Brodalumab: 5-Year US Pharmacovigilance Report.

INTRODUCTION: Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Although the US prescribing information for brodalumab includes a boxed warning regarding suicidal ideation and behavior, no causal association has been demonstrated. Here, we summarize 5 years of pharmacovigilance data, from August 15, 2017, through August 14, 2022, reported to Ortho Dermatologics by US patients and healthcare providers. METHODS: Prevalence of the most common adverse events (AEs) listed in the brodalumab package insert (incidence ≥ 1%) and AEs of special interest are described. Brodalumab exposure was estimated as the time from the first to last prescription-dispensing authorization dates. Data were collected from 4744 patients in the USA, with an estimated exposure of 5815 patient-years. RESULTS: Over 5 years, 11 cases of adjudicated major adverse cardiovascular events were reported (0.23 events/100 patients), a rate lower than that experienced by patients in the international Psoriasis Longitudinal Assessment and Registry. There were 106 serious infections. No serious fungal infections were reported. There were 40 confirmed and 2 suspected COVID-19 cases, with no new COVID-19-related deaths. Of 49 reported malignancies among 42 patients, 3 were deemed possibly related to brodalumab. No completed suicides and no new suicidal attempts were reported. CONCLUSION: Five-year pharmacovigilance data are consistent with the established safety profile reported in long-term clinical trials and previous pharmacovigilance reports, with no new safety signals.

Brodalumab is an injectable treatment approved for moderate-to-severe plaque psoriasis in adults who lacked response to previous treatments. In the USA, brodalumab is only available under a Risk Evaluation and Mitigation Strategy for increased suicidality risks; however, findings from 5 years of real-world safety data have demonstrated a lack of association. In this report, we discuss safety findings reported by US patients and healthcare providers for 4744 patients treated with brodalumab over 5 years. Joint pain (known as arthralgia) was the most common safety finding, with 122 cases reported over 5 years. Other safety findings of interest across 5 years included 106 serious infections (defined as prolonged infections or infections requiring treatment), 54 cases of depression, 49 cases of cancer (in 42 patients), 40 confirmed cases of COVID-19, and 11 cases of major cardiovascular events (such as stroke or heart attack). No completed suicides occurred throughout 5 years, and no new suicidal attempts were reported in year 5. In indirect comparisons with safety data from patients with psoriasis receiving or eligible to receive similar treatments, brodalumab was not associated with an increased risk of serious infection, cancer, major cardiovascular events, or inflammatory bowel disease. Taken together, these data are consistent with safety findings from long-term clinical trials and previous safety reports of brodalumab.

Shared decision-making in psoriasis care: Evaluation of how patients' perception of clinicians' delivery of care changes by age and sex.

BACKGROUND: Shared decision-making (SDM) refers to a collaborative process in which clinicians assist patients in making medically informed, evidence-based decisions that align with their values and preferences. There is a paucity of literature on SDM in dermatology. OBJECTIVE: We aim to assess whether male and female psoriasis patients evaluate their clinicians' engagement in SDM differently across different age groups. METHODS: Cross-sectional study using data from the 2014-2017 and 2019 Medical Expenditure Panel Surveys (MEPS). RESULTS: A weighted total of 7,795,608 psoriasis patients were identified. SDM Scores ranged from 1 to 4, with 4 representing the most favorable patient evaluation of their clinicians' engagement in SDM. We conducted multivariate linear regression to compare mean SDM Scores in male psoriasis patients versus female psoriasis patients across different patient age groups. Female patients ages 60-69 perceived significantly greater clinician engagement in SDM compared to age-matched male patients (female patient perception of SDM 3.65 [95%CI:3.61-3.69] vs. male patient perception of SDM 3.50 [95%CI:3.43-3.58], p<0.005). The same trend of older female patients evaluating their clinicians' engagement in SDM significantly higher than their age-matched male counterparts exists for the age group >70 (p<0.005). No significant differences between male and female patients' evaluations of their clinicians' engagement in SDM were demonstrated in subjects younger than 60. All calculations were adjusted for demographic and clinical factors. CONCLUSIONS: Compared to older male psoriasis patients, older female psoriasis patients evaluated their clinicians to be more engaged in shared decision-making.

