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The Role of Patients in Alopecia Areata Endpoint Development: Understanding Physical Signs and Symptoms

      Meaningful patient input to understand disease experience and patient expectations for improvement with treatment is essential for the selection and development of outcome measures for alopecia areata (AA) clinical trials. This study explored the physical signs and symptoms of AA through 30 semistructured interviews with adult (n = 25) and adolescent (n = 5) patients experienced with severe or very severe AA. Scalp hair loss was overwhelmingly the most important sign and symptom of AA. Nearly all patients (90%) considered scalp hair loss in their top three most bothersome physical signs and symptoms of AA, with 77% (n = 23) naming scalp hair loss as the most bothersome symptom. Other identified signs and symptoms in the top three most bothersome included eyebrow, eyelash, nose, body, and facial hair loss, as well as eye irritation and nail damage and/or appearance. Eyebrow (16%, n = 4), eyelash (4%, n = 1), nasal (4%, n = 1), and body (4%, n = 1) hair loss were identified by seven adult patients as the most bothersome signs and symptoms of AA. Conceptual saturation confirmed that a comprehensive understanding of this patient population’s physical AA-related signs and symptoms was obtained. These findings indicate that the primary objective for new AA treatments for this patient population should be meaningful improvement in scalp hair growth to address the most troubling unmet need.

      Abbreviations:

      AA (alopecia areata), JAKi (JAK inhibitor), SALT (Severity of Alopecia Tool)

      Introduction

      Alopecia areata (AA) is a chronic autoimmune disease characterized by patches of nonscarring hair loss that can affect the scalp and body (
      • Islam N.
      • Leung P.S.
      • Huntley A.C.
      • Gershwin M.E.
      The autoimmune basis of alopecia areata: a comprehensive review.
      ). AA can affect children, adolescents, and adults, and there is no preventative or currently approved therapy that sustains remission (
      • Hordinsky M.
      • Donati A.
      Alopecia areata: an evidence-based treatment update.
      ). To demonstrate that a potential treatment is efficacious, there is a need to obtain meaningful patient input for the selection and/or development of clinical trial outcomes that measure what matters most to patients and reflect patients’ expectations for improvement with treatment (
      U.S. Food and Drug Administration
      Discussion document for patient-focused drug development public workshop on guidance 2: methods to identify what is important to patients.
      ).
      To better understand and document the needs, perspectives, expectations, and priorities of patients with severe or very severe AA (≥50% scalp hair loss), this study explored the patient experience of AA through qualitative, open-ended exploration in one-on-one semistructured patient interviews. Although others have recently conducted and reported on AA qualitative studies (
      • Davey L.
      • Clarke V.
      • Jenkinson E.
      Living with alopecia areata: an online qualitative survey study.
      ;
      • Wolf J.J.
      • Baker P.H.
      Alopecia areata: factors that impact children and adolescents.
      ), none of the known previous research has aimed to understand the comparative significance of the many AA physical signs and symptoms that patients experience to inform clinical trial outcomes. The purpose of this paper is to document the physical signs and symptoms of AA and their relative importance to patients as reported during these interviews.

