Factors Affecting Treatment Selection Among Patients With Hidradenitis Suppurativa.

Importance: Despite the US Food and Drug Administration's approval of adalimumab for the treatment of hidradenitis suppurativa (HS), prescription rates remain low, indicating a critical gap between evidence-based guidelines and clinical practice. Understanding the medical decision-making process that these patients use when considering biologic agents and other HS therapies may uncover opportunities for improved patient-physician communication and HS disease control. Objective: To elucidate factors that affect the medical decision-making process for patients with HS, with an emphasis on biologic therapies. Design, Setting, and Participants: Open-ended semistructured interviews were conducted with English-speaking adults with HS (aged ≥18 years) recruited from 2 dermatology clinics that are part of Emory University School of Medicine in Atlanta, Georgia. All participants had an average 7-day pain score of 1 or higher on a 0- to 10-point numeric rating scale. Surveys were conducted between November 2019 and March 2020, and data were analyzed from December 2021 to August 2022. Data collection continued until thematic saturation was reached at 21 interviews. Results: A total of 21 participants (median [IQR] age, 38.5 [27.9-43.4] years; 16 females [76%]) were included in the analysis. Almost all participants (96%) had Hurley stage II or III disease, and 15 (71%) had a history of adalimumab use. Suffering threshold, perceptions of treatment risk, treatment fatigue, disease understanding, and sources of information (included dermatologists, the internet, advertisements, and friends and loved ones) were identified as factors affecting participants' decisions to initiate new treatments for HS. Conclusions and Relevance: Results of this qualitative study suggest that mitigating misconceptions about treatment risk, identifying gaps in disease knowledge, and emphasizing early treatment to prevent scarring and disease progression may empower patients with HS to engage in treatment planning and to try new therapies.

DaxibotulinumtoxinA-lanm (Daxxify™): A Comprehensive Overview.

Botulinum toxin A (BoNTA) is produced by Clostridium botulinum and widely used for aesthetic indications requiring neuromuscular blockade. For dynamic facial lines, BoNTA is effective and safe, but also temporary, requiring repeat injections approximately every 3-4 months for maintenance of effects. There is a desire by both patients and providers for a longer-lasting neurotoxin to prevent periods of suboptimal correction. Approved by the US Food and Drug Administration (FDA) in September 2022, daxibotulinumtoxinA for injection (DAXI or Daxxify™) is the first long-lasting BoNTA formulated with a 150-kDa BoNTA (RTT150) and proprietary stabilizing excipient peptide (RTP004) in place of human serum albumin. DAXI is approved for treatment of moderate to severe glabellar lines. The median duration of effect was 6 months and results lasted as long as 9 months in some patients. Its unique formulation and prolonged effectiveness positions DAXI as a safe, novel BoNTA for improved durability and patient satisfaction.

Highly Purified Microdroplet Liquid Injectable Silicone for the Treatment of Acne Scars in Lighter and Darker Skin Types: A Retrospective Review.

BACKGROUND: Treatment of acne scarring in darker skin types is fraught with challenges. Highly purified liquid injectable silicone (LIS) is effective in the treatment of acne scars, although its use in darker skin types has yet to be evaluated. OBJECTIVE: Retrospective evaluation of the safety and efficacy of highly purified LIS for the treatment of acne scars in lighter and darker skin types. MATERIALS AND METHODS: A retrospective chart review of patients who received highly purified LIS for acne scars between July 2010 and March 2021. RESULTS: Two hundred six total treatments in 96 patients, 32.29% ( n = 31) of whom were Fitzpatrick skin type IV ( n = 20, 20.83%) and V ( n = 11, 11.46%), with depressed and both broad-based and shallow acne scarring were reviewed. Mean age was 50.77 years (SD 16.77), and 83% were female. Complications such as granuloma formation, migration, extrusion of silicone, hyperpigmentation, hematoma, or infection were not observed. The average follow-up time was 6.31 years (SD 3.02). CONCLUSION: Highly purified LIS is a safe and effective permanent treatment for acne scars in all skin types. Injection of highly purified LIS using small volume microdroplet technique at 6- to 8-week intervals did not yield any complications, including in patients with darker skin types.