An OX-Tra'Ordinary Tale: The Role of OX40 and OX40L in Atopic Dermatitis.

The transmembrane glycoprotein OX40 receptor (OX40) and its ligand, OX40L, are instrumental modulators of the adaptive immune response in humans. OX40 functions as a costimulatory molecule that promotes T cell activation, differentiation, and survival through ligation with OX40L. T cells play an integral role in the pathogenesis of several inflammatory skin conditions, including atopic dermatitis (AD). In particular, T helper 2 (TH2) cells strongly contribute to AD pathogenesis via the production of cytokines associated with type 2 inflammation (e.g., IL-4, IL-5, IL-13, and IL-31) that lead to skin barrier dysfunction and pruritus. The OX40-OX40L interaction also promotes the activation and proliferation of other T helper cell populations (e.g., TH1, TH22, and TH17), and AD patients have demonstrated higher levels of OX40 expression on peripheral blood mononuclear cells than healthy controls. As such, the OX40-OX40L pathway is a potential target for AD treatment. Novel therapies targeting the OX40 pathway are currently in development, several of which have demonstrated promising safety and efficacy results in patients with moderate-to-severe AD. Herein, we review the function of OX40 and the OX40-OX40L signaling pathway, their role in AD pathogenesis, and emerging therapies targeting OX40-OX40L that may offer insights into the future of AD management.

Complementary and Alternative Medicine for Hidradenitis Suppurativa Discussed on TikTok: A Cross-Sectional Analysis.

BACKGROUND: Hidradenitis suppurativa (HS) is a painful, chronic inflammatory skin disease that negatively affects patient quality of life, and conventional treatments are variably effective. As a result, patients often turn to complementary and alternative medicine (CAM) for pain relief. Social media enables HS patients to share treatment recommendations. TikTok is a popular social media platform, but little is known about the HS treatments discussed in TikTok videos.  Objective: To evaluate the content and quality of information on TikTok regarding CAM HS therapies.  Methods: A cross-sectional analysis was conducted by performing a search in TikTok using the terms #hidradenitissuppurativa, #hswarrior, #naturalremedy, #complementarymedicine, #alternativemedicine, and #HStreatment. Two independent reviewers evaluated video quality using the DISCERN and AVA instruments. Linear regressions compared the engagement, DISCERN, and AVA scores among different uploader types. RESULTS: In total, 91 TikTok videos were analyzed. Videos were uploaded by non-physicians (82.4), dermatologists (6.6%), and private companies (11.0%). The average DISCERN and AVA scores were 36.2 and 1.6, respectively (poor quality). Common CAM therapies were natural salves, turmeric, Epsom salts, elimination diets, and zinc supplements. Physician-uploaded videos were of significantly higher quality than videos by other uploader types, with an average DISCERN and AVA score of 44.3 (P<0.009) and 2.6 (P<0.001), respectively (fair quality). CONCLUSION: TikTok videos were poor quality (low DISCERN and AVA scores); physician-uploaded videos were fair quality. Dermatologists can improve video quality by adequately discussing the supporting evidence, mechanisms of action, and remaining questions for HS treatments.  J Drugs Dermatol. 2024;23(3):e93-96. doi:10.36849/JDD.7738e.

Deucravacitinib in moderate-to-severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO-1 and PSO-2).

