Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Randomized Phase 3 Studies.

BACKGROUND: Atopic dermatitis (AD), a highly pruritic, inflammatory skin disease, affects approximately 7% of adolescents globally. A topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor, demonstrated safety and efficacy among adolescents/adults in two phase 3 studies (TRuE-AD1/TRuE-AD2). OBJECTIVE: To describe safety and efficacy of 1.5% ruxolitinib cream versus vehicle and long-term disease control of ruxolitinib cream among adolescents aged 12-17 years from pooled phase 3 study data. METHODS: Patients [≥ 12 years old with AD for ≥ 2 years, Investigator's Global Assessment score (IGA) 2/3, and 3-20% affected body surface area (BSA) at baseline] were randomized 2:2:1 to ruxolitinib cream (0.75%/1.5%) or vehicle for 8 weeks of continuous use followed by a long-term safety (LTS) period up to 52 weeks with as-needed use. Patients originally applying vehicle were rerandomized 1:1 to 0.75%/1.5% ruxolitinib cream. Efficacy measures at week 8 included IGA treatment success (IGA-TS; i.e., score of 0/1 with ≥ 2 grade improvement from baseline), ≥ 75% improvement in Eczema Area and Severity Index (EASI-75), and ≥ 4-point improvement in itch numerical rating scale (NRS4). Measures of disease control during the LTS period included IGA score of 0 (clear) or 1 (almost clear) and percentage affected BSA. Safety was assessed throughout the study. RESULTS: Of 1249 randomized patients, 245 (19.6%) were aged 12-17 years. Of these, 45 patients were randomized to vehicle and 92 patients to 1.5% ruxolitinib cream. A total of 104/137 (75.9%) patients continued on 1.5% ruxolitinib cream in the LTS period [82/92 (89.1%) continued on 1.5% ruxolitinib cream; 22/45 (48.9%) patients on vehicle were reassigned to 1.5% ruxolitinib cream], and 83/104 (79.8%) of these patients completed the LTS period. At week 8, substantially more patients who applied 1.5% ruxolitinib cream versus vehicle achieved IGA-TS (50.6% versus 14.0%), EASI-75 (60.9% versus 34.9%), and NRS4 (52.1% versus 17.4%; P = 0.009). The mean (SD) reduction in itch NRS scores was significantly greater in patients applying 1.5% ruxolitinib cream versus vehicle from day 2 [- 0.9 (1.9) versus -0.2 (1.4); P = 0.03]. During the LTS period, mean (SD) trough steady-state ruxolitinib plasma concentrations at weeks 12/52 were 27.2 (55.7)/15.5 (31.5) nM. The percentage of patients achieving IGA score of 0 or 1 was sustained or further increased with 1.5% ruxolitinib cream; mean affected BSA was generally low (< 3%; i.e., mild disease). Through 52 weeks, application site reactions occurred in 1.8% of adolescent patients applying 1.5% ruxolitinib cream at any time; no patients had serious adverse events. There were no serious infections, malignancies, major adverse cardiovascular events, or thromboembolic events. CONCLUSIONS: Meaningful anti-inflammatory and antipruritic effects were demonstrated with 1.5% ruxolitinib cream in the subset of adolescent patients with AD, comparable with those observed in the overall study population; long-term, as-needed use maintained disease control and was well tolerated. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifiers NCT03745638 (registered 19 November 2018) and NCT03745651 (registered 19 November 2018).

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.

Acne influences life-changing decisions among young adults.

