Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials.

BACKGROUND: Patients with hidradenitis suppurativa have substantial unmet clinical needs and scarce therapeutic options. We aimed to assess the efficacy and safety of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients with moderate-to-severe hidradenitis suppurativa. METHODS: BE HEARD I and II were two identically designed, 48-week randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Patients aged 18 years or older with moderate-to-severe hidradenitis suppurativa were randomly assigned 2:2:2:1 using interactive response technology (stratified by worst Hurley Stage at baseline and baseline systemic antibiotic use) to receive subcutaneous bimekizumab 320 mg every 2 weeks; bimekizumab 320 mg every 2 weeks to week 16, then every 4 weeks to week 48; bimekizumab 320 mg every 4 weeks to week 48; or placebo to week 16, then bimekizumab 320 mg every 2 weeks. The primary outcome was an hidradenitis suppurativa clinical response of at least 50%, defined as a reduction in total abscess and inflammatory nodule count of at least 50% from baseline with no increase from baseline in abscess or draining tunnel count (HiSCR50) at week 16. Efficacy analyses included all randomly assigned study patients (intention-to-treat population). Safety analyses included all patients who received at least one full or partial dose of study treatment in the safety set, and of bimekizumab in the active-medication set. These trials are registered at ClinicalTrials.gov, NCT04242446 and NCT04242498, and both are completed. FINDINGS: Patients for BE HEARD I were recruited from Feb 19, 2020, to Oct 27, 2021, and 505 patients were enrolled and randomly assigned. Patients for BE HEARD II were recruited from March 2, 2020, to July 28, 2021, and 509 patients were enrolled and randomly assigned. The primary outcome at week 16 was met in the group who received bimekizumab every 2 weeks using modified non-responder imputation; higher responder rates were observed with bimekizumab versus placebo in both trials: 138 (48%) of 289 patients versus 21 (29%) of 72 patients in BE HEARD I (odds ratio [OR] 2·23 [97·5% CI 1·16-4·31]; p=0·0060) and 151 (52%) of 291 patients versus 24 (32%) of 74 patients in BE HEARD II (2·29 [1·22-4·29]; p=0·0032). In BE HEARD II, HiSCR50 was also met in the group who were administered bimekizumab every 4 weeks (77 [54%] of 144 vs 24 [32%] of 74 with placebo; 2·42 [1·22-4·80]; p=0·0038). Responses were maintained or increased to week 48. Serious treatment-emergent adverse events were reported in 40 (8%) patients in BE HEARD I and in 24 (5%) patients in BE HEARD II treated with bimekizumab over 48 weeks. The most frequently reported treatment-emergent adverse events to week 48 were hidradenitis in both trials, in addition to coronavirus infection and diarrhoea in BE HEARD I, and oral candidiasis and headache in BE HEARD II. One death was reported across the two trials, and was due to congestive heart failure in a patient with substantial cardiovascular history treated with bimekizumab every 2 weeks in BE HEARD I (considered unrelated to bimekizumab treatment by the investigator). No new safety signals were observed. INTERPRETATION: Bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses that were maintained up to 48 weeks. Data from these two trials support the use of bimekizumab for the treatment of patients with moderate-to-severe hidradenitis suppurativa. FUNDING: UCB Pharma.

Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study.

BACKGROUND: Janus kinase 1 inhibition may alleviate hidradenitis suppurativa (HS)-associated inflammation and improve symptoms. OBJECTIVE: To assess efficacy and safety of povorcitinib (selective oral Janus kinase 1 inhibitor) in HS. METHODS: This placebo-controlled phase 2 study randomized patients with HS 1:1:1:1 to receive povorcitinib 15, 45, or 75 mg or placebo for 16 weeks. Primary and key secondary end points were mean change from baseline in abscess and inflammatory nodule count and percentage of patients achieving HS Clinical Response at week 16. RESULTS: Of 209 patients randomized (15 mg, n = 52; 45 mg, n = 52; 75 mg, n = 53; placebo, n = 52), 83.3% completed the 16-week treatment. At week 16, povorcitinib significantly reduced abscess and inflammatory nodule count from baseline (least squares mean [SE] change: 15 mg, -5.2 [0.9], P = .0277; 45 mg, -6.9 [0.9], P = .0006; 75 mg, -6.3 [0.9], P = .0021) versus placebo (-2.5 [0.9]). More povorcitinib-treated patients achieved HS Clinical Response at week 16 (15 mg, 48.1%, P = .0445; 45 mg, 44.2%, P = .0998; 75 mg, 45.3%, P = .0829) versus placebo (28.8%). A total of 60.0% and 65.4% of povorcitinib- and placebo-treated patients had adverse events. LIMITATIONS: Baseline lesion counts were mildly imbalanced between groups. CONCLUSION: Povorcitinib demonstrated efficacy in HS, with no evidence of increased incidence of adverse events among doses.

