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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.

Medicine evidence information to support formulary and decision making 

The information on this page has been pulled together to help with decision-making around Cibinqo (abrocitinib), and to support your submission of a formulary evidence pack if desired. The information forms the basis of the regulatory submission for Cibinqo and we hope it is sufficient. However, if you need more information to support your submission, other areas of this site contain more detailed information on the clinical trials and safety profile of Cibinqo. Alternatively, contact your Pfizer Medical Science Liaison for further support or information.

Name of the drug1

Cibinqo (abrocitinib)

​​​​​​​Available as:
Abrocitinib-Pfizer Europe MA 50 mg film-coated tablets
Abrocitinib-Pfizer Europe MA 100 mg film-coated tablets
Abrocitinib-Pfizer Europe MA 200 mg film-coated tablets

Indication1

Abrocitinib is licensed for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Description of the condition2

Atopic dermatitis, also known as eczema, is a common skin disease typified by dry, pruritic skin with erythema, scaling or vesicles. It most commonly affects children and is associated with a family history and/or the presence of other atopic conditions. While the majority of children ‘grow out’ of the condition by their teenage years, a significant proportion of patients continue to have atopic dermatitis as adults. In the UK, prevalence estimates vary in studies between 2.5–15%.

Atopic dermatitis is chronic and relapsing, and when moderate-to-severe, can have a significant impact on patients’ quality of life. 

Posology: How is the drug taken?1

The recommended dose is either 100 mg or 200 mg once daily. For most patients, particularly those with severe disease, 200 mg is the recommended starting dose. A dose of 100 mg once daily is the recommended starting dose for patients aged ≥65 years, for adolescents aged 12–17, and for those who have risk factors for developing an adverse reaction to abrocitinib or those who are less likely to tolerate the adverse reactions. The maximum daily dose is 200 mg. 

The dose may be decreased or increased based on tolerability and efficacy. Dose reduction can be considered after disease control is achieved in patients receiving 200 mg. Some patients may experience a disease flare after dose reduction. A higher risk of disease flare after dose reduction is associated with history of receiving systemic treatments for atopic dermatitis and extensive disease involving >50% of body surface area (BSA).
​​​​​​​
​​​​​​​Abrocitinib can be used with or without medicated topical therapies for atopic dermatitis.
​​​​​​​
Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 12 weeks. Some patients with initial partial response may subsequently improve with continued treatment beyond 12 weeks.

List price1

Cibinqo 50 mg, 28 film coated tablets, PLGB 00057/1703 £893.76; Cibinqo 100 mg, 28 film coated tablets, PLGB 00057/1704 £893.76; Cibinqo 200 mg, 28 film coated tablets, PLGB 00057/1705 £893.76.

Who can prescribe abrocitinib?1

Abrocitinib is a prescription only medicine and can only be prescribed by health professionals authorised to prescribe medicines.

MOA: How does it work?1

Abrocitinib is a Janus kinase (JAK)1 inhibitor.
 
JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane. Their role in signalling is to influence cellular processes of haematopoiesis and immune cell function. Within these signalling pathways, JAKs work by phosphorylating and activating Signal Transducers and Activators of Transcription (STATs). STATs modulate intracellular activity including gene expression.

Abrocitinib reversibly and selectively inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site. Abrocitinib has biochemical selectivity for JAK1 over the other 3 JAK isoforms; JAK2 (28-fold), JAK3 (>340-fold) and tyrosine kinase (TYK) 2 (43-fold). In cellular settings, where JAK enzymes transmit signals in pairs (i.e., JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, JAK2/JAK2, JAK2/TYK2), abrocitinib preferentially inhibits cytokine-induced STAT phosphorylation mediated by receptors utilising JAK1 relative to receptors utilising JAK2 only or JAK2/TYK2 pairs. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. Both the parent compound and the active metabolites inhibit cytokine signalling with similar levels of selectivity.

How is atopic dermatitis currently treated?2

First-line treatment is with emollients and topical corticosteroids. Trigger avoidance is also encouraged.

