This site is intended for Great Britain healthcare professionals only 

Visit Pfizer Medical site
Search

Menu

Close

Sign In or RegisterLog Out
Pfizer MedicinesTherapy AreasExplore ContentEventsVideosMaterialsLet’s ConnectStock Hub

Menu

Close

AboutAboutHow Cibinqo worksIntroducing CibinqoMOA OverviewPatient ProfilesPatient Profiles OverviewPatient Profile 1Patient Profile 2Patient Profile 3Patient Profile 4EfficacyEfficacyClinical EfficacyStudy OverviewJADE COMPAREJADE MONOJADE REGIMENJADE TEENJADE EXTENDSafety
Safety
 
Safety
 
Safety Guidance
DosingDosingDosingOral once-daily dosingPractical ConsiderationsSupport & ResourcesSupport & ResourcesHCP ResourcesMedicine Evidence InformationPatient ResourcesVideos
Materials

Information on how to access Cibinqo® (abrocitinib) prescribing information and adverse event reporting can be found at the bottom of the page.

JADE REGIMENEvaluating the durability of Cibinqo response with dose maintenance, reduction or withdrawal, and the potential to recapture efficacy1,2

A responder-enriched trial in which 1,233 patients with moderate-to-severe AD were enrolled in an initial 12-week open-label run-in period from which responders (defined as achieving an IGA of clear (0) or almost clear (1) with a reduction from baseline of ≥2 points and reaching an EASI-75 from baseline) continued onto a randomised, 40-week, double-blind, monotherapy, maintenance treatment period on Cibinqo 200 mg, 100 mg or placebo, followed by a 4-weeks untreated follow-up safety period. Patients who met the protocol definition of flare during the blinded treatment entered an open-label rescue treatment period during which they received another 12-week course of Cibinqo 200 mg with topical therapy and the ability to recapture response was assessed.2

STUDY DESIGN2

*Eligible patients had the option to enter JADE EXTEND, a long-term extension study, after completing the initial 12-week treatment, the 12-week rescue treatment, and the 40-week maintenance treatment.

Primary endpoint:
  • Protocol-defined flare requiring rescue treatment
Key secondary endpoints:
  • Loss of response defined as an IGA ≥2
Biases:
  • Study patients may exhibit greater aggregate efficacy responses in this type of trial design than the same measures from phase III, double-blind, placebo-controlled trials because randomised withdrawal studies are enriched with responders

  • ​​​​​The run-in phase was open label; all subjects knew they were taking Cibinqo 200 mg
Baseline characteristics2
Scroll left to view table


Randomised maintenance period

Open-label induction period (N=1,233) All (N=798) Placebo (N=267) Cibinqo 100 mg (N=265) Cibinqo 200 mg (N=266)  
Rescue period (N=351)

Age, years
​​​​​​​
• <18
• Median (Q1, Q3)
​​​​​​​• 246 (20.0)
• 28.0 (20.0, 41.0)
​​​​​​​• 145 (18.2)
• 29.0 (20.0, 41.0)
​​​​​​​• 49 (18.4)
• 29.0 (20.0, 40.0)
​​​​​​​• 49 (18.5)
• 29.0 (20.0, 41.0)
​​​​​​​• 47 (17.7)
• 28.0 (20.0, 42.0)
• 64 (18.2)
• 30.0 (21.0, 41.0)
Men, n (%)  
​​​​​​​684 (55.5)
​​​​​​

 
​​​​​​​439 (55.0)
​​​​

141 (52.8)  
148 (55.8)
​​​

150 (56.4)  
198 (56.4)
​​​​

Race, n (%)
• White
• Black or African American
 Asian
 Other*
• 931 (75.5)
• 75 (6.1)
• 196 (15.9)
• 31 (2.5)
​​​​​​​• 621 (77.8)
 33 (4.1)
​​​​​​​• 124 (15.5)
​​​​​​​• ​​​​​​​20 (2.6)
 209 (78.3)
 14 (5.2)
​​​​​​​• 38 (14.2)
​​​​​​​• 6 (2.3)
​​​​​​​• 208 (78.5)
 9 (3.4)
​​​​​​​• 41 (15.5)
​​​​​​​• 7 (2.9)
​​​​​​​• 204 (76.7)
 10 (3.8)
​​​​​​​• 45 (16.9)
​​​​​​​• 7 (2.9)
​​​​​​​• 268 (76.4)
 14 (4.0)
​​​​​​​• 61 (17.4)
​​​​​​​• 8 (2.2)
Ethnicity, n (%)
• Not Hispanic or Latino
• Hispanic or Latino
 Not reported/unknown
• 981 (79.6)
• 246 (20.0)
• 1 (0.1)
• 617 (77.3)
• 179 (22.4)
• 2 (0.3)
• 200 (74.9)
• 65 (24.3)
• 2 (0.7)
• 203 (76.6)
• 62 (23.4)
• 0
• 214 (80.5)
• 52 (19.5)
• 0
• 283 (80.6)
• 67 (19.1)
• 0
Disease duration, median y (Q1, Q3)  
​​​​​​​17.6 (9.4, 28.3)

