EASI-75 with rescue treatment (CIBINQO 200 mg + TCS) when flaring†
See full trial design & results Loading JADE EXTEND

An ongoing long-term extension safety and efficacy study evaluating CIBINQO +/- TCS in adults and adolescents aged  ≥12 years8,9

  • Safety and efficacy endpoints assessed beyond 92 weeks
  • Efficacy interim analysis at 48 weeks of treatment




 

An ongoing long-term extension safety and efficacy study evaluating CIBINQO +/- TCS in adults and adolescents aged ≥12 years7,8

  • Safety and efficacy endpoints assessed beyond 92 weeks
  • Efficacy interim analysis at 48 weeks of treatment
Patients who completed‡ a qualifying parent study were eligible to transition into JADE EXTEND. See full trial design & interim results Loading JADE DARE

Head-to-head clinical trial studied CIBINQO 200 mg vs dupilumab as a combination therapy with TCS in 727 adult patients6

  • Itch relief (PP-NRS4) at week 2 
  • Skin clearance (EASI-90) at week 4 and week 16



 

Head-to-head clinical trial studied CIBINQO 200 mg vs dupilumab as a combination therapy with TCS in 727 patients aged ≥18 years6

  • Itch relief (PP-NRS4) at week 2 
  • Skin clearance (EASI-90) at week 4 and week 16
Title
CIBINQO has been extensively studied in 7 phase 3 trials, including 1 ongoing long-term trial evaluating safety and efficacy in patients with moderate-to-severe AD1-7
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 and JADE DARE. Nonmedicated topicals were also required.1,6
TCS 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.
+/- 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.Responder criteria at week 12 are defined as achieving an IGA 0/1 with a reduction from baseline of ≥2 points and reaching EASI-75.Protocol-defined flare requiring rescue treatment: A loss of at least 50% of the EASI response achieved at week 12 (open-label induction period) plus a new IGA score of 2 or higher.Patients from JADE REGIMEN who completed the OL period and were nonresponders were eligible to transition into JADE EXTEND, in addition to patients who completed the rescue period.

Although some clinical trials 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.

Explore moreSee patient results with CIBINQO in the JADE clinical programBefore and After Photos Loading Dosing Find out more Loading

AD=atopic dermatitis; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; PP-NRS=Peak Pruritus Numerical Rating Scale; OL=open-label.

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.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.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.Eichenfield 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. [published correction appears in JAMA Dermatol. 2021 Oct 1;157(10):1246] JAMA Dermatol. 2021;157(10):1165-1173.Reich K, Thyssen JP, Blauvelt A et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. Lancet. 2022 Jul 23;400(10348):273-282.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.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
Take on the variability of your patients’ moderate-to-severe AD with CIBINQO▼, a once-daily oral treatment1-3

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy4

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.
+/- 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.
†Interim analysis of patients enrolled in JADE EXTEND after completing JADE MONO-1, JADE MONO-2, or JADE COMPARE, and who completed 96 weeks of observation in JADE EXTEND. Study is ongoing. Approx. 60% of subjects had reached week 96 at time of data cut-off (Sept. 2021). Data presented as observed.

AD=atopic dermatitis; EASI=Eczema Area and Severity Index; PP-NRS=Peak Pruritus Numerical Rating Scale; Q2W=every 2 weeks.

Although some clinical trials 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. Explore more Learn More About CIBINQOAbout CIBINQOLoading Skin Clearance With CIBINQO + Medicated Topicals 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.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.CIBINQO Summary of Product Characteristics.Data on file. Pfizer Inc.; New York, NY.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.
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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