Oral health-related quality of life in subjects with hidradenitis suppurativa suffering from periodontitis.

Introduction: Hidradenitis suppurativa (HS) is a chronic inflammatory disorder affecting the pilosebaceous unit in intertriginous body areas, and recent research suggests an association with periodontitis. Aim: To assess oral health-related quality of life (OHRQoL) in patients with HS diagnosed additionally with periodontitis and to compare it to patients with periodontitis alone. Material and methods: The study involved 55 HS patients, with 25 in the HS + P group (both HS and periodontitis) and matched controls in the periodontitis-only group (P group). Outcomes were assessed using the Oral Health Impact Profile (OHIP-14) questionnaire. Results: No significant difference was observed in the mean OHIP-14 total score between the HS + P group and the P group. Patients with HS + P were less likely to undergo the dental evaluation and floss their teeth less frequently compared to the P group. Conclusions: The findings reveal that the coexistence of HS in patients with periodontitis does not significantly influence OHRQoL. Lower dental evaluation frequency and less frequent flossing in HS+P patients suggest reduced attention to oral health practices.

"One blade, two cuts?" A multidisciplinary survey investigating practice variability of scalpel blade change for simultaneous excision of multiple skin lesions in the same patient.

BACKGROUND: Skin cancer incidence increases globally, requiring effective preventive measures and evidence-based treatment strategies. Current guidelines advocate for surgical excision as a first-line treatment for most early skin cancers. The study investigated practices regarding changing scalpel blades when excising multiple skin lesions in the same patient during the same visit (CSB) and explored how beliefs about iatrogenic seeding influence individual norms of practice. METHODS: A multidisciplinary survey was conducted among 173 medical specialists involved in skin cancer care. Participants provided demographic information, years of experience, and practices regarding CSB in four clinical scenarios (first excised tumor: basal cell carcinoma, squamous cell carcinoma, melanoma suspect, and evident melanoma). Practice variations based on specialty, experience, and beliefs about seeding risk were statistically assessed. RESULTS: Surgeons exhibited a significantly higher tendency to change blades compared to non-surgeons across all diagnoses. Iatrogenic seeding (56.52%) and clinical training (18.84%) were the main reasons provided for CSB. Beliefs about seeding risk did not differ significantly between specialties. CONCLUSIONS: Although the practice of CSB lacks strong scientific rationale, the approach to this practice significantly varies among different medical specialties. Healthcare professionals should critically evaluate and standardize evidence-based practices to ensure optimal patient care and mitigate potential harm.

Basal Cell Carcinoma: Comprehensive Review with Emphasis on Scar Tissue Manifestation and Post-Vaccination Incidence.

Basal cell carcinoma (BCC) arising within scar tissue is a rare but clinically significant phenomenon. This comprehensive review aims to provide a succinct overview of the current state of knowledge regarding the etiological factors, pathogenesis, clinical presentation, and management of BCC. This study constitutes a literature review pertaining to BCC, with a particular emphasis on BCC developing within scar tissue. It also provides a clinical case presentation of a patient who had developed BCC in a BCG post-vaccination scar and a review of analogous findings available in the existing literature. Despite the fact that an array of mechanisms play a role in injury-related BCC growth, the main mechanism remains ambiguous and yet to be elucidated. The review also includes a detailed description of the various therapeutic options available for BCC, ranging from surgical interventions to novel pharmacological treatments. By examining these intersections, the review seeks to elucidate the potential mechanisms, identify risk factors, and suggest considerations for clinical practice. The findings underscore the importance of vigilant dermatological assessment in patients with scar tissue and those recently vaccinated, aiming to improve early detection and optimize management strategies for BCC.

Psychological Aspects of Cutaneous Pain in Psoriasis.