      Results

      Sample characteristics

      A total of 30 patients participated in the interview study. Table 1 shows the patients’ clinical information summarized by oral JAK inhibitor (JAKi) treatment status and adult and adolescent subgroups, as reported on the case report forms by the recruiting clinicians. A total of 25 patients (83%) were adults, and five patients (17%) were adolescents. A total of 18 patients (60%) were currently treated (n = 15) or had previously been treated (n = 3) successfully with an oral JAKi (defined as patient had started to grow scalp hair). The mean Severity of Alopecia Tool (SALT) score for members of the JAKi-treated group (36.2 [SD = 36.09; range = 0.0–100.0]) was lower than the mean SALT score in the JAKi-treatment–naive group (90.5 [SD = 18.54; range = 50.2–100.0]). Just under half (n = 13, 43%) of the sample was receiving no treatment for AA at the time of their interviews.
      Table 1Clinical Characteristics of the Interviewed Patients (n = 30)
      Clinical CharacteristicJAKi-Experienced Patients (N = 18)JAKi-Naive Patients (N = 12)All Patients (N = 30)
      Adult Patients, n (%) (N = 13)Adolescent Patients, n (%) (N = 5)Total, n (%) (N = 18)Adult Patients, n (%) (N = 12)Adult Patients, n (%) (N = 25)Adolescent Patients, n (%) (N = 5)Total, n (%) (N = 30)
      Clinical description
       AA with ≥50% scalp hair loss experience2 (15)2 (40)4 (22)2 (17)4 (16)2 (40)6 (20)
       AA with ≥50% scalp hair loss experience with partial and/or full eyebrow and/or eyelash loss11 (85)3 (60)14 (78)10 (83)21 (84)3 (60)24 (80)
      Time since diagnosis, years
       Mean (Range)12.9 (1–47)3.2 (2–6)10.2 (1–47)13.9 (1–42)13.4 (1–47)3.2 (2–6)11.7 (1–47)
      Time since commencement of JAKi treatment, months
      For n = 15 patients who were currently receiving JAKi at the time of interview.
       Mean (Range)17.3 (1–34)5.6 (1–10)13.4 (1–34)NANANANA
      Current treatment
      Categories not mutually exclusive.
       Oral JAKi10 (77)5 (100)15 (83)0 (0)10 (40)5 (100)15 (50)
       Biotin Forte with zinc0 (0)0 (0)0 (0)1 (8)1 (4)0 (0)1 (3)
       Clobetasol ointment0 (0)0 (0)0 (0)1 (8)1 (4)0 (0)1 (3)
       Diphenylcyclopropenone2 (15)0 (0)2 (11)0 (0)2 (8)0 (0)2 (7)
       Excimer1 (8)0 (0)1 (6)0 (0)1 (4)0 (0)1 (3)
       Intralesional kenalog1 (8)0 (0)1 (6)1 (8)2 (8)0 (0)2 (7)
       Rogaine0 (0)0 (0)0 (0)1 (8)1 (4)0 (0)1 (3)
       Slow-release iron0 (0)0 (0)0 (0)1 (8)1 (4)0 (0)1 (3)
       Vitamin E0 (0)0 (0)0 (0)1 (8)1 (4)0 (0)1 (3)
       No treatment2 (15)0 (0)2 (11)11 (92)13 (52)0 (0)13 (43)
      Abbreviations: AA, alopecia areata; JAKi, JAK inhibitor; NA, not applicable.
      1 For n = 15 patients who were currently receiving JAKi at the time of interview.
      2 Categories not mutually exclusive.
      On average, patients in the interview sample received a diagnosis of AA 12 years before the interview. A total of 24 patients (80%) had experienced full or partial eyebrow and/or eyelash loss at some point during their experience of AA. Concomitant conditions primarily included atopic dermatitis (n = 7, 28%) and thyroid disease (n = 5, 20%) among adults, with no concomitant conditions reported among adolescent patients.
      Table 2 details the patients’ demographic characteristics summarized by adult and adolescent subgroups. The mean age of adults in the sample was 39.0 years (range = 18–72); on average, adolescent patients were 16.4 years old (range = 15–17). Just under half of the sample was male (43%), and almost a third (30%) of the sample was non-Caucasian. Over half of the adults had been educated to bachelor’s degree level or higher (56%); however, adult patients with only a high school diploma or less education (36%) were also represented in the patient sample.
      Table 2Demographic Characteristics of the Interviewed Patients (N = 30)
      Demographic CharacteristicAdult Patients, n (%) (N = 25)Adolescent Patients, n (%) (N = 5)Total, n (%)

      (N = 30)
      Sex
       Male11 (44)2 (40)13 (43)
       Female14 (56)3 (60)17 (57)
      Age, y
       Mean (Range)39.0 (18–72)16.4 (15–17)35.2 (15–72)
      Ethnicity and/or race
       Caucasian or White18 (72)3 (60)21 (70)
       Asian4 (16)1 (20)5 (17)
       Black or African American0 (0)1 (20)1 (3)
       Other3 (12)0 (0)3 (10)
      Education, highest level completed
       High school, no diploma or currently enrolled1 (4)5 (100)6 (20)
       High school diploma or equivalent8 (32)NA8 (27)
       Some college or associate degree2 (8)NA2 (7)
       Bachelor’s degree11 (44)NA11 (37)
       Master’s degree2 (8)NA2 (7)
       Doctoral degree1 (4)NA1 (3)
      Work status
      Categories not mutually exclusive for adolescent patients.
       Full-time or part-time paid work17 (68)1 (20)18 (60)
       Full-time homemaker3 (12)0 (0)3 (10)
       Student5 (20)5 (100)10 (33)
      Abbreviation: NA, not applicable.
      1 Categories not mutually exclusive for adolescent patients.