Pain experiences among those living with hidradenitis suppurativa: a qualitative study.

BACKGROUND: Pain is rated by patients with hidradenitis suppurativa (HS) as the disease's most impactful symptom. HS therapies are often insufficient to control inflammatory disease activity and pain. A better understanding of patient experiences with pain may improve patient-provider relationships and help identify strategies for addressing HS pain. OBJECTIVES: This qualitative study sought to characterize lived pain experiences of those with HS. METHODS: English-speaking patients ≥ 18 years old with a dermatologist-confirmed diagnosis of HS and an average numerical rating scale pain score of ≥ 1 over the preceding week were recruited from a single academic medical centre in Atlanta, Georgia, USA. Semistructured interviews were conducted from November 2019 to March 2020 to explore participants' HS pain experiences and the subsequent impact on their lives. Thematic saturation was reached after interviewing 21 participants. Interviews were audio recorded, transcribed, and analysed using thematic analysis. RESULTS: Among 21 study participants, the median 7-day average pain score was 6 (interquartile range 3-7; scale ranges from 0 to 10, with 10 being most pain). Participants' descriptions of pain were consistent with nociceptive pain, neuropathic pain and itch. Pain impacted multiple life domains, including physical limitations (decreased mobility and impaired sleep), decreased psychological wellbeing (irritability, depression, loss of control, and difficulty communicating pain experiences) and impaired social relationships (social isolation, intimacy problems and difficulty fulfilling social responsibilities). Although participants reported chronic discomfort, acutely painful and unpredictable HS disease flares caused more distress and quality-of-life (QoL) burden. Participants frequently treated their pain without input from the medical team, sometimes with unsafe medication doses or combinations. Factors contributing to self-management of pain included difficulty accessing timely outpatient care during disease flares and fear of stigma from healthcare providers. CONCLUSIONS: When present, HS-related pain may impact not only physical wellbeing but also mental health and relationships. In addition to therapies that target the inflammatory disease burden, treating the symptom of pain may improve patients' QoL and wellbeing. Because patients with HS have difficulty explaining their pain, proactively asking them about pain may identify unmet needs, facilitate better pain control and improve QoL. Further, the influence of HS-related pain on numerous aspects of QoL suggests the need for multidisciplinary, patient-centred approaches to HS pain management.

Demographic Gaps and Requirements for Participation: A Systematic Review of Clinical Trial Designs in Hidradenitis Suppurativa.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains the only therapy approved by the Food and Drug Administration for HS, many HS clinical trials for novel and re-tasked therapies are ongoing or upcoming. To optimize treatment equity, reflect the patient population, and facilitate trial participation, it is important to elucidate aspects of clinical trial protocols that may systematically exclude specific patient groups or impose hardships. OBJECTIVE: The study aimed to systematically review inclusion and exclusion criteria as well as participant demographics in HS clinical trials. METHODS: A literature search of PubMed, Embase, Cochrane Central, and Web of Science databases was conducted. Peer-reviewed publications of randomized controlled trials that were written in English and had at least 10 participants were included. Title and abstract screening and data extraction were completed by two independent reviewers, with disagreements resolved by a third. RESULTS: Twenty-three studies totaling 1,496 adult participants met the inclusion criteria. Race and ethnicity were not reported in 473/1,496 (31.6%) and 1,420/1,496 (94.9%) trial participants, respectively. Trial participants were predominantly white (811/1,023, 79.3%) and female (1,057/1,457, 72.5%). The median of each study's average age was 35.7 years (IQR 33.5-38.0), and 17/23 (73.9%) trials excluded pediatric patients. Nearly all participants had Hurley Stage II (499/958, 52.0%) or Hurley Stage III (385/958, 40.2%) disease. Many trials excluded patients who were pregnant (19/23, 82.6%) and breastfeeding (13/23, 56.5%), or who had HS that was "too severe" (8/23, 34.8%) or "too mild" (16/23, 70.0%). Frequently, trial protocols required prolonged washout periods from HS therapies, relatively long duration in the study's placebo arm, and prohibited concurrent analgesic use. CONCLUSIONS: This systematic review of 23 HS clinical trials totaling 1,496 participants identified substantial hardships imposed by trial participation, high rates of missing race and ethnicity data, and low representation of key patient groups, including those who identify as Black. Future trials with pragmatic study designs, broader inclusion criteria, and study sites in diverse communities may alleviate burdens of trial participation and improve enrollment of diverse patient groups.