Introduction: Psoriasis is a chronic inflammatory disease that negatively impacts patients' quality of life (QoL) and mental health. Itch and pain are prevalent symptoms of psoriasis and contribute to the psychosocial burden of this disease. This study aimed to evaluate the impact of skin pain on the prevalence and severity of symptoms of anxiety and depression and on the QoL in psoriasis patients. Methods: The studied population comprised 106 adults with psoriasis (34% female; mean age 42.1 ± 13.0 years). Disease severity was measured with the Psoriasis Area and Severity Index (PASI). The intensity of skin pain was assessed with the NRS and the Short Form McGill Pain Questionnaire (SF-MPQ). The Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) questionnaires were used to estimate the severity of depression and anxiety, respectively, as was the Hospital Anxiety and Depression Scale (HADS). Quality of life (QoL) was studied using the Dermatology Life Quality Index (DLQI). Results: Regarding anxiety assessment, females reported significantly higher scores with the HADS-A (8.42 ± 4.85 points vs. 5.14 ± 3.9 points; p < 0.001) and the GAD-7 compared to men (7.50 ± 5.58 points vs. 5.24 ± 4.79 points; p = 0.036). Similarly, the severity of depression was significantly higher in women, as measured with the PHQ-9 (7.50 ± 5.58 points vs. 5.24 ± 4.79 points, p = 0.021). Psoriasis patients with skin pain scored significantly higher in HADS Total score (p = 0.043), HADS-A (p = 0.022), PHQ-9 (p = 0.035), and DLQI (p < 0.001) than the rest of the studied group. The intensity of skin pain measured with the SF-MPQ correlated significantly with HADS Total score (p = 0.021), HADS-A (p < 0.001), HADS-D (p = 0.038), and PHQ-9 (p < 0.001). Additionally, there was a significant correlation between the intensity of cutaneous pain assessed using the VAS and the PHQ-9 (p = 0.022). Conclusions: Skin pain significantly influences the well-being of patients with psoriasis as well as the symptoms of anxiety and depression. In particular, women with psoriasis are at increased risk of developing anxiety and depression. Our findings underline the necessity for a multidisciplinary approach to the management of this dermatosis.

Chronic Itch Affects Patients' Ability to Experience Pleasure: Anhedonia in Itchy Disorders.

Anhedonia, the reduced ability to experience pleasure, is a prevalent symptom in various psychiatric disorders, but has not been investigated in dermatological conditions, particularly those characterized by chronic itch. This study aimed to examine the prevalence and clinical correlates of anhedonia in patients with chronic itch. A cross-sectional study was conducted in 137 patients with chronic itch, classified according to the International Forum for the Study of Itch (IFSI) classification. Anhedonia was assessed using the Snaith-Hamilton Pleasure Scale (SHAPS) and Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS). Itch severity, quality of life, and psychological distress were assessed using the Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), ItchyQoL, and Hospital Anxiety and Depression Scale (HADS), respectively. The mean SHAPS score was 1.0 ± 1.7 points, and the mean ACIPS total score was 76.9 ± 16.2 points. In the study sample, 13.1% of patients were identified as anhedonic, with a higher prevalence observed in those with severe and very severe itch. Anhedonia was significantly correlated with itch severity (R = 0.2, p=0.02 for 24 h VASmean and SHAPS; R = 0.2, p = 0.01 for 24 h VASmax and SHAPS), anxiety symptoms (R = 0.3, p < 0.001 for SHAPS and HADS-anxiety), depression symptoms (R = 0.4, p < 0.001 for SHAPS and HADS-depression), and impairment in quality of life (R = 0.2, p = 0.014 for SHAPS and ItchyQoL). Anhedonia is a significant and prevalent aspect of psychological distress in patients with chronic itch. Addressing this symptom may not only improve patients' overall mental health but also enhance the effectiveness of treatments for chronic itch. Future research is needed to elucidate further the mechanisms underlying the relationship between anhedonia and chronic itch and to develop targeted interventions for this population.

Approach to Mycosis Fungoides in children: Consensus-based recommendations.

BACKGROUND: Pediatric Mycosis fungoides (MF) management extrapolates from adult guidelines, despite differing clinical aspects. Recommendations are essential to address unique challenges in this distinct patient group. OBJECTIVE: This project aims to derive consensus recommendations for pediatric MF management. METHODS: Experts from pediatric dermatology, general dermatology, dermatopathology, and pediatric hematology-oncology (N = 83) were invited to contribute to consensus recommendations. The process involved 3 electronic Delphi rounds, concluding with a final consensus meeting using a modified Nominal Group Technique for unresolved items. RESULTS: Consensus included more clinical severity measures than tumor-node-metastasis-blood staging: pruritus, functional or esthetic impairment (eg, palms, soles, genitalia), quality of life impact, and psychological aspects (eg, embarrassment, anxiety, depression), plus parental anxiety. Ten recommendations were made for managing early and advanced pediatric MF. Disagreement emerged in choosing therapies beyond stage I of the disease. DISCUSSION: This multinational initiative aimed to standardize optimal pediatric MF management and successfully generated consensus recommendations. Additional work is needed for structured, prospective protocols in advanced-stage pediatric MF. LIMITATIONS: Lack of pediatric hematologists-oncologists and patients' representatives. CONCLUSION: Documentation of extended clinical severity and outcome measures is recommended. Addressing the need for structured protocols in advanced-stage pediatric MF and implementing systematic, prospective data collection is crucial.

