A qualitative interview study to explore adolescents' experience of alopecia areata and the content validity of sign/symptom patient-reported outcome measures.

BACKGROUND: The content validity (appropriateness and acceptability) of patient-reported outcome (PRO) measures for scalp hair loss, eyebrow loss, eyelash loss, nail damage and eye irritation has been demonstrated in adults with alopecia areata (AA) but not adolescents. OBJECTIVES: To explore the content validity of the suite of AA PRO measures and accompanying photoguides in an adolescent sample. METHODS: Semi-structured, 90-min, combined concept elicitation and cognitive interviews were conducted face-to-face with adolescents who experienced ≥ 50% AA-related scalp hair loss. Transcripts underwent thematic and framework analysis. RESULTS: Eleven adolescents (aged 12-17 years, 55% female, 45% nonwhite) diagnosed with AA for 5·9 years (mean) participated. Participants had 69·6% scalp hair (mean) and current eyebrow (82%) and/or eyelash loss (82%) and/or nail involvement (36%). Adolescents reported scalp, eyebrow and eyelash hair loss as their top three most bothersome signs/symptoms. Despite mostly accepting their AA, impacts related to visible areas of hair loss were prominent. Participants demonstrated good understanding and appropriate use of the PRO measures, and advocated including hair loss percentages alongside descriptive categories in the Scalp Hair Assessment PRO™. Results confirmed treatment success thresholds established with adults: achievement of ≤ 20% scalp hair loss, no/minimal eyebrow and eyelash loss, no/a little nail damage and eye irritation (PRO measure categories 0 or 1). CONCLUSIONS: The Scalp Hair Assessment PRO™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides are fit-for-purpose self-reported measures of AA signs/symptoms that are impactful to adolescents with AA.

Higher rates of skin clearance and efficacy in challenging body areas are associated with better health-related quality of life following ixekizumab maintenance treatment in pediatric patients with plaque psoriasis.

BACKGROUND/OBJECTIVES: Information is limited on the relationship between skin clearance, resolution of challenging body areas, and improvement of patient-reported outcomes (PROs) in pediatric psoriasis. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of moderate-to-severe psoriasis in patients aged 6 to <18 years. This study examines improvement in psoriasis clearance in challenging body areas in pediatric patients relative to health-related quality of life. METHODS: Data from the IXORA-PEDS trial (NCT03073200) were analyzed, and changes from baseline were measured for overall Psoriasis Area and Severity Index (PASI), static Physicians' Global Assessment of psoriasis (sPGA), Psoriasis Scalp Severity Index (PSSI), Palmoplantar Psoriasis Area and Severity Index (PPASI), and Nail Psoriasis Severity Index. Rates of Dermatology Life Quality Index (DLQI), or Children's DLQI (CDLQI), scores of 0 or 1 were evaluated using the Cochran-Armitage trend test. RESULTS: Higher rates of DLQI/CDLQI (0,1) scores were significantly associated with greater PASI and PSSI responses at both Week 12 and Week 48 (p < .0001). A significant association was also observed between DLQI/CDLQI (0,1) and sPGA scores (p < .0001). Significantly higher rates of DLQI/CDLQI (0,1) scores were achieved in patients with greater levels of palmoplantar clearance as measured by PPASI at Week 12 (p = .0139), but significance was not sustained at Week 48 (p = .0896). CONCLUSIONS: Greater skin clearance and scalp resolution are associated with better PROs over a short-term (12-week) and long-term (48-week) period. This demonstrates that greater improvement of skin clearance and scalp resolution may benefit quality of life in pediatric patients with psoriasis.

Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study.