BACKGROUND: Acne is a chronic inflammatory disease predominantly affecting young people. This study was undertaken to assess the impact of acne in young adults on their major life-changing decisions (MLCD), paying attention to the relationships between major life-changing decisions profile (MLCDP) and Quality of Life (QoL), feeling of stigmatization and acceptance of the disease. METHODS: The study was performed on 213 young people diagnosed with acne. A variety of questionnaires were employed to measure the clinical and psychological aspects of acne. RESULTS: The majority of patients (N.=148, 73.3%) reported at least one MLCD that acne affected in any way (mean number 2.9±3.2, range: 0-18). The most common MLCD influenced by acne appeared to be a decision of changing eating habits (N.=132, 65.3%), followed by changing habits associated with smoking and alcohol (N.=85, 42.1%) and deciding to be more active physically (N.=61, 30.2%). The total score of MLCDP ranged from 0 to 33 points (mean 5.41±6.23 points). MLCDP total score significantly correlated with clinical acne severity (P=0.006), QoL (P<0.001), stigmatization (P<0.001) and illness acceptance (P<0.001). CONCLUSIONS: Acne has an important impact on life-changing decisions in young adults. MLCDP correlates with impaired QoL, level of stigmatization and degree of illness acceptance. This should be taken into consideration in the holistic approach to acne patients.

Hidradenitis Suppurativa Online Documents Readability: An Analysis Including 23 European Languages.

Purpose: Hidradenitis suppurativa (HS) is a complex disease with the vast burden to patients. The aim of the study was to evaluate readability of online electronic materials dedicated to HS. Patients and Methods: The terms "hidradenitis suppurativa" and "acne inversa" translated into 23 official European Union languages were searched with Google. For each language, first 50 results were assessed for suitability. Included materials were focused on patient's education, had no barriers and were not advertisements. If both terms generated the same results, duplicated materials were excluded from the analysis. Origin of the article was categorized into non-profit, online-shop, dermatology clinic or pharmaceutical company class. Readability was evaluated with Lix score. Results: A total of 458 articles in 22 languages were evaluated. The overall mean Lix score was 57 ± 9. This classified included articles as very hard to comprehend. Across all included languages significant differences in Lix score were revealed (P < 0.001). No significant differences across all origin categories and Lix scores were observed (all P > 0.05). Conclusion: Despite the coverage of HS on the Internet, its complexity made it hard to comprehend. Dermatologist should ensure readable, barrier-free online educational materials. With adequate Google promotion, these would be beneficial for both physicians and patients.

Risk of cardiovascular disorders in hidradenitis suppurativa patients: a large-scale, propensity-matched global retrospective cohort study.

BACKGROUND: Patients with hidradenitis suppurativa (HS) often suffer from comorbid diabetes, metabolic syndrome, and hyperlipidemia and, therefore, are susceptible to the development of cardiovascular diseases (CVDs). Moreover, systemic inflammation plays a vital role in the development of atherosclerosis. The creation of atherosclerotic plaque is characterized by endothelial dysfunction driven by elevated concentrations of interleukin (IL)-1, IL-6, and IL-18 among others, as well as tumor necrosis factor (TNF) alpha. METHODS: This study aimed to assess the risk of HS patients developing CVDs. We performed a large-scale, propensity-matched global retrospective cohort study analyzing the risk of development of CVDs in patients suffering from HS. The analysis included 144,100 HS patients with 144,100 healthy controls (HC). The cohorts were matched regarding demographics and history of diseases relevant to CVDs, e.g., diabetes, obesity, and nicotine dependence. A total of 90 cardiovascular disorders were identified. The identification of cardiovascular disorders was based on ≥1% appearance of the event, based on absolute numbers, in both cohorts. RESULTS: Before the matching, HS patients displayed a higher frequency in excess weight or obesity (25 vs. 14.4%, respectively), nicotine dependence, and diabetes mellitus, but lower odds of primary hypertension in comparison to healthy controls. A total of 47 CVDs are associated with an increased risk of onset in HS patients. Although the highest hazard ratio (HR; 2.1; 95% CI: 1.95-2.269) was found for unspecified heart failure, the HS cohort was exceptionally predisposed to developing myocardial infarction (HR: 2.06; 95% CI: 1.88-2.27) and an acute embolism and deep vein thrombosis of the lower extremity (HR: 1.93; 95% CI: 1.74-2.14). CONCLUSIONS: This is the most extensive study on the association of HS with CVDs. We demonstrated that HS patients are at significantly greater risk of developing various CVDs compared to matched controls, with heart failure being the most common one.

Deciphering the enigma of itch sensation: insights and impact from a readability study.