Electronic Patient-Reported Outcomes in Hidradenitis Suppurativa: Content Validity and Usability of the Electronic Hidradenitis Suppurativa Symptom Daily Diary, Hidradenitis Suppurativa Symptom Questionnaire, and Hidradenitis Suppurativa Quality of Life Questionnaire.

BACKGROUND: Hidradenitis suppurativa (HS), a chronic skin condition that causes pain and physical dysfunction, can impact significantly on quality of life. Disease-specific tools have been designed to assess the impact of HS on patients, including the HS Symptom Daily Diary (HSSDD), the HS Symptom Questionnaire (HSSQ), and the HS Quality of Life (HiSQOL©) questionnaire, which have been developed into electronic instruments (eHSSDD, eHSSQ, and eHiSQOL©). OBJECTIVES: The objective of this study was to establish the content validity of the electronic version of the HSSDD and HSSQ, and the acceptability and usability of the HSSDD, HSSQ, and HiSQOL©, using concept elicitation and cognitive debriefing interviews. METHODS: This was a non-interventional qualitative video interview study involving participants aged ≥18 years with moderate to severe HS recruited from a single clinical site in the USA. Interviews gathered feedback on participants' symptom experience, followed by training and completion of the eHSSDD, eHSSQ, and eHiSQOL© questionnaires on electronic handheld devices. Participants were then interviewed on the content of the eHSSDD and eHSSQ and the acceptability and usability of all three instruments. Interviews were transcribed and qualitatively analysed. RESULTS: Twenty participants with moderate to severe HS (median age: 41.5 [range: 20.0-64.0]; n = 16/20 female) were included. All participants found the eHSSDD, eHSSQ, and eHiSQOL© instructions clear and described the instruments as "easy", "simple" and "self-explanatory". Overall understanding of individual items within the eHSSDD and eHSSQ was high; however, 6/20 participants had difficulty in understanding the average skin pain item in the eHSSDD. All participants were able to accurately recall their symptoms within the recall periods of the eHSSDD and eHSSQ, although 4/20 participants found the 24-h recall period of the eHSSDD limiting. Completion time was quick across all instruments, and usability was high, with the majority of participants reporting no difficulty in completing questionnaires on electronic devices. CONCLUSION: The concepts covered in the eHSSDD and eHSSQ are relevant and important to patients, supporting their content validity. The findings also provide evidence of acceptability and usability of the eHSSDD, eHSSQ, and eHiSQOL©. A limitation was that all participants were recruited from a single site, which may have introduced selection bias and thus limited the generalisability of results.

Discrepancies in hidradenitis suppurativa lesion characterization by providers and patients.

BACKGROUND: The hidradenitis suppurativa (HS) clinical response (HiSCR) has come under scrutiny as several HS clinical trials failed to meet primary endpoints with high placebo responses. This may be due to limitations of the tool and raters' ability to accurately characterize and count lesions, rather than lack of efficacy of the studied drug. Due to HS lesion complexity and potential differences in rater training, it was hypothesized that there would be discrepancies in how providers characterize and count lesions for HS clinical trials. OBJECTIVE: To evaluate how HS providers and patients name and count HS lesions and to identify discrepancies among providers to initiate the development of consensus-driven guidance for HS rater training. METHODS: An online survey was distributed to the members of HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC). Respondents were asked to classify lesion images composed of multiple and different morphology types and answer questions regarding inclusion of associated dermatological conditions. RESULTS: Forty-seven HISTORIC members responded (29 providers; 18 patients). There was variability in how respondents classified HS lesions. Of 12 questions containing images, four had ≥50% of respondents choosing the same answer. With an image of a lesion composed of different morphologies, 45% of providers counted it as a single lesion and 45% counted it as multiple distinct lesions. With an image of multiple interconnected draining tunnels, 7% of providers classified it as a single draining tunnel while 79% categorized it as multiple draining tunnels with the number estimated by visual inspection. There was also variability in deciding whether lesions occurring in associated conditions should be considered separately or included in HS lesion counts. Patient responses were also variable. CONCLUSIONS: The result of the current study reaffirms the gap in how providers characterize and count HS lesions for clinical trials and the need to develop consensus-driven rater training related to HS outcome measures.