      Summary of the patients’ physical signs and symptoms of AA

      All 30 patients discussed the physical signs and symptoms of AA at the beginning of the interviews. Figure 1 lists the 26 spontaneously reported signs and symptoms of AA noted by interviewees; in addition, other known signs and symptoms were probed by the interviewer. Scalp hair loss was overwhelmingly the most important sign and symptom of AA, with approximately three quarters (77%; n = 23) of the sample listing scalp hair loss as the most bothersome symptom of AA (Table 3).
      Figure thumbnail gr1
      Figure 1Saturation analysis of all spontaneously reported physical signs and symptoms of AA. X indicates that a patient spontaneously reported experiencing this concept; other patients may have experienced a sign and symptom and discussed their experience when probed by the interviewer. Dark blue boxes indicate the first patient report of a specific physical sign and symptom of AA. AA, alopecia areata.
      Table 3Most Bothersome Physical Signs and Symptoms of AA
      Sign and SymptomAdults (N = 25)Adolescents (N = 5)Total (N = 30)Example Patient Quotes
      Patient codes denoted the participant number (1–30), sex (F or M), adult (A) or adolescent (P), Severity of Alopecia Tool score (0–100), and previous JAKi treatment (JAK) or JAKi-naive (N).
      In Top Three
      Three adult and two adolescent patients described only scalp hair loss as a bothersome sign and symptom of AA.
      Most Bothersome, n (%)
      Most Bothersome, n (%)In Top Three
      Three adult and two adolescent patients described only scalp hair loss as a bothersome sign and symptom of AA.
      Most Bothersome, n (%)
      Most Bothersome, n (%)In Top Three
      Three adult and two adolescent patients described only scalp hair loss as a bothersome sign and symptom of AA.
      Most Bothersome, n (%)
      Most Bothersome, n (%)
      Scalp hair loss22 (88)18 (72)5 (100)5 (100)27 (90)23 (77)I would say scalp (…) Because it affects how I feel about myself to go out and resume a normal life, to go to a concert or go swimming or go to the beach. (27-F-A-100-N)
      Eyebrow hair loss16 (64)4 (16)2 (40)0 (0)18 (60)4 (13)A lot of people see bald people shave their heads, like it's a normal thing. It's accepted in society. But like the eyebrows, when people see that, they automatically think like there’s something wrong there. (07-M-A-100-JAK)
      Eyelash hair loss14 (56)1 (4)2 (40)0 (0)16 (53)1 (3)I’d probably rather have nice eyelashes than nice hair. (17-M-A-86.6-JAK)
      Nose hair loss3 (12)1 (4)0 (0)0 (0)3 (10)1 (3)So number one would be nose hairs (… because the) functional aspect of it. I need it to stop. Every day or every 20 minutes I’m blowing my nose and I can feel my sinuses just expanding exponentially. (26-M-A-100-N)
      Body hair loss2 (8)1 (4)0 (0)0 (0)2 (7)1 (3)The body hair, eyelashes and scalp hair, yeah. (24- F-A-1-JAK)
      Facial hair loss3 (12)0 (0)0 (0)0 (0)3 (10)0 (0)I had a full beard, literally. A full beard and it’s all gone. (26-M-A-100-N)
      Eye irritation2 (8)0 (0)0 (0)0 (0)2 (7)0 (0)Dust gets in my eyes. Sweat falls in, and it's more of a nuisance having to clean my eyes out every night. That's my biggest thing. Every night I got to clean my eyes. If I don’t, it irritates the hell out of me the next day. (01-M-A-100-N)
      Nail damage and/or appearance1 (4)0 (0)0 (0)0 (0)1 (3)0 (0)Just really ugly. … Can’t put any polish on, because then they start peeling, so – I can’t do anything to them. … I can’t use them like I used to, as a tool… they’ll just split right away. (05-F-A-100-N)
      Abbreviations: AA, alopecia areata; F, female; JAKi, JAK inhibitor; M, male.
      1 Three adult and two adolescent patients described only scalp hair loss as a bothersome sign and symptom of AA.
      2 Patient codes denoted the participant number (1–30), sex (F or M), adult (A) or adolescent (P), Severity of Alopecia Tool score (0–100), and previous JAKi treatment (JAK) or JAKi-naive (N).