BACKGROUND: Two phase 3 trials, POETYK PSO-1 and PSO-2, previously established the efficacy and overall safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in plaque psoriasis. OBJECTIVES: To further assess the safety of deucravacitinib over 52 weeks in the pooled population from these two trials. METHODS: Pooled safety data were evaluated from PSO-1 and PSO-2 in which patients with moderate-to-severe plaque psoriasis were randomized 1:2:1 to receive oral placebo, deucravacitinib or apremilast. RESULTS: A total of 1683 patients were included in the pooled analysis. Adverse event (AE) incidence rates were similar in each treatment group, serious AEs were low and balanced across groups, and discontinuation rates were lower with deucravacitinib versus placebo or apremilast. No new safety signals emerged with longer deucravacitinib treatment. Exposure-adjusted incidence rates of AEs of interest with placebo, deucravacitinib and apremilast, respectively, were as follows: serious infections (0.8/100 person-years [PY], 1.7/100 PY, and 1.8/100 PY), major adverse cardiovascular events (1.2/100 PY, 0.3/100 PY, and 0.9/100 PY), venous thromboembolic events (0, 0.2/100 PY, and 0), malignancies (0, 1.0/100 PY and 0.9/100 PY), herpes zoster (0.4/100 PY, 0.8/100 PY, and 0), acne (0.4/100 PY, 2.9/100 PY, and 0) and folliculitis (0, 2.8/100 PY, and 0.9/100 PY). No clinically meaningful changes from baseline in mean levels, or shifts from baseline to CTCAE grade ≥3 abnormalities, were reported in laboratory parameters with deucravacitinib. CONCLUSIONS: Deucravacitinib was well-tolerated with acceptable safety over 52 weeks in patients with psoriasis.

Comorbidity Burden in Psoriasis Patients with Skin of Color.

Background: Psoriasis is a chronic disease with increased risk of numerous comorbidities. Known differences exist regarding treatment outcomes for psoriasis patients with skin of color (SOC). However, factors contributing to these differences are relatively unknown. Objectives: This study aims to compare the comorbidity burden in SOC psoriasis patients vs. White patients, as measured by the Charlson Comorbidity Index (CCI) score. Methods: We utilized the National Ambulatory Medical Care Survey (NAMCS) to identify visits for adult psoriasis patients occurring in the years 2002-2016 and 2018. The CCI was used to objectively measure comorbidity burden. Patients were identified by race, and SOC was defined as any reported race besides White Only. A multiple linear regression was run to compare the CCI among adult psoriasis patients based on race and ethnicity, controlling for age, sex, insurance status, and geographic region. Results: A total of 39,176,928 weighted visits were analyzed. Compared to White patients, patients with SOC did not have statistically significant differences in comorbidity burden, as measured by CCI score (p=0.073 for Black/African American Only vs. White Only, p=0.073 for American Indian/Alaska Native Only vs. White Only, p=0.435 for Asian Only vs. White Only, p=0.403 for Native Hawaiian/Pacific Islander Only vs. White Only, p=0.195 for Other vs. White Only). Conclusion: Patients with SOC were not found to have differences in comorbidity burden compared to White patients. These results highlight that social factors such as socioeconomic status and access to healthcare may contribute more directly to psoriasis treatment outcomes than patient race.

Correlation between Dermatology Life Quality Index and Psoriasis Area and Severity Index in Patients with Psoriasis: A Cross-sectional Global Healthcare Study on Psoriasis.

Quality of life impairment in dermatology patients and severity of psoriasis are quantified by the Dermatology Life Quality Index (DLQI) and the Psoriasis Area and Severity Index (PASI), respectively. The aim of this study is to compare the correlation between PASI and DLQI in patients from different geographical areas and to identify predictors of high DLQI across geographical regions. Correlations between PASI and DLQI were evaluated using Spearman's rank correlation tests and quantile regression. The study included 1,158 patients with psoriasis, with a median (interquartile range) PASI and DLQI of 6.0 (3.0-12.0) and 8.0 (4.0-15.0), respectively. Correlations were demonstrated between PASI and DLQI, both overall and stratified by geographical region. Quantile (median) regression yielded coefficients of 0.75 (95% confidence interval (95% CI) 0.62, 0.88) for Switzerland, 0.50 (95% CI 0.42, 0.58) for Latin America, 0.34 (95% CI 0.16, 0.51) for Asia, and 0.31 (95% CI 0.08, 0.53) for the USA. Current age, age at diagnosis, sex, body mass index, and psoriasis arthritis affected DLQI in Latin America, while education had an impact among patients treated in Switzerland. Few countries were included within each continent; hence, more data from different countries are necessary for generalizability. The study showed correlations between PASI and DLQI among patients in all included geographical regions. The patients' characteristics affecting DLQI vary worldwide.

