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Background: There are limited data on the risk of new-onset anxiety disorders in patients with hidradenitis suppurativa (HS)., Objectives: To compare the risk of new-onset anxiety disorder in patients with HS and controls, and to describe risk factors for the development of anxiety in patients with HS., Methods: We carried out a retrospective cohort analysis of a US electronic health records database between 2011 and 2020. Adults newly diagnosed with HS at a dermatology or primary care visit and control participants were included. The primary outcome was a new diagnosis of generalized anxiety disorder, phobic disorders, panic disorder or unspecified anxiety. Cox proportional hazards regression was used to compare the crude risk of any anxiety disorder between groups and to assess the independent association with HS while controlling for potential demographic, clinical and healthcare-related confounders., Results: Among 9597 patients with HS and 959 493 controls, the incidence rate (IR) of anxiety was 5.74 and 3.86 per 100 person-years (PY), respectively. The crude risk among all patients was 48% higher for those with HS vs. controls [hazard ratio (HR) 1.48, 95% confidence interval (CI) 1.40-1.55]. When stratified by index encounter type, patients with HS had 2.43 (95% CI 2.13-2.77) times the risk of anxiety disorder than dermatology controls and 1.46 (95%CI 1.38-1.55) times the risk than primary care controls. The adjusted HR for patients with HS vs. controls was 1.11 (95% CI 1.05-1.17) overall, 1.26 (95% CI 1.07-1.48) in the dermatology subgroup and 1.07 (95% CI 1.01-1.13) in the primary care subgroup. Risk factors for an incident anxiety diagnosis among patients with HS included depression (HR 1.69, 95% CI 1.48-1.93), female sex (HR 1.41, 95% CI 1.23-1.60), younger age (HR 0.87 per 10-year increase, 95% CI 0.84-0.90), White race, in the Medicaid insurance programme (HR 1.22, 95% CI 1.07-1.40), tobacco smoking (HR 1.16, 95% CI 1.03-1.31) and having one or more emergency department visits in the year before a HS diagnosis. Absolute IRs of anxiety disorders were highest among patients with HS who were aged 18-29 years (7.10 per 100 PY), female (6.34 per 100 PY) and White (6.79 per 100 PY)., Conclusions: HS is independently associated with an increased risk of anxiety disorders. An increased risk remains but is attenuated when confounders are controlled for. The relative risk may be particularly high in patients managed by dermatologists., Competing Interests: Conflicts of interest A.G. is an advisor for AbbVie, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Cosmo Pharmaceutical, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, UCB, Union Therapeutics, Ventyx Biosciences and Viela Biosciences, and receives honoraria. A.G. receives research grants from AbbVie, UCB, the National Psoriasis Foundation and the CHORD COUSIN Collaboration (C3)., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

