This site is intended for Great Britain healthcare professionals only
Menu
Close
Menu
Close
Information on how to access Cibinqo®▼ (abrocitinib) prescribing information and adverse event reporting can be found at the bottom of the page.
A total of 3,128 patients were treated with Cibinqo in clinical studies in atopic dermatitis representing 2,089 patient-years of exposure. There were 994 patients with at least 48 weeks of exposure. Five placebo-controlled studies were integrated (703 patients on 100 mg once daily, 684 patients on 200 mg once daily and 438 patients on placebo) to evaluate the safety of Cibinqo in comparison to placebo for up to 16 weeks.1
A total of 635 adolescents (12 to <18 years of age) were enrolled in Cibinqo atopic dermatitis studies. The safety profile observed in adolescents in atopic dermatitis clinical studies was similar to that of the adult population.1
Very common (≥1/10) | Common (≥1/100 to <1/10) | Uncommon (≥1/1000 to <1/100) | |
---|---|---|---|
Infections and infestations | Herpes simplex,* Herpes zoster† | Pneumonia | |
Blood and lymphatic system disorders | Thrombocytopenia, Lymphopenia | ||
Metabolism and nutrition disorders | Hyperlipidaemia‡ | ||
Nervous system disorders | Headache, Dizziness | ||
Vascular disorders | Venous thrombotic events including pulmonary embolism and deep vein thrombosis§ | ||
Gastrointestinal disorders | Nausea | Vomiting, Abdominal pain upper | |
Skin and subcutaneous tissue disorders | Acne | ||
Investigations | Creatine phosphokinase elevations increased >5 x ULN§ |
*Herpes simplex includes oral herpes, ophthalmic herpes simplex, genital herpes and herpes dermatitis.
†Herpes zoster includes ophthalmic herpes zoster.
‡Hyperlipidaemia includes dyslipidaemia and hypercholesterolaemia.
§Includes changes detected during laboratory monitoring.
Placebo-controlled Short-term Studies Safety Pool2 | All-Cibinqo Long-term Safety Pool3 | ||||
---|---|---|---|---|---|
Cibinqo 100 mg (N=703) | Cibinqo 200 mg (N=684) | Placebo (N=438) | Cibinqo 100 mg (N=1,023) | Cibinqo 200 mg (N=2,105) | |
Patients with AEs, n (%) | 425 (60.5) | 462 (67.5) | 238 (54.3) | 747 (73.0) | 1547 (73.5) |
Patients with serious AEs,* n (%) | 19 (2.7) | 12 (1.8) | 13 (3.0) | 57 (5.6) | 88 (4.2) |
Patients with severe AEs,† n (%) | 29 (4.1) | 21 (3.1) | 22 (5.0) | 77 (7.5) | 117 (5.6) |
Discontinuations due to AEs, n (%) | 34 (4.8) | 34 (5.0) | 33 (7.5) | 93 (9.1) | 177 (8.4) |
Dose reduction or temporary discontinuations due to AEs, n (%) | 32 (4.6) | 31 (4.5) | 18 (4.1) | 108 (10.6) | 245 (11.6) |
*A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life threatening (immediate risk of death); Requires inpatient hospitalisation or prolongation of existing hospitalisation; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); Results in congenital anomaly/birth defect. Or that is considered to be: An important medical event.
†The maximum intensity of the AE is described using the adjectives Mild, Moderate or Severe. A severe adverse event is one that interferes significantly with a patient's usual function. A severe event is not to be classified as serious unless it meets one of the criteria for serious adverse events.
Cibinqo 100 mg (N=703) |
Cibinqo 200 mg (N=684) |
Placebo (N=438) |
|
---|---|---|---|
Nausea, n (%) |
44 (6.3) |
103 (15.1) |
8 (1.8) |
Headache, n (%) |
40 (5.7) |
54 (7.9) | 19 (4.3) |
Acne, n (%) |
13 (1.8) |
33 (4.8) | 1 (0.2) |
Herpes simplex, n (%) |
20 (2.8) |
29 (4.2) | 6 (1.4) |
Creatine phosphokinase increased >5 × ULN, n (%) |
13 (1.8) | 26 (3.8) | 8 (1.8) |
Vomiting, n (%) |
13 (1.8) |
24 (3.5) |
2 (0.5) |
Dizziness, n (%) |
11 (1.6) |
23 (3.4) |
4 (0.9) |
Abdominal pain upper, n (%) |
4 (0.6) |
15 (2.2) |
0 (0.0) |
Herpes zoster, n (%) |
4 (0.6) |
8 (1.2) |
0 (0.0) |
Randomised maintenance period |
All-Cibinqo Long-Term Safety Pool6 |
||||
---|---|---|---|---|---|
