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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 MONO

Cibinqo efficacy as monotherapy, without medicated topical therapy1–3​​​​​​​


Two identically designed Phase III studies (MONO-1 and MONO-2) evaluated the efficacy and safety of Cibinqo as monotherapy in 387 and 391 patients with moderate-to-severe AD. Patients were assessed without medicated topical therapy and rescue treatment was not permitted during the trials.1–3

*Patients not eligible for JADE EXTEND entered the 4-week off-treatment follow-up period.

Co-primary endpoints:

  • EASI-75 response at Week 12 vs placebo
  • ​​​​​​​IGA 0/1 response with ≥2-point improvement at Week 12 vs placebo

Key secondary endpoints:

  • PP-NRS4 response at Weeks 2, 4 and 12 (defined as an improvement of ≥4 points from baseline in the severity of PP-NRS)
  • PSAAD response at Week 12

Baseline characteristics: MONO-12

Placebo (N=77) ​​​​​​​​​​​​​

Cibinqo 100 mg (N=156)

Cibinqo 200 mg (N=154)

Age, years (SD) ​​​​​​​

31.5 (14.4)

32.6 (15.4)

33.0 (17.4)

Age group, years (%)
• <18
• 18–65
• ≥65


​​​​​​​• 17 (22)
 59 (77)
​​​​​​​• 1 (1)


​​​​​​​• 34 (22)
 118 (76)
​​​​​​​• 4 (3)


​​​​​​​• 33 (21)
 110 (71)
​​​​​​​• 11 (7)

Sex, female, n (%)

28 (36)

66 (42)

73 (47)

Race, n (%)
• White
• Black
 Asian
 Other*
​​​​​​​• Not reported

 


​​​​​​​• 62 (81)
• 6 (8)
• 6 (8)
• 2 (3)
​​​​​​​• 1 (1)


​​​​​​​• 113 (72)
• 15 (10)
• 26 (17)
• 2 (1)
​​​​​​​• 0


 104 (68)
• 11 (7)
• 26 (17)
• 11 (7)
​​​​​​​• 2 (1)

AD duration, years (SD)

22.5 (14.4)

24.9 (16.1)

22.7 (14.5)

Previous medication for AD
• Any previous medication
• Topical drugs alonealone
• Systemic medication ± topical therapy§
 ​​​​​​​Dupilumab


​​​​​​​• 77 (100)
• 34 (44)
• 41 (53)
• 8 (10)


​​​​​​​• 155 (99)
• 69 (44)
• 78 (50)
​​​​​​​• 13 (8)


​​​​​​​• 154 (100)
• 82 (53)
• 68 (44)
​​​​​​​• 9 (6)

IGA score
• 3 (moderate disease)
• 4 (severe disease)

 


​​​​​​​• 46 (60)
​​​​​​​• 31 (40)


​​​​​​​• 92 (59)
​​​​​​​• 64 (41)


​​​​​​​• 91 (59)
​​​​​​​• 63 (41)

EASI score

28.7 (12.5)

31.3 (13.6)

30.6 (14.1)

BSA affected, % (SD)

47.4 (22.7)

50.8 (23.4)

49.9 (24.4)

SCORAD score

64.5 (13.2)

67.1 (13.7)

64.3 (13.1)

PP-NRS score

7.0 (1.8)

6.9 (2.0)

7.1 (1.9)

PSAAD total score#

5.5 (2.0)

5.3 (2.3)

5.4 (2.1)

DLQI total score**

13.9 (7.3)

14.6 (6.5)

14.6 (6.8)

CDLQI total score††

13.6 (7.0)

11.7 (6.6)

13.2 (5.5)

POEM total score‡‡

19.9 (6.1)

19.5 (6.5)

19.6 (5.9)

*Includes patients that were American Indian or Alaskan Native, Native Hawaiian or Pacific Islander, or multiracial.
Patients were counted for each main category in an exclusive manner.
Topical agents includes corticosteroids and calcineurin inhibitors.
§Systemic agents includes mycophenolate mofetil, methotrexate, azathioprine, corticosteroids, ciclosporin and dupilumab.
Data were available for 77 patients in the placebo group, 155 patients in the Cibinqo 100 mg group, and 154 patients in the Cibinqo 200 mg group.
#Data were available for 68 patients in the placebo group, 137 patients in the Cibinqo 100 mg group, and 138 patients in the Cibinqo 200 mg group.
​​​​​​​**Assessed in patients aged 18 years; data were available for 60 patients in the placebo group, 121 patients in the Cibinqo 100 mg group, and 119 patients in the Cibinqo 200 mg group.
††Assessed in patients aged <18 years; data were available for 16 patients in the placebo group, 32 patients in the Cibinqo 100 mg group, and 32 patients in the Cibinqo 200 mg group.
‡‡Data were available for 77 patients in the placebo group, 153 patients in the Cibinqo 100 mg group, and 153 patients in the Cibinqo 200 mg group.