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., Competing Interests: Declaration of interests ABK reports grants paid to the institution from AbbVie, Admirx, Anapyts Bio, Aristea, Bristol Myers Squibb, Eli Lilly and Company, Incyte, Janssen, MoonLake Immunotherapeutics, Novartis, Pfizer, Prometheus, Sonoma Bio, and UCB Pharma; consulting fees from AbbVie, Alumis, Bayer, Boehringer Ingelheim, Eli Lilly and Company, Janssen, MoonLake Immunotherapeutics, Novartis, Pfizer, Priovant, Sonoma Bio, Sanofi, Target RWE, UCB Pharma, Union, and Ventyx; and serves on the board of directors of Almirall. GBEJ reports honoraria for participation on advisory boards from AbbVie, Boehringer Ingelheim, Chemocentryx, Incyte, Janssen-Cilag, LEO Pharma, Novartis, and UCB Pharma; and acted as an investigator for AbbVie, CJSL, InflaRx, Janssen-Cilag, LEO Pharma, Novartis, Regeneron, Sanofi, and UCB Pharma. CJS acted as an investigator for AbbVie, Chemocentryx, GSK, Incyte, InflaRx, Novartis, and UCB Pharma; reports consultancy fees from AbbVie, Alumis, InflaRx, Incyte, Logical Images, Sonoma Biotherapeutics, and UCB Pharma; and acted as a speaker for AbbVie and Novartis. JSK reports personal fees from AbbVie, ChemoCentryx, CJSL Behring, DermTech, Incyte, Insmed, Janssen, MoonLake, Novartis, and UCB Pharma; personal fees and grants from Incyte; is a co-copyright holder of HiSQOL; has been a consultant for and received honoraria from AbbVie, Alumis, DermTech, Incyte, Insmed, Janssen, MoonLake Immunotherapeutics, Novartis, and UCB Pharma; and has been a speaker for AbbVie, Janssen, Novartis, and UCB Pharma. EP has been a consultant, advisory board member, speaker for, and received honoraria from Almirall, Janssen-Cilag, GSK, MoonLake Immunotherapeutics, Novartis, and UCB Pharma; and his department received investigator-initiated grant support from AbbVie, Celgene, CHDR, Citryll, Kymera, Janssen-Cilag, and UCB Pharma. JRI receives a stipend as Editor‑in‑Chief of the British Journal of Dermatology and an authorship honorarium from UpToDate; has been a consultant for AbbVie, Boehringer Ingelheim, ChemoCentryx, Citryll, MoonLake Immunotherapeutics, Novartis, UCB Pharma, and Union Therapeutics, and has served on advisory boards for Insmed, Kymera Therapeutics, and Viela Bio; is a co‑copyright holder of the Hidradenitis Suppurativa Quality of Life score (HiSQOL) and hidradenitis suppurativa-Investigator Global Assessment; and his department receives income from copyright of the Dermatology Life Quality Instrument and related instruments. AG has been a consultant and receives honoraria from AbbVie, Aclaris Therapeutics, AnaptysBio, Aristea Therapeutics, Bristol Myers Squibb, Boehringer Ingelheim, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, UCB Pharma, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences; has received research grants from AbbVie, C3, National Psoriasis Foundation, and UCB Pharma; and is a co-copyright holder of HiSQOL and hidradenitis suppurativa-IGA. ABG reports honoraria as an advisory board member and consultant for Amgen, Almirall, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dice Therapeutics, Eli Lilly and Company, Janssen, Novartis, Sanofi, UCB Pharma, and Xbiotech; and research or educational grants from AnaptysBio, Bristol Myers Squibb, MoonLake Immunotherapeutics, Novartis, and UCB Pharma (all paid to Mount Sinai School of Medicine). JCJS has acted as a consultant and advisory board member of AbbVie, LEO Pharma, Novartis, Pierre Fabre, Sanofi Genzyme, and Trevi Therapeutics; acted as a speaker for AbbVie, Almirall, Eli Lilly and Company, LEO Pharma, Novartis, Pfizer, Pierre-Fabre, Sanofi, and UCB Pharma; and has acted as an investigator for AbbVie, Amgen, Bristol Myers Squibb, Galapagos, Galderma, Incyte, InflaRX, Janssen, Kliniksa, Kymab Limited, Menlo Therapeutics, Merck, Novartis, Pfizer, Regereron Pharmaceuticals, Trevi Therapeutics, and UCB Pharma. FGB reports honoraria for participation in advisory boards, in clinical trials, and as a speaker from AbbVie, AbbVie Deutschland, Boehringer Ingelheim, Celltrion, Dr. Wolff, Incyte, Janssen, Mölnlycke, MoonLake Immunotherapeutics, Novartis, and UCB Pharma. EJG-B reports honoraria from Abbott Products Operations, bioMérieux, Brahms, GSK, InflaRX, Sobi and XBiotech; independent educational grants from Abbott Products Operations, AxisShield, bioMérieux, InflaRx, Johnson & Johnson, MSD, Novartis, Sobi, and XBiotech; and funding from the Horizon2020 Marie Skłodowska-Curie International Training Network the European Sepsis Academy (granted to the National and Kapodistrian University of Athens), the Horizon 2020 European Grants ImmunoSep and RISCinCOVID (granted to the Hellenic Institute for the Study of Sepsis) and the Horizon Health grant EPIC-CROWN-2 (granted to the Hellenic Institute for the Study of Sepsis). HF reports honoraria or fees for serving on advisory boards, as a speaker, and as a consultant; and grants as an investigator from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly and Company, Janssen, Japan Blood Products Organization, JMEC, Kaken Pharmaceutical, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe, Nihon Pharmaceutical, Novartis, Otsuka Pharmaceutical, Sanofi, Sato Pharmaceutical, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, UCB Pharma, and Ushio. RR, PJ, PD, EM, and LP are employees and shareholders of UCB Pharma. CM is a former employee and shareholder of UCB Pharma. MB is an employee of UCB Pharma. CCZ reports grants paid to the institution from AstraZeneca, Boehringer Ingelheim, GSK, InflaRx, Novartis, Relaxera, and UCB Pharma for participation as a clinical and research investigator; consultant honoraria from AccureAcne, Almirall, Boehringer Ingelheim, Incyte, InflaRx, Janssen, L'Oréal, Luvos, NAOS-BIODERMA, Novartis, PPM, Sanofi, UCB Pharma, and Viatris; lecture fees from Almirall, Biogen, Novartis, Sobi, and UCB Pharma; and is the president of the European Hidradenitis Suppurativa Foundation, coordinator of the ALLOCATE Skin group of the European Reference Network for rare skin diseases, and chair of the Acne, Rosacea and Hidradenitis Suppurativa Task Force group of the European Academy of Dermatology and Venereology (EADV); is the editor of the EADV News; and co-copyright holder of the International Hidradenitis Suppurativa Severity Score System on behalf of the European Hidradenitis Supurativa Foundation., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: Several registries for hidradenitis suppurativa (HS) already exist in Europe and the USA. There is currently no global consensus on a core dataset (CDS) for these registries. Creating a global HS registry is challenging, owing to logistical and regulatory constraints, which could limit opportunities for global collaboration as a result of differences in the dataset collected. The solution is to encourage all HS registries to collect the same CDS of information, allowing registries to collaborate., Objectives: To establish a core set of items to be collected by all HS registries globally. The core set will cover demographic details, comorbidities, clinical examination findings, patient-reported outcome measures and treatments., Methods: Beginning in September 2022, 20 participants - including both clinicians with expertise in HS and patient advocates - from eight countries across three continents participated in a Delphi process consisting of four rounds of voting, with all participants completing each round. A list of potential items for inclusion in the core set was generated from the relevant published literature, including systematic reviews of comorbidities in HS, clinical and examination findings, and epidemiology. For disease severity and progression items, the Hidradenitis SuppuraTiva Core outcome set International Collaboration (HiSTORIC) core set and other relevant instruments were considered for inclusion. This resulted in 47 initial items. Participants were invited to suggest additional items to include during the first round. Anonymous feedback was provided to inform each subsequent round of voting to encourage consensus., Results: The eDelphi process established a CDS of 48 items recommended for inclusion in all HS registries globally., Conclusions: The routine adoption of this CDS in current and future HS registries should allow registries in different parts of the world to collaborate, enabling research requiring large numbers of participants., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Competing Interests: Conflicts of interest A.G. is an advisor for AbbVie, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, UCB, Union Therapeutics, Ventyx Biosciences and Viela Biosciences, and receives honoraria. A.G. receives research grants from AbbVie, UCB, National Psoriasis Foundation, and CHORD COUSIN Collaboration (C3). A.G. is a project lead for HiSTORIC. He is cocopyright holder of the Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA) and Hidradenitis Suppurativa Quality of Life (HiSQOL) instruments. J.R.I. reports receiving a stipend as Editor-in-Chief of the British Journal of Dermatology and an authorship honorarium from UpToDate. He is a consultant for AbbVie, Boehringer Ingelheim, ChemoCentryx, Novartis and UCB Pharma and has served on advisory boards for Insmed, Kymera Therapeutics and Viela Bio. J.R.I. is a project lead for HiSTORIC. He is cocopyright holder of the HS-IGA, Patient Global Assessment and HiSQOL instruments. His department receives income from copyright of the Dermatology Life Quality Instrument and related instruments.

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.

