Real-World Treatment Patterns among Patients with Alopecia Areata in the USA: A Retrospective Claims Analysis.

Alopecia areata is an autoimmune disorder characterized by hair loss, for which there are few treatment options. This claims-based study characterized recent real-world treatment patterns among patients in the USA with alopecia areata, including the subtypes alopecia totalis and alopecia universalis, in the first year after diagnosis of an episode of alopecia areata. Approximately 5% of all patients (adults (age ≥ 18 years), n = 7,703; adolescents (age 12-17 years), n = 595) had alopecia totalis or alopecia universalis. Corticosteroids were the most common first-line (1L) and second-line (2L) treatments. The mean time from diagnosis of alopecia areata to initiation of 1L treatment was 2.2 days for adults and 2.6 days for adolescents; mean 1L duration was 76.9 and 64.3 days, respectively. For adults (57.5%) and adolescents (59.7%) with 2L therapy, the mean time from 1L discontinuation to 2L initiation was 57.2 and 53.6 days, respectively; the mean duration of 2L treatment was 55.5 and 50.1 days, respectively. More patients with vs without alopecia totalis or alopecia universalis initiated 2L therapy (adults: 71.9% vs 56.8%; adolescents: 71.4% vs 58.9%). The proportion of days covered during the first year post-diagnosis was 36.7% (adults) and 34.1% (adolescents). These results highlight the substantial disease burden of alopecia areata and a need for more effective treatments.

Overall and Racial and Ethnic Subgroup Prevalences of Alopecia Areata, Alopecia Totalis, and Alopecia Universalis.

Importance: Prevalences of alopecia areata (AA), alopecia totalis (AT), and alopecia universalis (AU) are poorly established. Objective: To estimate overall and subgroup prevalences of AA and its subtypes. Design, Setting, and Participants: This cross-sectional study using electronic records comprising the Explorys database (Watson Health, IBM Corporation) included children, adolescents, and adults seeking healthcare across the 4 census regions in the US between January 1, 2019, and December 31, 2019. The statistical analysis was conducted between July 21, 2022, and December 22, 2022. Main Outcomes and Measures: Prevalent cases of AA, AT, and AU. Results: Of the 1 093 176 patients who met inclusion criteria, 1812 had at least 1 code for AA, 1216 female (67%) and 596 male (33%) patients. Overall age-and-sex standardized prevalences among adults and among children and adolescents were observed to be 0.18% and 0.10%, respectively. The age-standardized prevalence ratio in women to men was 1.32. Standardized prevalence was highest in those aged 30 to 39 (297 per 100 000; 95% CI, 263-335) and 40 to 49 (270 per 100 000; 95% CI, 240-303) years. The highest standardized prevalence was observed among Asian patients (414 per 100 000; 95% CI, 306-548), followed by patients reporting another race or multiple races (314 per 100 000; 95% CI, 266-368), Black (226 per 100 000; 95% CI, 199-255), and Hispanic/Latino (212 per 100 000; 95% CI, 129-328) patients. White patients had the lowest standardized prevalence (168 per 100 000; 95% CI, 157-179) among racial and ethnic subgroups. Relative to White patients, standardized prevalence ratios for Asian, Black, and Hispanic/Latino patients were 2.47 (95% CI, 2.17-2.81), 1.35 (95% CI, 1.26-1.44), and 1.26 (95% CI, 1.03-1.55), respectively. Cases of AT and AU comprised approximately 9% of patients diagnosed with AA. Conclusions and Relevance: The findings of this cross-sectional study suggest that there is a significant burden of AA, AT, and AU in the US in which people of color, particularly Asian Americans, appear to be disproportionately affected.

Trends in Prevalence and Incidence of Alopecia Areata, Alopecia Totalis, and Alopecia Universalis Among Adults and Children in a US Employer-Sponsored Insured Population.