Arterial Vascularization of the Forehead in Aesthetic Dermatology Procedures: A Review.

Background: The growing popularity of aesthetic procedures on the face raises the question of their safety. The forehead region is crucial aesthetically, but due to its abundant vascularization, it is also one of the most dangerous areas for dermatologic procedures, especially in the glabella area. The purpose of this article is to review the literature on the arterial vascularization of the forehead to identify potential high-risk zones for aesthetic dermatology procedures. Methods: A database search (PubMed, Web of Science, Scopus, and Embase) was conducted, and the titles and abstracts of all identified studies were screened, followed by full-text evaluation. Results: We identified 714 articles during the database search, and 25 articles were included in the review. The included studies used cadaveric dissection and computed tomography applied to cadavers as well as Doppler ultrasonography on volunteers to evaluate the forehead arteries (supratrochlear (STrA), supraorbital (SOA), central (CA), paracentral artery (PCA), and frontal branch of superficial temporal artery(FBSTA)). A total of 1714 cases involving the forehead arteries were analyzed. The included arteries were observed over a relatively large area, and their locations varied. The CA and PCA in cadaver studies were observed in an area of 0.2 to 10.8 mm and 0.8 to 16.2 mm, respectively, on the entire path from the glabellar point to the frontal prominence point. The distances from the midline in cadaveric studies at various measurement points ranged from 0.6 to 28.0 mm for the superficial branch of the STrA and 13.6 to 40.7 mm for the deep branch of STrA. In case of SOA, the distance from the midline ranged from 23 to 32 mm. Measurements from the midline in Doppler studies ranged from 0 to 23 mm for STrA and from 10 to 50 mm for the SOA. In studies using computed tomography, STrA was observed at a distance of 11 to 21 mm and the SOA at a distance of 21 to 32 mm, both lateral to the midline. Conclusions: Medical professionals should be aware of zones where frontal arteries are more likely to be encountered. The glabella region appears to be one of the most dangerous areas for dermatologic procedures. It is believed that the supratrochlear, supraorbital, and the paracentral arteries may cause ophthalmic complications due to occlusion of the ophthalmic artery, while this risk for the frontal branch of the superficial temporal artery seems to be low but cannot be completely excluded.

Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials.