Keratinocytes and immune cells in the epidermis are key drivers of inflammation in hidradenitis suppurativa providing a rationale for novel topical therapies.

BACKGROUND: Hidradenitis suppurativa (HS) is a debilitating inflammatory skin disease characterized by painful nodules, drainage and scarring in skin folds. Injectable adalimumab is the only drug approved by the US Food and Drug Administration for the treatment of HS. Although systemic Janus kinase (JAK) inhibitors show promise, serious side-effects have been reported. There are no highly effective topical treatments for HS; furthermore, the contribution of epidermal keratinocytes to the intense inflammation has largely been unexplored. OBJECTIVES: We investigated the role of keratinocytes and epidermal immune cells in HS inflammation at all Hurley stages of disease severity. We aimed to determine whether ruxolitinib can mitigate inflammation from keratinocytes and to develop a better understanding of how topical therapeutics might benefit patients with HS. METHODS: We used skin samples from 87 patients with HS (Hurley stages I-III) and 39 healthy controls to compare keratinocyte- and immune cell-driven epidermal inflammation, in addition to the response of lesional HS keratinocytes to treatment with interferon (IFN)-γ and ruxolitinib. We used haematoxylin and eosin staining, immunohistochemistry, immunoblotting and quantitative reverse-transcription polymerase chain reaction assessments in whole skin, isolated epidermis, and cultured keratinocytes from healthy controls and both nonlesional and lesional HS skin to identify and define epidermal and keratinocyte-mediated inflammation in HS and how this may be targeted by therapeutics. RESULTS: HS lesional keratinocytes autonomously secreted high levels of chemokines, such as CCL2, CCL3 and CXCL3, which recruited neutrophils, CD8 T cells, and natural killer cells to the epidermis. Keratinocytes were the dominant source of tumour necrosis factor-α and interleukin (IL)-6 in HS lesions with little to no contribution from underlying dermal immune cells. In the presence of IFN-γ, which is dependent on immune cell infiltrate in vivo, keratinocytes expressed increased levels of additional cytokines including IL-1ß, IL-12, IL-23 and IL-36γ. The JAK inhibitor ruxolitinib mitigated the expression of inflammatory cytokines and chemokines in HS lesional keratinocytes, thus providing a rationale for future study as a topical treatment for HS. CONCLUSIONS: This study demonstrates that keratinocytes actively recruit immune cells to HS epidermis and interactions between these cells drive a broad inflammatory profile in HS epidermis. Targeting epidermal inflammation in HS with novel topical formulations may be highly efficacious with reduced systemic side-effects.

Positive Predictive Value of Diagnosis Codes for Hidradenitis Suppurativa and Cutaneous Abscess.

BACKGROUND: Requisite to the application of clinical databases for observational research in hidradenitis suppurativa (HS) is the identification of an accurate case cohort. There is limited information on the validity of using diagnosis codes to identify HS and cutaneous abscess (CA) case cohorts. OBJECTIVES: The objective of the study was to assess the validity in utilizing diagnosis codes to establish the HS and CA cohorts from an integrated health system clinical database. METHODS: In this retrospective study, we evaluated a case-finding algorithm for HS which included the presence of at least one diagnosis code for HS and no diagnosis codes for CA of the axilla, groin, perineum, or buttock at any time. We evaluated a case-finding algorithm for CA which included the presence of at least one diagnosis code for abscess in the axilla, groin, perineum, or buttock and no codes for HS at any time. Medical records for a random sample of 100 patients meeting algorithm criteria were reviewed and adjudicated by dermatologists for accuracy of diagnosis. The positive predictive values (PPVs) of the ICD code-based case definitions were calculated, using the dermatologist's chart-based adjudication as the reference standard. RESULTS: Among 100 HS patients, median age (interquartile range) in the HS cohort was 33 (24.75, 43.25) years. HS patients were predominantly female (82%) and white (70%). Median age among 100 CA patients was 31.5 (95% CI 6.75, 47.25) years. The majority of CA patients were female (56%) and white (69%). The PPVs of the ICD-based case-finding algorithms for HS and CA were 88% (95% CI 81.6-94.4%) and 75.0% (95% CI 66.5-83.5%), respectively. CONCLUSION: The case-finding algorithms employing at least one diagnosis code for HS and CA of the axilla, groin, perineum, or buttock, with the exclusion of the other's diagnosis codes, has good to strong PPV and may provide balance in achieving accuracy and adequate power for cohorts identified within clinical databases.