Topical calcineurin inhibitors, antimicrobials, antihistamines and phototherapy may be added to severe cases. 

Patients who don’t respond to the above are managed with systemic immunomodulatory treatment, e.g., methotrexate, ciclosporin, azathioprine, IL4/IL13 inhibitors or mycophenolate mofetil. 

What clinical studies support the licensing of abrocitinib?1

The efficacy and safety of abrocitinib as monotherapy and in combination with background medicated topical therapies over 12–16 weeks were evaluated in 1,616 patients in 3 pivotal Phase III randomised, double-blind, placebo-controlled studies (MONO-1, MONO-2 and COMPARE). In addition, the efficacy and safety of abrocitinib as monotherapy over 52 weeks (with the option of rescue treatment in flaring patients) was evaluated in 1,233 patients in a Phase III induction, randomised withdrawal, double-blind, placebo-controlled study (REGIMEN). The patients in these 4 studies were 12 years of age and older with moderate-to-severe atopic dermatitis as defined by Investigator's Global Assessment (IGA) score ≥ 3, Eczema Area and Severity Index (EASI) score ≥16, BSA (body surface area) involvement ≥10%, and Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 at baseline prior to randomisation. Patients who had a prior inadequate response or for whom topical treatments were medically unadvisable, or who had received systemic therapies were eligible for inclusion. All patients who completed the parent studies were eligible to enrol in the long-term extension study EXTEND.

​​​​​​​In the placebo-controlled studies (MONO-1, MONO-2, COMPARE) and the open label induction, randomised withdrawal study (REGIMEN) across all treatment groups 41.4% to 51.1% were female, 59.3% to 77.8% were Caucasian, 15.0% to 33.0% were Asian and 4.1% to 8.3% were Black, and the mean age was 32.1 to 37.7 years. In these studies, 32.2% to 40.8% had a baseline IGA of 4 (severe atopic dermatitis), and 41.4% to 59.5% of patients had received prior systemic treatment for atopic dermatitis. The baseline mean EASI score ranged from 28.5 to 30.9, the baseline PP-NRS ranged from 7.0 to 7.3 and the baseline Dermatology Life Quality Index (DLQI) ranged from 14.4 to 16.0.

Eligible patients who completed the full treatment period of a qualifying parent study (e.g. MONO-1, MONO-2, COMPARE, REGIMEN) were considered for enrolment in the long-term extension study EXTEND. In EXTEND, patients received abrocitinib with or without background medicated topical therapy. Patients who were previously randomised to medicinal product 100 mg or 200 mg once daily in parent studies continued the same dose in EXTEND as in the parent study, and the blind was maintained.

Paediatric population
​​​​​​​
The efficacy and safety of abrocitinib as monotherapy was evaluated in 2 Phase III randomised, double-blind, placebo-controlled studies (MONO-1, MONO-2) which included 124 patients who were 12 to less than 18 years of age. The efficacy and safety were also evaluated in open label induction, randomised withdrawal study (REGIMEN) which included 246 patients who were 12 to less than 18 years of age. In these studies, the results in the adolescent subgroup were consistent with the results in the overall study population.

The efficacy and safety of abrocitinib in combination with background medicated topical therapy was evaluated in the Phase III randomised, double-blind, placebo-controlled study TEEN. The study included 285 patients who were 12 to less than 18 years of age with moderate-to-severe atopic dermatitis as defined by IGA score ≥3, EASI score ≥16, BSA involvement ≥10%, and PP-NRS ≥4 at the baseline visit prior to randomisation. Patients who had a prior inadequate response or who had received systemic therapy were eligible for inclusion..
​​​​​
The patients in these studies were 12 years of age and older with moderate-to-severe atopic dermatitis as defined by Investigator's Global Assessment (IGA) score ≥3, Eczema Area and Severity Index (EASI) score ≥16, BSA involvement ≥10%, and Peak Pruritus Numerical Rating Scale (PPNRS) ≥4 at baseline prior to randomisation. Patients who had a prior inadequate response or for whom topical treatments were medically unadvisable, or who had received systemic therapies were eligible for inclusion.