Introduction: Data concerning the global burden of hidradenitis suppurativa (HS) are limited. Reported prevalence estimates vary between 0.0003% and 4.1%, and data from various geographical regions are still to be collected. Previously reported prevalences have been limited by the methodological approach and source of data. This has resulted in great heterogeneity as prevalence data from physician-diagnosed cases poorly match those of self-reported apparent HS disease., Methods: The Global Hidradenitis Suppurativa Atlas (GHiSA) introduces an innovative approach to determine the global prevalence of HS. This approach involves using a previously validated questionnaire to screen apparently healthy adults accompanying a patient to a non-dermatological outpatient clinic visit in a hospital or a private/family medicine clinic. The screening questionnaire (i.e., the index test) is combined with a subsequent physician-based in-person validation (i.e., the reference standard) of the participants who screen positive. Approximately ten percent of the screen-negative participants are also clinically assessed to verify the diagnostic precision of the test. The local prevalence (pi) will be estimated from each country that submits the number of patients who are HS positive according to the index test and clinical examination (n), and the corresponding total number of observations (N)., Conclusion: The GHiSA Global Prevalence studies are currently running simultaneously in 58 countries across six continents (Africa, Europe, Australia, North America, South America, and Asia). The goal of the combined global proportion is the generation of a single summary (i.e., proportional meta-analysis), which will be done after a logit transformation and synthesized using a random-effects model. The novel standardization of the Global Prevalence Studies conducted through GHiSA enables direct international comparisons, which were previously not possible due to substantial heterogeneity in past HS prevalence studies., (© 2024 S. Karger AG, Basel.)

Introduction: Hidradenitis suppurativa (HS) is a chronic, autoinflammatory skin disease associated with many comorbidities. One biologic (adalimumab) is approved for HS. This study assessed the sociodemographic characteristics, comorbidities, treatment patterns, healthcare resource utilization (HCRU) and associated costs of patients with HS following biologic approval., Methods: This non-interventional, retrospective cohort study involved adult (≥ 18 years) and adolescent (12-17 years) patients diagnosed with HS in the United States (US) using Optum's de-identified Clinformatics ® Data Mart Database during the period 1 January 2016 to 31 December 2018., Results: Of 42,843 identified patients, 10,909 met the incident HS patient criteria (10,230 adults, 628 adolescents, 51 patients aged <12 years). Patients were mostly diagnosed by a general practitioner/pediatrician (adults: 41.6%; adolescents: 39.6%) or dermatologist (adults: 22.1%; adolescents: 30.6%). Commonly reported Charlson comorbidities at pre-index in adult patients were diabetes without complications (20.4%), chronic pulmonary disease (16.4%) and diabetes with complications (9.0%), and the most frequent Elixhauser comorbidities were uncomplicated hypertension (38.3%), obesity (22.5%), uncomplicated diabetes (19.0%) and depression (17.4%). The burden of comorbidities generally increased over time after diagnosis in both adults and adolescents. HS-related surgical procedures were uncommon in the 2-years post-index period: an incision and drainage procedure was reported in 7.6% of adults and 6.4% of adolescents. Patients were predominantly treated with both topical and systemic antibiotic treatments (adults: 25.0% and 65.1%, respectively; adolescents: 41.7% and 74.5%, respectively). Biologic prescription was higher in adults than adolescents (3.5% vs. 1.8%). Total healthcare costs for adult and adolescent patients in the 2-years post-index period were US$42,143 and US$16,057, respectively, with outpatient costs accounting for the majority of these costs (US$20,980 and US$8408, respectively)., Conclusion: In adult and adolescent patients with HS, comorbidity burden continues to increase after diagnosis. All-cause and HS-specific HCRU and costs are high in adults and adolescents with HS. These findings support the need for a multidisciplinary comprehensive care strategy for patients with HS., (© 2023. The Author(s).)

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.

Competing Interests: Conflicts of interest: N.S. has participated in advisory boards for Bristol Myers Squibb. A.G. is an advisor for AbbVie, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, UCB, Union Therapeutics, Ventyx Biosciences and Viela Biosciences, and receives honoraria. A.G. receives research grants from AbbVie, UCB, National Psoriasis Foundation and CHORD COUSIN Collaboration (C3). He is co-copyright holder of the HS-IGA and HiSQOL instruments. L.A.V.O. has participated on advisory boards for Novartis and UCB, was a consultant and investigator for ChemoCentryx and has received research grants from Pfizer.

Drainage from chronic wounds can significantly negatively impact a patient's quality of life. Change in severity of wound drainage is an important measure of treatment efficacy for wounds. This study reviews existing tools used to assess wound drainage. Qualitative drainage tools are overall less burdensome, and however, differences in user interpretation may reduce inter-rater reliability. Quantitative drainage tools enable more reliable comparisons of drainage severity and treatment response between patients but sometimes require equipment to administer, increasing responder burden. Gaps in the current wound drainage measurement landscape are highlighted. Many of the existing scales have not been validated in robust studies. There is also a lack of validated global drainage measurement tools for patients with chronic inflammatory skin disorders with drainage, such as hidradenitis suppurativa or pyoderma gangrenosum. Development of a succinct drainage measurement tool for inflammatory skin diseases where drainage is a prominent symptom will improve monitoring of meaningful treatment response., (© 2023. The Author(s).)

Competing Interests: Conflicts of interest Dr Garg is an advisor for AbbVie, Alcaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, UCB, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences, and receives honoraria. Dr Garg receives receives research grants from AbbVie, UCB, National Psoriasis Foundation, and CHORD COUSIN Collaboration (C3). He is co-copyright holder of the HS-IGA and HiSQOL instruments. Nicole Mastacouris and Andrew Strunk have no conflicts to declare.

Importance: Few simplified instruments exist for use in hidradenitis suppurativa (HS) trials., Objective: To assess psychometric properties of the Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA) score using a clinical trial data set., Design, Setting, and Participants: This retrospective analysis of a phase 2 randomized double-blind, placebo-controlled, active-reference arm trial (UCB HS0001) included adults with moderate-to-severe HS., Exposures: Trial participants were randomized at baseline to receive bimekizumab, adalimumab, or placebo., Main Outcomes and Measures: The HS-IGA score at prespecified time points up to 12 weeks after randomization., Results: The HS-IGA score showed strong convergent validity with IHS4 and HS-PhGA scores at baseline (Spearman correlation, 0.86 [P < .001] and 0.74 [P < .001], respectively) and at week 12 (Spearman correlation, 0.73 [P < .001] and 0.64 [P < .001], respectively). The HS-IGA scores assessed during predosing visits at screening and baseline showed good test-retest reliability (intraclass correlation coefficient [ICC] = 0.92). At week 12, HS-IGA responders were significantly associated with HiSCR-(50/75/90) responders (χ2 = 18.45; P < .001; χ2 = 18.11; P < .001; and χ2 = 20.83; P < .001, respectively). The HS-IGA score was predictive of HiSCR-50/75/90 and HS-PhGA response at week 12 (AUC, 0.69, 0.73, 0.85, and 0.71, respectively). However, the HS-IGA as a measure of disease activity showed low predictive validity with patient-reported outcomes at week 12., Conclusions and Relevance: The HS-IGA score demonstrated good psychometric properties compared with existing measures and may be considered for use as an end point in clinical trials for HS.

