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


JADE REGIMEN

Evaluating 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 endpoint:

  • 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


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 criteria2

INCLUSION 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 conditions affecting skin

• Prior treatment with any 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, platelet dysfunction, or Q wave interval abnormalities

• Presence or history of certain infections, cancer, 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

Help 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)1,2

Cumulative probability of patients experiencing a flare (200 mg OL →​​​​​​​ 100 mg)2

Help 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 mg2

Cumulative probability of IGA 0/1 response loss, Cibinqo 100 mg2

Cibinqo 200 mg combined with medicated topical therapy recaptured response to treatment after a flare2

Recapture 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 more

Safety

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

View safety guidance

References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.

Dosing

Learn more about flexible dosing in patients on Cibinqo.

Discover oral once-daily dosing

*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.
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics. 2. 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.

JADE REGIMEN

  • Study design
  • Efficacy results: Flare reduction (primary endpoint)
  • Efficacy results: Loss of IGA response (key secondary endpoint)
  • Efficacy results: Flare reduction (secondary endpoint)

Explore the JADE clinical trials

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