BACKGROUND: There are no treatments approved by the Food and Drug Administration for alopecia areata. OBJECTIVE: To evaluate the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss in a phase 2 study of adults with alopecia areata (BRAVE-AA1). METHODS: Patients were randomized 1:1:1:1 to receive placebo or baricitinib 1 mg, 2 mg, or 4 mg once daily. Two consecutive interim analyses were performed after all patients completed weeks 12 and 36 or had discontinued treatment prior to these time points. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score ≤20 at week 36. Logistic regression was used with nonresponder imputation for missing data. RESULTS: A total of 110 patients were randomized (placebo, 28; baricitinib 1-mg, 28; 2-mg, 27; 4-mg, 27). The baricitinib 1-mg dose was dropped after the first interim analysis based on lower SALT30 response rate. At week 36, the proportion of patients achieving a SALT score of ≤20 was significantly greater in baricitinib 2-mg (33.3%, P = .016) and 4-mg (51.9%, P = .001) groups versus placebo (3.6%). Baricitinib was well tolerated with no new safety findings. LIMITATIONS: Small sample size limits generalizability of results. CONCLUSION: These results support the efficacy and safety of baricitinib in patients with ≥50% scalp hair loss.

The experience of itch in children with psoriasis: A qualitative exploration of the Itch Numeric Rating Scale.

BACKGROUND/OBJECTIVES: Psoriasis is a chronic, immune-mediated dermatologic disorder with a prevalence among children estimated at 0.1%-0.45%, and a median age of onset at approximately 7-10 years. Pediatric psoriasis is known to have negative impacts on health-related quality of life. Among the most bothersome symptoms, itch has been measured using the Itch Numeric Rating Scale (NRS). This study explored the symptom and impacts of itch with pediatric psoriasis patients and evaluated the content validity of the Itch NRS in children. METHODS: Semi-structured qualitative interviews were conducted among a sample of pediatric patients diagnosed with plaque psoriasis. RESULTS: Concept elicitation interviews were completed with 22 children (ages 7-17 years). When asked about most frequent symptoms, 61% reported itching (n = 14) and 65% reported flaking (n = 15). The majority reported itching as bothersome; about half described impacts on their regular activities. Cognitive interviews were completed with 25 children (ages 8-17 years). Most reported that independently completing the Itch NRS would be easy, and all described the meaning of the response options similar to the intended value. Overall, the Itch NRS was received favorably, with comments that the scale was easy or relevant to their experience with psoriasis. CONCLUSIONS: This qualitative study supports the content validity of the Itch NRS for use in a pediatric psoriasis population aged 8-17. Given the established importance of itch to pediatric psoriasis patients, future research exploring the impact of itch on the lives of pediatric psoriasis patients may provide a valuable contribution to the field.

Ixekizumab treatment and the impact on SF-36: results from three pivotal phase III randomised controlled trials in patients with moderate-to-severe plaque psoriasis.

PURPOSE: To assess improvements in health-related quality of life (HRQoL) with ixekizumab treatment in patients with moderate-to-severe psoriasis. METHODS: Adults with plaque psoriasis were enrolled in phase III, double-blind, randomised, controlled trials (UNCOVER-1, UNCOVER-2, or UNCOVER-3). All 3 protocols included a 12-week, placebo-controlled induction period; UNCOVER-2 and UNCOVER-3 also had an active-control group (50 mg etanercept) during induction. After induction, patients in UNCOVER-1 and UNCOVER-2 entered a 48-week withdrawal (maintenance) period (Weeks 12-60), during which Week-12 sPGA (0,1) responders were rerandomized to receive placebo, or 80 mg ixekizumab every 4 weeks (Q4W) or 12 weeks. As a secondary objective, HRQoL was measured by the generic Medical Outcomes Survey Short Form-36 (SF-36) at baseline and Weeks 12 and 60. Changes in mean SF-36 Physical and Mental Component Summary (PCS and MCS) and domain scores and proportions of patients reporting improvements ≥ minimal important differences in SF-36 scores were compared between groups. RESULTS: At Week 12, ixekizumab-treated patients (both dose groups in UNCOVER-1, -2, and -3) reported statistically significantly greater improvements in mean SF-36 PCS and MCS and all 8 SF-36 domain scores versus placebo. Further, more ixekizumab-treated patients than placebo-treated patients reported at least minimal treatment responses in SF-36 PCS and MCS scores and domain scores. Overall improvements in SF-36 PCS and MCS scores were maintained through Week 60. CONCLUSIONS: Ixekizumab-treated patients reported statistically significant improvements in HRQoL at 12 weeks that persisted through 1 year.