Lebrikizumab in Uncontrolled Asthma: Reanalysis in a Well-Defined Type 2 Population.

BACKGROUND: LAVOLTA (L)I, LII, and ACOUSTICS were randomized, placebo-controlled, Phase 3 trials of lebrikizumab, a monoclonal antibody targeting IL-13 in patients with uncontrolled asthma. Failure to demonstrate efficacy may have been related to patient selection in those trials. OBJECTIVE: To assess the efficacy in a well-defined subpopulation of patients with elevated blood eosinophil counts and a minimum number of prior asthma exacerbations. We performed an additional analysis in a subpopulation of patients with elevated FeNO and prior exacerbations. METHODS: Adult (LI and LII) and adolescent patients (aged 12-17 years weighing ≥40 kg, ACOUSTICS) with uncontrolled asthma received lebrikizumab (125 mg, n = 832; or 37.5 mg, n = 829) or placebo (n = 833) subcutaneously every 4 weeks. Post hoc analysis of the annualized adjusted exacerbation rate (AER) was performed in a subpopulation of patients with baseline blood eosinophils of 300 cells/µL or greater and history of one or more exacerbations. In this subpopulation, there were 227 patients in the placebo group, 222 in the lebrikizumab 37.5-mg group, and 217 in the lebrikizumab 125-mg group. We summarized safety in patients who received at least one dose of lebrikizumab using adverse events. RESULTS: Lebrikizumab significantly reduced AER compared with placebo in adults (AER reduction: 125 mg [38%]; and 37.5 mg [41%]) and adolescents (AER reduction:125 mg [59%]; 37.5 mg [64%]) with baseline blood eosinophils of 300 cells/µL or greater and one or more exacerbations. Most adverse events were mild or moderate in severity and did not lead to treatment discontinuation. CONCLUSION: Lebrikizumab significantly reduced asthma exacerbations in a subpopulation of patients with elevated blood eosinophils, elevated FeNO, and a history of asthma exacerbation.

Vaccination recommendations for adults receiving biologics and oral therapies for psoriasis and psoriatic arthritis: Delphi consensus from the medical board of the National Psoriasis Foundation.

BACKGROUND: For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis. OBJECTIVE: To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving nonlive or live vaccines. METHODS: Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts. RESULTS: Key recommendations include continuing most oral and biologic therapies without modification for patients receiving nonlive vaccines; consider interruption of methotrexate for nonlive vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of live vaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4 weeks after live vaccination. LIMITATIONS: Studies regarding infection rates after vaccination are lacking. CONCLUSION: Interruption of antipsoriatic oral and biologic therapies is generally not necessary for patients receiving nonlive vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.

Comparing Cosmetic Outcomes of Straight-Line Versus W-Plasty Techniques for Linear Postauricular Wound Closure: A Randomized Evaluator Blind Split-Scar Trial.

BACKGROUND: Surgeons' opinions vary on the cosmetic outcome of straight-line (SL) versus broken-line (W-plasty) closure methods. To date, no studies have compared the 2 techniques in the split-scar design model that resolves the confounding individual patient factors that affects the scar outcome. OBJECTIVE: Compare outcomes and wound cosmesis with SL versus W-plasty closure techniques. METHODS: This clinical trial was conducted with 50 linear surgical wounds randomized to SL closure on half and W-plasty on the other half. At 3 months, patients and 2 masked observers evaluated each scar using the Patient and Observer Scar Assessment Scale (Patient Observer Scar Assessment Scale [POSAS]). RESULTS: The mean (SD) sum of the POSAS observer component scores were 16.6 (6.18) for the SL side and 15.5 (6.37) for the W-plasty side ( p = .49). The mean (SD) sum of the POSAS patient scores were 14.4 (6.8) in SL and 15.1 (8.2) in W-plasty ( p = .59). The mean (SD) complications were 0.08 (0.06) for SL and 0.02 (0.14) for W-plasty ( p = .18). CONCLUSION: No statistically significant difference in wound cosmesis or complications was noted between SL versus W-plasty closure techniques. Surgeons may want to consider whether the extra time involved in placing zigzag W-plasty lines is worthwhile.

