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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.
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
*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.
| 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.
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
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
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.
3,128 patients were treated with Cibinqo in clinical studies in AD representing 2,089 patient-years of exposure.1
Learn more about flexible dosing in patients on Cibinqo.
*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:
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
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