Efficacy of risankizumab across subgroups in patients with active psoriatic arthritis: a post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 randomized controlled trials.

In the KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) phase 3 trials, risankizumab demonstrated greater efficacy compared with placebo in patients with active psoriatic arthritis (PsA). This post hoc integrated analysis evaluated achieving the following efficacy outcomes at weeks 24 and 52 by baseline demographics and clinical characteristics: ≥20%/50%/70% improvement in American College of Rheumatology response criteria (ACR20/50/70), ≥90% improvement in Psoriasis Area and Severity Index, minimal disease activity status, Low Disease Activity status (Disease Activity in Psoriatic Arthritis), and minimal clinically important difference in pain. Baseline demographics and clinical characteristics were similar between risankizumab (n = 707) and placebo (n = 700) groups. Numerically higher ACR20 response rates at week 24 (primary endpoint) were observed among the risankizumab (46.3%-60.1%) vs. placebo (15.5%-36.2%) cohorts, regardless of subgroups. At week 52, consistent proportions of patients randomized to risankizumab achieved ACR20 (48.6%-75.8%) while those initially randomized to placebo and switched to risankizumab experienced an improvement from week 24 (43.7%-63.9%), regardless of subgroups. Similar trends were observed for other efficacy measures assessing rigorous skin response criteria, composite measures of overall disease activity, and PsA-related symptoms. Risankizumab treatment was efficacious among patients with varying demographic and psoriatic disease characteristics through 52 weeks.

Infectious Disease Screening Prior to Systemic Immunomodulatory Therapy in Hidradenitis Suppurativa: Consensus Guidelines from the Asia-Pacific Hidradenitis Suppurativa Foundation.

BACKGROUND: Current infectious disease screening recommendations for hidradenitis suppurativa (HS) are adopted from recommendations in chronic plaque psoriasis. No HS-specific guidelines for infectious disease screening prior to immunomodulatory therapy have been developed. OBJECTIVES: To establish an expert Delphi consensus of recommendations regarding infectious disease screening prior to systemic immunomodulatory therapy in HS. METHODS: Participants were identified via recent publications in the field and were sent a questionnaire regarding infectious diseases encountered in the setting of HS, and opinions regarding infectious disease screening prior to various systemic immunomodulatory therapies. All questions were informed by a systematic literature review regarding infections exacerbated or precipitated by immunomodulatory therapy. Questionnaire responses were followed by round-table discussion with a core group of 8 experts followed by a final round of questionnaires resulting in achievement of consensus. RESULTS: 44 expert HS physicians from 12 countries on 5 continents participated in the development of the expert consensus recommendations. Consensus recommendations include screening for hepatitis B, hepatitis C and tuberculosis in all individuals with HS prior to therapy. All immunomodulatory therapies (biologic and systemic immunosuppressant therapy) should be preceded by infectious disease screening including patient and location specific considerations for endemic local diseases and high-risk activities and occupations. Clinical assessment has a significant role in determining the need for laboratory screening in the setting of many uncommon or tropical diseases such as leprosy, leishmaniasis and strongyloidiasis. CONCLUSIONS: The presented consensus recommendations are the first specifically developed for pre-treatment infectious disease screening in Hidradenitis Suppurativa.

Outcome Measures for the Evaluation of Treatment Response in Hidradenitis Suppurativa for Clinical Practice: A HiSTORIC Consensus Statement.

Importance: Although several clinician- and patient-reported outcome measures have been developed for trials in hidradenitis suppurativa (HS), there is currently no consensus on which measures are best suited for use in clinical practice. Identifying validated and feasible measures applicable to the practice setting has the potential to optimize treatment strategies and generate generalizable evidence that may inform treatment guidelines. Objective: To establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied. Evidence Review: Clinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice. Findings: Among HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 [85.7%] vs 2 males [11.8%]) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 [71.8%]) and HS Quality of Life score (13 [92.9%]), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 [69.2%]). Conclusions and Relevance: An international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.

Factors associated with treatment satisfaction in patients with hidradenitis suppurativa: results from the Global VOICE project.