 
​​​​18.4 (9.3, 30.1)
17.6 (9.0, 30.1)  
​​​​​18.4 (10.0, 30.0)

19.5 (9.2, 30.2)  
​​​​​​​19.3 (10.0, 30.5)

IGA, n (%)
• Moderate
• Severe
​​​​​​​• 729 (59.1)
• 504 (40.9)

• 508 (63.7)
• 290 (36.3)

• 177 (66.3)
• 90 (33.7)
• 161 (60.8)
​​​​​​​• 104 (39.2)

• 170 (63.9)
​​​​​​​• 96 (36.1)
• 223 (63.5)
​​​​​​​• 128 (36.5)

EASI, median (Q1, Q3) 27.9 (21.0, 37.8) 27.2 (20.8, 36.0) 26.9 (20.6, 37.2) 27.7 (21.3, 36.5) 27.2 (20.7, 35.1) 27.7 (21.3, 37.2)
Percent BSA affected by AD, median % (Q1, Q3) 45.5 (31.0, 63.0)

44.8 (30.2, 62.0)

43.0 (30.6, 60.0) 46.0 (29.7, 63.0)

46.0 (31.0, 63.5) 46.2 (31.6, 64.0)

PP-NRS, median severity (Q1, Q3) 8.0 (6.0, 9.0)

7.0 (6.0, 8.0)

7.0 (6.0, 9.0) 7.0 (6.0, 8.0)

7.5 (6.0, 9.0) 7.0 (6.0, 9.0)

PSAAD, n
​​​​​​​
• Median score (Q1, Q3)
1143
​​​​​​​5.5 (3.9, 7.1)
739
​​​​​​​5.4 (3.8, 7.0)
248
​​​​​​​5.5 (3.8, 6.9)
240
​​​​​​​5.3 (4.0, 6.9)
251
​​​​​​​5.2 (3.9, 7.3)
314
5.3 (3.8, 6.9)
SCORAD, n
​​​​​​​
• Median (Q1, Q3)
1230 67.1 (57.7, 77.1) 797 66.3 (57.6, 76.0) 266 64.9 (57.4, 76.4) 265 67.8 (58.5, 75.8) 266 66.4 (56.8, 75.9) 350 66.3 (57.6, 76.2)
DLQI, n
​​​​​​​
• Median (Q1, Q3)
965
​​​​​​​16.0 (12.0, 21.1)
639
​​​​​​​16.0 (12.0, 21.0)
210
​​​​​​​16.0 (12.0, 21.0)
216
​​​​​​​16.0 (11.0, 20.0)
213
​​​​​​​16.0 (12.0, 22.0)
279
​​​​​​​16.0 (12.0, 21.0)
CDLQI, n
​​​​​​​
• Median (Q1, Q3)
235 12.0 (8.0, 16.0

140 12.0 (7.5, 16.0)

46
​​​​​​​12.5 (8.0, 19.0)
48
​​​​​​​12.0 (8.0, 15.5)

46 10.0 (7.0, 15.0) 62 11.0 (7.0, 16.0)

POEM, n
​​​​​​​
• Median (Q1, Q3)
1200
​​​​​​​21.0 (16.0, 25.0)
779 21.0 (16.0, 25.0) 256 21.0 (17.0, 24.0) 264 20.0 (16.0, 24.0) 259 21.0 (17.0, 25.0) 341 21.0 (17.0, 24.0)
​​​​​​​Prior medication
• No prior medication
• Topical agents only
• ​​​​​​​Systemic agents
   – Non-biologic
   – Biologic
     – Dupilumab
​​​​​​​     – Other biologic agents
•4 (0.3)
• 487 (39.5)
• 742 (60.2)
   - 656 (53.2)
   - 86 (7.0)
     - 65 (5.3)
​​​​​​​     - 27 (2.2)

 • 1 (0.1)
• 322 (40.4)
• 475 (59.5)
   - 431 (54.0)
   - 44 (5.5)
     - 32 (4.0)
​​​​​​​     - 15 (1.9)
​​​

• 0
• 102 (38.2)
• 165 (61.8)
   - 152 (56.9)
   - 13 (4.9)
     - 9 (3.4)
​​​​​​​     - 4 (1.5)
• 1 (0.4)
• 118 (44.5)
• 146 (55.1)
   - 130 (49.1)
   - 16 (6.0)
     - 12 (4.5)
​​​​​​​     - 5 (1.9)

 0
​​​​​​​• 102 (38.3)
• 164 (61.7)
   - 149 (56.0)
   - 15 (5.6)
     - 11 (4.1)
​​​​​​​     - 6 (2.3)
• 1 (0.3)
• 125 (35.6)
• 225 (65.1)
   - 201 (57.3)
   - 24 (6.8)
     - 19 (5.4)
​​​​​​​     - 6 (1.7)

*Other includes American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, multiracial, and not reported.

Topical agents include corticosteroids, calcineurin inhibitors, and crisaborole.

Systemic agents included corticosteroids, cyclosporin, nonbiologic agents, and biologic agents.

