The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata

The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions, and Common Infections in Alopecia Areata

This study series consists of four related studies and aims to explore and describe many important elements of alopecia areata over three key areas: (1) the current epidemiology of alopecia areata, (2) the prevalence and incidence of psychiatric co-morbidities in people with alopecia areata, (3) the prevalence and incidence of autoimmune and atopic conditions in people with alopecia areata, and (4) the incidence of common infections in people with alopecia areata.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Pneumonia; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Anxiety Disorders; Psoriasis; Asthma; Type 1 Diabetes; Graves Disease; Celiac Disease; Allergic Rhinitis; Urinary Tract Infections; Crohn Disease; Influenza; Ulcerative Colitis; Herpes Zoster; Herpes Simplex; Atopic Dermatitis; Vitiligo; Polymyalgia Rheumatica; Psoriatic Arthritis; Lower Resp Tract Infection; Sjogren's Syndrome; Infection; Alopecia Areata; Ankylosing Spondylitis; Depressive Episode; Hashimoto Thyroiditis; Gastrointestinal Infection; Recurrent Depressive Disorder; Infection Viral; Acute Bronchitis; Upper Respiratory Tract Infection; Skin Infection; Pernicious Anemia; Genital Infection
• Intervention / Treatment: Other: Exposure of interest (studies 2 & 3).

Detailed Description

The overall purpose of the first study (Study 1) is to describe the epidemiology of Alopecia areata (AA) and to assess the current level of primary care service utilisation and management patterns associated with patients diagnosed with AA.

The overall purpose of the second study (study 2) is to assess the prevalence and incidence of mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with AA relative to a control population of patients without a diagnosis of AA. In addition, the study will determine both the treatment, 'sick day' and unemployment burden. Treatment burden comprises that of medications and psychological interventions used to treat mental health conditions in adult patients diagnosed with Alopecia areata.

The overall purpose of the third study (Study 3) is to assess the prevalence and incidence of atopic and autoimmune conditions in adult patients diagnosed with AA relative to a control population of patients without AA.

The overall purpose of the fourth study (Study 4) is to assess the incidence of common infections in adult patients diagnosed with AA relative to a control population of patients without AA.

• Study Type: Observational
• Enrollment (Actual): 51955

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1X 8QT
    • Momentum Data Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

These studies will use routinely collected and collated data from the Royal College of General Practitioners Research and Surveillance Centre database to provide a broadly representative sample of the population of England.

Description

Inclusion Criteria:

• Patients contributing to Royal College of General Practitioners Research and Surveillance Centre(RCGP RCS) primary care database between January 1, 2009 and December 31, 2018, will be eligible for inclusion.
• Only patients aged ≥18 will be eligible for studies 2 and 3.
• Only patients aged ≥ 18 and ≤ 65 will be included in the unemployment and sick day analysis (study 2)

Exclusion Criteria:

• People with the alternative non-AA diagnoses.
• People with AA diagnosis within 6 months of registration.
• People with less than 1 year of follow up available