This pivotal Phase III clinical trial evaluated the efficacy and safety of abrocitinib in combination with medicated topical therapy vs placebo in 838 patients with moderate-to-severe atopic dermatitis, with a direct head-to-head comparison with dupilumab as an active comparator for itch relief at Week 2.3

Inclusion criteria3

•    ≥18 years of age
•    Clinically diagnosed with chronic atopic dermatitis for ≥1 year, confirmed by Hanifin and Rajka criteria of atopic dermatitis at the screening and baseline visits. Criteria for atopic dermatitis 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 or require systemic therapies to control their disease
•    Moderate-to-severe atopic dermatitis defined as BSA (body surface area) ≥10%, IGA (Investigator's Global Assessment)  ≥3, EASI (Eczema Area and Severity Index) ≥16 and PP-NRS (Peak Pruritus Numerical Rating Scale) ≥4 at the baseline visit


Exclusion criteria3,4
•    Active forms of other inflammatory skin diseases
•    Prior treatment with any systemic JAK inhibitors
•    Prior treatment with dupilumab and/or a history of hypersensitivity, intolerance, AE, or allergic reaction associated with prior exposure to the excipients of dupilumab
•    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 atopic dermatitis 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

JADE COMPARE study design3,4

Two identically designed Phase III studies (MONO-1 and MONO-2) evaluated the efficacy and safety of abrocitinib as monotherapy in 387 and 391 patients with moderate-to-severe atopic dermatitis. Patients were assessed without medicated topical therapy and rescue treatment was not permitted
during the trials.5,6

Inclusion criteria5,6

•    ≥12 years of age
•    Body weight ≥40 kg
•    Clinically diagnosed with chronic atopic dermatitis for ≥1 year, confirmed by Hanifin and Rajka criteria of atopic dermatitis at the screening and baseline visits. Criteria for atopic dermatitis 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 or require systemic therapies to control their disease
•    Moderate-to-severe atopic dermatitis defined as BSA (body surface area) ≥10%, IGA (Investigator's Global Assessment) ≥3, EASI (Eczema Area and Severity Index) ≥16 and PP-NRS (Peak Pruritus Numerical Rating Scale) ≥4 at the baseline visit


Exclusion criteria5,6
•    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 atopic dermatitis 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

JADE MONO-1/-2 study design5,6

A responder-enriched trial in which 1,233 patients with moderate-to-severe atopic dermatitis were enrolled in an initial 12-week open-label run-in period from which responders (defined as achieving an IGA (Investigator's Global Assessment) of clear (0) or almost clear (1) with a reduction from baseline of ≥2 points and reaching an EASI-75 (Ezcema Area and Severity Index) from baseline) continued onto a randomised, 40-week, double-blind, monotherapy, maintenance treatment period on abrocitinib 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 abrocitinib 200 mg with topical therapy and the ability to recapture response was assessed.7

Inclusion criteria7

•    ≥12 years of age
•    Body weight ≥40 kg
•    Clinically diagnosed with chronic atopic dermatitis for ≥1 year, confirmed by Hanifin and Rajka criteria of atopic dermatitis at the screening and baseline visits.
•    Have a documented history of inadequate response to treatment with topical medications or require systemic therapies to control their disease
•    Moderate-to-severe atopic dermatitis defined as BSA (body surface area) ≥10%, IGA (Investigator's Global Assessment) ≥3, EASI (Eczema Area and Severity Index) ≥16 and PP-NRS (Peak Pruritus Numerical Rating Scale) ≥4 at the baseline visit


Exclusion criteria7
•    Active forms of other inflammatory skin diseases or conditions affecting skin
•    Prior treatment with any JAK inhibitors
•    Unwillingness to discontinue current atopic dermatitis 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