Competing Interests: Conflicts of interest A list of conflicts of interest can be found in Appendix S1 (see Supporting Information).

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., Competing Interests: Conflicts of interest: L.A.V.O. has participated on advisory boards for Novartis, was a consultant and investigator for ChemoCentryx, and received a research grant from Pfizer. A.G. is an advisor for AbbVie, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, InflaRx, Insmed, Janssen, Novartis, Pfizer, UCB, Union Therapeutics and Viela Biosciences, and receives honoraria. A.G. also receives research grants from AbbVie, UCB and the National Psoriasis Foundation., (© The Author(s) 2022. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Hidradenitis suppurativa (HS) is an inflammatory skin condition which predominantly affects women of childbearing age in the USA. There is a lack of research on the association between HS and fertility., Objectives: The aim of this study was to understand the perspectives of females with HS regarding the impact of their disease on reproductive health, the impact of fertility treatments on HS, and the impact of HS treatments on fertility., Methods: An anonymous, online survey was disseminated through HS support groups from June to July 2022. Respondents aged 18-50 who were assigned female sex at birth were eligible for participation. Comparative statistics were performed using t tests/χ2 tests to assess associations between respondents' demographics and survey responses., Results: Among the 312 respondents (80.8% White, mean age 35.7 ± 7.4 [range 18-50]), two-thirds of respondents (66.6%, 207/311) had been pregnant before and 79.5% (248/312) had ever tried to conceive. 41.5% (103/248) had unsuccessfully tried to conceive for 12 months or more. Of the 59 respondents who had never attempted to conceive, 39% reported that HS had impacted this decision. Amongst respondents who experienced fertility challenges but did not pursue fertility treatments, top barriers to fertility treatments include concerns about financial support/insurance coverage (47.5%, 29/61) and fertility treatments worsening HS (21.3%, 13/61). Most respondents who used fertility treatments reported either no change (73.7%, 28/38 or 77.8%, 14/18) or improvement (15.8%, 6/38 or 11.1%, 2/18) in their HS symptoms with oral or injectable medications. Respondents were most concerned about the effects of oral antibiotics (44.9%, 140/312), followed by hormonal medications (38.8%, 121/312) and biologics (35.9%, 112/312) on fertility., Conclusion: Females with HS reported high rates of infertility compared to the general population. The majority reported no change in HS symptoms with fertility treatments, and clinicians can use this finding to help counsel patients during family planning discussions. Further research in the field of HS and fertility is needed., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

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., (© 2022 S. Karger AG, Basel.)

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., (© 2022 British Association of Dermatologists.)

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., (© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Purpose: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules, abscesses, sinus tract formation and scarring. The relationship between HS and strokes is not well established. To assess this potential association, a systematic review and meta-analysis was performed according to PRISMA guidelines., Materials and Methods: Electronic searches were performed from six online databases. All eligible case-control studies comparing patients with HS versus non-HS were included. All studies must have included either the proportion of patients with strokes (identified via ICD-9 or ICD-10 codes) in each group, or the summary effect size for association between HS and strokes. Odds ratio (OR) with 95% confidence interval (CI) was used as the effect size., Results: Through our search, we identified six case-control studies for inclusion. From pooled data, we found a significantly higher proportion of strokes in HS cases compared with controls (OR 1.74, 95% CI 1.45-2.09; p  < .00001). Limitations included those studies reviewed were observational by design which are susceptible to bias and lack of randomization., Conclusion: Our pooled findings demonstrate that the odds of stroke are increased in patients with HS when compared with controls. Dermatologists and other clinicians should be vigilant cerebrovascular risk assessment and risk mitigation in patients with HS.