BACKGROUND: Nemolizumab, an interleukin (IL)-31 receptor subunit α antagonist, inhibits the IL-31 pathway of itch and skin inflammation in atopic dermatitis. Two international phase 3 studies were done to assess the efficacy and safety of nemolizumab in atopic dermatitis. In this Article we report results for the 16-week initial treatment period of both trials. METHODS: ARCADIA 1 and ARCADIA 2 were identical 48-week randomised, double-blind, placebo-controlled phase 3 trials in adult and adolescent participants (aged ≥12 years) with moderate-to-severe atopic dermatitis, associated pruritus, and inadequate response to topical steroids. Participants were enrolled from 281 clinics, hospitals, and academic centres in 22 countries across both trials, and were randomly assigned (2:1) to receive nemolizumab 30 mg subcutaneously (baseline loading dose 60 mg) or matching placebo once every 4 weeks with background topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI; ie, TCS-TCI background treatment). Randomisation was done via interactive response technology and stratified by baseline disease and pruritus severity. Study staff and participants were masked throughout the study, with outcome assessors masked until database lock. Coprimary endpoints at week 16 post-baseline were Investigator's Global Assessment (IGA) success (score of 0 [clear skin] or 1 [almost clear skin] with a ≥2-point improvement from baseline) and at least 75% improvement in Eczema Area and Severity Index score from baseline (EASI-75 response). Outcome rates were compared between groups with the Cochran-Mantel-Haenszel test adjusting for randomisation strata. The key secondary endpoints were the proportion of participants with Peak Pruritus Numerical Rating Scale (PP-NRS) score improvement of at least 4 points at weeks 1, 2, 4, and 16; PP-NRS score below 2 at weeks 4 and 16; Sleep Disturbance Numerical Rating Scale score improvement of at least 4 points at week 16; EASI-75 response plus PP-NRS score improvement of at least 4 points at week 16; and IGA success plus PP-NRS score improvement of at least 4 points at week 16. Efficacy analyses were done on an intention-to-treat basis; safety analyses included all participants who received one dose of nemolizumab or placebo. Both studies are completed (ClinicalTrials.gov: ARCADIA 1, NCT03985943 and ARCADIA 2, NCT03989349). FINDINGS: Between Aug 9, 2019, and Nov 2, 2022, 1728 participants were enrolled across both trials: 1142 were allocated to nemolizumab plus TCS-TCI (620 in ARCADIA 1 and 522 in ARCADIA 2) and 586 to placebo plus TCS-TCI (321 in ARCADIA 1 and 265 in ARCADIA 2). ARCADIA 1 included 500 (53%) male participants and 441 (47%) female participants, and ARCADIA 2 included 381 (48%) male participants and 406 (52%) female participants. Mean age ranged from 33·3 (SD 15·6) years to 35·2 (17·0) years across the treatment groups. Both trials met the coprimary endpoints; at week 16, a greater proportion of participants receiving nemolizumab plus TCS-TCI versus placebo plus TCS-TCI had IGA success (ARCADIA 1: 221 [36%] of 620 vs 79 [25%] of 321, adjusted percentage difference 11·5% [97·5% CI 4·7-18·3], p=0·0003; ARCADIA 2: 197 [38%] of 522 vs 69 [26%] of 265, adjusted difference 12·2% [4·6-19·8], p=0·0006) and an EASI-75 response (ARCADIA 1: 270 [44%] vs 93 [29%], adjusted difference 14·9% [7·8-22·0], p<0·0001; ARCADIA 2: 220 [42%] vs 80 [30%], adjusted difference 12·5% [4·6-20·3], p=0·0006). Significant benefits were observed with nemolizumab for all key secondary endpoints including improvement in itch, as early as week 1, and sleep improvement by week 16. The safety profile was similar between nemolizumab plus TCS-TCI and placebo plus TCS-TCI. In the safety sets, 306 (50%) of 616 participants (ARCADIA 1) and 215 (41%) of 519 participants (ARCADIA 2) who received nemolizumab plus TCS-TCI had at least one treatment-emergent adverse event (serious treatment-emergent adverse events in six [1%] and 13 [3%], respectively); and 146 (45%) of 321 (ARCADIA 1) and 117 (44%) of 263 (ARCADIA 2) who received placebo plus TCS-TCI had at least one treatment-emergent adverse event (serious treatment-emergent adverse events in four [1%] and three [1%], respectively). Ten serious treatment-emergent adverse events possibly related to nemolizumab were reported in five (1%) participants in ARCADIA 2. No deaths occurred. INTERPRETATION: Nemolizumab plus TCS-TCI was efficacious and showed statistically and clinically significant improvements in inflammation and itch in adults and adolescents with moderate-to-severe atopic dermatitis. Nemolizumab might offer a valuable extension of current therapies if approved. FUNDING: Galderma.

Quality of life measurement in assessing treatment effectiveness in urticaria: European experts position statement.

In this study, the European Academy of Dermatology and Venereology (EADV) Task Forces on Quality of Life and Patient-Oriented Outcomes and Urticaria and Angioedema has examined the Health-Related Quality of Life (HRQoL) measurement in the treatment of urticaria. The Dermatology Life Quality Index was the most frequently used HRQoL instrument in clinical trials on urticaria. Many reports of clinical trials of urticaria gave no exact numeric results related to HRQoL changes, making clear conclusions and comparisons with other studies impossible. The interpretation of HRQoL impairment data is more difficult when assessed by instruments without severity stratification systems. The minimal clinically significant difference (MCID) is a more clinically oriented and relevant parameter than depending on statistically significant changes in HRQoL scores. Therefore, using HRQoL instruments with established MCID data in clinical trials and clinical practice is preferred.

Profound Sexual Dysfunction Among Patients with Hidradenitis Suppurativa: A Cross-sectional Study.