JADE REGIMEN study design7

This pivotal Phase III clinical trial evaluated the efficacy and safety of abrocitinib in combination with medicated topical therapy versus placebo in 285 adolescent patients aged 12–17 years with moderate-to-severe atopic dermatitis.8

Inclusion criteria8

•    12 to <18 years of age
•    Clinically diagnosed with chronic atopic dermatitis, confirmed by Hanifin and Rajka criteria of atopic dermatitis at the screening and baseline visits
•    Criteria for atopic dermatitis 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 or a candidate for systemic therapies
•    Moderate-to-severe atopic dermatitis defined as BSA (body surface area) ≥10%, IGA (Investigator's Global Assessment) ≥3, EASI (Eczema Area and Severity Index) ≥16 and PP-NRS (Peak Pruritus Numerical Rating Scale) ≥4 at the baseline visit
•    Body weight ≥25 kg


Exclusion criteria8
•    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 atopic dermatitis medications prior to the study
•    Requiring treatment with prohibited medications during the study
•    Medical history of thrombocytopenia, coagulopathy or platelet dysfunction
•    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

JADE TEEN study design8

A long-term extension study evaluating the safety and efficacy of abrocitinib, with or without medicated topical therapy, in adults and adolescent patients with moderate-to-severe atopic dermatitis.9


Inclusion criteria9

•    ≥12 years of age
•    Body weight ≥40 kg if applicable from qualifying parent study
•    Completed the full treatment or full rescue treatment of a qualifying Phase III study, or completed the full open-label run-in of REGIMEN but did not meet response criteria


Exclusion criteria9
•    Active forms of other inflammatory skin diseases
•    Presence of other medical or psychiatric conditions that would make the patient inappropriate for entry into the study
•    Pregnant or breastfeeding women
•    Women of childbearing potential who are unwilling to use contraception
•    Discontinued from treatment (or rescue treatment) early in a qualifying Phase III study
​​​​​​​•    Ongoing adverse event in qualifying study

JADE EXTEND study design9

Efficacy1

Clinical response
In both monotherapy studies (MONO-1, MONO-2) and the head-to-head study (COMPARE), significantly more patients who received abrocitinib achieved an IGA and/or EASI-75 response compared with placebo at Week 12.

In MONO-1 and 2, a significantly higher proportion of patients achieved PP-NRS4 (defined as an improvement of ≥4 points in the severity of PP-NRS) with abrocitinib compared with placebo at Week 2, persisting through Week 12.

In COMPARE, superiority of abrocitinib compared with dupilumab was demonstrated for the proportion of patients achieving PP-NRS 4-point improvement with significantly higher itch responses seen as early as Day 4 after the first dose.

Treatment effects were consistent across subgroups (e.g., weight, age, sex, race and prior systemic immunosuppressant treatment) in MONO-1 and MONO-2 and in COMPARE.

For further detail please see additional pages within the 'Efficacy' section of this website.

Proportion of patients who achieved PP-NRS4 over time in MONO-1

Proportion of patients who achieved PP-NRS4 over time in MONO-2

Long-term efficacy1
In patients who achieved response at Week 12 during a Phase III trial and then entered
EXTEND, most maintained their response at Week 48 of cumulative abrocitinib treatment for both doses of abrocitinib [53% and 57% for IGA (0 or 1) response, 69% and 71% for EASI-75, and 52% and 69% for PP-NRS4 with 100 mg once daily and 200 mg once daily, respectively].

Late-onset efficacy1
Among all patients who did not achieve IGA (0 or 1) response after 12 weeks of abrocitinib treatment during Phase III trials and then entered the EXTEND trial: 
    •  22% and 27% of patients continuing abrocitinib in EXTEND achieved IGA (0 or 1) response by Week 24 (with 12 additional weeks of treatment), with 100 mg once daily and 200 mg once daily, respectively.

Among all patients who did not achieve EASI-75 after 12 weeks and then entered EXTEND: 
    •  45% and 54% of patients continuing abrocitinib in EXTEND achieved EASI-75 by Week 24 (with 12 additional weeks of treatment), with 100 mg once daily and 200 mg once daily, respectively.