Impact of ixekizumab on psoriasis itch severity and other psoriasis symptoms: Results from 3 phase III psoriasis clinical trials.

BACKGROUND: Itch is a prevalent symptom of psoriasis that impacts quality of life. OBJECTIVE: We sought to describe improvements in itch severity, skin pain, and bothersomeness of skin appearance caused by psoriasis among patients who received ixekizumab, etanercept, or placebo in three 12-week, phase III clinical trials (UNCOVER-1, -2, and -3). METHODS: The itch numeric rating scale evaluated psoriasis itch severity in all 3 trials. Skin pain was assessed by skin pain visual analog scale. Bothersomeness because of redness/discoloration, thickness, and scaling/flaking was assessed with the Psoriasis Skin Appearance Bothersomeness instrument. Psoriasis skin appearance bothersomeness and skin pain were assessed at baseline and week 12; itch numeric rating scale score was assessed at baseline and weeks 1, 2, 4, 8, and 12. RESULTS: Patients who received ixekizumab demonstrated statistically significant improvements (P < .001) in itch severity, reduction in skin pain, and degree of bothersomeness compared with those who received etanercept or placebo. Clinically meaningful improvements in itch severity were achieved as early as week 1. LIMITATIONS: Longer-term evaluations of psoriasis symptom improvement with ixekizumab treatment are needed. CONCLUSION: After treatment with ixekizumab, patients reported fast, significant, and clinically meaningful improvements in itch severity and other psoriasis-related symptoms such as skin pain and skin appearance bothersomeness.

Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis.

BACKGROUND: Type 17 helper T cells have been suggested to play a pathological role in psoriasis. They secrete several proinflammatory cytokines, including interleukin-17A (also known as interleukin-17). We evaluated the safety and efficacy of ixekizumab (LY2439821), a humanized anti-interleukin-17 monoclonal antibody, for psoriasis treatment. METHODS: In our phase 2, double-blind, placebo-controlled trial, we randomly assigned 142 patients with chronic moderate-to-severe plaque psoriasis to receive subcutaneous injections of 10, 25, 75, or 150 mg of ixekizumab or placebo at 0, 2, 4, 8, 12, and 16 weeks. The primary end point was the proportion of patients with reduction in the psoriasis area-and-severity index (PASI) score by at least 75% at 12 weeks. Secondary end points included the proportion of patients with reduction in the PASI score by at least 90% or by 100%. RESULTS: At 12 weeks, the percentage of patients with a reduction in the PASI score by at least 75% was significantly greater with ixekizumab (except with the lowest, 10-mg dose)--150 mg (82.1%), 75 mg (82.8%), and 25 mg (76.7%)--than with placebo (7.7%, P<0.001 for each comparison), as was the percentage of patients with a reduction in the PASI score by at least 90%: 150 mg (71.4%), 75 mg (58.6%), and 25 mg (50.0%) versus placebo (0%, P<0.001 for each comparison). Similarly, a 100% reduction in the PASI score was achieved in significantly more patients in the 150-mg group (39.3%) and the 75-mg group (37.9%) than in the placebo group (0%) (P<0.001 for both comparisons). Significant differences occurred at as early as 1 week and were sustained through 20 weeks. Adverse events occurred in 63% of patients in both the combined ixekizumab groups and in the placebo group. No serious adverse events or major cardiovascular events were observed. CONCLUSIONS: Use of a humanized anti-interleukin-17 monoclonal antibody, ixekizumab, improved the clinical symptoms of psoriasis. Further studies are needed to establish its long-term safety and efficacy in patients with psoriasis. (Funded by Eli Lilly; ClinicalTrials.gov number, NCT01107457.).

Disease burden and quality of life in psoriasis patients with and without comorbid psoriatic arthritis: results from National Psoriasis Foundation panel surveys.