Baseline characteristics: MONO-23

Placebo (N=78) ​​​​​​​​​​​​​

Cibinqo 100 mg (N=158)

Cibinqo 200 mg (N=155)

Age, years (SD) ​​​​​​​

33.4 (13.8)

37.4 (15.8)

33.5 (14.7)

Age group, years (%)
• <18
• 18–65
• ≥65


​​​​​​​• 8 (10.3)
• 69 (88.5)
​​​​​​​• 1 (1.3)


​​​​​​​• 17 (10.8)
• 130 (82.3)
​​​​​​​• 11 (7.0)


​​​​​​​• 15 (9.7)
• 133 (85.8)
​​​​​​​• 7 (4.5)

Male

47 (60.3)

94 (59.5)

88 (56.8)

Race, n (%)
• White
• Asian
 Black
 Multiracial
​​​​​​​• Not reported


​​​​​​​• 40 (51.3)
• 29 (37.2)
​​​​​​​• 6 (7.7)
• 1 (1.3)
​​​​​​​• 2 (2.6)


​​​​​​​• 101 (63.9)
• 46 (29.1)
• 9 (5.7)
• 1 (0.6)
​​​​​​​• 1 (0.6)


 91 (58.7)
• 54 (34.8)
• 6 (3.9)
• 2 (1.3)
​​​​​​​• 2 (1.3)

Disease duration, years (SD)

21.7 (14.3)

21.1 (14.8)

20.5 (14.8)

Prior prescribed or OTC medication for AD*
• Any
• Anti-inflammatory topical agents
• Systemic agents
 ​​​​​​​Dupilumab


​​​​​​​​​​​​​​
​​​​​​​• 78 (100)
• 46 (59.0)
• 32 (41.0)
​​​​​​​• 2 (2.6)


​​​​​​​
​​​​​​​•157 (99.4)
• 87 (55.1)
• 70 (44.3)
​​​​​​​• 7 (4.4)


​​​​​​​
​​​​​​​• 153 (98.7)
• 93 (60.0)
• 60 (38.7)
​​​​​​​• 5 (3.2)

IGA score
• 3 (moderate disease)
• 4 (severe disease)

 


​​​​​​​• 52 (66.7)
​​​​​​​• 26 (33.3)


​​​​​​​•107 (67.7)
​​​​​​​• 51 (32.3)


​​​​​​​• 106 (68.4)
​​​​​​​• 49 (31.6)

EASI score, mean (SD)

28.0 (10.2)

28.4 (11.2)

29.0 (12.4)

BSA affected, % (SD)

48.2 (20.8)

48.7 (21.4)

47.7 (22.3)

SCORAD score, mean (SD)

64.3 (12.4)

63.8 (11.4)

64.1 (13.1)

PP-NRS score, mean (SD)

6.7 (1.9)

7.1 (1.6)

7.0 (1.6)

PSAAD score, mean (SD)

5.1 (2.1)

5.4 (2.1)

5.2 (2.0)

DLQI score, mean (SD)

15.0 (7.1)

15.4 (7.3)

14.8 (6.0)

POEM score, mean (SD)

19.2 (5.5)

20.9 (5.7)

19.7 (5.7)

*Patients were counted once for each main category in an exclusive manner, with systemic agents, biologics and/or topical agents taking precedence over anti-inflammatory topical agents alone.

Inclusion/exclusion criteria2,3

INCLUSION CRITERIA2,3

• ≥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. 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, is not medically advisable, 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 CRITERIA2,3

• 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, 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

With Cibinqo, significantly more patients achieved skin clearance vs placebo1–3

In 12 weeks, ~60% of patients achieved EASI-75 with Cibinqo 200 mg monotherapy in both MONO 1 and MONO 2 trials vs ~11% for placebo.2,3

Proportion of patients achieving EASI-75, MONO-11,2​​​​​​​

EASI-75 at Week 12

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

Cibinqo 200 mg

96/153 (62.7%; 55.1–70.4)

Cibinqo 100 mg

62/156 (39.7%; 32.1–47.4)

Placebo

9/76 (11.8%; 4.6–19.1)

Proportion of patients achieving EASI-75, MONO-21,3,4

In 12 weeks, ~40% of patients achieved IGA 0/1 with Cibinqo 200 mg monotherapy in both MONO-1 and MONO-2 trials vs ~9% for placebo.2,3​​​​​​​

EASI-75 at Week 12

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

Cibinqo 200 mg

94/154 (61.0%; 53.3–68.7)

Cibinqo 100 mg

69/155 (44.5%; 36.7–52.3)

Placebo

8/77 (10.4%; 3.6–17.2)

Proportion of patients achieving IGA 0/1, MONO-11,2​​​​​​​

IGA 0/1 at Week 12

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

Cibinqo 200 mg

67/153 (43.8%; 35.9–51.7)

Cibinqo 100 mg

37/156 (23.7%; 17.0–30.4)

Placebo

6/76 (7.9%; 1.8–14.0)

Proportion of patients achieving IGA 0/1, MONO-21,3,4

IGA 0/1 at Week 12

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

Cibinqo 200 mg

59/155 (38.1%; 30.4–45.7)

Cibinqo 100 mg

44/155 (28.4%; 21.3–35.5)

Placebo

7/77 (9.1%; 2.7–15.5)

Cibinqo achieved rapid and significant itch relief vs placebo1–3

As early as Week 2, both doses of Cibinqo achieved differentiation from placebo in itch relief, as measured by PP-NRS4.1–3

Proportion of patients achieving PP-NRS4, MONO-11,2​​​​​​​

Proportion of patients achieving PP-NRS4, MONO-21,3,4

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; DLQI​​​​​​​=Dermatology Life Quality Index; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; JAK=Janus kinase; OT=over-the-counter; 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.
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics. 2. Simpson E, et al. Lancet 2020;396:P255–266. 3. Silverberg J, et al. JAMA Dermatol 2021;156(8):863–873. 4. Silverberg J, et al. JAMA Dermatol 2021;156(8):863–873. Supplementary appendix.
PP-CIB-GBR-0063. 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 MONO

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

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