BACKGROUND: Itch terminology is ambiguous. How itch was described in online materials and how terminology influenced the readability of these materials was previously unknown. MATERIALS AND METHODS: Two groups of search terms, itch and prurigo, were translated into five of the most prevalent European Union (EU) languages. The itch group consisted of "itch" and "pruritus." The prurigo group consisted of "prurigo," "prurigo nodularis," and "chronic prurigo". Then, a search of the terms in each language was queried in the Google search engine in the private mode of the Internet browser. The first 50 results generated were assessed for suitability. Patient education was the primary objective of the materials provided, with no barriers or advertisements included. In cases where the terms yielded identical outcomes, any duplicated materials were omitted from the analysis. When translating search terms within a group led to just one shared transcription, the results were attributed to the search term with the most similar syntax. The Lix score was utilized to assess readability. RESULTS: 314 articles in English, German, Italian, French, and Spanish were evaluated. The term "pruritus" was the most commonly used description for the sensation of itching, with 142 (45%) articles included. Overall, the mean Lix score was 54 ± 9, classifying all articles as hard to comprehend. Articles in the itch group had significantly (P < 0.001) lower mean Lix score (52 ± 9) than materials in the prurigo group (56 ± 10). CONCLUSIONS: Despite being more accessible to conceptualize, skin conditions such as prurigo had lower readability compared to information about the itch itself. The distinction between "itch" and "pruritus" was unclear.

Psychometric Evaluation of the Multidimensional Scale-Uremic Pruritus in Dialysis Patients (UP-Dial): Comparison in Hemodialysis and Peritoneal Dialysis Patients with Chronic Pruritus.

BACKGROUND: High-quality patient-reported outcome (PRO) measures for dialysis patients with chronic pruritus are urgently needed. However, no known, well-validated multidimensional tools have been investigated to measure pruritus symptoms in dialysis patients. OBJECTIVES: To examine the psychometric properties of a multidimensional tool of chronic pruritus, the Uremic Pruritus in Dialysis (UP-Dial) 14-item, by comparing hemodialysis and peritoneal dialysis modality. METHODS: This validation study used data from the Thai Renal Outcomes Research-Uremic Pruritus, a prospective, multicenter, longitudinal study. Data for this study were collected from February 1, 2019, to May 31, 2022. The adult sample of 226 hemodialysis and 327 peritoneal dialysis patients fulfilled the criteria of chronic pruritus based on the International Forum for the Study of Itch. Psychometric properties of the UP-Dial included validity and reliability, as measured across hemodialysis and peritoneal dialysis patients. Patients completed a set of anchor-based measurement tools, including global itching, Dermatology Life Quality Index (DLQI), EuroQoL-5 dimension-5 level (EQ-5D-5L), Kidney Disease Quality of Life-36 (KDQOL-36), Pittsburgh Sleep Quality Index (PSQI), global fatigue, Somatic Symptom Scale-8 (SSS-8), and Patient Health Questionnaire-9 (PHQ-9). RESULTS: From the patient's perspective, face validity was satisfactory for both dialysis samples. Psychometric analyses of the UP-Dial for each dialysis sample had good convergent validity. Spearman rho correlations indicate a positively strong correlation (0.73 to 0.74) with global itching, a positively moderate correlation (0.33 to 0.58) with DLQI, PSQI, global fatigue, SSS-8, and PHQ-9, and a negatively moderate correlation (-0.39 to -0.58) with EQ-5D-5L and KDQOL-36. The discriminant validity was satisfactory with a group of moderate and severe burden of pruritus for both dialysis samples. For scale reliability, the UP-Dial revealed excellent internal consistency (Cronbach's α = 0.89 and McDonald's ω = 0.90) and reproducibility (intraclass correlation: 0.84 to 0.85) for both dialysis samples. Regarding psychometric properties, no statistically significant differences between dialysis samples were observed (all P > 0.05). CONCLUSIONS: The findings reaffirm good measurement properties of the UP-Dial 14-items in hemodialysis and peritoneal dialysis patients with chronic pruritus. These suggest a transferability of the UP-Dial as a PRO measure in clinical trial and practice settings.

The NLRP3 Inflammasome Gene Is Overexpressed in Hidradenitis Suppurativa Lesions: A Preliminary Study on the Role of Pyroptosis in Disease Pathogenesis.