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., Competing Interests: Conflicts of interest Dr Garg has served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, Incyte, Janssen, Novartis, Pfizer, UCB, and Viela Bio; has received honoraria from AbbVie, Amgen, Boehringer Ingelheim, Incyte, Janssen, Novartis, Pfizer, UCB, and Viela Bio; and has received grants: from AbbVie and the National Psoriasis Foundation. Dr Alavi has served as a consultant for AbbVie, Boehringer Ingelheim, Incyte, Janssen, Pfizer, UCB, Actelion, Celgene, Galderma, GlaxoSmithKline, Leo Pharma, Novartis, Sanofi-Genzyme, Kymera, Eli Lily, InflaRx, Sanofi, and Bausch; has received honoraria from AbbVie, Boehringer Ingelheim, Incyte, Janssen, Pfizer, UCB, Actelion, Celgene, Galderma, GlaxoSmithKline, Leo Pharma, Novartis, Genzyme, Kymera, Eli Lily, Sanofi, and Bausch; has received grants from AbbVie; and has received donations of medical equipment from Galderma and Swift. Dr Alhusayen has served as a consultant for AbbVie, Janssen, Leo Pharma, Hidramed Solutions and has received honoraria from AbbVie, and Eli Lilly. Dr Daveluy has served as a consultant for AbbVie; has received honoraria from AbbVie; has served on the speakers bureau for AbbVie; and has received grants from AbbVie, InflaRx, Regeneron, and Pfizer. Dr Delorme has served as a consultant for AbbVie, Celgene, Eli-Lilly, Janssen, Novartis, and Sanofi-Genzyme; has received honoraria from AbbVie, Amgen, Avene, Celgene, Eli Lilly, Janssen, Novartis, and UCB Pharma; has served on the speakers bureau for AbbVie, Bausch Health, Celgene, Eli Lilly, Janssen, Novartis, and Sanofi Genzyme; and has received grants from AbbVie, InflaRx, Regeneron, and Pfizer. Dr Gulliver has served as a consultant for AbbVie, Amgen, Bausch Health, Celgene, Cipher, Eli Lilly, Janssen, LEO Pharma, Novartis, PeerVoice, Pfizer, Sanofi-Genzyme, UCB, and Valeant; has received honoraria from AbbVie, Amgen, Bausch Health, Celgene, Cipher, Eli Lilly, Janssen, LEO Pharma, Novartis, PeerVoice, Pfizer, Sanofi-Genzyme, UCB, and Valeant; and has received grants from AbbVie, Amgen, Eli Lilly, Novartis, and Pfizer. Dr Hamzavi has served as a consultant for Incyte, UCB, and Pfizer and has received grants from Lenicura and Boehringer Ingelheim. Dr Jaleel has served as a consultant for Eli Lilly and ChemoCentryx/IQVIA and has received grants from the Dermatology Foundation and Skin of Color Society. Dr Kimball has served as a consultant for AbbVie, Janssen, Lilly, Novartis, Pfizer, UCB, and Kymera; has received honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer, UCB, and Kymera; and has received royalties from Pfizer, Trifecta, and UCB. Dr Kirby has served as a consultant for AbbVie, ChemoCentryx, Incyte, Novartis, and UCB; has received honoraria from AbbVie, Incyte, and Viela Bio; and has served on the speakers bureau for AbbVie. Dr Kirchhof has served as a consultant for AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Sanofi-Genzyme; has served on the speakers bureau for AbbVie, Janssen, Novartis, Pfizer, UCB, and Sanofi-Genzyme; and has received grants from the Canadian Dermatology Foundation. Dr Lev-Tov has served as a consultant for Pfizer, Mölnlycke, and NextScience; has received honoraria from Essity; has received grants from NextScience and Essity; and has received donations of medical equipment from Essity, Mölnlycke, and NextScience. Dr Lowes has served as a consultant for AbbVie, Janssen, Viela Bio, Almirall, BSN, Incyte, Janssen, Kymera, and XBiotech. Dr Naik has served as a consultant for Boehringer Ingelheim, Janssen, and 23andme and has received grants from AbbVie, Hidradenitis Suppurativa Foundation. Dr Orenstein has received a Hidradenitis Suppurativa Foundation Danby Research Grant. Dr Piguet has served as a consultant for Pfizer, AbbVie, Janssen, UCB, Novartis, Almirall, and Celgene; has received honoraria from Kyowa Kirin Co Ltd, AbbVie, and Novartis; has received grants from AbbVie, Bausch Health, Celgene, Janssen, LEO Pharma, Lilly, NAOS, Novartis, Pfizer, Pierre-Fabre, and Sanofi; and has received a donation of medical equipment from La Roche-Posay. Dr Sayed has served as a consultant for UCB, InflaRx, and AbbVie; has received honoraria from UCB and AbbVie; and has served on the speakers bureau for AbbVie and Novartis. Dr Tan has served as a consultant for Almirall, Bausch, Boots/Walgreens, Botanix, Cipher, Galderma, Incyte, L’Oréal, Novartis, Pfizer, Promius, Sun, and UCB; has received honoraria from Almirall, Bausch, Boots/Walgreens, Botanix, Galderma, L’Oréal, Novartis, Pfizer, Promius, and Sun; has served on the speakers bureau for Galderma and L’Oréal; and has received grants from Incyte and UCB. Drs Alikhan and Goldfarb, Author Lester, Drs Malviya and Micheletti, and Authors Strunk and Wright have no conflicts of interest to declare., (Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: The International Dermatology Outcome Measures (IDEOM) initiative is a non-profit organization that aims to develop evidence-based outcome measurements to evaluate the impact of treatments for patients with dermatological disease. IDEOM includes all key stakeholders in dermatology (patient, physician, industry, insurer, and government) during the process of developing such outcome measurements., Summary: Here, we provide an update of IDEOM activities that were presented at the 2020 IDEOM Virtual Annual Meeting (October 23-24, 2020). During the meeting, multiple IDEOM workgroups (psoriasis, psoriatic arthritis, hidradenitis suppurativa, acne, pyoderma gangrenosum, and actinic keratosis) shared their progress to date, as well as future directions in developing and validating Patient-Reported Outcome Measures. Updates on demonstrating efficacy in clinicals trials by the US Food and Drug Administration are also summarized., Key Messages: In this report, we summarize the work presented by each IDEOM workgroup (psoriasis, psoriatic arthritis, hidradenitis suppurativa, acne, pyoderma gangrenosum, and actinic keratosis) at the 2020 IDEOM Virtual Annual Meeting., (The Author(s). Published by S. Karger AG, Basel.)

Background: Information on prevalence of depression among children, adolescents, and adults with hidradenitis suppurativa (HS) is limited., Objective: To compare prevalence of depression in HS patients with that of controls., Methods: Cross-sectional analysis of 38,140 adult and 1162 pediatric HS patients and controls identified using data from electronic health records. Primary outcome was prevalent depression., Results: Prevalence of depression among adults with HS was 30.0% (95% Confidence interval [CI], 29.6-30.5), compared with 16.9% (95% CI, 16.7-17.1) among controls. Among children and adolescents with HS, prevalence of depression was 11.7% (95% CI, 10.0-13.7), compared with 4.1% (95% CI, 3.6-4.7) among controls. In adjusted analyses, adults and children/adolescents with HS had 1.26 (95% CI, 1.25-1.28; P < .001) and 1.42 (95% CI, 0.999-2.01; P = .051) times the odds of having depression relative to controls, respectively., Limitations: We could not evaluate the influence of disease severity on the outcome., Conclusion: Depression is prevalent among children, adolescents, and adults with HS. Periodic screening for depression may be warranted., Competing Interests: Conflicts of interest Dr. Garg has served as an advisor for AbbVie, Amgen, Boehringer Ingelheim, Janssen, Pfizer, Incyte, InfalRx, Viela Bio, UCB, and has received honoraria. Authors Wright and Strunk have no conflicts of interest to disclose., (Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Hidradenitis suppurativa (HS) disproportionately affects women of childbearing age. However, pregnancy and maternal outcomes for women with HS are unknown., Objective: To compare risk of adverse pregnancy and maternal outcomes among women with and without HS and to evaluate the influence of comorbid conditions., Methods: Retrospective cohort analysis between January 1, 2011, and September 30, 2015., Results: Compared to control pregnancies (n = 64,218), HS pregnancies (n = 1862) had a higher risk of spontaneous abortion (15.5% vs 11.3%), preterm birth (9.1% vs 6.7%), gestational diabetes mellitus (11.6% vs 8.4%), gestational hypertension (6.1% vs 4.4%), preeclampsia (6.6% vs 3.8%), and cesarean section (32.4% vs 27.1%). Relative risk of some pregnancy and maternal outcomes were attenuated after comorbidity adjustment. In the fully adjusted model, HS pregnancies were independently associated with spontaneous abortion (odds ratio, 1.20; 95% CI, 1.04-1.38), gestational diabetes mellitus (odds ratio, 1.26; 95% CI, 1.07-1.48), and cesarean section (odds ratio, 1.09; 95% CI, 1.004-1.17)., Limitations: We could not evaluate potential influences of disease duration, activity, or severity. Newborn outcomes could not be evaluated., Conclusion: HS appears to be an independent risk factor for adverse pregnancy and maternal outcomes. This risk is influenced by comorbidities that may be modifiable with early identification and management., Competing Interests: Conflicts of interest Dr Hsiao has served as an advisor for Novartis. Dr Garg is an advisor for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, InflaRx, Incyte, Janssen, Novartis, Pfizer, UCB, and Viela Biosciences, and receives research grants from AbbVie and National Psoriasis Foundation. Dr Fitzpatrick and Authors Tannenbaum and Strunk have no conflicts of interest to declare., (Copyright © 2021 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