Examination of Treatment Satisfaction Instruments in Psoriasis: 2017 Results from the Psoriasis Working Group of the International Dermatology Outcome Measures (IDEOM).

BACKGROUND/AIMS: In dermatology clinical trials, assessment of patients' treatment satisfaction is crucial but often lacking. To address this need, IDEOM's Psoriasis Working Group seeks to evaluate, develop, and validate treatment satisfaction instruments for the psoriasis population. The Psoriasis Working Group aimed to determine (1) factors affecting psoriasis patients' satisfaction with their therapies, (2) adequacy of two commonly used generic treatment satisfaction instruments in reflecting the psoriasis patients' perspective, and (3) whether a need exists to develop a new treatment satisfaction instrument. METHODS: Patient perspectives on satisfaction with treatment efficacy, safety, convenience, and overall satisfaction were elicited.Stakeholders were presented with information regarding the feasibility and content validity of two generic treatment instruments, the Treatment Satisfaction Questionnaire for Medication (TSQM) and the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). We conducted a nominal group discussion and survey to determine whether stakeholders considered these instruments feasible and adequate to address treatment satisfaction for psoriasis therapies. RESULTS: Forty-five stakeholders participated in the nominal group discussion and survey. 53% of participants voted that the TSQM and SATMED-Q are not adequate and that we should create a new dermatology-specific treatment satisfaction instrument. Patients and other stakeholders also provided feedback on aspects of treatment satisfaction important to them. These include speed of onset and durability of therapeutic effect of a medication, permanence of side effects, and convenience of administering the medication. CONCLUSION: Stakeholders, including patients and providers, determined that generic treatment satisfaction questionnaires are not adequate to evaluate treatment satisfaction in psoriasis patients.

Differences in wage earnings between psoriasis patients on biologics versus those on oral therapies: a population-based study in the United States.

INTRODUCTION: A critical gap exists in determining how various systemic treatments may differentially impact patients' wage earnings. METHODS: We compared personal economic indicators (annual and hourly wages, weekly hours worked, and disability days) between psoriasis patients on biologic therapies versus those on oral medications. Using the 2003-2015 Medical Expenditure Panel Survey, we performed multivariate linear regression analyses to investigate the relationship between personal economic indicators and psoriasis treatment. RESULTS: The number of U.S. respondents with psoriasis who reported using biologic or oral therapies between 2003 and 2015 was 2,638,681 (weighted). The mean annual wage among patients on biologics ($52,141.34 [95% CI 40,976-63,306]) was significantly higher than that of patients on oral therapies ($33,584.87 [95% CI 27,687-39,483]) (p=.019). The mean weekly hours worked among patients on biologics (43.7 h [95% CI 40.01-47.47]) was significantly higher than that of patients on oral therapies (40.6 h [95% CI 39.66-41.59]) (p = .003). Hourly wage and disability days were not significantly different between the two groups. CONCLUSIONS: Psoriasis patients on biologics earned higher annual wages compared to those on oral therapies, and this is primarily due to the increased number of work hours by those on biologic therapies.

Investigator and Patient Global Assessment Measures for Psoriasis Clinical Trials: A Systematic Review on Measurement Properties from the International Dermatology Outcome Measures (IDEOM) Initiative.

