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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 TEEN

Evaluating the efficacy and safety of Cibinqo in adolescent patients aged 12–171,2​​​​​​​


​​​​​​​This pivotal Phase III clinical trial evaluated the efficacy and safety of Cibinqo in combination with medicated topical therapy versus placebo in 285 adolescent patients age 12–17 years with moderate-to-severe AD.2

​​​​​STUDY DESIGN2

*Patients not eligible for JADE EXTEND entered the 4-week off-treatment follow-up period.
Patients used non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors, or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study.

Co-primary endpoints:

  • IGA response (0/1 with a ≥2-grade improvement) at Week 12 vs placebo
  • EASI-75 response at Week 12 vs placebo

Key secondary endpoints:

  • PP-NRS4 improvement at Weeks 2, 4 and 12
  • Change from baseline in PSAAD at Week 12

Baseline characteristics2

No. (%)

Cibinqo

Placebo (N=96)

100 mg (N=95)

200 mg (N=94)

All
​​​​​​​(N=285)

Age, median (IQR), y

14.0 (13.5–16.5)

16.0 (14.0–17.0)

15.0 (13.0–16.0)

15.0 (13.0–17.0)

Age group, y
• 12–17*
•  ≥18


​​​​​​​• 95 (99.0)
​​​​​​​• 1 (1.0)


​​​​​​​• 95 (100.0)
​​​​​​​• 0


• 94 (100.0)
​​​​​​​• 0


• 284 (99.6)
​​​​​​​• 1 (0.4)

Female

52 (54.2)

50 (52.6)

38 (40.4)

140 (49.1)

Male

44 (45.8)

45 (47.4)

56 (59.6)

145 (50.9)

Race, n (%)
• White
• Asian
 Black or African American
 Multiracial​​​​​​​
• Other
​​​​​​​
• Not reported


​​​​​​​• 56 (58.3)
• 32 (33.3)
• 3 (3.1)
• 1 (1.0)
• 2 (2.0)
​​​​​​​• 2 (2.1)


​​​​​​​• 52 (54.7)
• 31 (32.6)
• 9 (9.5)
• 0
​​​​​​​• 3 (3.2)
 0


​​​​​​​• 52 (55.3)
• 31 (33.0)
• 5 (5.3)
• 1 (1.1)
• 5 (5.4)
​​​​​​​• 0


​​​​​​​• 160 (56.1)
• 94 (33.0)
• 17 (6.0)
• 2 (0.7)
• 10 (3.5)
​​​​​​​• 2 (0.7)

Ethnicity, n (%)
• Not Hispanic or Latino
• Hispanic or Latino
• Not reported


​​​​​​​• 65 (67.7)
• 25 (26.0)
• 6 (6.3)


• 63 (66.3)
• 26 (27.4)
​​​​​​​• 6 (6.3)


• 69 (73.4)
​​​​​​​• 25 (26.6)
​​​​​​​• 0


​​​​​​​•197 (69.1)
• 76 (26.7)
• 12 (4.2)

Disease duration, mean (SD), y

10.5 (4.8)

9.8 (5.4)

9.7 (5.3)

10.0 (5.2)

Prior medication for AD§
• Any prior medication
• Topical agents alone
• Systemic ± topical agents#
• Dupilumab


• 95 (99.0)
• 71 (74.0)
• 24 (25.0)
​​​​​​​• 1 (1.0)


• 95 (100.0)
• 68 (71.6)
• 27 (28.4)
​​​​​​​• 1 (1.1)


• 92 (97.9)
• 70 (74.5)
• 22 (23.4)
​​​​​​​• 1 (1.1)


• 282 (98.9)
• 209 (73.3)
• 73 (25.6)
​​​​​​​• 3 (1.1)

IGA score
• 3
• 4


• 57 (59.4)
​​​​​​​• 39 (40.6)


• 57 (60.0)
​​​​​​​• 38 (40.0)


• 61 (64.9)
​​​​​​​• 33 (35.1)


• 175 (61.4)
​​​​​​​• 110 (38.6)

EASI score, mean (SD)

29.2 (12.7)

31.0 (12.8)

29.5 (12.2)

29.9 (12.5)

BSA affected, mean (SD), %

45.8 (22.4)

51.2 (21.7)

48.7 (21.7)

48.6 (22.0)

PP-NRS total score

7.2 (1.7)

7.0 (1.8)

6.8 (2.0)

​​​​​7.0 (1.8)

PSAAD
• No. of patients
• Total score, mean (SD)​​​​​​​


• 95
​​​​​​​• 5.0 (2.4)


• 95
​​​​​​​• 4.9 (2.1)


• 93
​​​​​​​• 4.8 (2.3)


• 283
​​​​​​​• 4.9 (2.3)

SCORAD
• No. of patients
• Total score, mean (SD)​​​​​​​


​​​​​​​• 96
​​​​​​​• 68.5 (13.4)


• 95
​​​​​​​• 67.6 (13.5)


​​​​​​​• 93
​​​​​​​• 66.2 (13.3)


​​​​​​​• 284
​​​​​​​• 67.5 (13.4)

SCORAD Sleep Loss VAS
• No. of patients
• Total score, mean (SD)​​​​​​​


• 96
​​​​​​​• 5.7 (2.9)


• 95
​​​​​​​• 5.3 (2.9)


• 93
​​​​​​​• 5.6 (2.9)


• 284
​​​​​​​• 5.5 (2.9)

CDLQI
​​​​​​​
• No. of patients
• Total score, mean (SD)