Hidradenitis suppurativa (HS) is a debilitating inflammatory skin disorder, and its pathogenesis remains incompletely understood. This study aimed to investigate the role of the P2X7 receptor (P2X7R) and NLRP3 inflammasome in HS pathogenesis. RNA sequencing and real-time PCR were performed to assess the gene expression levels of P2X7R and NLRP3 in the skin biopsies of HS patients and healthy controls (HC). The results of our study revealed a significantly increased expression of the NLRP3 gene in both the lesional and perilesional skin of HS patients compared to healthy controls. Moreover, the mRNA levels of NLRP3 were significantly higher in lesional skin compared to non-lesional skin in HS patients, indicating the spread of inflammation to adjacent tissues. In contrast, no significant differences in P2X7R gene expression were observed between the three groups. These findings suggest the involvement of NLRP3 inflammasomes in HS pathogenesis, while P2X7R may not play a significant role in the disease. This research sheds light on the complex inflammatory pathways in HS, highlighting the potential of NLRP3 as a therapeutic target. Understanding the molecular mechanisms underlying HS is crucial for the development of targeted treatment modalities for this debilitating condition.

Enhancing Quality of Life and Sexual Functioning in Female Androgenetic Alopecia: Therapeutic Potential of Hair Follicle-Derived Stem Cells.

BACKGROUND: The study aimed to examine the impact of stem cell treatment on quality of life (QoL) and sexual functioning in women with androgenetic alopecia (AGA). METHODS: Twenty-three women underwent a single session of autologous cellular micrografts (ACMs). The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) and Female Sexual Function Index (FSFI) were used before and after 6 months. RESULTS: The AGA severity decreased by an average of 1 point on the Ludwig scale (p = 0.004) after treatment. FSFI scores indicated sexual dysfunction in over half of the women at baseline, but they improved significantly post-treatment for arousal [median (IQR): 4.8 (1.5) vs. 5.10 (0.9); p = 0.035] and satisfaction [4.4 (1.4) vs. 4.8 (1.8); p = 0.025]. QoL scores improved after treatment in psychological health (57.96 ± 19.0 vs. 69.35 ± 14.0; p = 0.031) and environment (72.96 ± 13.4 vs. 81.09 ± 12.6; p = 0.007), but not in physical health and social relationships. No associations were found between the WHOQOL-BREF or FSFI domains versus age and AGA severity. CONCLUSIONS: AGA reduces QoL and impacts sexual functioning in women with AGA. The high treatment burden arises from the chronic and progressive nature of AGA, coupled with limited treatment effectiveness. Effective treatments for AGA, like ACM, are urgently needed to enhance patient-reported outcomes along with clinical results.

Extra-Anogenital Giant Cutaneous Squamous Cell Carcinomas.

Extra-anogenital giant cSCCs are rare but have worse outcomes compared to smaller tumors. Prompted by limited data, the authors conducted a retrospective study to gather more information about giant cSCCs to optimize clinical care. We identified seven cases of giant cSCCs from a review of cSCC cases treated in the Unit of Dermatosurgery between 2016 and 2022. Most patients were male (85.71%) with a mean age of 80.29 ± 12.22 years. UV radiation was the most common risk factor (five cases) followed by smoking (three cases) and hidradenitis suppurativa (one case). Most giant cases were located in the head area (71.4%) and the diameter of lesions ranged from 6 to 18 cm. All patients corresponded to tumor stage T3, and 42.86% of patients had lymph node metastases. Surgical excision was the treatment of choice in most cases (85.71%), while a combination of cemiplimab and RP1 was used in some cases due to the ineffectiveness of treatment or contraindications to other therapies. The authors emphasize the importance of early detection and prevention of modifiable risk factors, such as UV radiation, and a multidisciplinary approach to treatment. Other therapies, including immunotherapy, may become increasingly important.

Readability of Patient Electronic Materials for Atopic Dermatitis in 23 Languages: Analysis and Implications for Dermatologists.