Tips, Trends, and Truths: A Study of Psoriasis Treatment Content on TikTok.

INTRODUCTION: With more than two billion downloads since its launch, TikTok is the fastest-growing video-sharing platform in the world. Many people turn to TikTok for dermatologic medical information. However, there is limited data about psoriasis and psoriasis treatment content on this social media platform. OBJECTIVE: To compare the viewer engagement, content quality, and viewer experience of psoriasis treatment TikTok videos between physicians and non-physicians. METHODS: We searched the terms "psoriasis" and "psoriasis treatment" on TikTok. Video characteristics were collected. Content quality was evaluated using DISCERN. Viewer experience was assessed using the AVA. RESULTS: Viewer engagement did not significantly differ between physicians and non-physician content creators (0.033 plus/minus 0.005 vs 0.047 plus/minus 0.001, P=0.066). Compared to non-physicians, physicians created videos of higher quality (DISCERN: 1.76 plus/minus 0.058 vs 1.44 plus/minus 0.032, P<0.001) and of greater viewer experience (AVA: 2.55 plus/minus 0.183 vs 1.96 plus/minus 0.081, P=0.001). However, there is room for improvement in terms of creating videos of higher quality by both physicians and non-physicians. CONCLUSION: TikTok can be a powerful tool to promote health literacy and dispel misinformation. Dermatologists may consider focusing their efforts on creating comprehensive educational content and incorporating trending features to reach a wider audience. J Drugs Dermatol. 2024;23(2): doi:10.36849/JDD.7050e.

Patient-Reported Outcome Measures for Health-Related Quality of Life in Patients With Psoriasis: A Systematic Review.

Importance: Multiple patient-reported outcome measures (PROMs) for health-related quality of life (HRQL) exist for patients with psoriasis. Evidence for the content validity and other measurement properties of these PROMs is critical to determine which HRQL PROMs could be recommended for use. Objective: To systematically review the validity of HRQL-focused PROMs used in patients with psoriasis. Evidence Review: Using PubMed and Embase, full-text articles published in English or Spanish on development or validation studies for psoriasis-specific, dermatology-specific, or generic HRQL PROMs were included. Development studies included original development studies, even if not studied in psoriasis patients per Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) recommendations. If a study included multiple diagnoses, more than 50% of patients had to have psoriasis or psoriasis-specific subgroup analyses available. Data extraction and analysis followed the COSMIN guidelines. Two independent reviewers extracted and analyzed the data, including PROM characteristics, quality of measurement properties (structural validity, internal consistency, cross-cultural validity, reliability, measurement error, criterion validity, construct validity, and responsiveness), and level of evidence. PROMs were classified into 3 levels of recommendations: (1) PROM recommended for use; (2) PROM requires further validation; and (3) PROM not recommended for use. Findings: Overall, 97 articles were identified for extraction. This included 19 psoriasis-specific, 8 skin-specific, and 6 generic PROMs. According to COSMIN standards, most measures identified received a B recommendation for use, indicating their potential but requiring further validation. Only the Rasch reduced version of the Impact of Psoriasis Questionnaire (IPSO-11 Rasch) received an A recommendation for use given that it had sufficient content validity, structural validity, and internal consistency. Conclusions and Relevance: This study identified a significant lack of information concerning the quality of HRQL measures in psoriasis. This gap in knowledge can be attributed to the fact that traditional measures were developed using validation criteria that differ from the current standards in use. Consequently, additional validation studies in accordance with contemporary standards will be useful in aiding researchers and clinicians in determining the most suitable measure for assessing HRQL in patients with psoriasis.