The comorbidity profile and overall disease impact are not well understood in psoriasis with and without comorbid psoriatic arthritis (PsA). The objective of this study was to compare disease characteristics, comorbidities, and psoriasis-related quality of life (QOL) in patients with moderate to severe psoriasis with and without comorbid PsA using results from National Psoriasis Foundation (NPF) surveys. The study included 3395 and 2072 patients with psoriasis alone and psoriasis with PsA, respectively. The results showed the burden of psoriasis either independently or with comorbid PsA. As severity of psoriasis increased, patient health and QOL were found to decline.

Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared with moderate to severe plaque psoriasis.

BACKGROUND: The impact of palmoplantar psoriasis on health-related quality of life (QoL) is largely unknown. OBJECTIVE: We sought to compare clinical characteristics and patient-reported outcomes between patients with palmoplantar psoriasis and moderate to severe plaque psoriasis. METHODS: We conducted a cross-sectional study of patients with plaque psoriasis (N=1153) and palmoplantar psoriasis (N=66) currently receiving systemic or light treatment for psoriasis. RESULTS: Patients with palmoplantar psoriasis were more likely to report Dermatology Life Quality Index scores that correspond to at least a moderate impact on QoL (odds ratio [OR] 2.08; 95% confidence interval [CI] 1.20-3.61); problems with mobility (OR 1.98; 95% CI 1.10-3.58), self-care (OR 3.12; 95% CI 1.24-7.86), and usual activities (OR 2.47; 95% CI 1.44-4.22) on the European Quality of Life-5 Dimensions questionnaire; and heavy topical prescription use of at least twice daily in the preceding week (OR 2.81; 95% CI 1.63-4.85) than those with plaque psoriasis. LIMITATIONS: Our assessment tools may not account for all dimensions of health-related QoL affected by palmoplantar disease, and these results may not be generalizable to patients with milder forms of psoriasis. CONCLUSION: Patients with palmoplantar psoriasis experience greater health-related QoL impairment and are more likely to report heavy use of topical prescriptions than those with moderate to severe plaque psoriasis.

Development of a disease-specific version of the EQ-5D-5L for use in patients suffering from psoriasis: lessons learned from a feasibility study in the UK.

OBJECTIVES: The EuroQol five-dimensional (EQ-5D) questionnaire is a generic measure widely used for the assessment of health status. Research has suggested that it may be insensitive to the burdens associated with particular conditions. This study was designed to explore the feasibility of developing and valuing a disease-specific "bolt-on" version of the EQ-5D questionnaire for use in psoriasis. METHODS: A series of steps were undertaken to develop, test, and evaluate dimensions for a psoriasis-specific version of the EQ-5D questionnaire (hereafter referred to as the EQ-PSO questionnaire). Candidate dimensions were explored through a review of published literature, in-depth qualitative interviews with patients, and consultation with a clinical expert. A psychometric validation exercise was then undertaken to establish how well dimensions functioned. Two dimensions were selected for inclusion in a draft measure alongside the existing EQ-5D questionnaire dimensions: "skin irritation" and "self-confidence." Last, a time trade-off valuation exercise was conducted with 300 members of the UK general public to derive utilities for health states described by the measure. RESULTS: The psychometric analyses indicated that the two new candidate dimensions captured additional variance over and above the existing five dimensions. Data from the valuation exercise were analyzed by using different models. A collapsed random effects model was put forward as a parsimonious and accurate approach. Based on this model, estimated utilities ranged from 0.98 ± 0.02 for state "1111111" to 0.03 ± 0.29 for state "5555555." CONCLUSIONS: This study has developed the EQ-PSO questionnaire to support future psoriasis research and has informed the development of future bolt-on versions of the EQ-5D questionnaire.

The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS).

