Actinic Keratoses, Basal Cell Carcinoma, Melanoma (Skin), Nonmelanoma Skin Cancer, Squamous Cell Carcinoma, Vitiligo
Conditions
Brief summary
This study examines melanoma and nonmelanoma skin cancer in people diagnosed with vitiligo compared to matched controls.
Detailed description
For the primary analysis, this study examines the risk of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma in people diagnosed with vitiligo. It also examines actinic keratoses. In secondary analysis, this study examines the prevalence of skin cancer in people diagnosed with vitiligo compared to matched controls. This study also examines whether the susceptibility to melanoma and nonmelanoma skin cancer may vary between different patient subgroups, e.g. ethnicity, those who undergo phototherapy or treatment with the new targeted biologic immunosuppressive therapies.
Interventions
OTHERExposure of skin cancer of interest
Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Sponsors
Pfizer
Momentum Data
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* All eligible adult patients (aged ≥ 18) registered with General Practioner (GP) practices contributing data to OPCRD between January 1, 2010 and December 31, 2020, were eligible for inclusion in the study. People diagnosed with vitiligo prior to the study period (prevalent vitiligo) and people newly diagnosed with vitiligo during the study period (incident vitiligo) are included as cases.
Exclusion criteria
* People actively registered with the GP practice at that date without a history of vitiligo require a minimum one-year registration with their GP practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of New Onset Skin Cancers in the Least Deprived Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the least deprived subgroup category |
| Number of New Onset Skin Cancers in the Female Sex Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in female vitiligo cases and matched controls. |
| Number of New Onset Skin Cancers in the Male Sex Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in male vitiligo cases and matched controls. |
| Number of New Onset Skin Cancers in the >=65 Age Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged \>=65 |
| Number of New Onset Skin Cancers in the White Ethnicity Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of white ethnicity |
| Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of non-white ethnicity |
| Number of New Onset Skin Cancers in the Most Deprived Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the most deprived subgroup category |
| Number of New Onset Skin Cancers in the <45 Age Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged \<45 |
| Number of New Onset Skin Cancers in the 45-64 Age Subgroup | 10 years from the index date | Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged 45-64 |
| Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo | 10 years from the index date | Number of new onset skin cancer assessed prospectively in vitiligo cases and matched controls. The skin cancer outcome comprises of the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo | At index date. | Prevalence of melanoma skin cancer in adult people diagnosed with vitiligo at or before recruitment |
| Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | At index date. | Prevalence of squamous cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment |
| Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | At index date. | Prevalence of basal cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment |
| Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo | 10 years from the index date | Number of new onset actinic keratoses in adult people assessed in vitiligo cases and matched controls. |
| Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo | At index date. | Prevalence of actinic keratoses in adult people diagnosed with vitiligo at or before recruitment |
| Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo | At index date | Skin cancer is defined as the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cases Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. | 15,156 |
| Controls The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level.
Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses. | 60,615 |
| Total | 75,771 |
Baseline characteristics
| Characteristic | Cases | Controls | Total |
|---|---|---|---|
| Age, Continuous | 47 years | 47 years | 47 years |
| Age, Customized 18-44 | 6724 Participants | 26843 Participants | 33567 Participants |
| Age, Customized 45-64 | 5393 Participants | 21596 Participants | 26989 Participants |
| Age, Customized 65+ | 3,039 Participants | 12,176 Participants | 15215 Participants |
| Index of Multiple Deprivation | 3 Quintile of deprivation | 3 Quintile of deprivation | 3 Quintile of deprivation |
| Race/Ethnicity, Customized Asian or Asian British | 2,067 Participants | 6,096 Participants | 8163 Participants |
| Race/Ethnicity, Customized Black or Black British | 345 Participants | 1,272 Participants | 1617 Participants |
| Race/Ethnicity, Customized Missing data | 3555 Participants | 16084 Participants | 19639 Participants |
| Race/Ethnicity, Customized Mixed | 155 Participants | 557 Participants | 712 Participants |
| Race/Ethnicity, Customized Not stated | 367 Participants | 1,685 Participants | 2052 Participants |
| Race/Ethnicity, Customized Other | 618 Participants | 2,725 Participants | 3343 Participants |
| Race/Ethnicity, Customized White | 8,049 Participants | 32,196 Participants | 40245 Participants |
| Sex: Female, Male Female | 8,256 Participants | 33,016 Participants | 41272 Participants |
| Sex: Female, Male Male | 6,900 Participants | 27,599 Participants | 34499 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 New Onset Skin Cancer in Adult People Diagnosed With Vitiligo
Number of new onset skin cancer assessed prospectively in vitiligo cases and matched controls. The skin cancer outcome comprises of the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma.