Importance: Alopecia areata (AA) is characterized by nonscarring hair loss of the scalp, face, and/or body. Alopecia totalis (AT) and alopecia universalis (AU) involve complete loss of the scalp and body hair, respectively. The epidemiology of AA in the US remains unclear, having previously been extrapolated from older studies that were limited to specific geographic areas or clinical settings, or from self-reported data. Objective: To estimate the annual prevalence and incidence of AA and AT and/or AU (AT/AU) in the US. Design, Setting, and Participants: This retrospective, population-based cohort study was conducted from January 2016 to December 2019 and included enrollees in the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental databases and their dependents, with plan enrollment during each study calendar year and the year prior. Exposures: Prevalent cases were identified by 1 or more claims for AA or AT/AU (International Statistical Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] codes L63.x, L63.0, L63.1) during each year of interest or the year prior. Incident cases were identified by 1 or more claims for AA or AT/AU during a specific year and no diagnosis the year prior. Main Outcomes and Measures: Annual incidence and prevalence rates were calculated and stratified by age, sex, and region. National employer-sponsored insurance population estimates were obtained using population-based weights. Results: Among eligible patients (2016: n = 18 368 [mean (SD) age, 40.6 (17.9) years; 12 295 women (66.9%)]; 2017: n = 14 372 [mean (SD) age, 39.6 (17.7) years; 9195 women (64.0%)]; 2018: n = 14 231 [mean (SD) age, 38.9 (17.3) years; 8998 women (63.2%)]; 2019: n = 13 455 [mean (SD) age, 39.1 (17.4) years; 8322 women (61.9%)]), AA prevalence increased from 0.199% (95% CI, 0.198%-0.200%) in 2016 to 0.222% (95% CI, 0.221%-0.223%) in 2019. Roughly 5% to 10% of prevalent and incident cases of AA were AT/AU. The prevalence of AT/AU increased from 0.012% (95% CI, 0.012%-0.013%) to 0.019% (95% CI, 0.018%-0.019%) from 2016 to 2019. Incidence of AA per 100 000 person-years ranged from 87.39 (95% CI, 86.84-87.96) in 2017 to 92.90 (95% CI, 92.35-93.45) in 2019. Incidence of AT/AU ranged from 7.09 (95% CI, 6.94-7.25) in 2017 to 8.92 (95% CI, 8.75-9.09) in 2016. Prevalence and incidence of AA and AT/AU were higher among female vs male individuals, adults vs children and adolescents, and in the Northeast vs other regions. Conclusions and Relevance: The results of this cohort study suggest that these recent AA prevalence and incidence estimates could help improve current understanding of the disease burden. Further research is warranted to elucidate subpopulation differences and trends in AA in the broader US population.

Out-of-Pocket Costs in Alopecia Areata: A Cross-Sectional Study in German-speaking Countries.

Alopecia areata is a common skin disease which is associated with psychosocial and financial burden. No curative therapy exists and, hence, affected persons resort to self-financed cosmetic solutions. However, studies on the economic impact of alopecia areata on individuals are limited. To estimate annual individual out-of-pocket costs in persons with alopecia areata, a cross-sectional study using a standardized online questionnaire was performed in Germany, Austria and Switzerland. A total of 346 individuals (95.1% women, mean age: 38.5 ± 11.6 years) with alopecia areata participated between April and August 2020. Mean additional spending on everyday necessities was 1,248€ per person per year, which was significantly influenced by the duration of the illness, the treatment provider, and disease severity. Hair replacement products and cosmetics accounted for the highest monthly costs, followed by costs for physician visits, hospital treatments, and medication. Most participants (n = 255, 73.7%) were currently not undergoing treatment, due to lack of efficacy, side-effects, costs and acceptance of the disease. Sex differences in expenses were observed, with women having higher expenditures. Alopecia areata-related out-of-pocket costs place a considerable financial burden on affected individuals, are higher compared with those of other chronic diseases, and should be considered in economic assessments of the impact of this disease.

Patient and physician perspectives on alopecia areata: A real-world assessment of severity and burden in Japan.

The criteria used by physicians to assess alopecia areata severity and its associated burden from the patients' point of view are not well understood. We aimed to understand physician-assessed determinants of disease severity, factors associated with severity, patient-physician concordance, and patient-reported burden by severity. Data were drawn from the Adelphi Alopecia Areata Disease Specific Programme™, a point-in-time survey of dermatologists and their alopecia areata patients in real-world practice in Japan conducted between January and March 2021. Patients were categorized into three groups by current disease severity according to physician subjective assessment: mild, moderate, or severe. Demographics, clinical characteristics, and outcomes were described within and compared between the three patient groups. Our study of 97 dermatologists and 587 patients found overall scalp hair loss was the most important factor considered by physicians in determining disease severity. More severe disease was associated with loss of eyebrow hair, eyelashes, and hair loss from other body areas. Agreement on disease severity between physicians and patients was moderate. From the patient perspective, greater severity of alopecia areata was associated with greater anxiety and depression, with lower work productivity and worse quality of life. Our study provides insights into which factors physicians use to determine alopecia areata severity, how physician and patient severity assessments compare, and the burden of alopecia areata on patients.

The Alopecia Areata Consensus of Experts (ACE) study part II: Results of an international expert opinion on diagnosis and laboratory evaluation for alopecia areata.