BACKGROUND: Ankylosing spondylitis (AS) is an autoimmune disorder characterized by inflammation of the spine and large joints. Fatigue is a common symptom that many AS patients find significantly impacts their health-related quality of life. The Worst Fatigue - Numeric Rating Scale (WF-NRS) assesses the severity of this symptom during the previous 24-hour period. The objective of this study was to perform qualitative research to support the development and content validity of the WF-NRS. METHODS: Patients with AS were recruited from clinical sites in the U.S. for a qualitative study which first entailed concept elicitation interviews to gain understanding of the patients' experience with AS and fatigue. Subsequently, cognitive debriefing interviews were undertaken to assess the understandability, clarity, and appropriateness from the patient's perspective, of the content of a measure of fatigue severity. RESULTS: Thirteen patients with AS participated in concept elicitation interviews and cognitive debriefing of the Brief Fatigue Inventory (BFI) fatigue severity subscale. The WF-NRS was developed from the worst fatigue item of the BFI as patients generally reported it to be understandable and covered an important concept, the completion instructions were modified, but the response scale remained as it was familiar and readily completed, and the recall period was appropriate. CONCLUSIONS: Patient responses resulted in the development of and supported the content validity of the WF-NRS. Further quantitative evaluation of the WF-NRS is warranted in order to assess its psychometric properties and confirm its usefulness as a clinical trial tool.

Patient characteristics and disease burden of alopecia areata in the Danish Skin Cohort.

PURPOSE: Alopecia areata (AA) is a common disorder of patchy hair loss which carries a substantial psychological burden for patients. The current understanding of AA prevalence, disease course and burden is limited, and further research is needed to improve patient care. This prospective cohort of AA patients within the Danish Skin Cohort was established to provide data that can serve as a tool in future studies of for example, AA epidemiology and disease burden. PARTICIPANTS: A total of 1494 patients with dermatologist-verified AA were included in the cohort. Patients were invited and included through electronic or phone-based questionnaires. Information regarding demographics, biometrics, lifestyle factors, skin type, AA onset and development, health-related quality of life and self-reported severity assessment was collected. FINDINGS TO DATE: The mean (SD) age of AA onset was 32.7 (17.6) years. The mean body mass index and history of cigarette smoking was comparable with the general population. The majority (92.5%) of participants were Caucasian. In total, 72.4% of patients received their diagnosis by a physician within a year after onset of symptoms, and 66.9% reported to still have symptoms of AA within the past year. A total of 12% reported to have a first-degree family member with AA. In total, 31.4% of patients were missing all or nearly all hairs on their scalp, 32.2% had no or barely no eyelashes and 36.2% had no or barely no eyebrow hairs. Overall, most patients (55.7%) did not experience irritated eyes, but 30% reported slight eye irritation and 47.2% reported no damage to finger nails or toenails. FUTURE PLANS: Observational studies regarding comorbidities, psychosocial burden of AA and efficacy of pharmacological interventions will be carried out and additional data will be linked from nationwide registries of routinely collected data. Furthermore, follow-up survey data will be added for longitudinal analyses.

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.

Treatment Goals for Psoriasis as Measured by Patient Benefit Index: Results of a National Psoriasis Foundation Survey.

INTRODUCTION: This cross-sectional survey was conducted with National Psoriasis Foundation (NPF) to capture treatment perspectives and expectations in patients with psoriasis (PsO) using Patient Needs Questionnaire (PNQ) of Patient Benefit Index (PBI). METHODS: Adult participants with self-reported diagnosis of PsO responded to the PNQ portion of PBI by indicating how much they valued different treatment attributes. All the treatment goals were captured on a five-point Likert scale (0 = "Not important", 4 = "Very important"). Treatment goals were obtained for overall population and subgroups based on severity of disease Patient Global Assessment (PGA), age, gender, and Dermatology Life Quality Index (DLQI) total score. All data were expressed as mean and standard deviation [SD]. RESULTS: A total of 1200 participants completed the survey (mean age 51.5 years). Top treatment goal in the overall population was "to have confidence in the therapy" (3.46 [1.01]). Unique to the higher severity subgroup (PGA ≥ 3), "to find a clear diagnosis and therapy" was a top five goal and "to get better skin quickly" was for those with lesser severity (PGA < 3). "To be free of itching" (3.36 [0.99]) was the unique goal in the < 40 age group whereas it was "to get better skin quickly" (3.27 [1.12]) in the ≥ 40 group. In women and men, "to be free of itching" (3.38 [1.13]) and "to get better skin quickly" (3.20 [1.09]) were top five goals, respectively. Patients with ≥ 10 DLQI scores expressed higher treatment goal "to regain control of the disease" (3.66 [0.67]) compared to those with ≤ 10 DLQI scores who expressed "to have confidence in the therapy" (3.40 [1.11]) as the topmost treatment goal. CONCLUSION: Our results suggest that in patients with PsO, treatment preferences can vary with different characteristics such as age, severity, and gender as measured by using PNQ. Further exploration of this data will help inform treatment decisions and optimize patient outcomes.