Time frame: 10 years from the index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo | 133 Participants |
| Controls | Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo | 812 Participants |
Primary
Number of New Onset Skin Cancers in the 45-64 Age Subgroup
Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged 45-64
Time frame: 10 years from the index date
Population: The number of participants analyzed for this outcome is a subset of the overall population:age 45 tp 64 years subgroup
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the 45-64 Age Subgroup | 42 Participants |
| Controls | Number of New Onset Skin Cancers in the 45-64 Age Subgroup | 315 Participants |
Primary
Number of New Onset Skin Cancers in the <45 Age Subgroup
Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged \<45
Time frame: 10 years from the index date
Population: The number of participants analyzed for this outcome is a subset of the overall population:age less than 45 years subgroup
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the <45 Age Subgroup | 11 Participants |
| Controls | Number of New Onset Skin Cancers in the <45 Age Subgroup | 72 Participants |
Primary
Number of New Onset Skin Cancers in the >=65 Age Subgroup
Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged \>=65
Time frame: 10 years from the index date
Population: The number of participants analyzed for this outcome is a subset of the overall population:age 65+ years subgroup
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the >=65 Age Subgroup | 80 Participants |
| Controls | Number of New Onset Skin Cancers in the >=65 Age Subgroup | 425 Participants |
Primary
Number of New Onset Skin Cancers in the Female Sex Subgroup
Number of new onset skin cancers assessed prospectively in female vitiligo cases and matched controls.
Time frame: 10 years from the index date
Population: The number of participants analyzed for this outcome is a subset of the overall population: female sex subgroup
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the Female Sex Subgroup | 78 Participants |
| Controls | Number of New Onset Skin Cancers in the Female Sex Subgroup | 429 Participants |
Primary
Number of New Onset Skin Cancers in the Least Deprived Subgroup
Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the least deprived subgroup category
Time frame: 10 years from the index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the Least Deprived Subgroup | 66 Participants |
| Controls | Number of New Onset Skin Cancers in the Least Deprived Subgroup | 355 Participants |
Primary
Number of New Onset Skin Cancers in the Male Sex Subgroup
Number of new onset skin cancers assessed prospectively in male vitiligo cases and matched controls.
Time frame: 10 years from the index date
Population: The number of participants analyzed for this outcome is a subset of the overall population: male sex subgroup
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the Male Sex Subgroup | 55 Participants |
| Controls | Number of New Onset Skin Cancers in the Male Sex Subgroup | 383 Participants |
Primary
Number of New Onset Skin Cancers in the Most Deprived Subgroup
Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the most deprived subgroup category
Time frame: 10 years from the index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the Most Deprived Subgroup | 46 Participants |
| Controls | Number of New Onset Skin Cancers in the Most Deprived Subgroup | 345 Participants |
Primary
Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup
Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of non-white ethnicity
Time frame: 10 years from the index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup | 9 Participants |
| Controls | Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup | 66 Participants |
Primary
Number of New Onset Skin Cancers in the White Ethnicity Subgroup
Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of white ethnicity
Time frame: 10 years from the index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Skin Cancers in the White Ethnicity Subgroup | 103 Participants |
| Controls | Number of New Onset Skin Cancers in the White Ethnicity Subgroup | 563 Participants |
Secondary
Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo
Number of new onset actinic keratoses in adult people assessed in vitiligo cases and matched controls.
Time frame: 10 years from the index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo | 264 Participants |
| Controls | Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo | 1108 Participants |
Secondary
Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo
Prevalence of actinic keratoses in adult people diagnosed with vitiligo at or before recruitment
Time frame: At index date.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo | 111 Participants |
| Controls | Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo | 363 Participants |
Secondary
Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo
Prevalence of basal cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Time frame: At index date.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | 31 Participants |
| Controls | Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | 161 Participants |
Secondary
Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo
Prevalence of melanoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Time frame: At index date.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo | 85 Participants |
| Controls | Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo | 27 Participants |
Secondary
Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo
Skin cancer is defined as the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma.
Time frame: At index date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo | 66 Participants |
| Controls | Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo | 293 Participants |
Secondary
Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo
Prevalence of squamous cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment
Time frame: At index date.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cases | Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | 13 Participants |
| Controls | Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo | 72 Participants |