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.

Damage in hidradenitis suppurativa: a narrative review emphasizing the need for a novel outcome measure.

Cutaneous damage caused by hidradenitis suppurativa (HS) is an important contributor to disease burden, independent of active lesions. Outcome measures used to specifically assess damage are becoming commonplace in the assessment of inflammatory diseases. However, no standardized method for assessing HS damage currently exists. The purpose of this study was to review outcome measures in HS that include constructs of both active disease and damage, review damage-specific instruments used in other inflammatory and destructive diseases, and review instruments used to assess scars of various aetiologies. This ultimately provides insight into how attributes of different tools can be applied to develop an outcome measure specific to HS damage. What is already known about this topic? Hidradenitis suppurativa (HS) is a chronic, relapsing, inflammatory skin condition, which causes consequent cutaneous damage and scarring. Damage caused by HS is highly prevalent and an important contributor to its morbidity. Damage is an important component of inflammatory diseases that has proven its utility in a number of outcome measures; however, no standardized method for assessing HS damage currently exists. What does this study add? This narrative review assesses outcome measures used to measure damage in other inflammatory and destructive diseases. Instruments used to assess damage in other diseases can provide a starting point for the development of a damage outcome measure for HS.

Development and initial validation of the HS-IGA: a novel hidradenitis suppurativa-specific investigator global assessment for use in interventional trials.

BACKGROUND: Few validated instruments exist for use in hidradenitis suppurativa (HS) trials. OBJECTIVES: To develop a novel HS Investigator Global Assessment (HS-IGA) and to validate its psychometric properties. METHODS: Development of HS-IGA involved discussion among stakeholders, including patients, within HISTORIC. Data from replicate phase III randomized controlled trials evaluating HS treatment were utilized. Multivariate models identified lesion type and body region as variables of importance. Classification and regression trees for ordinal responses were built. Validation included assessment of test-retest reliability, predictive validity, responsiveness and clinical meaningfulness. RESULTS: There were 3024 unique measurements available in PIONEER I. Mean and median lesion counts by region were largely <10 and were highest in axillary and inguinal regions. The mean and median number of regions involved were ≤ 3 for individual lesions and combinations. Regardless of lesion type, axillary and inguinal regions most influenced the HS-IGA score. Accordingly, regions were combined into a six-point IGA based on the maximum lesion number in either upper or lower body regions with a score of 0 (0-1 lesions), 1 (2-5), 2 (6-10), 3 (11-15), 4 (16-20) and 5 (≥ 20 lesions). The intraclass correlation coefficient for test-retest reliability was 0·91 (95% confidence interval 0·87-0·94). Spearman's rank order correlations (SROCs) with HS-PGA and Hidradenitis Suppurativa Clinical Response (HiSCR) were 0·73 and 0·51, respectively (P < 0·001 for both comparisons). SROCs with Dermatology Life Quality Index (DLQI), pain numerical rating scale and HS-QoL were 0·42, 0·34 and -0·25, respectively (P < 0·001 for all comparisons). HS-IGA was responsive at weeks 12 and 36. Predictive convergent validity was very good with HS-PGA (area under the curve = 0·89) and with HiSCR (area under the curve = 0·82). Predictive divergent validity was low with DLQI and HS-QoL. CONCLUSIONS: HS-IGA has moderate-to-strong psychometric properties and is simple to calculate.

Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase II studies.