Inclusion/exclusion criteria2INCLUSION CRITERIA2
  • ≥12 years of age
  • Body weight ≥40 kg
  • Clinically diagnosed with chronic AD for ≥1 year, confirmed by Hanifin and Rajka criteria of AD at the screening and baseline visits
  • Have a documented history of inadequate response to treatment with topical medications or require systemic therapies to control their disease
  • Moderate-to-severe AD defined as BSA ≥10%, IGA ≥3, EASI ≥16, and PP-NRS ≥4 at the baseline visit
EXCLUSION CRITERIA2
  • Active forms of other inflammatory skin diseases or condition affecting skin
  • Prior treatment with any systemic JAK inhibitors
  • Unwillingness to discontinue current AD medications prior to the study
  • Requiring treatment with prohibited medications during the study
  • Medical history of thrombocytopenia, coagulopathy or platelet dysfunction, or Q wave interval abnormalities
  • Presence or history of certain infections, cancers, lymphoproliferative disorders, and other medical conditions at the discretion of the investigator
  • Pregnant or breastfeeding women
  • Women of childbearing potential who are unwilling to use contraception
PRIMARY ENDPOINT – FLARE REDUCTIONHelp your patients reduce flares* with Cibinqo1,2

Whether continuing on Cibinqo 200 mg or decreasing dose to Cibinqo 100 mg, patients had a significantly higher probability of preventing flares up to Week 52 with Cibinqo vs placebo.1,2

Cumulative probability of patients experiencing a flare (200 mg OL →​​​​​​​ 200 mg)1,2Cumulative probability of patients experiencing a flare (200 mg OL →​​​​​​​ 100 mg)2KEY SECONDARY ENDPOINT – LOSS OF IGA RESPONSEHelp your patients maintain skin clearance with Cibinqo2

Whether continuing on Cibinqo 200 mg or decreasing dose to Cibinqo 100 mg, patients had a significantly higher probability of maintaining IGA 0/1 response up to Week 52 with Cibinqo vs placebo.2

Cumulative probability of IGA 0/1 response loss, Cibinqo 200 mg2Cumulative probability of IGA 0/1 response loss, Cibinqo 100 mg2SECONDARY ENDPOINT – FLARE REDUCTIONCibinqo 200 mg combined with medicated topical therapy recaptured response to treatment after a flare2Recapture of EASI-75 response with 12 weeks of rescue treatment (in combination with medicated topical therapy)2

Data limitations: These are prespecified secondary endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made. Patients in the open-label rescue period received a 12-week course of Cibinqo 200 mg with medicated topical therapy per local standard of care.

Recapture was defined as an improvement of EASI-75 relative to EASI score at the start of rescue therapy.
Explore moreSafety

3,128 patients were treated with Cibinqo in clinical studies in AD representing 2,089 patient-years of exposure.1

View safety guidanceLoading
Dosing

Learn more about flexible dosing in patients on Cibinqo.

Discover oral once-daily dosingLoading

*Protocol-defined flare definition: A loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.
This study included a 12-week induction period.

​​​​​​​AD=atopic dermatitis; BSA=body surface area; CI=confidence interval; CDLQI=Children's Dermatology Life Quality Index; DLQI=Dermatology Life Quality Index; EASI=Eczema Area and Severity Index; HR=hazard ratio; IGA=Investigator’s Global Assessment; JAK=Janus kinase; OL=open label; POEM=Patient-Oriented Eczema Measure; PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis; PtGA​​​​​​​=Patient Global Assessment; SCORAD=SCORing Atopic Dermatitis.

Prescribing information:​​​​​​​
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 200 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 100 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 50 mg film-coated tablets.

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.Blauvelt A, et al. JAAD 2021; doi.org/10/1016/j.jaad.2021.05.075.
PP-CIB-GBR-0064. October 2021

Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc. Patients treated with Cibinqo should be given the Patient Card.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store


Adverse events should also be reported to Pfizer Medical Information on 01304 616161

PfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign In or RegisterAccountSign Out

This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc


This website is brought to you by Pfizer Limited, a company registered in England 

and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ


Copyright © 2021 Pfizer Limited. All rights reserved.


VAT registration number GB201048427

PP-PFE-GBR-3849. November 2021

Add indication message here. It can link a link,
and you can EMBOLDEN text

OK, We will need you to sign in before we can determine if you are aligned with a Pfizer promotional colleague.

If you have already registered with pfizerpro.co.uk and select ‘yes’, you will be directed to the sign-in page where you will be required to enter your username and password.

Would you like to register or sign in now?

You are now leaving PfizerPro
​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned or controlled by Pfizer Ltd. 

​​​​​​​Pfizer accepts no responsibility for the content or services of the linked site.​​​​​​​​​​​​​​

​​​​​​​PP-PFE-GBR-3858. November 2021​​​​​​​
​​​​​​​
For UK Healthcare Professionals *

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021

Yes No
You are now leaving PfizerPro
​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to ​​​​​Pfizer medicines or 
business which it has provided or reviewed.

PP-PFE-GBR-3859. November 2021
​​​​​​​