Open-label induction period (N=1,233) | All (N=798) |
Placebo (N=267) |
Cibinqo 100 mg (N=265) | Cibinqo 200 mg (N=266) |
|
All infections • n (%) • IR (95% CI) |
• 245 (34.9) • 168.78 (148.30, 191.29) |
• 238 (34.8) • 164.96 (152.32, 182.44) |
• 120 (27.4) • 131.58 (109.09, 157.34) |
• 488 (47.7) • 92.09 (84.10, 100.63) |
• 908 (43.1) • 120.10 (112.41, 128.17) |
Herpes simplex • n (%) • IR (95% CI) |
• 20 (2.8) • 11.21 (6.85, 17.32) |
• 29 (4.2) • 16.53 (11.07, 23.74) |
• 6 (1.4) • 5.49 (2.02, 11.95) |
• 60 (5.9) • 7.14 (5.45, 9.20) |
• 135 (6.4) • 11.13 (9.34, 13.18) |
Herpes zoster • n (%) • IR (95% CI) |
• 4 (0.6) • 2.21 (0.60, 5.67) |
• 8 (1.2) • 4.50 (1.94, 8.87) |
• 0 (0.0) • 0.00 (0.00, 3.34) |
• 18 (1.8) • 2.08 (1.23, 3.28) |
• 54 (2.6) • 4.30 (3.23, 5.61) |
Pneumonia • n (%) • IR (95% CI) |
• 1 (0.1) • 0.55 (0.01, 3.07) |
• 1 (0.1) • 0.56 (0.01, 3.11) |
• 0 (0.0) • 0.00 (0.00, 3.34) |
• 10 (1.0) • 1.14 (0.55, 2.10) |
• 11 (0.5) • 0.86 (0.43, 1.54) |
Eczema herpeticum • n (%) • IR (95% CI) |
• 7 (1.0) • 3.88 (1.56, 7.99) |
• 0 (0.0) • 0.00 (0.00, 2.06) |
• 3 (0.7) • 2.82 (0.56, 7.96) |
• 18 (1.8) • 2.06 (1.22, 3.26) |
• 9 (0.4) • 0.70 (0.32, 1.34) |
Serious infection • n (%) • IR (95% CI) |
• 6 (0.9) • 3.32 (1.22, 7.22) |
• 2 (0.3) • 1.12 (0.14, 4.04) |
• 2 (0.5) • 1.81 (0.22, 6.55) |
• 19 (1.9) • 2.18 (1.31, 3.40) |
• 27 (1.3) • 2.11 (1.39, 3.07) |
Cibinqo 100 mg (N=1,023) |
Cibinqo 200 mg (N=2,105) |
All Cibinqo (N=3,128) |
|
---|---|---|---|
Malignancies excluding NMSC |
|||
Number of subjects with event, n (%) |
1 (0.1) |
2 (0.1) |
3 (0.1) |
Total drug exposure, PY |
878.27 |
1,282.05 |
2,160.32 |
Incidence rate (95% CI) |
0.11 (0.00, 0.63) |
0.16 (0.02, 0.56) |
0.14 (0.03, 0.41) |
NMSC |
|||
Number of subjects with event, n (%) |
3 (0.3) |
4 (0.2) |
7 (0.2) |
Total drug exposure, PY |
875.81 |
1,282.65 |
2,158.46 |
Incidence rate (95% CI) |
0.34 (0.07, 1.00) |
0.31 (0.08, 0.80) |
0.32 (0.13, 0.67) |
Incidence rates reported in per 100 patient-years.
Cibinqo 100 mg (N=1,023) | Cibinqo 200 mg (N=2,105) | All Cibinqo (N=3,128) | |
---|---|---|---|
Pulmonary embolism (PE) |
|||
Number of subjects with event, n (%) | 0 | 3 (0.1) | 3 (0.1) |
Total drug exposure, PY | 878.35 |
1,282.99 |
2,161.34 |
Incidence rate (95% CI) | 0.00 (0.00, 0.42) |
0.23 (0.05, 0.68) |
0.14 (0.03, 0.41) |
Deep vein thrombosis (DVT) |
|||
Number of subjects with event, n (%) | 0 | 3 (0.1) |
3 (0.1) |
Total drug exposure, PY | 878.35 |
1,282.91 |
2,161.25 |
Incidence rate (95% CI) | 0.00 (0.00, 0.42) |
0.23 (0.05, 0.68) |
0.14 (0.03, 0.41) |
Major adverse cardiovascular events (MACE) |
Learn more about flexible dosing in patients on Cibinqo.
Learn more about monitoring patients on Cibinqo.
AE=adverse event; ALC=absolute lymphocyte count; CI=confidence interval; CPK=creatine phosphokinase; DVT=deep vein thrombosis; HDL-c=high-density lipoprotein cholesterol; IR=incidence rate; LDL-c=low-density lipoprotein cholesterol; MACE=major adverse cardiovascular events; NMSC=non-melanoma skin cancer; PE=pulmonary embolism; PY=patient years; ULN=upper limit of normal.
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
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc
This website is brought to you by Pfizer Limited, a company registered in England
and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ
Copyright © 2021 Pfizer Limited. All rights reserved.
VAT registration number GB201048427
Add indication message here. It can link a link,
and you can EMBOLDEN text
OK, We will need you to sign in before we can determine if you are aligned with a Pfizer promotional colleague.
If you have already registered with pfizerpro.co.uk and select ‘yes’, you will be directed to the sign-in page where you will be required to enter your username and password.
Would you like to register or sign in now?
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-PFE-GBR-3863. November 2021