Evaluating Treatment Choice in Patients with Moderate to Severe Psoriasis in the United States: Results from a US Patient Survey.

INTRODUCTION: While multiple treatments are available for moderate to severe psoriasis, patient preferences are rarely systematically studied. This study aims to identify factors associated with choice of a new once-daily oral psoriasis treatment, elicit patient views on treatment characteristics, and rank treatment characteristics by importance. METHODS: This noninterventional, cross-sectional survey study, conducted from December 2021 to June 2022, recruited US adults with moderate to severe psoriasis. Demographics, clinical characteristics, and perspectives on psoriasis treatment were collected. Factors associated with the choice of a new oral treatment were identified using multivariable logistic regression analysis. Treatment characteristics and reasons for treatment choice were ranked using bivariate comparisons. RESULTS: The study included 882 participants [mean (standard deviation; SD) age, 45.7 (12.8) years; female, 67.7%; White, 74.9%]; 92.7% were currently receiving treatment [mean (SD) duration, 2.9 (4.8) years]. Half of participants rated their psoriasis symptoms over the past week as mild, very mild, or nonexistent; 36.5% as moderate; and 12.7% as severe or very severe. Most (66.5%) indicated willingness to start a new oral treatment; 65.0% indicated that the new oral treatment would cause less anxiety than injections/infusions. Participants were significantly more likely to start the new oral treatment if they were currently receiving a tumor necrosis factor inhibitor [odds ratio (OR): 2.1, 95% confidence interval (CI): 1.4-3.1] or ustekinumab (OR: 2.7, 95% CI: 1.6-5.0) versus apremilast (P < 0.001) or if they reported mild (OR: 3.2, 95% CI: 2.0-4.9), moderate (OR: 5.0, 95% CI: 3.1-8.2), or severe (OR: 7.6, 95% CI: 3.9-15.0) psoriasis symptoms compared with those who reported no symptoms in the past week (P < 0.001). CONCLUSION: Most participants indicated willingness to start a new once-daily oral treatment, viewing it as less anxiety provoking than injections/infusions. Current treatment and psoriasis severity affected participants' willingness to start a new oral treatment.

Patients with psoriasis have multiple treatment options available to them. We surveyed 882 adults with moderate to severe psoriasis in the US to assess their perspectives and the values placed on treatment characteristics that are most important to them when making treatment-related decisions. Participants were assigned to one of five groups based on their psoriasis treatment at the time of the survey: (1) apremilast (oral), (2) a tumor necrosis factor inhibitor (TNFi) treatment (injectable), (3) ustekinumab (injectable), (4) a topical therapy or phototherapy, or (5) over-the-counter medications or participants who were untreated (this group included those who were not currently using a psoriasis treatment). The extent of skin clearance associated with a drug, how a drug is taken, and a drug's safety profile were among the top-ranked treatment characteristics that are important to survey participants when they choose a psoriasis treatment. Most participants (66.5%) were willing to start a new oral treatment, with 65.0% indicating that the new oral treatment would cause less anxiety than injections or infusions. Participants were more willing to switch to a new oral psoriasis treatment if they were currently receiving an injectable treatment, such as ustekinumab or a TNFi, compared with those who were already taking an oral treatment. These findings suggest that, when prescribing treatments for psoriasis, health care providers should consider the treatment characteristics that are important to their patients and consider that patients generally prefer an oral versus injectable drug.

Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type.