The Relationship Between Patient-Reported Severity of Hair Loss and Health-Related Quality of Life and Treatment Patterns Among Patients with Alopecia Areata.

INTRODUCTION: Alopecia areata (AA) is an autoimmune disease characterized by hair loss. Patients with AA experience a range of social and emotional impacts, and the lack of effective treatments and multiple affected locations can deepen the burden of illness. The objective of the current study was to assess health-related quality of life (HRQL) among patients with AA, and to evaluate the relationship between patient-reported AA severity, HRQL and treatment patterns. METHODS: A web survey was completed by participants recruited through the National Alopecia Areata Foundation. The survey included questions on disease characteristics, burden and impact (evaluated by the Skindex-16 for AA and items on work/school and sexual relationships), healthcare utilization and treatment experience. Analyses were conducted for the overall sample and by key subgroups, including AA severity and disease duration. RESULTS: A total of 1327 participants with AA completed the survey. The mean age was 39.7 [standard deviation (SD) 12.3] years and 58.4% were female. On average, participants had experienced signs and symptoms of AA for 11.5 years (SD 12.5) and were diagnosed by a healthcare provider (HCP) 10.5 (SD 12.2) years ago. Participants reported a range of severity of current scalp hair loss, including 0% (2.6%), 1-20% (39.8%), 21-49% (26.2%), 50-94% (10.2%) and 95-100% (21.3%). Participants reporting 95-100% of scalp hair missing were less likely to be currently seeing an HCP and to currently be on treatments for AA. There was a non-linear relationship between HRQL and current AA severity. Participants with 1-20% to 50-94% of current scalp hair missing reported higher symptom, functioning and emotional impacts due to AA than participants with 0% missing scalp hair and/or 95-100% missing scalp hair. Similar findings were observed for current eyebrow and eyelash severity, except for emotional impacts. CONCLUSION: Severity of AA plays an important role in understanding the burden of illness and healthcare patterns of people living with AA.

Predictors of QOL in Patients with Alopecia Areata.

Although alopecia areata (AA) severity is often defined by the degree of scalp hair loss, its impact on QOL can also be a defining measure of severity. In this cross-sectional study (AA Disease Specific Program), 259 patients were surveyed for demographics, AA illness characteristics, QOL (Skindex-16 AA), and daily impairment (Work Productivity and Activity Impairment). The association between patient demographics and illness variables, the Skindex-16 AA scores, and the Work Productivity and Activity Impairment scores were analyzed using regression analyses. The mean age of patients was 39 years (51% female). Self-reported severity of current AA was rated as mild (21%), moderate (54%), and severe (25%). The highest impairment was observed for the Skindex-16 AA emotions and the Work Productivity and Activity Impairment daily activity performance scores. Although the degree of scalp hair loss (physician Severity of Alopecia Tool score) was not predictive of QOL, patients' self-report of moderate or severe disease, sex (females more impacted), and eyebrow and eyelash involvement were predictors of diminished QOL, consistently and incrementally. The present results suggest patients' perception of severity as well as the presence of eyelash and eyebrow hair loss are also impactful and should be considered in defining the severity of disease.

Dermatologist and Patient Perceptions of Treatment Success in Alopecia Areata and Evaluation of Clinical Outcome Assessments in Japan.