INTRODUCTION: Sexual health, a critical aspect of overall well-being, is often compromised in individuals with chronic disorders. Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that mainly affects intertriginous areas, potentially impacting sexual health as a result of its specific symptoms and psychosocial burden. METHODS: This cross-sectional study utilized data from the EpiCAi project, focusing on 199 patients with HS. Participants completed digital questionnaires assessing sexual health via sex-specific instruments: the Female Sexual Function Index (FSFI) for women and the International Index of Erectile Function (IIEF) for men, alongside different psychosocial scales. The disease severity was assessed using the Hurley stage and the Lesion Identification Scheme for Acne Inversa (LISAI). RESULTS: The majority of the participants reported impaired sexual health, with significant clinical sexual dysfunctions noted in 71.8% of women (FSFI score < 26) and erectile dysfunction in 63.8% of men. Sexual dysfunction was associated with several factors, including age, and marital status. Psychosocial factors, notably depression and quality of life, showed strong correlations with sexual health outcomes. Notably, women over 40 and those treated with biologics reported more severe dysfunction, while among men, employment status significantly influenced sexual health. CONCLUSIONS: HS profoundly affects the sexual health of both male and female patients, with significant impacts on their quality of life and psychological well-being. The findings underscore the necessity for healthcare providers to address sexual health proactively in the management of HS, considering both physical symptoms and psychosocial impacts. This holistic approach is essential for improving patient outcomes and overall quality of life. TRIAL REGISTRATION: German Register for Clinical Trials, identifier DRKS00025315.

Insights into Gut Microbiome Composition in Hidradenitis Suppurativa: A Comprehensive Examination of Dietary Habits and Environmental Influences.

This study explores the relationship between dietary habits, environmental influences, and gut microbiome composition in individuals with hidradenitis suppurativa (HS), a chronic inflammatory skin condition. A cohort of 80 participants, equally divided into HS patients and healthy controls, was assessed through comprehensive questionnaires capturing demographics, dietary habits, and other health-related information. Fecal samples were collected and analyzed using next-generation sequencing to examine microbiome composition. Despite previous studies suggesting gut dysbiosis in HS, this research found no significant differences in alpha-diversity and Shannon diversity index between the groups. However, significant disparities in dietary habits were observed, with HS patients showing higher sugar and milk consumption. The study also identified a significant correlation between coffee consumption and the presence of certain bacterial genera. While the study did not reveal major differences in microbiome diversity, the findings on dietary habits and specific microbiome components suggest potential targets for therapeutic intervention. These results underscore the importance of further research into the gut-skin axis and its role in HS, aiming to enhance management strategies through dietary modifications and lifestyle interventions.

Cutaneous Sarcoidosis Induced by Laser Therapy: Case Report and Review of the Literature.

BACKGROUND: Sarcoidosis, characterized by non-caseating epithelioid granulomas, presents diagnostic and therapeutic challenges. METHOD: Here we present a 38-year-old woman who exhibited erythematous and infiltrated skin lesions on her facial region following fractional laser treatment. RESULTS: Histological analysis confirmed cutaneous sarcoidosis. Initial interventions with topical clobetasol and oral chloroquine provided transient relief. Subsequent outpatient management comprised topical tacrolimus and clobetasol, as well as systemic methotrexate, later substituted with prednisone. Gradual tapering resulted in lesion reduction. CONCLUSIONS: This case underscores the intricate nature of cutaneous sarcoidosis and the necessity for personalized therapeutic approaches. The association with cosmetic procedures highlights the importance of understanding potential triggers. The presented case highlights and reminds the medical community that lasers are not only used for therapeutic purposes but can also induce specific responses through laser therapy. Notably, while laser therapy is frequently employed in treating cutaneous sarcoidosis, its role in inducing sarcoidosis warrants further investigation.

Clinical Characteristics of Cutaneous Pain in Psoriasis.

