Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

CIBINQO

Study drug International non-proprietary name (INN) or common name

ABROCITINIB

Anatomical Therapeutic Chemical (ATC) code

(D11AH08) abrocitinib
abrocitinib

Additional medical condition(s)

Atopic dermatitis
Population studied

Short description of the study population

The study population will include patients with a dispensing of abrocitinib as recorded in routinely collected electronic healthcare data in Denmark, France, Sweden, Spain and Hungary during the study period (study start: country-specific aRMM distribution [01 March 2022, Sweden; 09 March 2022, Denmark; 31 July 2022, France; 30 Jan 2023, Spain; 05 April 2024, Hungary]; study end: December 2026). These countries have universal healthcare.

Age groups

All

Special population of interest

Hepatic impaired
Pregnant women
Study design details

Study design

This will be a descriptive drug utilization study using secondary data from healthcare databases in Denmark, France, Sweden, Spain and Hungary.

Main study objective

The study objectives are to evaluate, to the extent measurable in the available routinely collected data, indicators of healthcare professional’s adherence to the risk minimization measures in accordance with the abrocitinib.
Summary of Product Characteristics and prescriber’s brochure: indicators of adherence to performing laboratory tests of complete blood count (CBC), lipid panel, hepatitis B/C, and tuberculosis (TB) screening prior to initiation of abrocitinib treatment, indicators of adherence to performing laboratory tests of CBC and lipid panel at week 4 (± 2 weeks) after initiation of abrocitinib treatment, indicators of adherence to consideration of risk factors for venous thromboembolism (VTE), major adverse cardiovascular event (MACE), malignancy excluding non-melanoma skin cancer (NMSC), NMSC, and serious infection prior to treatment with abrocitinib, indicators of adherence to avoid live attenuated vaccines immediately prior to and during treatment with abrocitinib, indicators of adherence to contraindications for use during pregnancy, indicators of adherence to contraindications for use among patients with severe hepatic impairment, indicators of adherence to no use in patients aged < 12 years, and indicators of adherence to recommended posology (estimated average daily dose).

Setting

The study population will include patients with a dispensing of abrocitinib as recorded in routinely collected electronic secondary population data in Denmark, France, Sweden, Spain and Hungary between the study start (country-specific additional Risk Minimization Measure (aRMM) distribution [01 Mar 2022, Sweden; 09 Mar 2022, Denmark; 31 Jul 2022, France; 30 Jan 2023, Spain; 05 April 2024, Hungary]) and study end (December 2026). Details on the data sources are in Section 9.4). All participating countries have universal health care.

Comparators

Not applicable

Outcomes

Outcomes include:
(1) the count and proportion of patients with evidence of having performed CBC, lipid panel, TB screening, and viral hepatitis B and C screening tests within 3 months prior to initiation of abrocitinib;
(2) the count and proportion of patients with evidence of having performed the CBC and lipid panel laboratory tests at week 4 (± 2 weeks) after initiation of abrocitinib;
(3) the proportion of patients with evidence of having risk factors and the number of risk factors for VTE, MACE, malignancy excluding NMSC, NMSC, and serious infection (including age 65 years or older, estimated dose of >100 mg/day for patients ages 65 or older, history of atherosclerotic disease, malignancy, pregnancy, history of VTE, use of combined hormonal contraceptives or hormone replacement therapy, major surgery, inherited coagulation disorder, diabetes, history of serious or opportunistic infection, TB) within 6 months prior to initiation of treatment with abrocitinib;
(4) the count and proportion of patients with evidence of having received live attenuated vaccines (e.g., measles, mumps, rubella) 4 weeks prior to and during treatment with abrocitinib;
(5) the count and proportion (among all pregnant women identifiable in a given database) of women in whom pregnancy overlaps with abrocitinib use;
(6) the count and proportion patients identified with severe hepatic impairment up to 6 months prior to or during treatment with abrocitinib;
(7) the count and proportion of patients aged <12 years on the index date; and (8) the count of proportion of patients with an estimated starting dose > 100mg/day, and a description of the duration of use (median and IQR).

Data analysis plan

For each country, patient baseline characteristics will be reported to the extent measured in each database, including demographics (age and sex), comorbidities (including asthma, food allergies, depression) and prior and current medication use (including treatments for atopic dermatitis and medications noted for interactions in the abrocitinib label as captured in outpatient dispensing data or other available secondary routinely collected data on medication use).
Other characteristics frequently diagnosed among patients with atopic dermatitis may be added given acceptable validity and completeness measured via diagnoses or treatment proxies and known in time for inclusion in planned data extractions; existing ethical and data protection permissions and the associated data applications may need to be amended to enable inclusion of additional variables. Counts and proportions for categorical variables and mean, median with range or interquartile ranges (IQRs) for continuous variables will be reported to address the study objectives.