Allergic Rhinitis, Allergy to Animal Dander, Allergy to House Dust Mite, Atopic Dermatitis, Cows Milk Allergy, Deep Vein Thrombosis, Food Allergy, Pulmonary Embolism, Venous Thromboembolism
Conditions
Brief summary
This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.
Detailed description
The aim of this study is to examine whether venous thromboembolism is higher in people with atopic dermatitis compared and those without and to explore the risk in particular subgroups of people with AD such as those with higher body mass index or using oestrogen containing contraceptives. Such insights will be valuable for clinicians in advising patients with atopic dermatitis regarding venous thromboembolism prevention and detection and when selecting atopic dermatitis treatments.
Interventions
OTHERExposure of venous thromboembolism
Composite of pulmonary embolism and deep vein thrombosis
Sponsors
Pfizer
Momentum Data
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* All eligible adult people (aged ≥ 18) registered with GP practices contributing data to OPCRD between January 1, 2010 and January 1, 2020, were eligible for inclusion in the study.
Exclusion criteria
* People with less than 5 years potential follow up. People with atopic dermatitis that was not active atopic dermatitis during the study period. People without atopic dermatitis but diagnosed with other skin conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person. | 10 years from index date | To describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person | 10 years from index date | To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population. |
| Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore the risk of VTE stratified by the male sex at the baseline in people with active AD compared to a matched control population. |
| Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore the risk of VTE stratified by the female sex at the baseline in people with active AD compared to a matched control population. |
| Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore the risk of VTE stratified by those aged 18-44 at the baseline in people with active AD compared to a matched control population. |
| Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore the risk of VTE stratified by those aged 45-64 at the baseline in people with active AD compared to a matched control population. |
| Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person | 10 years from index date | To describe the risk of pulmonary embolism in people with active AD compared to a matched control population. |
| Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore the risk of VTE stratified by those with a BMI \<30 at the baseline with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded. |
| Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore the risk of VTE stratified by those with a BMI ≥30 at the baseline in people with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded. |
| Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore the risk of VTE stratified by oestrogen contraceptive use in females aged 18-44 years at the baseline in people with active AD compared to a matched control population. |
| Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline in people with active AD compared to a matched control population.. Allergic conditions will comprise common allergies; allergic rhinitis, allergy to dust mites or animal dander, and food allergies e.g., nut, fruit, shellfish, eggs and cows' milk allergies. Medication and other allergies will not be included. |
| Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 10 years from index date | To explore the risk of VTE stratified by those aged ≥65 at the baseline in people with active AD compared to a matched control population. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cases All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis | 150,975 |
| Controls Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.
Exposure of venous thromboembolism: Composite of pulmonary embolism and deep vein thrombosis | 603,770 |
| Total | 754,745 |
Baseline characteristics
| Characteristic | Cases | Controls | Total |
|---|---|---|---|
| Age, Continuous | 40.0 years | 41.0 years | 41.0 years |
| Age, Customized 18-29 | 54634 Participants | 213727 Participants | 268361 Participants |
| Age, Customized 30-39 | 20599 Participants | 80118 Participants | 100717 Participants |
| Age, Customized 40-49 | 17903 Participants | 80211 Participants | 98114 Participants |
| Age, Customized 50-59 | 15765 Participants | 61343 Participants | 77108 Participants |
| Age, Customized 60-69 | 17375 Participants | 71571 Participants | 88946 Participants |
| Age, Customized 70-79 | 15081 Participants | 58452 Participants | 73533 Participants |
| Age, Customized 80+ | 9618 Participants | 38348 Participants | 47966 Participants |
| Alcohol status Excess | 18660 Participants | 64716 Participants | 83376 Participants |
| Alcohol status Harmful | 2374 Participants | 8743 Participants | 11117 Participants |
| Alcohol status Missing | 23953 Participants | 132695 Participants | 156648 Participants |
| Alcohol status None | 47083 Participants | 170663 Participants | 217746 Participants |
| Alcohol status Within limits | 58905 Participants | 226953 Participants | 285858 Participants |
| BMI 18.5-24.9 Normal weight | 46458 Participants | 174953 Participants | 221411 Participants |
| BMI < 18.5 Underweight | 5931 Participants | 24532 Participants | 30463 Participants |
| BMI 25-29.9 Overweight | 43720 Participants | 159607 Participants | 203327 Participants |
| BMI 30-34.9 Class I obesity | 21317 Participants | 77432 Participants | 98749 Participants |
| BMI 35-39.9 Class II obesity | 8711 Participants | 30258 Participants | 38969 Participants |