BACKGROUND: Response to abrocitinib treatment for moderate-to-severe atopic dermatitis (AD) has not been evaluated across racial and ethnic subpopulations. OBJECTIVE: To assess the efficacy and safety of abrocitinib on the basis of patient race, ethnicity, and Fitzpatrick skin type (FST). METHODS: Data were pooled post hoc from patients treated with abrocitinib 200 mg, 100 mg, or placebo in 3 monotherapy trials (NCT02780167, NCT03349060, and NCT03575871). Race and ethnicity were self-reported; FST was determined by study investigators. Evaluations through Week 12 include the following: (1) Investigator's Global Assessment of clear or almost-clear skin; (2) greater than or equal to 75% improvement in Eczema Area and Severity Index or SCORing AD; (3) a greater-than-or-equal-to 4-point improvement in Peak Pruritus Numerical Rating Scale score; (4) least squares mean changes in Dermatology Life Quality Index and Patient-Oriented Eczema Measure scores; and (5) treatment-emergent adverse events. RESULTS: The sample comprised 628 White, 204 Asian, and 83 Black patients; 37 were Hispanic or Latino; 624 had FST I to III and 320 had FST IV to VI. Treatment with either abrocitinib dose was associated with greater proportions of patients achieving Investigator's Global Assessment of clear or almost-clear skin, ≥ 75% improvement in Eczema Area and Severity Index, ≥ 75% improvement in SCORing AD, and a ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale, or greater score changes from baseline in Dermatology Life Quality Index and Patient-Oriented Eczema Measure vs placebo regardless of race, ethnicity, or FST. Dose-response was most prominent in White patients. In Black patients, the effects of the 2 doses were similar. Treatment-emergent adverse events were more common in White and Black than in Asian patients. CONCLUSION: Abrocitinib was more efficacious than placebo across the racial and ethnic groups and ranges of phototypes analyzed. Studies with increased representation of populations of color are warranted to elucidate potential variations in response across diverse populations. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02780167 (phase 2b), NCT03349060 (phase 3 MONO-1), and NCT03575871 (phase 3 MONO-2).

Safety and efficacy of eblasakimab, an interleukin 13 receptor α1 monoclonal antibody, in adults with moderate-to-severe atopic dermatitis: A phase 1b, multiple-ascending dose study.

BACKGROUND: Eblasakimab, an interleukin (IL)-13 receptor α1 antagonist, blocks IL-4 and IL-13 signaling through the type 2 receptor. OBJECTIVE: The safety and efficacy of eblasakimab was evaluated in adults with moderate-to-severe atopic dermatitis (AD). METHODS: In this phase 1b randomized, double-blinded study, 52 patients with moderate-to-severe AD received weekly subcutaneous injections of eblasakimab 200, 400, or 600 mg, or placebo for 8 weeks. Primary outcome was the incidence of treatment-emergent adverse events. Secondary outcomes included percentage change in the Eczema Area and Severity Index from baseline; Eczema Area and Severity Index improvement of at least 50%, 75%, or 90% from baseline; and percentage change in the peak-pruritus numeric rating scale score from baseline. RESULTS: Treatment-emergent adverse events were reported in 47% placebo and 71% eblasakimab patients; most were considered mild or moderate and did not lead to study discontinuation. At week 8 eblasakimab 600 mg showed statistically significant improvement in mean percentage change in Eczema Area and Severity Index versus placebo (-65% vs -27%, P = .014). Other key secondary physician- and patient-reported end points were met. LIMITATIONS: Longer studies are required to confirm eblasakimab safety and efficacy in AD patients. CONCLUSIONS: Treatment of adults with moderate-to-severe AD with eblasakimab was well-tolerated and associated with significant clinical improvements versus placebo.

Evaluation of DermSat-7 for Assessing Treatment Satisfaction in Patients with Acne.