      Adult patients

      All (100%, n = 25) adult patients named scalp hair loss as an AA sign and symptom; 88% (n = 22) considered it among their top three most bothersome signs and symptoms, with 72% (n = 18) naming it the most bothersome sign and symptom of AA. The three patients who did not name it in the top three most bothersome signs and symptoms were male and had become used to living without scalp hair, which they felt was socially acceptable.
      Other signs and symptoms identified in the top three most bothersome included eyebrow, eyelash, nose, body, and facial hair loss, as well as eye irritation and nail damage and/or appearance. Eyebrow (16%, n = 4), eyelash (4%, n = 1), nasal (4%, n = 1), and body (4%, n = 1) hair loss were identified by seven patients as the most bothersome signs and symptoms.
      A total of 22 adult patients had self-reported eyelash and/or eyebrow involvement. Of these patients, 19 (86%) named eyebrow and/or eyelash hair loss, or eye irritation secondary to eyebrow and/or eyelash hair loss, among the three most bothersome sign and symptoms. Nearly all of these patients (21 of 22; 95%) reported that they would be interested in a treatment for AA scalp hair loss even if it did not address eyebrow and/or eyelash hair loss. However, when 19 of these patients were further queried, nine patients (47%) expressed they might not consider a treatment fully successful if it did not also address eyebrow and/or eyelash hair loss. One patient was not interested or willing to take a treatment for scalp hair loss that did not grow her eyelashes because her eye irritation was so severe.

      Adolescent patients

      All adolescent patients (100%, n = 5) named scalp hair loss as the most bothersome sign and symptom of AA. Only two other signs and symptoms were named in the top three most bothersome: eyebrow and eyelash hair loss. The three patients with eyebrow and/or eyelash hair loss noted that they would be interested in a treatment for AA scalp hair loss alone, although would be most satisfied with a treatment that addressed eyelashes and eyebrows hair loss as well.

      Saturation analysis

      A saturation analysis for the physical signs and symptoms of AA details the breadth of the interviewed patients’ physical experiences (Figure 1). All mentioned signs and symptoms of AA were spontaneously reported by patients in the first 24 interviews (Set 1–Set 4). With no new physical sign and symptom concepts emerging in the interviews with the final set of six patients (set 5; gray columns in Figure 1), saturation was achieved, demonstrating that a comprehensive understanding of the patient experience of the physical signs and symptoms of AA was obtained during these interviews.

      Discussion

      This study provided greater understanding of patients’ physical signs and symptoms of AA through extensive one-on-one concept elicitation interviews. Understanding what is most important to patients is essential to adequately identify and measure meaningful treatment outcomes. Systematically collected patient input can identify key unmet medical needs and important clinical outcomes to be studied in clinical trials (
      U.S. Food and Drug Administration
      Discussion document for patient-focused drug development public workshop on guidance 3: select, develop or modify fit-for-purpose clinical outcome assessments.
      ). Moreover, an understanding of these signs and symptoms is necessary in the selection and/or development of key primary and secondary outcome measures and associated endpoints for AA treatment investigations.
      Although not surprising, scalp hair loss was confirmed as the most bothersome physical symptom of AA, as noted by 77% of the sample. Despite overenrollment of patients with eyebrow and/or eyelash involvement (80% of the sample), scalp hair loss remained the top-ranked bothersome physical sign and symptom. This finding substantiates that the primary objective for new AA treatments should meaningfully address this unmet patient need.
      The reported bothersome aspects of eyebrow and/or eyelash loss cannot be ignored in these data. Although few patients named either eyebrows or eyelashes as the most bothersome sign and symptom overall, many adult and adolescent patients named eyebrow and eyelash hair loss as one of their three most bothersome symptoms. Although nearly all patients with missing eyebrow or eyelash hairs reported that they would be interested in a treatment for AA scalp hair loss even if it did not address eyebrow and/or eyelash hair loss, nine of these patients may not consider such a treatment to be fully successful. The value of eyebrows and eyelashes was noted by this sample and deserves meaningful assessments in AA treatment investigations as key outcomes important to patients with AA with hair loss in these areas.
      Nose hair loss and body hair loss were each reported in great detail by two adult patients as their most bothersome symptom of AA. Nonetheless, neither may warrant current inclusion as key assessments in clinical trials owing to their rarity, as documented in this sample. The systematic concept elicitation process provides confidence that no other key physical aspects of AA are being overlooked owing to our sampling; all 26 spontaneously reported physical signs and symptom concepts emerged before the final six patient interviews as detailed in the saturation grid.
      There are limitations in this study. This study focused on patients who had experienced severe or very severe AA (≥50% scalp hair loss), and the generalizability of these findings to patient populations with milder AA has not been investigated. In addition, adolescent patients aged 12–17 years were targeted for inclusion; however, all participating adolescents were in the upper ages of this range (aged 15–17 years), which therefore limits the generalizability of the findings to younger adolescents with AA. In addition, this study was completed in United States patients only and, as a result, may not be generalizable to other countries and cultures without further exploration. Finally, this paper focused on physical signs and symptoms; the patient-reported psychosocial impacts of AA will be reported in a future publication.
      The successful development of new treatments includes engaging, listening to, and trusting patients to voice their needs, perspectives, expectations, and priorities throughout the drug development process. In collaboration with other stakeholders, including clinicians, caregivers, regulators, and payers, the valuable input from patients can provide a clear focus to inform the selection and/or development of clinical outcomes. These systematic interviews of patients with AA who had experienced ≥50% scalp hair loss indicate that the primary objective for new AA treatments for this patient population is a meaningful improvement in scalp hair growth.