BACKGROUND: Janus kinase (JAK)-mediated cytokine signalling contributes to local and systemic inflammation in hidradenitis suppurativa (HS). OBJECTIVES: To describe the safety and efficacy results from two multicentre phase II trials of the JAK1 inhibitor INCB054707 in patients with moderate-to-severe HS. METHODS: Patients received open-label INCB054707 15 mg once daily (QD; Study 1) or were randomized to INCB054707 30, 60 or 90 mg QD or placebo (3 : 1 within each cohort; Study 2) for 8 weeks. Eligible patients were aged 18-75 years and had moderate-to-severe HS (Hurley stage II/III disease), lesions present in at least two anatomical locations, and a total abscess and inflammatory nodule count ≥ 3. The primary endpoint for both studies was safety and tolerability. Secondary endpoints included HS Clinical Response (HiSCR) and other efficacy measures. RESULTS: Ten patients were enrolled in Study 1 (15 mg INCB054707) and 35 in Study 2 (INCB054707: 30 mg, n = 9; 60 mg, n = 9; 90 mg, n = 8; placebo, n = 9). Overall, 70% of patients in Study 1 and 81% of patients receiving INCB054707 in Study 2 experienced at least one treatment-emergent adverse event; 30% and 42% of patients, respectively, had at least one treatment-related adverse event. Among the evaluable patients, three (43%) in Study 1 and 17 (65% overall: 30 mg, 56%; 60 mg, 56%; 90 mg, 88%) receiving INCB054707 vs. 4 patients (57%) receiving placebo in Study 2 achieved HiSCR at week 8. CONCLUSIONS: INCB054707 was well tolerated, with responses observed in patients with moderate-to-severe HS. The safety and efficacy findings from these studies demonstrate proof of concept for JAK1 inhibition in HS. The studies are registered on ClinicalTrials.gov (NCT03569371 and NCT03607487).

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.

Outcomes of pregnancy and childbirth in women with hidradenitis suppurativa.

BACKGROUND: Many women affected by hidradenitis suppurativa (HS) are of childbearing age. To date, the literature is limited on pregnancy-related outcomes for women with HS. OBJECTIVE: To investigate maternal and obstetric outcomes and treatment utilization among women with HS. METHODS: This retrospective analysis used the IBM MarketScan Commercial Claims Database. Pregnant women with HS (n = 998) and 5:1 age-matched pregnant women without HS (n = 5065) were identified and information on claims related to diagnoses, procedures, and medications were analyzed. RESULTS: Compared to women without HS, pregnant women with HS had significantly lower odds of having a live birth (odds ratio [OR], 0.45; 95% confidence interval [CI], 0.39-0.51) and significantly higher odds of having elective terminations (OR, 2.51; 95% CI, 2.13-2.96), gestational hypertension (OR, 1.44; 95% CI, 1.12-1.84), and cesarean deliveries (OR, 1.28; 95% CI, 1.06-1.55), and of receiving HS designated treatment during pregnancy (OR, 4.41; 95% CI, 3.56-5.46). LIMITATIONS: Retrospective and convenience sampling and absence of clinical information to correlate HS severity and outcomes. CONCLUSION: Pregnant women with HS have an increased probability of select complicated maternal and obstetric outcomes. Women planning for pregnancy or who are currently pregnant may benefit from coordinated care by dermatologists and obstetric providers.

Comorbidity screening in hidradenitis suppurativa: Evidence-based recommendations from the US and Canadian Hidradenitis Suppurativa Foundations.

BACKGROUND: Hidradenitis suppurativa (HS) is associated with comorbidities that contribute to poor health, impaired life quality, and mortality risk. OBJECTIVE: To provide evidence-based screening recommendations for comorbidities linked to HS. METHODS: Systematic reviews were performed to summarize evidence on the prevalence and incidence of 30 comorbidities in patients with HS relative to the general population. The screening recommendation for each comorbidity was informed by the consistency and quality of existing studies, disease prevalence, and magnitude of association, as well as benefits, harms, and feasibility of screening. The level of evidence and strength of corresponding screening recommendation were graded by using the Strength of Recommendation Taxonomy (SORT) criteria. RESULTS: Screening is recommended for the following comorbidities: acne, dissecting cellulitis of the scalp, pilonidal disease, pyoderma gangrenosum, depression, generalized anxiety disorder, suicide, smoking, substance use disorder, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction. It is also recommended to screen patients with Down syndrome for HS. The decision to screen for specific comorbidities may vary with patient risk factors. The role of the dermatologist in screening varies according to comorbidity. LIMITATIONS: Screening recommendations represent one component of a comprehensive care strategy. CONCLUSIONS: Dermatologists should support screening efforts to identify comorbid conditions in HS.

Efficacy of pediatric dermatology Extension for Community Healthcare Outcomes (ECHO) sessions on augmenting primary care providers' confidence and abilities.