Background: Psoriasis is a common inflammatory disease that is often associated with itch and pain. This study aimed to evaluate the clinical characteristics of skin pain among patients with psoriasis. Materials: A total of 106 patients diagnosed with psoriasis were included in the study (34% female; mean age 42.1 ± 13.0 years). Disease severity was assessed using the Psoriasis Area and Severity Index (PASI). Itch severity was evaluated using the numeric rating scale (NRS) and 4-Item Itch Score (4IIS). The intensity of skin pain was measured through the NRS, short-form McGill pain questionnaire (SF-MPQ), visual analog scale (VAS), and Douleur Neuropathique-4 questionnaire (DN4). Results: In the past week, 84.9% of psoriasis patients reported itch, while 50% of them reported skin pain. The average NRS for itch was 4.52 ± 2.88 points, and the 4IIS yielded a mean score of 6.79 ± 4.37 points. In terms of the intensity of cutaneous pain, the mean NRS was 2.42 ± 2.96 points; the SF-MPQ score averaged 4.84 ± 7.51 points; and the VAS score was 1.92 ± 2.65 points. Furthermore, 17% of adult psoriasis patients reported neuropathic pain. In 84.9% of the participants, skin pain was concurrent with areas affected by itch, while 18.9% of patients exhibited cutaneous pain encompassing all itchy areas. The pain NRS demonstrated significant correlations with the SF-MPQ (r = 0.531, p < 0.001), VAS (r = 0.779, p < 0.001), itch NRS (r = 0.551, p < 0.001), and 4IIS (r = 0.569, p < 0.001). No association was found between the pain NRS and PASI or disease duration. Conclusions: Skin pain of mild intensity and itch of moderate intensity are prevalent symptoms in psoriasis patients. Strong correlations between skin pain and itch can be explained by the process of neurogenic inflammation.

Real-world effectiveness and safety of the LAight-therapy in patients with hidradenitis suppurativa.

BACKGROUND AND OBJECTIVES: Hidradenitis suppurativa (HS)/Acne inversa (Ai) is a chronic debilitating disease with limited therapy options. The device-based LAight therapy was approved in Europe in 2017. The aim of this study was to evaluate the effect of real-world care with at least one treatment with LAight therapy on disease activity and burden in 3,437 patients. PATIENTS AND METHODS: Patients were included in the analysis if they had a diagnosis of HS and received at least one treatment. The endpoints Hidradenitis Suppurativa Severity Score System (IHS4), pain on the numeric rating scale (pain-NRS) and Dermatology Life Quality Index (DLQI) were analyzed using a linear mixed model for repeated measures (MMRM) over 26 weeks of care with LAight therapy. Furthermore, responder rates were calculated for all endpoints, and the therapy's safety profile and patient satisfaction were thoroughly examined. RESULTS: A significant decrease in IHS4, pain-NRS, and DLQI was achieved during 26 weeks of care with LAight. The BMI at baseline had a significant negative effect on therapy response for pain-NRS and DLQI. CONCLUSIONS: This study confirms that LAight therapy leads to satisfactory disease control in all stages of severity and is a valuable addition to the therapeutic repertoire of HS.

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.

Italian S3-Guideline on the treatment of Atopic Eczema - Part 1: Systemic therapy, adapted from EuroGuiDerm by the Italian Society of Dermatology and STD (SIDEMAST), the Italian Association of Hospital Dermatologists (ADOI) and the Italian Society of Allergological and Environmental Dermatology (SIDAPA).

SIDeMaST (Società Italiana di Dermatologia Medica, Chirurgica, Estetica e delle Malattie Sessualmente Trasmesse) contributed to the development of the present guideline on the systemic treatment of chronic plaque psoriasis. With the permission of EuroGuiDerm, SIDeMaST adapted the guideline to the Italian healthcare context to supply a reliable and affordable tool to Italian physicians who take care of patients affected by atopic dermatitis. The evidence- and consensus-based guideline on atopic eczema was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. This first part of the guideline includes general information on its scope and purpose, the health questions covered, target users and a methods section. It also provides guidance on which patients should be treated with systemic therapies, as well as recommendations and detailed information on each systemic drug. The systemic treatment options discussed in the guideline comprise conventional immunosuppressive drugs (azathioprine, ciclosporin, glucocorticosteroids, methotrexate and mycophenolate mofetil), biologics (dupilumab, lebrikizumab, nemolizumab, omalizumab and tralokinumab) and janus kinase inhibitors (abrocitinib, baricitinib and upadacitinib). Part two of the guideline will address avoidance of provocation factors, dietary interventions, immunotherapy, complementary medicine, educational interventions, occupational and psychodermatological aspects, patient perspective and considerations for pediatric, adolescent, pregnant and breastfeeding patients.

Italian S3-Guideline on the treatment of Atopic Eczema - Part 2: non-systemic treatments and treatment recommendations for special AE patient populations, adapted from EuroGuiDerm by the Italian Society of Dermatology and STD (SIDEMAST), the Italian Association of Hospital Dermatologists (ADOI) and the Italian Society of Allergological and Occupational Dermatology (SIDAPA).