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., (© 2020 S. Karger AG, Basel.)

Background: Information on the risk of depression among children, adolescents, and adults with hidradenitis suppurativa (HS) is limited., Objective: To compare the risk of new-onset depression in patients with HS with that of control individuals., Methods: Retrospective cohort analysis of 49,280 adult and 3042 pediatric patients with HS and matched control individuals identified by using electronic health record data. The primary outcome was incident depression., Results: The crude incidence rate was 4.8 per 100 person-years in adult patients with HS compared to 3.0 per 100 person-years in control individuals. Among pediatric patients, the crude incidence rate was 4.2 per 100 person-years in patients with HS compared with 2.3 per 100 person-years in control individuals. In adjusted analysis, adults and pediatric patients with HS had a 10% (hazard ratio, 1.10; 95% confidence interval, 1.07-1.13; P < .001) and 26% (hazard ratio, 1.26; 95% confidence interval, 1.10-1.44; P < .001), respectively, increased risk of developing depression compared to control individuals. Among patients with HS, factors associated with depression included female sex, white race, smoking, and body mass index/obesity in adults and pediatric patients and substance abuse in adults only., Limitations: Patients not seeking care in health systems within the database were not captured., Conclusion: Children, adolescents, and adults with HS are at an increased risk for developing depression, independent of other common risk factors for depression., (Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Importance: Although hidradenitis suppurativa (HS) is associated with several cardiovascular risk mediators, information on the risk of myocardial infarction (MI) and cerebrovascular accident (CVA) in this population is sparse., Objective: To compare risk of MI, CVA, and composite disease (MI or CVA) in patients with HS, stratified by use of biologic agents, with controls without HS., Design, Setting, and Participants: A retrospective cohort analysis was conducted between January 1, 1999, and April 1, 2019, using a demographically heterogeneous population-based sample of over 56 million unique patients. Individuals with HS (n = 49 862) and without HS (n = 1 421 223) were identified using electronic health records data., Main Outcomes and Measures: The primary outcome was incidence of composite MI or CVA., Results: Of the 49 862 patients with HS, 37 981 were women (76.2%), 29 711 were white (59.6%), and mean (SD) age was 38.3 (13.3) years. Crude incidence rate of composite disease was 6.6 (95% CI, 6.3-7.0) per 1000 person-years in patients with HS compared with 6.8 (95% CI, 6.7-6.8) per 1000 person-years in controls. In patients with HS, crude incidence rates were 2.9 (95% CI, 2.6-3.1) per 1000 person-years for MI alone and 4.1 (95% CI, 3.9-4.4) per 1000 person-years for CVA alone compared with 3.2 (95% CI, 3.18-3.25) per 1000 person-years for MI alone in control patients and 4.1 (95% CI, 4.0-4.1) per 1000 person-years for CVA alone in control patients. In adjusted analysis, patients with HS had a 23% increased risk of composite disease (hazard ratio [HR], 1.23; 95% CI, 1.17-1.30; P < .001) and a similar increase in the risk of MI alone (HR, 1.21; 95% CI, 1.12-1.32; P < .001) and CVA alone (HR, 1.22; 95% CI, 1.14-1.31; P < .001) compared with control patients. The relative difference in composite MI or CVA risk between patients with HS and controls was highest among younger patients HR in subgroup aged 18-29 years: 1.67; 95% CI, 1.37-2.03)., Conclusions and Relevance: Patients with HS appear to have an increased risk of MI and CVA. Early management of modifiable cardiovascular risk mediators may be warranted in patients with HS.

Background: The mortality risk for patients with hidradenitis suppurativa (HS) is largely unknown., Objective: To compare mortality risk among individuals with and without HS in the United States., Methods: Retrospective cohort study in a population sample identified by using electronic health records data between January 1, 2012, and December 31, 2016. Primary outcome was incidence of 5-year all-cause mortality., Results: The crude 5-year mortality rate among patients with HS was 2.4% (321/13 289), compared with 2.7% (18 508/685 573) among control individuals. In the fully adjusted model, the increase in HS mortality risk was 14% (odds ratio [OR], 1.14; 95% confidence interval [CI], 1.01-1.28). Overall, excess risk of death attributable to HS was 3.1 deaths per 1000 patients (95% CI, 0.2-6.0) during the study period. Characteristics associated with mortality among patients with HS included age (OR, 1.05; 95% CI, 1.04-1.06), male sex (OR, 1.40; 95% CI, 1.09-1.79), ever-smoking status (OR, 1.48; 95% CI, 1.16-1.92), and Charlson Comorbidity Index score (OR, 1.25; 95% CI, 1.21-1.29)., Limitations: The follow-up period may not have been long enough to assess the influence of disease severity or duration on mortality., Conclusion: HS appears to confer an independent risk of all-cause mortality. This risk is also influenced by tobacco smoking and comorbidities, which may be modifiable., (Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Importance: The overall comorbidity burden among patients with hidradenitis suppurativa (HS) has not been systematically evaluated., Objectives: To investigate the standardized overall comorbidity burden among patients with HS and to compare it with the comorbidity burden in patients with psoriasis and a control group., Design, Setting, and Participants: A cross-sectional analysis was conducted of 5306 patients with HS, 14 037 patients with psoriasis, and 1 733 810 controls identified using electronic health records data from October 1, 2013, through October 1, 2018., Main Outcome and Measure: The primary outcome was the mean Charlson Comorbidity Index (CCI) score., Results: Each matched cohort had 3818 patients (2789 women and 1029 men; mean [SD] age, 45.7 [15.0]). Before matching, the overall mean (SD) CCI score was highest among the psoriasis cohort (2.33 [3.13]), followed by the HS cohort (1.80 [2.79]) and control cohort (1.26 [2.35]). In matched analyses, the overall mean (SD) CCI score was highest among the HS cohort (1.95 [2.96]), followed by the psoriasis cohort (1.47 [2.43]; P < .001) and control cohort (0.95 [1.99]; P < .001) patients. A total of 516 patients with HS (13.5%) had an overall mean CCI score of 5 or greater. Mean CCI score was highest for patients with HS across all sex, race, and age groups. The most common comorbidities among patients with HS were chronic pulmonary disease (1540 [40.3%]), diabetes with chronic complications (365 [9.6%]), diabetes without chronic complications (927 [24.3%]), and mild liver disease (455 [11.9%]). Patients with HS with a CCI score of 5 or greater had 4.97 (95% CI, 1.49-16.63) times the adjusted risk of 5-year mortality compared with patients with HS with a CCI score of zero., Conclusions and Relevance: Patients with HS have a higher overall comorbidity burden compared with patients with psoriasis and a control group. A significant proportion of patients with HS have CCI scores of 5 or greater, which are associated with increased mortality. This degree of comorbidity burden may warrant multidisciplinary implementation of routine screening measures.