​​​​​​​• 96
​​​​​​​• 14.0 (6.7)


​​​​​​​• 95 
 14.3 (6.1)


​​​​​​​• 94
 13.6 (7.0)


​​​​​​​• 285
 14.0 (6.6)

POEM
• No. of patients
• Total score, mean (SD)​​​​​​​


​​​​​​​• 95
• 19.8 (5.9)


• 95
​​​​​​​• 19.5 (6.4)


• 94
​​​​​​​• 19.2 (6.2)


• 284
​​​​​​​• 19.5 (6.2)

*One patient in the Cibinqo 200 mg group was age 11 years at the time of consent to participate in the study, which was a protocol deviation.
​​​​​​​One patient in the placebo group was enrolled at age 18 years, which was a protocol deviation.
Includes patients who identified as American Indian or Alaskan native and native Hawaiian or Pacific Islander.
§Patients were counted once for each main category (i.e., topical agents or systemic agents) in an exclusive manner.
Topical agents included corticosteroids, calcineurin inhibitors, and crisaborole.
#Systemic agents included corticosteroids, cyclosporin, nonbiologic agents, and biologic agents.

Inclusion/exclusion criteria2

INCLUSION CRITERIA2

• 12 to <18 years of age

• Clinically diagnosed with chronic AD, confirmed by the Hanifin and Rajka criteria of AD at the screening and baseline visits

• Criteria for AD diagnosis include ≥3 of the basic features of pruritus: typical morphology and distribution, including flexural lichenification or linearity in adults and facial and extensor involvement in infants and children; chronic or chronically relapsing dermatitis; and personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis); along with ≥3 of 23 minor features specified in the criteria

• Have a documented history of inadequate response to treatment with topical medications or a candidate for systemic therapies

• Moderate to severe AD defined as BSA ≥10%, IGA ≥3, EASI ≥16, and PP-NRS ≥4 at the baseline visit

• Body weight ≥25 kg

EXCLUSION CRITERIA2

• Active forms of other inflammatory skin diseases

• Prior treatment with any systemic JAK inhibitors

• Vaccination with, or exposure to, a live or attenuated vaccine within 6 weeks prior to the first dose

• Participation in other clinical studies involving investigational drug(s) within 8 weeks prior to study entry

• Uncontrolled, clinically significant laboratory abnormality that could affect study interpretation

• Any major psychiatric condition

•  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

• 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

Significantly more patients achieved skin clearance with Cibinqo vs placebo1,2

In 12 weeks, 68.5% of adolescent patients treated with Cibinqo 100 mg achieved EASI-75 vs 41.5% with placebo (P<0.05).1–3

Proportion of patients achieving EASI-75 (in combination with medicated topical therapy)1–3

EASI-75 at Week 12

no./Total no. (%, 95% CI)

Cibinqo 200 mg

67/93 (72.0%; 62.9–81.2)

Cibinqo 100 mg

61/89 (68.5%; 58.9–78.2)

Placebo

39/94 (41.5%; 31.5–51.4)

The recommended starting dose for adolescents (12–17 years old) is 100 mg once daily.

In 12 weeks, 41.6% of adolescent patients treated with Cibinqo 100 mg achieved IGA 0/1 vs 24.5% with placebo (P<0.05).1–3

Proportion of patients achieving IGA 0/1 at 12 weeks (in combination with medicated topical therapy)1–3

IGA 0/1 at Week 12

no./Total no. (%, 95% CI)

Cibinqo 200 mg

43/93 (46.2%; 36.1–56.4)

Cibinqo 100 mg

37/89 (41.6%; 31.3–51.8)

Placebo

23/94 (24.5%; 15.8–33.2)

The recommended starting dose for adolescents (12–17 years old) is 100 mg once daily.

Itch relieved with Cibinqo in adolescents1,2

After 2 weeks, 27.2% of adolescent patients treated with Cibinqo 100 mg achieved PP-NRS4 vs 12.6% with placebo (P=0.0119).1,2

Proportion of patients achieving PP-NRS4 (in combination with medicated topical therapy)1–3​​​​​​​

PP-NRS4 at Week 12

no./Total no. (%, 95% CI)

Cibinqo 200 mg

41/74 (55.4%; 44.1–66.7)

Cibinqo 100 mg

40/76 (52.6%; 41.4–63.9)

Placebo

25/84 (29.8%; 20.0–39.5)

The recommended starting dose for adolescents (12–17 years old) is 100 mg once daily.

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

AD=atopic dermatitis; BSA=body surface area; CDLQI=Children's Dermatology Life Quality Index; CI=confidence interval; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; IQR=interquartile range; JAK=Janus kinase; NS=not significant; PDE4=Type 4 cyclic nucleotide phosphodiesterase; POEM=Patient-Oriented Eczema Measure; PP-NRS=Peak Pruritus Numerical Rating Scale; PSAAD=Pruritus and Symptoms Assessment for Atopic Dermatitis; SCORAD=SCORing Atopic Dermatitis; SD=standard deviation; VAS=Visual Analog Scale.
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics. 2. Eichenfield L, et al. JAMA Dermatol 2021; doi: 10.1001/jamadermatol.2021.2830. 3. Eichenfield L, et al. JAMA Dermatol 2021; doi:10.1001/jamadermatol.2021.2830. Supplementary appendix 3.
PP-CIB-GBR-0065. 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 TEEN

  • Study design
  • Efficacy results: Skin clearance (primary endpoint)
  • Efficacy results: Itch reduction (key secondary endpoint)

Explore the JADE clinical trials

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