Importance: Treatment satisfaction is important to achieving therapeutic success in patients with inflammatory dermatological diseases, such as acne. Objective: To evaluate the structural validity, internal consistency, and construct validity of the DermSat-7, a questionnaire-based measure of treatment satisfaction, in patients with acne seen in routine clinical practice. Design, Setting, and Participants: This cross-sectional study included adults with acne who were fluent in English and treated at an outpatient clinic at Brigham and Women's Hospital between July 2022 and May 2023. At each visit, patients completed a self-administered, patient-reported outcome questionnaire, including a patient global assessment (PGA) of their acne severity and the DermSat-7. The DermSat-7 consists of 7 items assessing 3 domains of treatment: effectiveness (3 items), convenience (3 items), and overall satisfaction (1 item). At subsequent visits, patients were asked an anchor item related to change in disease severity ("How has your acne changed compared to your last visit?") that was scored on a 7-point scale (-3 = much worse to 3 = much better). Also at each visit, a dermatologist completed the Comprehensive Acne Severity Scale (CASS). Main Outcomes and Measures: The main outcomes were structural validity (assessed by factor analysis), internal consistency (assessed by Cronbach α), and construct validity (assessed using linear regression models and Pearson correlation coefficients). Results: The analysis included 142 patients with acne (mean [SD] age, 25.1 [5.1] years; 96 females [67.6%]) taking acne medication who completed the DermSat-7. Exploratory factor and confirmatory factor analysis supported the unidimensionality of the 3 DermSat-7 domains. Cronbach α values of 0.89 and 0.80 supported good internal consistency in the effectiveness and convenience domains, respectively. Known-groups validity was supported by increasing DermSat-7 effectiveness and overall satisfaction scores with increasing levels of positive change in disease severity (linear regression coefficient, 7.51; 95% CI, 4.94-10.08; P < .001). Construct validity was further supported by moderate correlations with the anchor, PGA, and CASS scores (effectiveness domain: anchor r = 0.567, PGA r = -0.538, and CASS r = -0.485; overall satisfaction domain: anchor r = 0.467, PGA r = -0.486, and CASS r = -0.489). Conclusion and Relevance: This cross-sectional study found that the DermSat-7 may be an effective tool for measuring treatment satisfaction, particularly effectiveness and overall satisfaction domains, among patients with acne. Further research is needed to examine additional measurement properties of the DermSat-7, such as content validity and interpretability, as well as to validate the DermSat-7 in other populations of patients with acne.

Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Change from baseline score on the validated Psoriasis Symptoms and Signs Diary (PSSD) is a widely used, patient-reported end point in clinical trials for psoriasis. Meaningful score change thresholds anchored to patient-reported assessments have not been established in a clinical trial setting. Objective: To evaluate meaningful within-patient score change thresholds for the PSSD using data from the phase 3 Program to Evaluate the Efficacy and Safety of Deucravacitinib, a Selective TYK2 Inhibitor (POETYK), PSO-1 clinical trial, which compared the efficacy and safety of deucravacitinib vs placebo and apremilast among adults with moderate to severe plaque psoriasis. Design, Setting, and Participants: In this predefined analysis using data from the POETYK PSO-1 multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, conducted from August 7, 2018, to September 2, 2020, 666 adults with moderate to severe plaque psoriasis completed the PSSD daily throughout the trial. Meaningful change thresholds were derived by anchoring mean PSSD score change from baseline to week 16 to category improvements on the Patient Global Impression of Change (PGI-C) and the Patient Global Impression of Severity (PGI-S). Interventions: Deucravacitinib, 6 mg, once daily; placebo; or apremilast, 30 mg, twice daily. Main Outcome and Measures: The main outcome was score change from baseline to week 16 on the PSSD, anchored to the PGI-C and PGI-S. Results: The trial included 666 patients (mean [SD] age, 46.1 [13.4] years; 453 men [68.0%]). Three thresholds were identified using an analysis set of 609 patients. Score improvement of at least 15 points from baseline reflected meaningful within-patient change anchored to the PGI-C. Score improvements of 25 points were supported by both the PGI-C and the PGI-S, while a 30-point score change identified patients with greater improvements in their psoriasis symptoms and signs. Conclusions and Relevance: This analysis suggests that PSSD score improvements of 15, 25, or 30 points represent increasing improvements in disease burden that are meaningful to patients with psoriasis.