BACKGROUND: We previously reported the Alopecia Areata Consensus of Experts study, which presented results of an international expert opinion on treatments for alopecia areata. OBJECTIVE: To report the results of the Alopecia Areata Consensus of Experts international expert opinion on diagnosis and laboratory evaluation for alopecia areata. METHODS: Fifty hair experts from 5 continents were invited to participate in a 3-round Delphi process. Consensus threshold was set at greater than or equal to 66%. RESULTS: Of 148 questions, expert consensus was achieved in 82 (55%). Round 1 consensus was achieved in 10 of 148 questions (7%). Round 2 achieved consensus in 47 of 77 questions (61%). The final face-to-face achieved consensus in 25 of 32 questions (78%). Consensus was greatest for laboratory evaluation (12 of 14 questions [86%]), followed by diagnosis (11 of 14 questions [79%]) of alopecia areata. Overall, etiopathogenesis achieved the least category consensus (31 of 68 questions [46%]). LIMITATIONS: The study had low representation from Africa, South America, and Asia. CONCLUSION: There is expert consensus on aspects of epidemiology, etiopathogenesis, clinical features, diagnosis, laboratory evaluation, and prognostic indicators of alopecia areata. The study also highlights areas where future clinical research could be directed to address unresolved hypotheses in alopecia areata patient care.

Development of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata.

BACKGROUND: Eyebrow and eyelash hair loss and nail damage-in addition to scalp hair loss-are important signs/symptoms of alopecia areata (AA) to patients and deserve assessment in AA clinical trials. OBJECTIVES: Our objective was to develop clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures and accompanying photoguides to aid in the assessment of AA-related eyebrow, eyelash and nail signs/symptoms. METHODS: Iterative rounds of qualitative, semi-structured interviews were conducted with US expert dermatologists and North American patients with AA. Patients with eyebrow, eyelash and nail involvement were purposefully sampled. Interview transcripts were qualitatively analyzed. RESULTS: Dermatologists (n = 10) described eyebrow and eyelash loss as concerning for affected patients and, along with nail appearance, as deserving assessment. Dermatologist data informed the development of single item, 4-point Likert-type ClinRO and PRO measures of current eyebrow loss, eyelash loss and nail appearance and a PRO measure of eye irritation. Patients (n = 45, age 15-72 years) confirmed the importance and relevance of these signs/symptoms. Interim revision resulted in measures that were understood by and relevant to patients. Dermatologists (n = 5) and patients (n = 10, age 21-54 years) participated in the development of the eyebrow, eyelash and nail photoguides and confirmed that they included photos that appropriately represented different severity levels and were helpful to derive and standardize ratings across raters. CONCLUSIONS: The ClinRO and PRO measures for eyebrow, eyelash and nail appearance, with their accompanying photoguides and the PRO Measure for Eye Irritation provide clear and meaningful assessments of outcomes important to patients with AA.

Development of the Scalp Hair Assessment PRO™ measure for alopecia areata.

BACKGROUND: Valid patient-reported outcome (PRO) measures are required to evaluate alopecia areata (AA) treatments. OBJECTIVES: To develop a content-valid and clinically meaningful PRO measure to assess AA scalp hair loss with scores comparable with the five-response-level Alopecia Areata Investigator Global Assessment (AA-IGA™). METHODS: A draft PRO measure was developed based on input from 10 clinical experts in AA. The PRO measure was cognitively debriefed, modified and finalized through two rounds of qualitative semistructured interviews with patients with AA who had experienced ≥ 50% scalp hair loss. Data were thematically analysed. RESULTS: Adults (round 1: n = 25; round 2: n = 15) and adolescents aged 15-17 years (round 1: n = 5) in North America participated. All patients named scalp hair loss as a key AA sign or symptom. Patients demonstrated the ability to self-report their current amount of scalp hair using percentages. In round 1 not all patients interpreted the measurement concept consistently; therefore, the PRO was modified to clarify the measurement concept to improve usability. Following modifications, patients in round 2 responded without difficulty to the PRO measure. Patients confirmed that they could use the five-level response scale to rate their scalp hair loss: no missing hair, 0%; limited, 1-20%; moderate, 21-49%; large, 50-94%; nearly all or all, 95-100%. Almost all patients deemed hair regrowth resulting in ≤ 20% scalp hair loss a treatment success. CONCLUSIONS: The Scalp Hair Assessment PRO™ is a content-valid, clinically meaningful assessment of distinct gradations of scalp hair loss for evaluating AA treatment for patients with ≥ 50% hair loss at baseline.

Evaluation of complete blood cell and inflammatory parameters in patients with alopecia areata: Their association with disease severity.