BACKGROUND: Nearly half of patients with hidradenitis suppurativa (HS) report dissatisfaction with their treatment. However, factors related to treatment satisfaction have not been explored. OBJECTIVES: To measure associations between treatment satisfaction and clinical and treatment-related characteristics among patients with HS. METHODS: Treatment satisfaction was evaluated utilizing data from a cross-sectional global survey of patients with HS recruited from 27 institutions, mainly HS referral centres, in 14 different countries from October 2017 to July 2018. The primary outcome was patients' self-reported overall satisfaction with their current treatments for HS, rated on a five-point scale from 'very dissatisfied' to 'very satisfied'. RESULTS: The final analysis cohort comprised 1418 patients with HS, most of whom were European (55%, 780 of 1418) or North American (38%, 542 of 1418), and female (85%, 1210 of 1418). Overall, 45% (640 of 1418) of participants were either dissatisfied or very dissatisfied with their current medical treatment. In adjusted analysis, patients primarily treated by a dermatologist for HS had 1·99 [95% confidence interval (CI) 1·62-2·44, P < 0·001] times the odds of being satisfied with current treatment than participants not primarily treated by a dermatologist. Treatment with biologics was associated with higher satisfaction [odds ratio (OR) 2·36, 95% CI 1·74-3·19, P < 0·001] relative to treatment with nonbiologic systemic medications. Factors associated with lower treatment satisfaction included smoking (OR 0·78, 95% CI 0·62-0·99; active vs. never), depression (OR 0·69, 95% CI 0·54-0·87), increasing number of comorbidities (OR 0·88 per comorbidity, 95% CI 0·81-0·96) and increasing flare frequency. CONCLUSIONS: There are several factors that appear to positively influence satisfaction with treatment among patients with HS, including treatment by a dermatologist and treatment with a biologic medication. Factors that appear to lower treatment satisfaction include active smoking, depression, accumulation of comorbid conditions and increasing flare frequency. Awareness of these factors may support partnered decision making with the goal of improving treatment outcomes. What is already known about this topic? Nearly half of patients with hidradenitis suppurativa report dissatisfaction with their treatments. What does this study add? Satisfaction with treatment is increased by receiving care from a dermatologist and treatment with biologics. Satisfaction with treatment is decreased by tobacco smoking, accumulation of comorbid conditions including depression, and higher flare frequency. What are the clinical implications of this work? Awareness of the identified factors associated with poor treatment satisfaction may support partnered decision making and improve treatment outcomes.

BAPoma presenting as an incidental scalp papule: case report, literature review, and screening recommendations for BAP1 tumor predisposition syndrome.

OBJECTIVE: BRCA1-associated protein 1 (BAP1) tumor predisposition syndrome (BAP1-TPDS) is associated with an increased risk for aggressive cancers. BAP1-inactivated melanocytic tumors (BIMTs) are observed in 75% of BAP1-TPDS, often presenting as early as the second decade of life. These lesions may serve as a predictive marker to identify patients who carry germline BAP1 mutations and thus are at higher risk of developing associated cancers. Early diagnosis for these malignancies is crucial for curative treatment. METHODS: We report a patient who presented with an incidental scalp papule for which biopsy was consistent with a BIMT. A review of literature was conducted by accessing the PubMed database to delineate present knowledge of BIMTs, assess recommendations for screening of germline BAP1 mutations, and evaluate cancer surveillance strategies for BAP1-TPDS associated cancers. RESULTS: Consensus in literature indicates that genetic evaluation should be encouraged in patients presenting with multiple BIMTs or a new BIMT with significant family history of BAP1-TPDS related cancers. If positive for a germline BAP1 mutation, cancer surveillance should be recommended for early diagnosis and timely intervention. CONCLUSIONS: Further workup should be encouraged in patients who meet the proposed screening criteria for germline BAP1 mutations. Patients could benefit from cancer surveillance for earlier diagnosis, management, and improved outcomes.

Interleukin-17 and Interleukin-23: A Narrative Review of Mechanisms of Action in Psoriasis and Associated Comorbidities.

Psoriasis is an immune-mediated inflammatory skin disease associated with numerous inflammatory comorbidities, including increased cardiovascular risk. The interleukin (IL)-23/IL-17 axis plays a central role in the immunopathogenesis of psoriasis and related comorbidities by acting to stimulate keratinocyte hyperproliferation and feed-forwarding circuits of perpetual T cell-mediated inflammation. IL-17 plays an important role in the downstream portion of the psoriatic inflammatory cascade. This review discusses the distinct mechanisms of action of IL-17 and IL-23 in the immunopathogenesis of psoriasis and related comorbidities plus the significant therapeutic benefits of selectively inhibiting these cytokines in patients with moderate to severe plaque psoriasis.