BACKGROUND AND OBJECTIVE: The International Dermatology Outcome Measures (IDEOM) has defined a core set of domains to be measured in all psoriasis clinical trials. This set comprises the following domains: skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global, patient global, and treatment satisfaction. The next step is to define how to measure these domains. The objective of this article was to evaluate the quality of available instruments to assess 'investigator global' and 'patient global' domains to identify the most appropriate instruments. METHODS: Reviewers conducted a systematic literature review to retrieve studies on the measurement properties of instruments including either an investigator global assessment or a patient global assessment. Following the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, three independent reviewers rated the quality of each study. We then performed a qualitative synthesis of the evidence. RESULTS: We identified nine investigator global assessments and three patient global assessments, reflecting substantial variability in global assessment instruments. Overall, most measures lacked evidence for content validity and feasibility. The Lattice System-Physician Global Assessment, Product of the Investigator Global Assessment and Body Surface Area, and the professional-Simplified Psoriasis Index had higher levels of evidence for validity, reliability, and/or responsiveness than the 5- and 6-point investigator global assessments. The self-assessment-Simplified Psoriasis Index was the only patient global assessment with evidence for validity, reliability, and responsiveness. CONCLUSIONS: The 5- and 6-point investigator global assessments, which are the most widely used investigator global assessments in registered clinical trials, have less evidence for measurement properties as compared with the Lattice System-Physician Global Assessment, professional-Simplified Psoriasis Index, and the Product of the Investigator Global Assessment and Body Surface Area. However, all instruments lack evidence for content validity and feasibility. Further validation studies of investigator global assessments and patient global assessments are required to recommend the best global measure for psoriasis clinical trials.

Sorafenib Toxicity Mimicking Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome

Sorafenib is an oral multikinase inhibitor approved by the United States Food and Drug Administration for the treatment of advanced hepatocellular and renal cell carcinoma. Cases of sorafenib-induced Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome have been reported in the literature. DRESS syndrome is a potentially fatal, drug-induced hypersensitivity reaction that occurs 2-8 weeks after drug exposure. DRESS syndrome presents with generalized morbilliform eruption, facial edema, eosinophilia, and end-organ damage. We present the first reported case of sorafenib toxicity mimicking DRESS syndrome in a patient with metastatic adrenocortical carcinoma presenting with fever, morbilliform rash, and transaminitis in the absence of eosinophilia three days following initiation of sorafenib therapy. It is critical that clinicians are equipped to accurately diagnose DRESS syndrome due to its high mortality rate and the morbidity associated with prolonged steroid therapy. J Drugs Dermatol. 2019;18(5):468-469.

Economic burden of cutaneous infections in children and adults with atopic dermatitis.

BACKGROUND/OBJECTIVES: Atopic dermatitis (AD) is a chronic, inflammatory disease affecting both children and adults. AD is associated with multiple comorbidities and complications. In particular, AD patients are susceptible to developing cutaneous infections. Studies show that comorbidities have contributed significantly to increased health care utilization and costs in AD. However, evidence regarding the degree to which this increased health care utilization and expenditure in AD is attributable to cutaneous infections is lacking. The aim of this study was to assess the impact of skin infections on health care utilization and expenditures among patients with atopic dermatitis. METHODS: This cross-sectional study examined health care utilization and expenditures for AD patients of all ages with and without skin infections in the United States using the nationally representative 1996-2015 Medical Expenditure Panel Survey (MEPS) data. RESULTS: In this study, a total of 4 825 668 (weighted) patients had a diagnosis of AD (mean age 5.7). Of these, 776 753 patients (16%) experienced skin infections (mean age 4.4). Compared to AD patients without skin infections, those with skin infections had more frequent visits to ambulatory clinics (P = 0.001) and the emergency department (P = 0.011), and increased hospitalization (P = 0.010), after adjustments for demographic and clinical factors. AD patients with skin infections were also given 3.3 more prescriptions (P < 0.0001). AD patients with skin infections incurred significantly greater health care costs, which included an additional $351/patient/year for ambulatory visits (P < 0.0001) and an additional $177/patient/year for prescription medications (P < 0.0001). CONCLUSIONS: Atopic dermatitis patients with cutaneous infections incurred significantly greater health care utilization and expenditures than those without cutaneous infections.