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients with a confirmed diagnosis of Alopecia areata within the study period will be included as cases for analysis.	Other: Exposure of interest (studies 2 & 3).; Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder Atopic conditions consist of Atopic dermatitis, allergic rhinitis, asthma Autoimmune conditions consist of Crohn's disease, ulcerative colitis, Coeliac disease, Pernicious anaemia, Type 1 diabetes, Hashimoto's thyroiditis, Grave's disease, Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Systemic lupus erythematosus, polymyalgia rheumatica, Sjögren's syndrome, Psoriasis, vitiligo, Multiple sclerosis
Controls; The control cohorts will be defined by matching cases with patients who have never been diagnosed with Alopecia areata either prior to or during the study period, by age and sex, at General Practice practice level.	Other: Exposure of interest (studies 2 & 3).; Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder Atopic conditions consist of Atopic dermatitis, allergic rhinitis, asthma Autoimmune conditions consist of Crohn's disease, ulcerative colitis, Coeliac disease, Pernicious anaemia, Type 1 diabetes, Hashimoto's thyroiditis, Grave's disease, Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Systemic lupus erythematosus, polymyalgia rheumatica, Sjögren's syndrome, Psoriasis, vitiligo, Multiple sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 1: The incidence of Alopecia Areata	The incidence of Alopecia areata within the study cohort during the study period	Overall during 2009-2018 inclusive
Study 1: The incidence of Alopecia Areata stratified by sociodemographic factors	This will comprise of the incidence of Alopecia Areata over the study period, by age group, gender, ethnicity, and Social Economic Status.	Overall during 2009-2018 inclusive
Study 1:The annual rate of primary care visits for people with Alopecia Areata.	The annual rate of visits to primary care for any reason within one year of diagnosis.	Within one year of diagnosis of Alopecia Areata
Study 1: Secondary care dermatology service utilisation	The percent of people reviewed in secondary care dermatology services within one year of diagnosis of Alopecia Areata	Within one year of diagnosis of Alopecia Areata
Study 2: The prevalence of common mental health conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis	Prevalence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with Alopecia Areata in a contemporary real-world population compared with matched controls.	At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 2: Describe the incidence of common mental health conditions in adult patients with Alopecia Areata	Incidence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within two years of diagnosis of Alopecia Areata
Study 2: Describe the mental health medication treatment burden of adult patients diagnosed with Alopecia Areata.	This will comprise of the number of medications used to treat mental health conditions in patients diagnoses with Alopecia Areata. Antidepressant medication classes to be examined comprise; selective serotonin reuptake inhibitors and related medications (serotonin and norepinephrine reuptake inhibitors (SNRIs)), tricyclic antidepressants and related medications (tetracyclic antidepressant), and monoamine oxidase inhibitors. Anxiolytic medications to be examined comprise all benzodiazepines and other related medications indicated for use in anxiety states.	Within two years of diagnosis of Alopecia Areata
Study 2: Number of patients diagnosed with Alopecia Areata receiving mental health psychological intervention.	This will comprise of the number of psychological interventions used to treat mental health conditions in patients diagnoses with Alopecia Areata. Psychological interventions comprise of counselling, Cognitive Behavioural Therapy, and psychotherapy.	Within two years of diagnosis of Alopecia Areata
Study 3: Describe the prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis	Prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata in a contemporary real-world population at diagnosis compared with matched controls.	At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 3: Describe the incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata.	Incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of a composite of common infections in adult patients with Alopecia Areata	Incidence of a composite of any common infection (composite comprising a diagnosis of: upper and lower respiratory tract infection, pneumonia, acute bronchitis, influenza, skin infection, urinary tract infection, genital infections, gastrointestinal infection, herpes simplex and herpes zoster) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of a composite of viral infections in adult patients with Alopecia Areata	Incidence of a composite of any viral infection (composite comprising a diagnosis of: influenza, herpes simplex and herpes zoster infections, bronchitis, and any upper respiratory tract infections specifically coded as being viral) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region.	By region across England.	Overall during 2009-2018 inclusive
Study 2: Prevalence (percentage) of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder), by socio-demographic factors, in adult patients diagnosed with Alopecia Areata.	By age group, gender, ethnicity, and Social Economic Status.	At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 2: Describe the burden of 'sick days' in adult patients diagnosed with Alopecia Areata relating to mental health conditions.	Sick days will be indicated by the issuing of Med 3 certification from primary care (Statement of Fitness for Work) certification.	Within one year of diagnosis of Alopecia Areata
Study 2: Describe the prevalence of unemployment in adult patients diagnosed with Alopecia Areata.	Unemployment will be identified using Read codes relating to unemployment recorded in the clinical record or the issuing of an Incapacity Benefit (IB113) or Employment and Support Allowance (ESA113) form.	Within one year of diagnosis of Alopecia Areata
Study 4: The incidence of upper respiratory tract infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of upper respiratory tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of lower respiratory tract infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of lower respiratory tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of influenza infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of influenza or influenza-like illness (where direct swab confirmed diagnosis is not performed) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of acute bronchitis in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of acute bronchitis in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of pneumonia in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of pneumonia in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of gastrointestinal infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of gastrointestinal infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of stool confirmed gastrointestinal infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of gastrointestinal infection confirmed by stool culture or microscopy results (or other microbiological diagnosis confirmation) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of skin infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of skin infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of urinary tract infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of urinary tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of genital infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of genital infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of herpes zoster infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of herpes zoster infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Study 4: The incidence of herpes simplex infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of herpes simplex infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis

Collaborators and Investigators

• Sponsor: Momentum Data
• Collaborators: Pfizer; University of Oxford; University of Surrey

Publications and helpful links

General Publications

• Macbeth AE, Holmes S, Harries M, Chiu WS, Tziotzios C, de Lusignan S, Messenger AG, Thompson AR. The associated burden of mental health conditions in alopecia areata: a population-based study in UK primary care. Br J Dermatol. 2022 Jul;187(1):73-81. doi: 10.1111/bjd.21055. Epub 2022 May 11.
• Harries M, Macbeth AE, Holmes S, Thompson AR, Chiu WS, Gallardo WR, Messenger AG, Tziotzios C, de Lusignan S. Epidemiology, management and the associated burden of mental health illness, atopic and autoimmune conditions, and common infections in alopecia areata: protocol for an observational study series. BMJ Open. 2021 Nov 16;11(11):e045718. doi: 10.1136/bmjopen-2020-045718.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): November 28, 2022

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Infection; Prevalence; Anxiety; Epidemiology; Incidence; Autoimmune disease; Alopecia areata; Common mental health conditions; Atopic conditions
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Respiratory Tract Diseases; Mood Disorders; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Lung Diseases; Urologic Diseases; Eye Diseases; Endocrine System Diseases; Disease Attributes; Hematologic Diseases; Gastrointestinal Diseases; Bronchial Diseases; Nutrition Disorders; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Gastroenteritis; Thyroid Diseases; Muscular Diseases; Stomatognathic Diseases; Mouth Diseases; Intestinal Diseases; DNA Virus Infections; Pathological Conditions, Anatomical; Anemia; Vasculitis; Skin Diseases, Vascular; Skin Diseases, Infectious; Skin Diseases, Papulosquamous; Avitaminosis; Deficiency Diseases; Malnutrition; Lung Diseases, Obstructive; Skin Diseases, Viral; Spinal Diseases; Bone Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Lacrimal Apparatus Diseases; Malabsorption Syndromes; Inflammatory Bowel Diseases; Herpesviridae Infections; Spondylarthropathies; Spondylarthritis; Varicella Zoster Virus Infection; Pigmentation Disorders; Vitamin B Deficiency; Psoriasis; Hypopigmentation; Vasculitis, Central Nervous System; Arthritis, Rheumatoid; Arteritis; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Hypotrichosis; Hair Diseases; Bone Diseases, Infectious; Ankylosis; Thyroiditis, Autoimmune; Anemia, Megaloblastic; Anemia, Macrocytic; Vitamin B 12 Deficiency; Depressive Disorder; Multiple Sclerosis; Arthritis; Disease; Lupus Erythematosus, Systemic; Infections; Communicable Diseases; Virus Diseases; Anxiety Disorders; Dermatitis; Celiac Disease; Urinary Tract Infections; Crohn Disease; Arthritis, Psoriatic; Herpes Zoster; Respiratory Tract Infections; Vitiligo; Polymyalgia Rheumatica; Giant Cell Arteritis; Sjogren's Syndrome; Bronchitis; Alopecia; Alopecia Areata; Spondylitis; Spondylitis, Ankylosing; Herpes Simplex; Hashimoto Disease; Graves Disease; Thyroiditis; Anemia, Pernicious
• Other Study ID Numbers: P005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
• IPD Sharing Time Frame: There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
• IPD Sharing Access Criteria: As above
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No