Ixekizumab in the treatment of moderate-to-severe plaque psoriasis: Patient adherence, satisfaction, and preferences.

Ixekizumab is a humanized monoclonal antibody that exhibits its immunomodulatory effects by binding to interleukin 17A (IL-17A), a proinflammatory cytokine. It was approved for the treatment of plaque psoriasis by the Food and Drug Administration in 2016. Ixekizumab has demonstrated superiority in clinical trials against etanercept, with no significant difference in the side effect profile. The chronicity of psoriasis requires continual treatment to achieve disease clearance. Many factors may affect adherence to treatment including patient satisfaction, patient preferences, medication cost, and medication side effects. Limited data on patient adherence, satisfaction, and preference exists in formal literature. Often, surrogate measures must be used to extrapolate information regarding these measures. In this narrative review, we describe patient adherence, satisfaction, and preferences via both direct and surrogate measures as they relate to ixekizumab treatment for moderate-to-severe plaque psoriasis.

Hidradenitis suppurativa for the nondermatology clinician.

Hidradenitis suppurativa (HS) is a chronic, recurrent inflammatory skin condition resulting in the formation of nodules, sinus tracts, and abscesses typically in intertriginous regions. HS management is often difficult and involves a multimodal approach, evaluating the benefit of both medical and surgical treatment options, along with treating associated pain and medical comorbidities that present concomitantly with the disease. In this article, we synthesize for the nondermatology clinician the evidence for various HS treatments, along with the diagnostic and therapeutic guidelines for HS published by the British Association of Dermatologists, US and Canadian HS Foundations, HS ALLIANCE, Canadian Dermatology Association, and Brazilian Society of Dermatology. Management of HS requires an individualized, patient-centered approach due to the lack of rigorous evidence for many interventions.

Punctate porokeratosis-pruritic and hyperkeratotic papules on the palms and feet.

Porokeratosis is an uncommon cutaneous condition with multiple clinical variants that is defined by round patches with a raised, fine scaling border. Punctate porokeratosis is a rare variant of porokeratosis that is characterized by elevated, seed-like lesions of the palms and soles. While variants of porokeratosis may be associated with an increased risk of squamous cell carcinoma within the lesion, punctate porokeratosis does not increase the risk of squamous cell carcinoma. However, punctate porokeratosis may mimic other dermatoses affecting the palms and soles including spiny keratoderma, arsenical keratosis, and nevus comedonicus. Distinguishing punctate porokeratosis and spiny keratoderma is important, as spiny keratoderma may be associated with underlying solid organ malignancy or chronic medical conditions, including chronic kidney disease. Here, we present a case of punctate porokeratosis mimicking spiny keratoderma in order to distinguish the two conditions and aid in their differentiation from other dermatologic conditions involving the palms and soles.

Analysis of Characteristics and Trends in Treatment Response of Hidradenitis Suppurativa Patients: A Southern US Cohort Study.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that has a substantial impact on patients' quality of life. As the exact pathogenesis remains unclear, treatment is complex and not yet standardized. OBJECTIVES: The aim of this study was to describe patient characteristics and to broadly examine trends in treatment response of various therapeutic strategies in patients with HS in a single academic referral center in the southern USA. METHODS: A retrospective chart review was conducted of a cohort of HS patients seen in a faculty general dermatology practice with academic affiliation to Baylor University Medical Center in Dallas, TX, between February 2015 and February 2018. Patient demographics, clinical features, prescribed treatments, and response to treatment were analyzed using the Pearson χ2 test or Fisher exact test, and by the Mann-Whitney U test for categorical and continuous variables, respectively. RESULTS: A total of 149 patients (113 females, 36 males) were included. Hurley stages I, II, and III were diagnosed in 29.6, 36.5, and 33.9% of patients, respectively. 44.2% of patients had a positive family history of HS, 39.5% of patients were current or former smokers, and 52.8% reported alcohol use. 80.9% of patients were overweight or obese (BMI ≥25), compared to 68.5% in Texas in 2016 (p = 0.0012). The most frequently prescribed treatments were oral antibiotic therapy (83.9%), topical antibiotic therapy (74.5%), metabolic medications such as metformin/zinc (67.1%), intralesional Kenalog (63.1%), and biologic therapies (tumor necrosis factor-α inhibitors; TNF-α inhibitors; 49%). In examining the response rate, patients with disease localized to the buttocks had significantly higher response rates (60.4 vs. 25%, p = 0.043) and approached statistical significance in responders versus nonresponders in treatment with biologics (p = 0.0632) when compared against all other treatments. CONCLUSIONS: HS is a complex inflammatory skin condition associated with obesity and smoking. In this cohort, the most frequently prescribed therapies were oral and topical antibiotics. However, the use of biologic agents (TNF-α inhibitors) appears to be associated with the most significant treatment response. KEY POINTS: This is the first study to evaluate trends in treatment response of various therapeutic strategies in HS patients at an academic referral center in Dallas, TX, a unique geographic region of the southern USA. Biologic therapy (TNF-α inhibitor) appears to be associated with the most significant treatment response.