INTRODUCTION: The content validity and treatment success thresholds of clinical outcome assessments (COAs) for alopecia areata (AA)-including the Alopecia Areata-Investigator Global Assessment™ (AA-IGA™), Scalp Hair Assessment Patient-Reported Outcome™ (PRO), and clinician-reported outcome (ClinRO) and PRO measures for eyebrows, eyelashes, eye irritation, and nails-were established in interviews with dermatologists and patients in North America. This study aimed to confirm the content validity and treatment success thresholds of these measures with clinicians and patients in Japan. METHODS: Qualitative interviews were conducted in Japan with dermatologists with AA expertise and adults with AA who experienced ≥ 50% scalp hair loss. Interviews included concept elicitation and cognitive interview questions. Data were analyzed using thematic and framework techniques. RESULTS: Seven dermatologists and 15 patients participated. Scalp hair loss was the most important sign/symptom of AA and the greatest treatment priority. Dermatologists and patients understood the AA-IGA™, Scalp Hair Assessment PRO™, and other COAs, and found these measures to be appropriate, relevant, and clinically meaningful. Dermatologists and patients confirmed that achieving ≤ 20% scalp hair loss (AA-IGA™/Scalp Hair Assessment PRO™ categories 0 or 1) indicated treatment success for patients with ≥ 50% scalp hair loss. Categories 0 or 1 on the other COAs represented treatment success. CONCLUSION: This study confirmed the content validity and treatment success thresholds of the AA-IGA™, Scalp Hair Assessment PRO™, and other ClinRO and PRO measures for AA in Japan. These findings were aligned with interview results in North America and support the use of these measures in AA treatment studies.

About 2% of people in the world have alopecia areata, which causes them to lose hair on their scalp, face, and body. We interviewed 15 Japanese adults who had lost at least half of the hair on their scalp and seven dermatologists who treated alopecia areata. The dermatologists felt that scalp hair loss was more important to treat than eyebrow and eyelash hair loss. Patients were most bothered about losing their scalp hair and reported feeling anxious or worried about what other people might think about it. Patients and dermatologists were also shown several questionnaires and thought the questionnaires were appropriate to measure the most important symptoms of alopecia areata. Patients considered that a treatment worked well if it gave them at least 80% of their scalp hair; dermatologists also wanted the treatment to give patients at least 80% scalp hair. These interviews agree with what has previously been found in interviews with patients and dermatologists in North America.

Alopecia Areata Treatment Patterns, Healthcare Resource Utilization, and Comorbidities in the US Population Using Insurance Claims.

INTRODUCTION: Alopecia areata (AA) is an autoimmune disorder causing sudden, non-scarring hair loss. There are currently no drugs approved for AA treatment. This study assessed prevalence of comorbidities, treatments, and healthcare costs and resource utilization among patients with AA in the USA. METHODS: Patients diagnosed with AA between January 2011 and December 2018 were identified in IBM MarketScan® Research Databases. Eligible patients had no other hair loss-related disorders and were continuously enrolled with medical and pharmacy benefits at least 12 months before and after AA diagnosis. Descriptive statistics were used to summarize comorbid conditions, treatments related to AA or other autoimmune/inflammatory conditions, and all-cause and AA-specific healthcare costs and resource utilization identified from claims data. RESULTS: A total of 68,121 patients with AA were identified. Mean (SD) age was 40.3 (17.8) years and 61.0% were female. The most common comorbidities included hyperlipidemia (22.4%), hypertension (21.8%), thyroid disorders (13.1%), contact dermatitis or eczema (10.8%), depression (9.5%), and anxiety (8.4%). Comorbid autoimmune diseases included atopic dermatitis (2.8%), psoriasis (2.1%), chronic urticaria (1.5%), and rheumatoid arthritis (1.1%). During the 12-month follow-up period, 37,995 patients (55.8%) were prescribed treatment for their AA or other comorbid autoimmune/inflammatory disease; 44.9% of treated patients were prescribed therapy within 7 days of AA diagnosis. Of patients receiving treatment, 80.3% received topical steroids and 30.0% received oral steroids. Mean (SD) total healthcare costs were $11,241.21 ($43,839.69) for all-causes and $419.12 ($1534.99) for AA. AA-related expenses were driven by outpatient and prescription costs. CONCLUSION: Patients with AA have a high comorbidity burden and lack of treatment. Current AA treatments, including systemic therapies other than oral steroids, were not frequently utilized in this study population. Healthcare costs incurred by patients with AA went beyond AA-related expenses. Longitudinal data are needed to better understand treatment trajectories and the disease burden in patients with AA.

