Safety Guidance | Cibinqo®▼ (abrocitinib)

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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.

Safety guidance

Safety profile of Cibinqo: Tabulated list of adverse reactions¹

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

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	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.

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

Summary of AEs in the JADE clinical trial progamme with Cibinqo^2,3

Summary of AEs in the placebo-controlled short-term studies safety pool and the All-Cibinqo long-term safety pool

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	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)

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*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.

Placebo-controlled short-term studies safety pool included patients from the Phase 2b dose-ranging study, JADE MONO-1, MONO-2, COMPARE and TEEN.

All-Cibinqo long-term safety pool included patients treated with Cibinqo from the Phase 2b dose-ranging study, JADE MONO- 1, MONO-2, COMPARE, TEEN, REGIMEN (induction open-label phase; all in 200 mg) and EXTEND. Data cut was July 2020.

A higher proportion of patients 65 years and older discontinued from clinical studies and were more likely to have serious AEs compared to younger patients.

Most frequent AEs in the JADE clinical trial programme with Cibinqo^1,4

Most frequent AEs with Cibinqo from pivotal trials, placebo-controlled short-term studies safety pool^1,4

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	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)

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

Important safety considerations with Cibinqo¹

Infections¹

Summary of infection events in the placebo-controlled short-term studies safety pool⁵ and the All-Cibinqo long-term safety pool⁶

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	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)

Incidence rates reported in per 100 patient-years.
The incidence rate of herpes zoster in patients 65 years of age and older was higher than that of young patients.

Serious infections¹
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Cibinqo.

A patient who develops a new infection during treatment with Cibinqo should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated. The patient should be closely monitored, and Cibinqo therapy should be interrupted if the patient is not responding to standard therapy.

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

Malignancies¹

Malignancies observed in JADE clinical trials, All-Cibinqo Long-Term Safety Pool⁷

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	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)

Clinical data are insufficient to assess the potential relationship of exposure to Cibinqo and the development of malignancies. Long-term safety evaluations are ongoing.

Malignancy¹
The risks and benefits of Cibinqo treatment should be considered prior to initiating in patients with a known malignancy other than a successfully treated NMSC or cervical cancer in situ or when considering continuing Cibinqo therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION

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Incidence rates reported in per 100 patient-years.

Cardiovascular events¹

Venous thrombotic events (including deep vein thrombosis and pulmonary embolism) and major adverse cardiovascular events in JADE clinical trials, All- Cibinqo Long-Term Safety Pool^1,8,9

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	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)

Incidence rates reported in per 100 patient-years.

Venous thrombotic events¹
Cibinqo should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient’s risk for DVT/PE include older age, obesity, a medical history of DVT/PE, prothrombotic disorder, use of combined hormonal contraceptives or hormone replacement therapy, patients undergoing major surgery, or prolonged immobilisation.

If clinical features of DVT/PE occur, Cibinqo treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

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Laboratory abnormalities in patients taking Cibinqo¹

Thrombocytopenia

In placebo-controlled studies, for up to 16 weeks, treatment with Cibinqo was associated with a dose-related decrease in platelet count. Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned towards baseline despite continued therapy.

Confirmed platelet counts of <50 × 10³/mm³ were reported in 0.1% of patients exposed to Cibinqo 200 mg, 0 patients treated with Cibinqo 100 mg or placebo. Among all patients exposed to Cibinqo, including the long-term extension study, confirmed platelet counts of <50 × 10³/mm³ were reported in 0.1% of patients, both treated with Cibinqo 200 mg occurring at Week 4. No clinically meaningful adverse events for haemorrhage were associated with low platelet counts.¹⁰

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

Lymphopenia

In placebo-controlled studies, for up to 16 weeks, confirmed ALC <0.5 × 10³/mm³ occurred in 0.3% of patients treated with Cibinqo 200 mg and 0% of patients treated with Cibinqo 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure.

Among all patients exposed to Cibinqo, including the long-term extension, confirmed ALC <0.5 × 10³/mm³were reported in 0.3% of patients treated with Cibinqo 200 mg and 0.1% of patients treated with Cibinqo 100 mg, all of whom were 65 years of age and older.

PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

Lipid elevations

In placebo-controlled studies, for up to 16 weeks, there was a dose-related increase in LDL-c, total cholesterol, and HDL-c relative to placebo at Week 4 which remained elevated through the final visit in the treatment period.

The median % change in LDL-c at Week 4 was 9.1%, 4.9% and -2.8% in patients exposed to 200 mg, 100 mg and placebo, respectively; at Month 12 the median % change was 22.8% and 13.7% in the 200 mg and 100 mg groups, respectively; at Month 12 the median % change was 22.8% and 13.7% in the 200 mg and 100 mg groups, respectively. The median % change in HDL-c at Week 4 was 20.0%, 12.1%, and 0% in patients exposed to 200 mg, 100 mg and placebo, respectively; at Month 12 the median % change was 17.1% and 8.9% in the 200 mg and 100 mg groups, respectively.

Events related to hyperlipidaemia occurred in 0.4% of patients exposed to Cibinqo 100 mg, 0.6% of patients exposed to 200 mg and 0% of patients exposed to placebo.

Creatine phosphokinase elevations

In placebo-controlled studies, for up to 16 weeks, significant increases in CPK values (>5 × ULN) occurred in 1.8% of patients treated with placebo, 1.8% of patients treated with 100 mg and 3.8% of patients treated with 200 mg of Cibinqo, respectively. Most elevations were transient, and none led to discontinuation. In the clinical studies, there were no reported events of rhabdomyolysis.¹¹

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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.

Prescribing information:
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 200 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 100 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 50 mg film-coated tablets.

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.

Pfizer Data on File Ref-CIB0005 Cibinqo Summary of AE in the placebo-controlled short term studies safety pool.

Pfizer Data on File Ref-CIB0006 Cibinqo Summary of AE in the All-Cibinqo Long-term Safety Pool.

Pfizer Data on File Ref-CIB0007 Cibinqo most frequent adverse events in the placebo-controlled short term studies safety pool.

Pfizer Data on File REF-CIB0008 Cibinqo Summary of infection events in the placebo-controlled short term studies safety pool.

Pfizer Data on File REF-CIB0009 Cibinqo Summary of infection events in the All-Cibinqo long term safety pool.

Pfizer Data on File REF-CIB0010 Cibinqo Malignancies, including NMSC in the All-Cibinqo long term safety.

Pfizer Data on File REF-CIB0011 Cibinqo Venous thrombotic events, including DVT and PE in the All-Cibinqo long term safety pool.

Pfizer Data on File REF-CIB0012 Cibinqo Major Adverse Cardiovascular Events in the All-Cibinqo long term safety pool.

Pfizer data on file. REF-CIB0029. Haematology changes.

Pfizer data on file. REF-CIB0028. Creatine kinase changes.

PP-CIB-GBR-0067. 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.

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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