Comparison of physical and mental functioning among moderate-to-severe psoriasis patients on biologic versus oral therapy.

With the extensive variety of available treatments for psoriasis, it is paramount that clinicians understand the differences between therapies. A critical literature gap exists regarding the effects of different systemic therapies on physical and mental functioning in the US psoriasis population. We sought to compare the impact of biologic versus oral therapy on measures of physical and mental functioning among US adults with moderate-to-severe psoriasis. We performed a nationwide, cross-sectional study of 2,431,282 (weighted) (183 non-weighted) US adults with psoriasis on biologic or oral therapy using the 2003-2015 Medical Expenditure Panel Survey (MEPS). Physical and mental functioning were measured with the Short Form-12 version 2 (SF-12v2) Physical Component Summary (PCS) and Mental Component Summary (MCS), respectively. The mean PCS score among patients on biologic therapy was significantly higher than that of patients on oral therapy (46.25 [95% CI 43.91-48.59] versus 42.39 [95% CI 41.05-43.73]; P < 0.01). The mean MCS score among patients on biologic therapy was also significantly higher than that of patients on oral therapy (52.46 [95% CI 50.51-54.41] versus 50.19 [95% CI 49.00-51.38]; P < 0.05). Based on adjusted multiple linear regression, biologic therapy was associated with a significantly greater increase in measures of physical functioning (P < 0.05) and mental functioning (P < 0.001) as compared to oral therapy. In conclusion, clinicians need to account for physical and mental health when making treatment decisions. Biologic therapy is associated with significantly greater increases in measures of physical and mental functioning when compared to oral therapy in the US adult psoriasis population.

Non-pruritic bullous scabies in an immunosuppressed pediatric patient.

Bullous scabies is an uncommon subtype of scabies that frequently mimics other blistering skin diseases. Nocturnal pruritus is a hallmark symptom of bullous scabies. We report an unusual case of bullous scabies presenting in the absence of pruritus in an immunosuppressed pediatric patient. It is critical that clinicians consider the diagnosis of bullous scabies in any patient with bullae, irrespective of pruritus symptoms.

Comparison of mental health outcomes among adults with psoriasis on biologic versus oral therapies: a population-based study.

PURPOSE: We sought to compare the impact of biologic versus oral therapies on mental health outcomes among adult U.S. residents with moderate-to-severe psoriasis. METHODS: We performed a nationwide, cross-sectional study comparing 2,303,534 (weighted) adults with moderate-to-severe psoriasis on biologic versus oral therapies and their associated mental health outcomes using the 2003-2015 Medical Expenditure Panel Survey (MEPS). Mental health outcomes were measured with the Kessler 6 (K6), a validated measure of psychological distress, and Patient Health Questionnaire 2 (PHQ2), a screening tool for depression. RESULTS: The mean K6 score for residents on biologic therapies was significantly lower than that of residents on oral therapies (2.72 [95% CI: 2.27-3.17] versus 3.70 [95% CI: 3.27-4.12]; p < .001). The mean PHQ2 score for residents on biologic therapies was also significantly lower than that of residents on oral therapies (0.540 [95% CI: 0.390-0.690] versus 0.890 [95% CI: 0.749-1.031]; p < .001). Based on adjusted multivariable linear regression models, biologic therapy was associated with significant reductions in K6 (p < .001) and PHQ2 (p = .016) scores compared to oral therapy. CONCLUSIONS: Therapeutic choices for psoriasis impact mental health outcomes. Biologic therapy is associated with reductions in psychological distress and depression as compared to oral therapy in the U.S. adult moderate-to-severe psoriasis population.

