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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.
Updated Safety Recommendation - Abrocitinib should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older, patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers), patients with malignancy risk factors (e.g. current malignancy or a history of malignancy). (Cibinqo Summary of Product Characteristics)
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.
Placebo (N=77) | Cibinqo 100 mg (N=156) | Cibinqo 200 mg (N=154) | |
---|---|---|---|
Age, years | 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.
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.
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
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) |
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
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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) |
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) |
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) |
As early as Week 2, both doses of Cibinqo achieved differentiation from placebo in itch relief, as measured by PP-NRS4.1–3
Access safety information for abrocitinib.
References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics.
Learn more about flexible dosing in patients on Cibinqo.
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:
Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc/product/12874/rmms. 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
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