      Materials and Methods

      Sample and eligibility criteria

      This study aimed to recruit 30 adult or adolescent patients (aged ≥ 12 years) from the United States with a clinician-confirmed diagnosis of AA and experience with ≥50% scalp hair loss.
      Purposive sampling was used to recruit patients with eyebrow and/or eyelash involvement in addition to scalp involvement to allow exploration of the comparative importance of these experiences to patients. In addition, some patients who had previously been treated with JAKi were recruited so that this study could explore these patients’ experiences and expectations for treatment success. The JAKi-treatment–naive patients were required to have a current AA episode (stable or worsening) lasting >6 months but <8 years. Patients with androgenic alopecia or other significant dermatologic conditions (e.g., psoriasis and atopic dermatitis) that in the opinion of their clinician may be severe enough to impact the results of this study were excluded.
      A protocol and semistructured interview guide were developed with input from expert dermatologists. The study protocol was reviewed and approved by Western Institutional Review Board #20171820.

      Recruitment procedure

      All patients were recruited via clinician referral from two clinical sites in the United States, University of California, Irvine and Yale University. Participants who met the eligibility criteria were invited to participate and provided with a verbal explanation of the study requirements. Adult patients (aged ≥18 years) who were interested in participating were then provided with an information and consent form that detailed the requirements of the study. For adolescent patients (aged 12–17 years), the informed consent process required both the adolescent participant and their parent and/or guardian to read and sign the information and consent form.

      Interview procedure

      In accordance with the Food and Drug Administration’s PRO Guidance for Industry (
      U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH)
      Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims.
      ), this study was designed to gather open-ended patient input. The semistructured interview guide included open-ended questions to explore patients’ experience of AA, including the physical signs and symptoms they experienced. Interviews were conducted between October 10, 2017 and October 25, 2017 by an experienced qualitative researcher trained in interview techniques and clinical outcome assessment development. Interviews lasted approximately 90 minutes and were conducted face-to-face at the clinical site of the referring dermatologist or a nearby hotel meeting room. All interviews were audio-recorded and transcribed verbatim.

      Analysis

      Demographic and clinical information was descriptively summarized. Interview transcripts were reviewed in full and all identifying information, such as names and specific locations, was removed. Participants were allocated a code to allow data to be reported anonymously. The codes used denoted the participant number, sex, age group, SALT score, and previous treatment with JAKi. For example, patient 27-F-A-100-N was the 27th patient to be interviewed, a female, an adult, had a SALT score of 100, and was naive to JAKi treatment. Conversely, patient 22-M-P-20-JAK was the 22nd patient to be interviewed, a male, an adolescent, had a SALT score of 20, and had received successful JAKi treatment.
      Transcripts were analyzed using thematic techniques (
      • Braun V.
      • Clarke V.
      Using thematic analysis in psychology.
      ) aided by ATLAS.ti version 7.5, computer-assisted qualitative data analysis software, which facilitated the coding and organization of data. The analysis took a phenomenological interpretative approach, seeking to understand the multiple realities of participants rather than one true reality and focusing on the perceptions, feelings, and lived experiences of participants (
      • Guest G.
      • MacQueen K.M.
      • Namey E.E.
      Applied thematic analysis.
      ). Three phases of thematic analysis were followed to explore open-ended data: transcripts were reviewed by the lead analysts and overarching ideas identified; descriptive codes were assigned to quotes within the transcripts; and codes were collated into potential themes and compared and contrasted to identify relationships between them. In this way, the key signs and symptoms of AA were identified with supportive quotes.
      The first two transcripts were coded by the research team to develop a preliminary codebook for the interview. Using this codebook, the research team coded remaining interview transcripts and identified any new codes that emerged in subsequent interviews. When a new concept emerged, a retrospective review of previous interview transcripts was conducted to ensure that this concept was not overlooked during the initial coding.