| BMI 40+ Class III obesity | 5353 Participants | 17515 Participants | 22868 Participants |
| BMI Missing | 19485 Participants | 119473 Participants | 138958 Participants |
| GP visit in last 12 months No | 4535 Participants | 67259 Participants | 71794 Participants |
| GP visit in last 12 months Yes | 146440 Participants | 536511 Participants | 682951 Participants |
| Hospital admission No | 147317 Participants | 592210 Participants | 739527 Participants |
| Hospital admission Yes | 3658 Participants | 11560 Participants | 15218 Participants |
| Race/Ethnicity, Customized Asian or Asian British | 12635 Participants | 38388 Participants | 51023 Participants |
| Race/Ethnicity, Customized Black or Black British | 2021 Participants | 7903 Participants | 9924 Participants |
| Race/Ethnicity, Customized Missing | 35034 Participants | 173225 Participants | 208259 Participants |
| Race/Ethnicity, Customized Mixed | 1396 Participants | 4281 Participants | 5677 Participants |
| Race/Ethnicity, Customized Not stated | 4638 Participants | 21349 Participants | 25987 Participants |
| Race/Ethnicity, Customized Other | 7503 Participants | 26907 Participants | 34410 Participants |
| Race/Ethnicity, Customized White | 87748 Participants | 331717 Participants | 419465 Participants |
| Sex: Female, Male Female | 89093 Participants | 356311 Participants | 445404 Participants |
| Sex: Female, Male Male | 61882 Participants | 247459 Participants | 309341 Participants |
| Smoking status Current | 27,173 Participants | 116,895 Participants | 144068 Participants |
| Smoking status Ex-smoker | 74,860 Participants | 255,950 Participants | 330810 Participants |
| Smoking status Missing | 3020 Participants | 39914 Participants | 42934 Participants |
| Smoking status Never | 45,152 Participants | 189,107 Participants | 234259 Participants |
| Smoking status Passive | 770 Participants | 1,904 Participants | 2674 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.
To describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person. | 2576 Participants |
| Controls | Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person. | 7563 Participants |
Secondary
Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore the risk of VTE stratified by oestrogen contraceptive use in females aged 18-44 years at the baseline in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 31 Participants |
| Controls | Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 34 Participants |
Secondary
Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore the risk of VTE stratified by the female sex at the baseline in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 1506 Participants |
| Controls | Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 4393 Participants |
Secondary
Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore the risk of VTE stratified by the male sex at the baseline in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 1070 Participants |
| Controls | Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person | 3170 Participants |
Secondary
Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore the risk of VTE stratified by those aged 18-44 at the baseline in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 503 Participants |
| Controls | Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 1592 Participants |
Secondary
Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore the risk of VTE stratified by those aged 45-64 at the baseline in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 639 Participants |
| Controls | Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 1858 Participants |
Secondary
Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore the risk of VTE stratified by those aged ≥65 at the baseline in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 1434 Participants |
| Controls | Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 4113 Participants |
Secondary
Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore the risk of VTE stratified by those with a BMI \<30 at the baseline with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 1398 Participants |
| Controls | Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 3188 Participants |
Secondary
Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore the risk of VTE stratified by those with a BMI ≥30 at the baseline in people with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 685 Participants |
| Controls | Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 760 Participants |
Secondary
Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
To explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline in people with active AD compared to a matched control population.. Allergic conditions will comprise common allergies; allergic rhinitis, allergy to dust mites or animal dander, and food allergies e.g., nut, fruit, shellfish, eggs and cows' milk allergies. Medication and other allergies will not be included.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 193 Participants |
| Controls | Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person | 203 Participants |
Secondary
Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person
To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person | 1887 Participants |
| Controls | Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person | 4934 Participants |
Secondary
Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person
To describe the risk of pulmonary embolism in people with active AD compared to a matched control population.
Time frame: 10 years from index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person | 797 Participants |
| Controls | Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person | 2942 Participants |