Real-World Claims Analyses of Comorbidity Burden, Treatment Pattern, Healthcare Resource Utilization, and Costs in Pediatric Psoriasis.

INTRODUCTION: There are limited real-world data on treatment patterns, comorbidities, and healthcare burden in pediatric patients with psoriasis. We examined patient demographics, comorbidity burden, treatment patterns, and healthcare use and costs in pediatric psoriasis. METHODS: A retrospective, real-world, exploratory study was conducted using US claims databases. Pediatric patients aged < 18 years with newly diagnosed psoriasis (index date) were selected from IBM® MarketScan® databases (2016-2018). Patients were enrolled continuously for ≥ 12 months pre- and post-index date. Pre-index demographics, comorbidity, treatment drug classes prescribed, and post-index healthcare resource utilization and costs were studied. Study measures are reported for total population and by severity (categorized as mild and moderate-to-severe psoriasis). Variables were compared using t-test (continuous) or chi-square and Fisher's exact test (categorical). RESULTS: Overall, 4754 pediatric patients with psoriasis (58.3% females) met the selection criteria and were included in the study. Mean and standard deviation (SD) age was 12.6 (3.7) years on index date, with 13.4% patients having moderate-to-severe psoriasis. The mean (SD) Deyo-Charlson Comorbidity Index was 0.14 (0.40); anxiety (6.6%), depression (4.1%), and obesity (3.9%) were the most prevalent comorbidities observed. Topical treatments were prescribed to most patients as first-line treatment of mild (79.1%) and moderate-to-severe (52.0%) psoriasis. Other first-line therapies prescribed in moderate-to-severe cases included non-biologic systemics (21.0%), phototherapy (15.0%), and biologics (9.2%). Healthcare use and costs increased with psoriasis severity during the post-index period. Mean annual total all-cause costs per patient were higher for patients with moderate-to-severe psoriasis compared with mild psoriasis ($27,541 vs. $5,034; P < 0.001). CONCLUSIONS: Psychiatric, metabolic, and inflammatory disorders were observed comorbidities in pediatric patients with psoriasis. For moderate-to-severe psoriasis, topicals, phototherapy, and biologics were a common first-, second-, and third-line treatment sequence. Higher unadjusted healthcare costs by severity were driven by outpatient prescription costs.

Development of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis: qualitative and quantitative analyses.

Background: Psoriasis is a chronic inflammatory skin disease.Objective: To establish content validity and assess psychometric properties of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis (Ps).Methods: The PSS is an eight-item patient-completed questionnaire assessing symptoms (itch, pain, stinging, burning), signs (redness, scaling, cracking), and discomfort. Content validity was established during interviews of patients (n = 14) with Ps. PSS Symptoms and Signs domain scores were evaluated for reliability, construct validity, and responsiveness using data from a clinical study (NCT02899988) in Ps (n = 205).Results: Patients confirmed content validity; the PSS was understandable and relevant. Cronbach's alphas were 0.84 (Symptoms) and 0.86 (Signs), demonstrating internal consistency reliability. Test-retest reliability was confirmed in patients before receiving study drug (intraclass coefficient: 0.82 [Symptoms]; 0.81 [Signs]). Convergent and discriminant validity were demonstrated at baseline and Week 16 by large (≥0.50) correlations between PSS Symptoms and Signs domain scores and Dermatology Life Quality Index total and symptoms and feelings domain scores, and small (<0.30) correlations with Short Form-36 Mental Component Summary score, respectively. Symptoms and Signs scores responded to clinical changes (p < .001).Conclusions: The PSS Symptoms and Signs domains are valid and reliable assessments of patient-reported symptoms and signs, useful for assessing treatment efficacy.