A provider global assessment quality measure for clinical practice for inflammatory skin disorders.

In our evolving health care system, dermatologists are increasingly being asked to prove the value of care they provide to patients with severe skin diseases. Current quality measures for inflammatory dermatoses have limited validity and feasibility. Through collaboration and a modified Delphi process, International Dermatology Outcome Measures and the American Academy of Dermatology sought to reach consensus on a valid and feasible provider-assessed global disease severity metric to be incorporated into a quality measure for inflammatory dermatoses. To inform the modified Delphi process, a review of the literature was performed, and data were collected on current provider-assessed global disease severity metrics. After literature review, 36 members of International Dermatology Outcome Measures and the American Academy of Dermatology participated in the modified Delphi process to reach consensus on features of the metric. Psoriasis, atopic dermatitis, and acne achieved overwhelming consensus for inflammatory dermatoses that could be measured in a global disease severity metric. Consensus was also reached on the use of a 5-point ordinal scale with descriptors provided through referenced electronic platforms. Expert development of quality measures incorporating this metric and its inclusion in data collection platforms are critical to enabling dermatologists to prove the value of care provided to patients with severe inflammatory dermatoses.

Are Your Patients Satisfied A Systematic Review of Treatment Satisfaction Measures in Psoriasis.

Treatment satisfaction is paramount to the field of dermatology. Treatment dissatisfaction directly impacts patient outcomes and health care delivery. A critical need exists for standardized, validated treatment satisfaction measures in dermatology. Comprehensive evaluation of the performance of treatment satisfaction instruments used in psoriasis is lacking. We sought to critically appraise the literature on measurement properties of treatment satisfaction instruments used in psoriasis. We performed a systematic review to identify treatment satisfaction instruments used in psoriasis and corresponding studies on their measurement properties. We followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology to inform a best evidence synthesis. Eleven instruments were identified. Six achieved positive content validity ratings, 2 achieved positive reliability and structural validity ratings, and 1 achieved a positive internal consistency rating. The REFlective evaLuation of psoriasis Efficacy of Treatment and Severity (REFLETS) and the Spanish Satisfaction With Treatment of Psoriasis Questionnaire (SSWTPQ) had the highest overall performance. Measurement property data for treatment satisfaction instruments were found to be insufficient in identifying a single best treatment satisfaction instrument for psoriasis. Additional studies are required to better characterize the measurement properties of treatment satisfaction measures and allow for standardized assessments across psoriasis clinical trials and clinical practice.

Patient-Reported Outcome Measures for Pediatric Psoriasis: A Systematic Review and Critical Appraisal from International Dermatology Outcome Measures (IDEOM).

Childhood onset psoriasis has a profound impact on the development and quality of life of pediatric patients. Consequently, validated patient-reported outcome measures (PROMs) for pediatric psoriasis are vital to patient care. We sought to critically appraise the literature on the measurement properties of PROMs used in the pediatric psoriasis population. We performed a 2-stage systematic literature synthesis in MEDLINE (1950-2017) and EMBASE (1947-2017) to identify PROMs and studies evaluating their measurement properties. Analysis of studies followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology to inform a best evidence synthesis. From 1,128 articles, we identified 29 PROMs. Subsequently, we identified 8 studies evaluating the measurement properties of 7 instruments. Among these instruments, the Simplified Psoriasis Index (SPI) achieved a positive rating for criterion validity, the Dutch version of the Children's Dermatology Life Quality Index (CDLQI) achieved a positive rating for hypothesis testing, and the Swedish version of the CDLQI achieved a negative rating for hypothesis testing. All other assessed measurement properties received indeterminate or unknown ratings due to flaws in study design. PROMs are paramount to the management of pediatric psoriasis. This synthesis emphasizes the critical need for additional studies to further describe the measurement properties of PROMs used in pediatric psoriasis and identify validated, standardized measures for use in clinical practice and research.