Patient reported outcomes1
Treatment with either dose of abrocitinib as monotherapy or combination therapy resulted in improved patient-reported outcomes at 12 weeks compared with placebo.

Higher proportions of patients treated with abrocitinib had clinically meaningful reductions in Dermatology Life Quality Index (DLQI) total scores from baseline to Week 12 compared with placebo (defined as a 4-point improvement):
    •  72.6–86.4% and 67.2–74.7% with abrocitinib 200 mg and 100 mg, respectively, vs 32.3–56.5% for placebo and separately;
    •  26.6–31.9% and 20.3–21.9% achieved a DLQI score <2, representing “no effect” of their disease on their quality of life, with abrocitinib 200 mg and 100 mg, respectively, vs 5.7–12.1% for placebo.

Abrocitinib also improved patient-reported atopic dermatitis symptoms and sleep disruption compared with placebo at 12 weeks as measured by:
    •  The Patient Oriented Eczema Measure (POEM): LSM changes were -10.6 to -12.6 and -6.8 to -9.6 with abrocitinib 200 mg and 100 mg, respectively, vs -3.6 to -5.1 with placebo
•    SCORing Atopic Dermatitis (SCORAD) sleep loss subscale: LSM changes were -3.7 to -4.6 and -2.1 to -3.8 with abrocitinib 200 mg and 100 mg, respectively, vs -2.4 to -4.6 with placebo

Safety1

Summary of safety
The most commonly reported adverse reactions occurring in ≥2% of patients treated with abrocitinib 200 mg in placebo-controlled studies are nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%).

The safety profile of abrocitinib is based on a total of 3,128 patients treated with abrocitinib across five clinical trials in atopic dermatitis representing 2,089 patient-years of exposure. There were 994 patients with at least 48 weeks of exposure. 
 

​​​​​​​Tabulated list of adverse reactions

System organ class

Very common

Common

Uncommon

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 >5x 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.

Infections: overall, serious and opportunistic
In placebo-controlled studies, over 16 weeks, infections were reported in a quarter (27.4%) of patients treated with placebo and in a third of patients treated with abrocitinib (34.9% and 34.8% with 100 mg and 200 mg, respectively). Most of these infections were mild or moderate.

In the same studies, the rate of serious infections was 1.81 per 100 patient-years in patients treated with placebo, 3.32 per 100 patient-years in patients treated with abrocitinib 100 mg, and 1.12 per 100 patient-years in patients treated with abrocitinib 200 mg. Among all patients treated with abrocitinib, including the long-term extension study, the rate of serious infections was 2.18 per 100 patient-years in patients treated with abrocitinib 100 mg and 2.11 per 100 patient-years in patients treated with abrocitinib 200 mg. The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia.

All opportunistic infections were cases of multidermatomal cutaneous herpes zoster (0.6%). Most cases of opportunistic herpes zoster were mild or moderate.


Venous thromboembolism
Across patients treated with abrocitinib, including the long-term extension study, the rate of pulmonary embolism was 0.23 per 100 patient-years, all in patients treated with abrocitinib 200 mg. The rate of deep vein thrombosis was 0.23 per 100 patient-years, all in patients treated with abrocitinib 200 mg.​​​​​​​

Elderly patients
A total of 145 patients 65 years of age and older were enrolled in Phase III studies. The safety profile observed in elderly patients was similar to that of the adult population with the following exceptions: a higher proportion of patients 65 years of age and older discontinued from clinical studies and were more likely to have serious adverse events compared to younger patients; patients 65 years and older were more likely to develop low platelet and ALC values; the incidence rate of herpes zoster in patients 65 years of age and older was higher than that of younger patients. The incidence rate of herpes zoster in patients 65 years of age and older treated with abrocitinib (7.40 per 100 patient-years) was higher than that of patients 18 to less than 65 years of age (3.44 per 100 patient-years) and less than 18 years of age (2.12 per 100 patient-years).