Due to the shortage of pediatric dermatologists and the abundance of skin disorders presenting in childhood, general pediatricians shoulder the management of many pediatric dermatologic disorders and would benefit from additional dermatology-specific training. To address this educational gap, general pediatricians were enrolled in a pediatric dermatology-specific Project Extension for Community Healthcare Outcomes (ECHO) program and surveyed to assess the efficacy of the program in increasing providers' ability and confidence in managing pediatric dermatologic conditions. Providers unanimously reported increased confidence and abilities in assessment and management of pediatric dermatologic conditions. Pediatric dermatology Project ECHO demonstrated high efficacy in improving general practitioners' comfort and knowledge on dermatology-specific topics and may be used as an education model for enhancing primary care providers' knowledge and management of common disorders.

Hidradenitis Suppurativa: Diagnosis and Management in the Emergency Department.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic immune-mediated inflammatory skin disease characterized by abscesses and inflammatory nodules, and occasionally tunnels and scars, in the axillae, groin, and inframammary areas. OBJECTIVE: HS can be challenging to diagnose because it mimics localized soft-tissue infection. The process of differentiating HS from soft-tissue infection is discussed. Patients with HS frequently visit emergency departments (EDs) for acute management of pain and drainage from HS lesions. This review updates emergency and urgent care physicians on how to educate and initiate treatment for patients with HS, and to coordinate care with dermatologists and other physicians early in their disease course. DISCUSSION: Recent updates on the epidemiology, diagnosis, and management of HS are reviewed. CONCLUSIONS: Practice variations between how care for HS is provided in the ED setting and what HS treatment guidelines recommend are identified.

Development and Validation of HSCAPS-1: A Clinical Decision Support Tool for Diagnosis of Hidradenitis Suppurativa over Cutaneous Abscess.

BACKGROUND: A clinical decision support tool may improve recognition of hidradenitis suppurativa (HS) and reduce diagnosis delay. OBJECTIVE: To develop and initially validate a clinical decision support to predict diagnosis of HS and distinguish it from cutaneous abscess of the axilla, groin, perineum, and buttock. METHODS: This was a retrospective, cross-sectional analysis between January 2012 and June 2017 (development set) and July 2017 and March 2019 (validation set). We used an electronic records sample of 56 million patients from the Explorys database to identify patients with an ambulatory visit associated with either HS or cutaneous of the axilla, groin, perineum, and buttock. The outcome was predicted probability of HS diagnosis. RESULTS: Development set included 7,974 patients with mean age of 41.4 years, who were predominantly female (66%) and white (62%). Validation set included 1,560 patients with similar demographic composition. Factors which were stronger independent predictors of HS included female sex (OR 2.17 [95% CI 1.96-2.40]); African American race (1.28 [95% CI 1.15-1.44]); increasing BMI (OR 1.05 [95% CI 1.05-1.06)]; history of acne (OR 3.46 [95% CI 2.83-4.23]); Down syndrome (OR 5.35 [95% CI 2.03-14.12]); and prescription for at least 7 opioid medications in the past year (OR 1.05 [95% CI 0.83-1.33]). Up to age 45 years, increasing age was a stronger predictor of HS diagnosis. The simplified model showed good discrimination (c-statistic 0.746 [SE 0.013]) and moderate calibration (calibration intercept -0.260 [SE 0.055]; calibration slope 1.142 [SE 0.076]). CONCLUSION: This clinical decision support tool shows good performance in predicting diagnosis of HS and distinguishing it from cutaneous abscess that involves the axilla, groin, perineum, and buttock.

Proceedings Report of the Fifth Symposium on Hidradenitis Suppurativa Advances (SHSA) 2020.

The Symposium on Hidradenitis Suppurativa Advances (SHSA) is a joint meeting of the United States Hidradenitis Suppurativa Foundation (HSF) and the Canadian Hidradenitis Suppurativa Foundation (CHSF). This annual cross-disciplinary meeting brings together experts from around the world in an opportunity to discuss the most recent advances in the study of hidradenitis suppurativa (HS). The fifth annual meeting was held virtually on 9-11 October 2020. A record 347 attendees, including 79 people with HS, from 20 different countries attended. Key take-home points included: Clinicians can optimize each visit by listening, provide education, and discuss treatments; a patient decision aid for HS (HS-PDA) is a freely available tool (www.informed-decisions.org); COVID-19 severity in HS patients was not different for patients treated with/without a biologic; comorbidity screening recommendations will be published soon; neutrophil extracellular traps (NETs) may play a role in HS; memory B cells, T helper 1 cytokines, and interleukin 1 signaling contributes to HS pathogenesis and are targets for new therapies; novel therapies are showing promise including a new JAK1 inhibitor (INCB054707) and brodalumab; and HS-specific outcome measures have emerged to better monitor disease severity, flare, and progression including a patient reported measure (HiSQOL) and an HS-specific investigator global assessment. J Drugs Dermatol. 2021;20(8):868-873. doi:10.36849/JDD.5836.