Background: Hidradenitis suppurativa (HS) and pyoderma gangrenosum (PG) are reported to coexist, although the prevalence of PG among patients with HS has not been systematically evaluated., Objective: To evaluate PG prevalence among patients with HS., Methods: Cross-sectional analysis of adults with PG among patients with HS and patients without HS through use of electronic health records data from a population-based sample of 55 million patients., Results: The prevalence of PG among 68,232 patients with HS was 0.18% (125 of 68,232), compared with 0.01% (1835 of 31,435,166) among those without HS (P < .0001). Prevalence was markedly higher among patients with HS and Crohn's disease (CD) (3.68%) than among patients with HS but without CD (0.12%). The odds of having PG were 21.14 (95% confidence interval [CI], 17.51-25.51) times greater among patients with HS than among those without HS. Patients with HS with CD had 12.38 (95% CI, 9.15-16.74) times the odds of having PG than did patients without HS but with CD. Among patients without CD, compared with patients without HS, those with HS had 26.51 (95% CI, 21.07-33.36) times the odds of having PG., Limitations: We could not establish HS phenotype among those having coexistent PG, nor could we distinguish syndromic from nonsyndromic cases., Conclusion: Patients with HS have an increased prevalence of PG, regardless of CD status. Painful ulcerations among patients with HS warrant additional evaluation for PG., (Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Evidence establishing a link between acne vulgaris (AV) and hidradenitis suppurativa (HS) is limited, and the burden of AV in adults with HS is unknown., Objective: To determine the prevalence of AV among adults with HS and determine the strength of this association., Methods: Cross-sectional analysis identifying adults with AV among patients with and without HS by using electronic health record data from a population-based sample of more than 55 million patients., Results: The prevalence of AV among adults with HS was 15.2% (7315 of 48,085) compared with 2.9% (497,360 of 16,899,470) for adults without HS (P < .001). The prevalence was greatest among patients with HS who were female (5870 of 35,790 [16.4%]), were 18 to 44 years old (5260 of 28,870 [18.2%]), were nonwhite (3120 of 17,825 [17.5%]), were obese (5430 of 35,135 [15.5%]), and had polycystic ovarian syndrome (685 of 2385 [28.7%]). Patients with HS had 4.51 [95% confidence interval, 4.40-4.63] times the odds of having AV than did patients without HS, with the higher likelihood of having AV persisting across all subgroups of patients with HS. The association between HS and AV was generally stronger for patients who were male, and 65 years of age or older., Limitations: Influence of disease severity in HS, or in acne, on the strength of the association could not be assessed., Conclusion: Patients with HS may benefit from assessment of acne status and optimization of comanagement strategies., (Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

The prevalence of hidradenitis suppurativa (HS) in the pediatric population is unknown. We sought to establish standardized overall as well as gender-, age-, and race-specific prevalence estimates of HS among children and adolescents in the United States. We performed a cross-sectional analysis in a heterogeneous sample of 55 million patients across all census regions. We identified 1,240 patients with HS in whom the ratio of girls to boys was 3.8:1. Almost all (96.8%) patients with HS were ≥10 years of age. Overall, HS prevalence was 0.028%, or 28.1 (95% confidence interval [CI] 26.5-29.7) per 100,000 children and adolescents. Standardized prevalence was higher in girls (44.6 [95% CI 41.8-47.5] per 100,000), in patients aged 15-17 years (113.7 [95% CI 106.4-121.4] per 100,000), and among African Americans (78.7 [95% CI 71.0-86.9] per 100,000). Highest prevalence of HS was observed among female adolescents aged 15-17 years who were African Americans (525.1 [95% CI 459.4-597.5] per 100,000) and biracial (253.2 [95% CI 121.4-465.6] per 100,000). Patients with HS who went undiagnosed were not captured, and as such prevalence estimates may be underestimated. HS appears to be a postpubertal disease that disproportionately afflicts girls and African Americans in the pediatric population., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Patients with hidradenitis suppurativa (HS) experience chronic pain and have significant physical, emotional, and psychological disease impact. These patients may be at risk for substance abuse., Objective: To evaluate substance use disorder (SUD) among patients with HS in the United States., Methods: This cross-sectional analysis of adult HS patients (n = 32,625) identified using electronic health records data was pulled from a population-based sample of >50 million patients., Results: The prevalence of SUD among patients with HS was 4.0% (1315/32,625) compared to 2.0% (195,260/9,581,640) for patients without HS (P < .001). The most common forms of substance misuse among HS patients were alcohol (630/1315, 47.9% of SUD cases), followed by opioids (430/1315, 32.7% of SUD cases) and cannabis (430/1315, 29.7% of SUD cases). Patients with HS had 1.50 (95% confidence interval 1.42-1.59) times the adjusted odds of SUD compared to patients without HS. Patients with HS had significantly greater odds of SUD across demographic subgroups. The association between HS and SUD was generally stronger for patients 45 to 64 years of age, nonwhites, privately insured, and those without depressive or anxiety disorder., Limitations: SUD may not be accurately diagnosed., Conclusion: Patients with HS have higher odds of SUD and may benefit from periodic screening for substance abuse., (Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Importance: Limited evidence supports a link between hidradenitis suppurativa (HS) and Crohn disease (CD), and this relationship has not been established in the United States., Objective: To evaluate the prevalence of CD among patients with HS in the United States and to determine the strength of association between the 2 conditions., Design, Setting, and Participants: Cross-sectional analysis of data from 51 340 patients with HS identified using electronic health records data in the Explorys multiple health system data analytics and research platform, which includes data from more than 50 million unique patients across all US census regions., Main Outcomes and Measures: Primary outcome was diagnosis of CD., Results: Of the 18 455 660 total population considered, 51 340 had HS (35 000 women). Of these patients with HS, 29 010 (56.5%) were aged 18 to 44 years; 17 580 (34,2%), 45 to 64 years; and 4750 (9.3%), 65 years or older. Prevalence of CD among patients with HS was 2.0% (1025/51 340), compared with 0.6% (113 360/18 404 260) among those without HS (P < .001). Prevalence of CD was greatest among patients with HS who were white (2.3%), aged 45 to 64 years (2.4%), nonobese (2.8%), and tobacco smokers (2.3%). In univariable and multivariable analyses, patients with HS had 3.29 (95% CI, 3.09-3.50) and 3.05 (95% CI, 2.87-3.25) times the odds of having CD, respectively, compared with patients without HS. Crohn disease was associated with HS across all patient subgroups. The association was strongest for men (OR, 3.61; 95% CI, 3.24-4.03), patients aged 45 to 64 years (OR, 3.49; 95% CI, 3.16-3.85), nonobese patients (OR, 4.09; 95% CI, 3.69-4.54), and nonsmokers (OR, 3.44; 95% CI, 3.10-3.82)., Conclusions and Relevance: These data suggest that patients with HS are at risk for CD. Gastrointestinal symptoms or signs suggestive of CD warrant additional evaluation by a gastroenterologist.