There are limited data in patients above 75 years of age.

Drug–drug interactions1
When the indicated dose in a patient is 100 mg or 200 mg abrocitinib once daily, the dose should be reduced by 50% to 50 mg or 100 mg once daily, respectively, in patients receiving strong inhibitors of cytochrome P450 (CYP) 2C19 (e.g., fluvoxamine, fluconazole). The use of abrocitinib is not recommended concomitantly with strong inducers of CYP enzymes.

Required monitoring1

Some laboratory monitoring is required in patients taking abrocitinib, namely platelet counts, absolute lymphocyte counts, absolute neutrophil counts, haemoglobin and lipids.

Laboratory measure

Monitoring guidance

What to do

Platelet count

Before treatment initiation, 4 weeks after initiation and thereafter according to routine patient management

Treatment should be discontinued if platelets are <50 x 103/mm3

Absolute lymphocyte count (ALC)

Treatment should be interrupted if ALC is <0.5 × 103/mm3 and may be restarted once ALC returns above this value

Absolute neutrophil count (ANC)

Treatment should be interrupted if ANC is <0.1 × 103/mm3 and may be restarted once ANC returns above this value

Haemoglobin (Hgb)

Treatment should be interrupted if Hgb <8 g/dL and may be restarted once Hgb returns above this value

Lipid parameters

Before treatment initiation, 4 weeks after initiation and thereafter according to clinical guidelines for hyperlipidaemia

Patients should be monitored according to clinical guidelines for hyperlipidaemia

Abrocitinib is rapidly absorbed (peak plasma concentrations are reached within 1 hour), with an elimination half-life of about 5 hours. Steady-state plasma concentrations are achieved within 48 hours after once daily administration.

​​​​​​​Abrocitinib is well-absorbed orally and has absolute oral bioavailability of approximately 60%. Taking abrocitinib with a high-fat meal had no clinically relevant effect on abrocitinib exposures. In clinical studies, abrocitinib was administered without regard to food.

Abrocitinib is eliminated by metabolic clearance mechanisms, with <1% of the dose excreted in urine as unchanged drug.

Pharmacokinetic properties1


References: 1. Cibinqo (abrocitinib) Summary of Product Characteristics. 2. de Lusignan S, et al. BMJ Open 2020;10:e037518. doi:10.1136/bmjopen-2020-037518. 3. Bieber T, et al. N Eng J Med 2021;384:1101–1112. 4. Bieber T, et al. N Eng J Med 2021;384:1101–1112. Supplementary appendix. 5. Simpson E, et al. Lancet 2020;396:P255–266. 6. Silverberg J, et al. JAMA Dermatol 2021;156(8):863–873. 7. Blauvelt A, et al. JAAD 2021; doi.org/10/1016/j.jaad.2021.05.075. 8. Eichenfield L, et al. JAMA Dermatol 2021; doi:10.1001/jamadermatol.2021.2830. 9. ClinicalTrials.gov. NCT03422822. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03422822.
PP-CIB-GBR-0071. November 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.

Contents

1. Name of the drug

2. Indication

3. Description of the condition

4. Posology: How is the drug taken?

5. List price

6. Who can prescribe abrocitinib?

7. MOA: How does it work?

8. How is atopic dermatitis currently treated?

9. What clinical studies support the licensing of abrocitinib?

10. JADE COMPARE study design

11. JADE MONO-1/-2 study design

12. JADE REGIMEN study design

13. JADE TEEN study design

14. JADE EXTEND study design

15. Efficacy
  • Clinical response
  • Long-term efficacy
  • Late-onset efficacy
  • Health-related outcomes
16. Safety
  • Summary of safety  
  • Common adverse reactions
  • Infections: Overall, serious, and opportunistic
  • Venous thromboembolism
  • Elderly patients
  • Drug–drug interactions
17.   Required monitoring

18.   Pharmacokinetic properties

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