Advances and Considerations in the Management of Actinic Keratosis: An Expert Consensus Panel Report.

BACKGROUND: Actinic Keratosis (AK) is a potentially pre-malignant tumor with a poorly defined risk of progression to invasive squamous cell carcinoma (SCC). Because of the typical need for recurrent cycles of AK treatment, outcomes can be limited by both therapeutic efficacy and patient adherence. OBJECTIVE: To synthesize the available and most current literature into overarching principles to provide guidance on the management of AKs, improving patient experiences and treatment outcomes. METHODS: A systematic review querying epidemiology, natural history, prognosis, management of AKs as well as the mechanism of action of and adherence to current AK therapy was conducted. After reviewing the literature, an expert consensus panel consisting of 10 expert dermatologists and dermatopathologists used a modified Delphi process to develop statements regarding the pathogenesis and management of AKs. Final statements were only adopted with a supermajority vote (≥7/10). RESULTS: The panel developed 7 consensus statements regarding AKs pathogenesis and management. CONCLUSION: The poorly defined risk for AK progression into invasive SCC without universally accepted clinical-histopathological factors highlights the importance of long-term efficacious treatment. To effectively counsel and treat patients with actinic keratoses, dermatologists must understand how newer therapeutic approaches with mechanisms of action that have more rapid onset of action, shorter treatment courses, and less intense local skin reaction (LSRs) may promote adherence and improve long-term outcomes. J Drugs Dermatol. 2021;20(8):888-893. doi:10.36849/JDD.6078 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL fTEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Hidradenitis Suppurativa Quality of Life (HiSQOL): creation and validation of the Polish language version.

INTRODUCTION: Hidradenitis suppurativa (HS) is a chronic, inflammatory and painful cutaneous disease which often has a negative influence on patients' quality of life. Dermatology-specific instruments, such as Dermatology Life Quality Index and Skindex, are commonly used to evaluate HS patients' quality of life. However, due to the lack of specific questions, these scales may not be adequate and may not reflect the real problem. AIM: To translate and validate the Polish version of a newly created HS-specific questionnaire - Hidradenitis Suppurativa Quality of Life (HiSQOL). MATERIAL AND METHODS: A forward and backward translation was conducted from the original English version of the questionnaire to Polish language according to international standards. The validation was performed on a group of 30 patients suffering from HS, who completed the questionnaire twice with a 4-5 days' interval. RESULTS: The Polish version of HiSQOL questionnaire showed a very good internal consistency (Cronbach α coefficient was 0.96 for total score). Excellent reproducibility with the intraclass correlation coefficient (ICC) of 0.97 was demonstrated. CONCLUSIONS: The Polish version of HiSQOL questionnaire has high internal reliability, validity and reproducibility. It can be used as a tool to assess health-related quality of life in the patients suffering from hidradenitis suppurativa.

What causes hidradenitis suppurativa ?-15 years after.

The 14 authors of the first review article on hidradenitis suppurativa (HS) pathogenesis published 2008 in EXPERIMENTAL DERMATOLOGY cumulating from the 1st International Hidradenitis Suppurativa Research Symposium held March 30-April 2, 2006 in Dessau, Germany with 33 participants were prophetic when they wrote "Hopefully, this heralds a welcome new tradition: to get to the molecular heart of HS pathogenesis, which can only be achieved by a renaissance of solid basic HS research, as the key to developing more effective HS therapy." (Kurzen et al. What causes hidradenitis suppurativa? Exp Dermatol 2008;17:455). Fifteen years later, there is no doubt that the desired renaissance of solid basic HS research is progressing with rapid steps and that HS has developed deep roots among inflammatory diseases in Dermatology and beyond, recognized as "the only inflammatory skin disease than can be healed". This anniversary article of 43 research-performing authors from all around the globe in the official journal of the European Hidradenitis Suppurativa Foundation e.V. (EHSF e.V.) and the Hidradenitis Suppurativa Foundation, Inc (HSF USA) summarizes the evidence of the intense HS clinical and experimental research during the last 15 years in all aspects of the disease and provides information of the developments to come in the near future.