Evaluating patients' unmet needs in hidradenitis suppurativa: Results from the Global Survey Of Impact and Healthcare Needs (VOICE) Project.

BACKGROUND: A needs assessment for patients with hidradenitis suppurativa (HS) will support advancements in multidisciplinary care, treatment, research, advocacy, and philanthropy. OBJECTIVE: To evaluate unmet needs from the perspective of HS patients. METHODS: Prospective multinational survey of patients between October 2017 and July 2018. RESULTS: Before receiving a formal HS diagnosis, 63.7% (n = 827) of patients visited a physician ≥5 times. Mean delay in diagnosis was 10.2 ± 8.9 years. Patients experienced flare daily, weekly, or monthly in 23.0%, 29.8%, and 31.1%, respectively. Most (61.4% [n = 798]) rated recent HS-related pain as moderate or higher, and 4.5% described recent pain to be the worst possible. Access to dermatology was rated as difficult by 37.0% (n = 481). Patients reported visiting the emergency department and hospital ≥5 times for symptoms in 18.3% and 12.5%, respectively. An extreme impact on life was reported by 43.3% (n = 563), and 14.5% were disabled due to disease. Patients reported a high frequency of comorbidities, most commonly mood disorders. Patients were dissatisfied with medical or procedural treatments in 45.9% and 34.6%, respectively. LIMITATIONS: Data were self-reported. Patients with more severe disease may have been selected. CONCLUSION: HS patients have identified several critical unmet needs that will require stakeholder collaboration to meaningfully address.

Basal cell carcinoma within nevus sebaceous of the trunk.

We report the first case of an 82-year-old woman with five basal cell carcinomas within a large nevus sebaceous of the trunk. Nevus sebaceous of Jadassohn is a congenital cutaneous hamartoma affecting 0.3% of newborns. Clinical diagnosis is based on its distinctive hairless, orange-brown appearance. Up to 51% of nevus sebaceous may exhibit secondary neoplasia, and basal cell carcinoma is thought to occur in approximately 1% of lesions. Our patient presented with an asymptomatic, pigmented verrucous plaque on the upper right back that had been present since birth. Histopathology of concerning papules within the nevus sebaceous were consistent with five basal cell carcinomas and two follicular adnexal neoplasms. The patient was treated with local excisions, topical imiquimod, and close monitoring.

Milia within resolving bullous pemphigoid lesions.

Bullous pemphigoid (BP) is a blistering dermatosis characterized by an autoimmune response to two hemidesmosomal proteins, BP180 and BP230. We describe a case of an 80-year-old man diagnosed with BP by clinical features, histopathology, and immunosorbent assay who developed milia within resolving BP lesions. Milia formation during recovery is common in cases of mucous membrane pemphigoid and epidermolysis bullosa acquisita but has rarely been reported in cases of BP.

Diet in hidradenitis suppurativa: a review of published and lay literature.

Hidradenitis suppurativa (HS) is a chronic, recurring, inflammatory skin disorder resulting in skin abscesses and sinus tracts of the skin folds. Hidradenitis suppurativa remains a disease with limited treatment options. Management of disease activity with dietary modification has been of considerable interest to the HS patient community. Limited evidence exists to support dietary changes for treatment of HS. Strategies such as eliminating dairy products, limiting simple carbohydrate and sugar intake, and avoiding nightshades (Solanaceae) and foods containing brewer's yeast have been reported to be helpful in some patients. Several supplements have also been touted as beneficial. Herein, we review the existing dietary recommendations in both peer-reviewed and lay literature in an attempt to consolidate and evaluate existing information, while stimulating further inquiry into the role of diet in HS. Although dietary modifications are often of considerable interest to HS patients, there is a paucity of data regarding diet as it relates to HS. It is unclear whether diet may prove to be of value in limiting the severity of HS. Further research is needed to determine the potential benefits of these dietary changes.