Background: Few studies have evaluated the relationship between hidradenitis suppurativa (HS) and type 2 diabetes mellitus (T2DM), and the existing data show conflicting results., Objective: To determine the prevalence of T2DM among patients with HS and identify at-risk demographic subgroups., Methods: Cross-sectional analysis identifying T2DM among patients with and without HS from a demographically heterogeneous population-based sample of more than 50 million patients in the United States., Results: The overall prevalence of T2DM among patients with HS was 24.8% (10,705 of 43,105) compared with 15.6% (1,993,320 of 12,527,570) among patients without HS. The prevalence was highest among patients with HS who were male (3045 of 10,785 [28.2%]), older (1945 of 3950 [49.2%]), nonwhite (4665 of 17,495 [26.7%]), obese (9065 of 30,855 [29.4%]), tobacco smokers (6880 of 25,005 [27.5%]), hypertensive (8595 of 19,610 [43.8%]), and hyperlipidemic (7965 of 17,190 [46.3%]). In univariable and multivariable analyses, patients with HS had 1.75 (95% confidence interval [CI], 1.71-1.79) and 1.58 (95% CI, 1.54-1.62) times the odds, respectively, of having T2DM. HS was associated with T2DM across all demographic subgroups. The association was stronger for younger patients (an OR of 1.67 and 95% CI of 1.60-1.72 for ages 18-44 years vs an OR of 1.50 and 95% CI of 1.41-1.61 for ages ≥65 years)., Limitations: We lacked information on HS disease severity., Conclusion: Patients with HS with risk factors, signs, or symptoms of T2DM should be screened., (Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Polycystic ovary syndrome (PCOS) has been linked to hidradenitis suppurativa (HS). However, evidence establishing a relationship between the two conditions is limited. We sought to determine the prevalence of PCOS among patients with HS and the strength of the association. We performed a cross-sectional analysis involving 22,990 patients with HS using clinical data from a multihealth system analytics platform comprising more than 55 million unique patients across all census regions of the United States. The prevalence of PCOS among patients with HS was 9.0%, compared with 2.9% in patients without HS (P < 0.0001). The likelihood of patients with HS having PCOS was 2.14 (95% confidence interval 2.04-2.24) times that of patients without HS, and PCOS was associated with HS across all subgroups. The strength of the HS association with PCOS was similar to that of diabetes mellitus (odds ratio 2.88, 95% confidence interval 2.83-2.93) and obesity (odds ratio 3.93, 95% confidence interval 3.87-3.99) with PCOS. The influence of disease severity on the strength of association with PCOS could not be assessed, nor could an HS phenotype for patients also having PCOS. This analysis could not establish directionality of relationship, nor causal link. In conclusion, PCOS is associated with HS, and patients with HS who have symptoms or signs of androgen excess should be screened for PCOS., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Importance: The true prevalence of hidradenitis suppurativa (HS) is unknown., Objective: To establish standardized overall and group-specific prevalence estimates for HS in the United States., Design, Setting, and Participants: This retrospective analysis included a demographically heterogeneous population-based sample of more than 48 million unique patients across all US census regions. As of October 27, 2016, a total of 47 690 patients with HS were identified using electronic health record data., Main Outcomes and Measures: Standardized overall point prevalence for HS and sex-, age-, and race-specific prevalence estimates of HS in the general US population., Results: Of the 47 690 patients with HS (26.2% men and 73.8% women), the overall HS prevalence in the US population sample was 0.10%, or 98 per 100 000 persons (95% CI, 97-99 per 100 000 persons). The adjusted prevalence in women was 137 per 100 000 (95% CI, 136-139 per 100 000), more than twice that of men (58 per 100 000; 95% CI, 57-59 per 100 000; P < .001). The prevalence of HS was highest among patients aged 30 to 39 years (172 per 100 000; 95% CI, 169-275 per 100 000) compared with all other age groups (range, 15-150 per 100 000; P < .001). Adjusted HS prevalences among African American (296 per 100 000; 95% CI, 291-300 per 100 000) and biracial (218 per 100 000; 95% CI, 202-235 per 100 000) patients were more than 3-fold and 2-fold greater, respectively, than that among white patients (95 per 100 000; 95% CI, 94-96 per 100 000; P < .001)., Conclusions and Relevance: Hidradenitis suppurativa is an uncommon, but not rare, disease in the United States that disproportionately affects female patients, young adults, and African American and biracial patients.