SIDeMaST (Società Italiana di Dermatologia Medica, Chirurgica, Estetica e delle Malattie Sessualmente Trasmesse) contributed to the development of the present guideline on the systemic treatment of chronic plaque psoriasis. With the permission of EuroGuiDerm, SIDeMaST adapted the guideline to the Italian healthcare context to supply a reliable and affordable tool to Italian physicians who take care of patients affected by atopic dermatitis. The evidence- and consensus-based guideline on atopic eczema was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. This second part of the guideline includes recommendations and detailed information on basic therapy with emollients and moisturizers, topical anti-inflammatory treatment, antimicrobial and antipruritic treatment and UV phototherapy. Furthermore, this part of the guideline covers techniques for avoiding provocation factors, as well as dietary interventions, immunotherapy, complementary medicine and educational interventions for patients with atopic eczema and deals with occupational and psychodermatological aspects of the disease. It also contains guidance on treatment for pediatric and adolescent patients and pregnant or breastfeeding women, as well as considerations for patients who want to have a child. A chapter on the patient perspective is also provided. The first part of the guideline, published separately, contains recommendations and guidance on systemic treatment with conventional immunosuppressive drugs, biologics and janus kinase (JAK) inhibitors, as well as information on the scope and purpose of the guideline, and a section on guideline methodology.

Italian S3-Guideline on the treatment of Atopic Eczema - First Update, adapted from EuroGuiDerm by the Italian Society of Dermatology and STD (SIDEMAST), the Italian Association of Hospital Dermatologists (ADOI) and the Italian Society of Allergological and Occupational Dermatology (SIDAPA).

The evidence- and consensus-based guideline on atopic eczema, published in JEADV on 18 August 2022 (part 1) and 3 September 2022 (part 2) was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. Four consensus conferences were held between December 2020 and July 2021. Twenty-nine experts (including clinicians and patient representatives) from 12 European countries participated. To reflect the most recent evidence on novel systemic medications, an update was published in October 2022. According to the purpose of the Italian Society of Dermatology and STD (SIDEMAST), the Italian Association of Hospital Dermatologists (ADOI) and the Italian Society of Allergological and Environmental Dermatology (SIDAPA) to adapt the EuroGuiDerm guideline on the treatment of atopic eczema into the Italian Healthcare setting, the original update has been supplemented by inserting notes, well highlighted by the original text, to emphasize the laws, rules, procedures and suggestions of the Italian Ministry of Health and regional Health authorities.

Exploring pharmacological treatment for trichotillomania: do we need better education?

BACKGROUND: Trichotillomania, also known as hair-pulling disorder, is a chronic psychiatric condition with a fluctuating course in which an individual pulls out their hair, leading to visible hair loss and psychosocial sequelae. Due to the unknown pathogenesis, the treatment of this disorder is complex and remains a challenge for dermatologists and psychiatrists. Since guidelines for treating trichotillomania are lacking and, consequently, no common treatment strategy exists, we decided to perform a large-scale, global retrospective cohort study to assess the characterized real-world prescription patterns in treating trichotillomania. METHODS: The research used the TrinetX database for patients with trichotillomania (ICD 10 - F63.3) within the European and the United States Collaborative Network (EC and UC, respectively). After consulting with a psychodermatology expert, a list of 25 medications was investigated. RESULTS: Data on the prescription drugs of 1,275 patients from the EC and 109,741 patients from the UC were collected. In both the EC and UC cohorts, benzodiazepine derivatives, particularly lorazepam and midazolam, were the most commonly prescribed sedatives/hypnotics. Antipsychotic prescriptions, primarily haloperidol, followed benzodiazepines. After the trichotillomania diagnosis, notable changes in drug prescriptions for the EC cohort, including an increased likelihood of receiving acetylcysteine, haloperidol, quetiapine, sertraline, olanzapine, and risperidone were observed. The UC cohort showed minimal changes. Overall, both cohorts leaned toward benzodiazepine prescriptions (37% UC, 21% EC) and had limited antidepressant usage. Haloperidol (19.3%) and quetiapine (15.1%) were commonly prescribed in both cohorts. CONCLUSIONS: The results of our study indicate that the real-world prescription patterns for trichotillomania differ significantly from the expert-proposed therapeutic approach and point toward the necessity of creating standards of pharmacological care and better education.