      Saturation analysis

      Conceptual saturation was used as a method to guide sampling and analysis for this qualitative study (
      U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH)
      Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims.
      ). Defined as the point at which no new concept-relevant information emerges (
      • Fusch P.I.
      • Ness L.R.
      Are we there yet? Data saturation in qualitative research.
      ), reaching saturation is an indication that comprehensive understanding of the patient experience has been achieved and that no more interviews are required.
      After completion of all 30 interviews, conceptual saturation was assessed in line with industry guidelines (
      • Patrick D.L.
      • Burke L.B.
      • Gwaltney C.J.
      • Leidy N.K.
      • Martin M.L.
      • Molsen E.
      • et al.
      Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument.
      ,
      • Patrick D.L.
      • Burke L.B.
      • Gwaltney C.J.
      • Leidy N.K.
      • Martin M.L.
      • Molsen E.
      • et al.
      Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding.
      ). First, transcripts were divided into five sets of six patients based on the chronological order of interview completion. Next, transcripts in set two were compared with the previous interviews to identify whether any new concepts had arisen. If no new concepts had emerged in set two, saturation was considered to have been attained. However, if new concept(s) were identified by at least four patients, the third set of interviews were reviewed. This process continued for all sets, and saturation was deemed to have been achieved when no new concepts arose.

      Data availability statement

      Owing to the sensitive nature of this qualitative data set, the data cannot be shared for ethical reasons to protect patients’ identities that may be disclosed in the detailed responses provided during the interviews.

      Conflict of Interest

      HK, SK, NVJA, and JM are employees of DRG Abacus, a health economic and outcomes research consultancy that consults with various pharmaceutical companies. FN and YD are employees and stockholders at Eli Lilly and Company. KWW was an employee and stockholder at Eli Lilly and Company at the time this research was conducted; she is now an employee and stockholder at Pfizer Inc. BAK has served on advisory boards and is a consultant and clinical trial investigator for Eli Lilly and Company; he is a consultant for Aclaris Therapeutics, Eli Lilly and Company, Concert Pharmaceuticals, Pfizer Inc, and Dermavant Sciences. Eli Lilly and Company have commissioned DRG Abacus, JMK, and BAK to consult on clinical outcomes assessment strategies for AA.

      Acknowledgments

      This article is published as part of a supplement sponsored by the National Alopecia Areata Foundation .
      Funding for the Summit and publication of this supplement was provided by the National Alopecia Areata Foundation. This Summit was supported (in part) by the National Institute of Arthritis and Musculoskeletal and Skin Diseases under Award Number R13AR074890 . The opinions or views expressed in this professional supplement are those of the authors and do not necessarily reflect the official views, opinions, or recommendations of the National Institutes of Health or the National Alopecia Areata Foundation. The authors thank the interviewed patients in this study who shared their AA physical signs and symptoms with great clarity and courage. The authors also thank the site coordinators and staff at the Department of Dermatology, University of California, Irvine and Yale University School of Medicine who facilitated the recruitment and access to these patient interviewees. This work was funded by Eli Lilly and Company .

      Author Contributions

      Conceptualization: KWW, HK, SK, NVJA, JM, FN, BAK; Data Curation: HK, SK, NVJA, JM, NAM, BAK; Formal Analysis: HK, SK, NVJA, JM; Funding Acquisition: FN; Investigation: KWW, NVJA, BAK; Methodology: KWW, HK, SK, NVJA, FN, BAK; Project Administration: KWW, HK, SK, NVJA, FN, YD, NAM, BAK; Resources: HK, SK, NVJA; Software: HK, SK, NVJA, JM; Supervision: KWW, HK, SK, NVJA, F, BAK; Validation: KWW, HK, SK, NVJA, JM, YMK, BAK; Visualization: KWW, HK, SK, NVJA, JM, FN, YD, BAK; Writing - Original Draft Preparation: KWW, HK, SK, NVJA, JM, FN, YD, NAM, YMK, BAK; Writing - Review and Editing: KWW, HK, SK, NVJA, JM, FN, YD, NAM, YMK, BAK

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