BACKGROUND: Alopecia areata (AA) is a chronic inflammatory disease characterized by non-cicatricial hair loss. The cause of the disease is still unknown. It can appear at any age and occurs in 0.2% of the general population. Red cell distribution width (RDW), mean platelet volume (MPV), plateletcrit (PCT), the ratio of neutrophils to lymphocytes (NLR), and the ratio of platelets to lymphocytes (PLR) have all been reported as inflammatory markers in recent studies. However, these parameters have not been investigated in AA patients. AIM: We investigated the haematological and inflammatory parameters of AA and considered their association with disease severity. PATIENTS/METHODS: One hundred and five patients with AA and 108 healthy controls were enrolled in the study. RDW, MPV, PCT, NLR, PLR, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were studied retrospectively. Disease severity was evaluated by using the Severity of Alopecia Tool (SALT) score. RESULTS: There were no statistically significant differences between RDW, MPV, PCT, NLR, and PLR levels in AA patients and in healthy controls. Only the CRP values were significantly higher in the AA group. CONCLUSION: Complete blood count (CBC) parameters are low-cost tests that can be used to define inflammation levels in inflammatory diseases. Our study shows that CRP can be used as a marker in diagnosing AA.

Assessment of a Bidirectional Association Between Major Depressive Disorder and Alopecia Areata.

Importance: Alopecia areata (AA) is an autoimmune disease characterized by hair loss that can impose a substantial psychological burden on patients, including major depressive disorder (MDD), yet many patients report mental health symptoms prior to the onset of AA. As such, there may be an association between MDD and AA that acts in both directions. Objective: To assess the bidirectional association between MDD and AA. Design, Setting, and Participants: This population-based retrospective cohort study included patients 10 to 90 years of age registered with The Health Improvement Network in general practices in the United Kingdom between January 1, 1986, and May 16, 2012. Statistical analysis was conducted from August 17, 2017, to April 23, 2018. To assess the risk of AA, the following 2 cohorts were defined: patients with an incident diagnosis of MDD (exposure) and a reference general population cohort. To assess the risk of MDD, the following 2 cohorts were defined: patients with an incident diagnosis of AA (exposure) and a reference general population cohort. Person-time was partitioned into unexposed and exposed time in the exposure cohorts. Main Outcomes and Measures: In the analysis of the risk of AA, development of incident AA during follow-up was considered the main outcome measure. In the analysis of the risk of MDD, development of incident MDD during follow-up was considered the primary outcome measure. Results: In the analysis of the risk of AA, 405 339 patients who developed MDD (263 916 women and 141 423 men; median age, 36.7 years [interquartile range, 26.6-50.5 years]) and 5 738 596 patients who did not develop MDD (2 912 201 women and 2 826 395 men; median age, 35.8 years [interquartile range, 25.3-52.6 years]) were followed up for 26 years. After adjustment for covariates, MDD was found to increase the risk of subsequently developing AA by 90% (hazard ratio, 1.90; 95% CI, 1.67-2.15; P < .001). Antidepressants demonstrated a protective effect on the risk of AA (hazard ratio, 0.57; 95% CI, 0.53-0.62; P < .001). In the analysis of the risk of MDD, 6861 patients who developed AA (3846 women and 3015 men; median age, 31.5 years [interquartile range, 18.2 years]) and 6 137 342 patients who did not develop AA (3 172 371 women and 2 964 971 men; median age, 35.9 years [interquartile range, 27.0 years]) were followed up for 26 years. After adjustment for covariates, AA was found to increase the risk of subsequently developing MDD by 34% (hazard ratio, 1.34; 95% CI, 1.23-1.46; P < .001). Conclusions and Relevance: These temporal analyses suggest that, while patients with AA are at risk for subsequently developing MDD, having MDD also appears to be a significant risk factor for development of AA, with antidepressant use confounding this risk.

Development and pilot-testing of the Alopecia Areata Assessment Tool (ALTO).

BACKGROUND: Alopecia areata (AA) is an autoimmune disease characterized by non-scarring hair loss. The lack of a definitive biomarker or formal diagnostic criteria for AA limits our ability to define the epidemiology of the disease. In this study, we developed and tested the Alopecia Areata Assessment Tool (ALTO) in an academic medical center to validate the ability of this questionnaire in identifying AA cases. METHODS: The ALTO is a novel, self-administered questionnaire consisting of 8 closed-ended questions derived by the Delphi method. This prospective pilot study was administered during a 1-year period in outpatient dermatology clinics. Eligible patients (18 years or older with chief concern of hair loss) were recruited consecutively. No patients declined to participate. The patient's hair loss diagnosis was determined by a board-certified dermatologist. Nine scoring algorithms were created and used to evaluate the accuracy of the ALTO in identifying AA. RESULTS: 239 patients (59 AA cases and 180 non-AA cases) completed the ALTO and were included for analysis. Algorithm 5 demonstrated the highest sensitivity (89.8%) while algorithm 3 demonstrated the highest specificity (97.8%). Select questions were also effective in clarifying disease phenotype. CONCLUSION: In this study. we have successfully demonstrated that ALTO is a simple tool capable of discriminating AA from other types of hair loss. The ALTO may be useful to identify individuals with AA within large populations.