INTRODUCTION: Patients search on the Internet for information about various medical procedures and conditions. The main aim of this study was to evaluate the readability of online health information related to atopic dermatitis (AD). Online resources are becoming a standard in facilitating shared decision-making processes. With a pipeline of new therapeutic options like immunomodulators, understanding of the complexity of AD by the patients is crucial. METHODS: The term "atopic dermatitis" translated into 23 official European Union languages was searched using the Google search engine. The first 50 records in each language were evaluated for suitability. Included materials were barrier-free, focused on patient education, and were not categorized as advertisements. Article sources were classified into four categories: non-profit, online shops, pharmaceutical companies, and dermatology clinic. Readability was assessed with Lix score. RESULTS: A total of 615 articles in Swedish, Spanish, Slovenian, Slovak, Romanian, Portuguese, Polish, Lithuanian, Latvian, Irish, Italian, Hungarian, Greek, German, French, Finnish, Estonian, English, Dutch, Danish, Czech, Croatian, and Bulgarian were evaluated. The overall mean Lix score was 56 ± 8, which classified articles as very hard to comprehend. Significant differences in mean Lix scores were observed across all included languages (all P < 0.001). Articles released by non-profit organizations and pharmaceutical companies had the highest readability (P < 0.001). Low readability level was correlated with high article prevalence (R2 = 0.189, P = 0.031). CONCLUSIONS: Although there was an abundance of online articles related to AD, the readability of the available information was low. As online health information has become essential in making shared decisions between patients and physicians, an improvement in AD-related materials is needed.

"Tattoo Characteristics and Testing for Body Dysmorphic Disorder: An Internet-based Self-questionnaire Survey of 4,809 Individuals with Tattoos".

Tattoos have become very popular worldwide in recent years. The aim of this study was to analyse a group of people interested in having tattoos, and screen them for body image disturbances. This cross-sectional self-administered internet-based survey included 4,809 individuals interesting in having tattoos. The majority of the study population were female (79.1%). The survey was conducted using a self-created questionnaire and the Body Dysmorphic Disorder Questionnaire - Dermatology version. Most tattoos in the study group were located on the forearms and hands (28.1%). The most popular motifs were plants (17.5%) and animals (16.9%). Out of 4,809 individuals, 19.9% had problems with acceptance of some parts of their body and 9.8% were screened for body dysmorphic disorder with the Body Dysmorphic Disorder Questionnaire - Dermatology version. Four percent of individuals reported that tattoos helped to improve their own perception of the appearance of their body by distracting attention from the other problems. Limitations of this study include possible participant selection bias and the overrepresentation of women. In conclusion, clinicians may expect to see more patients with tattoos and, of these, approximately 10% may be screened for body dysmorphic disorder.

Five decades of the use of botulinum toxin in ophthalmology.

Botulinum toxin (BoNT) has been known for over 50 years. It has conquered many areas of medicine and has become indispensable in contemporary medicine. Now, BoNT is used to treat at least 26 conditions in six medical specialties. Although the use of BoNT began in strabology, it became the gold standard for many ophthalmologic pathologies. The present review of the literature focuses on the use of BoNT in ophthalmology and treatment of the following conditions: blepharospasm, facial hemispasm, facial palsy, spastic entropion, strabismus, endocrine orbitopathy, convergence spasm, and facial trauma. We conclude that nearly half a century of experience in utilizing BoNT in ophthalmology ensured a satisfactory level of effectiveness and safety for patients with many pathologies. Areas of future research include the application of BoNT in new selected indications, the development of the route of application without injections, and the development of long-acting BoNT forms for patients who require repeated long-term treatment.

Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase III POETYK trials.

BACKGROUND: In the phase III POETYK PSO-1 and PSO-2 trials, deucravacitinib, an oral selective allosteric tyrosine kinase 2 inhibitor, was well tolerated and efficacious over 1 year in patients with psoriasis. OBJECTIVE: To evaluate deucravacitinib safety and efficacy over 2 years in patients participating in the phase III trials. METHODS: In the POETYK long-term extension (LTE), an ongoing phase IIIb open-label trial, adults with moderate-to-severe plaque psoriasis who completed PSO-1 or PSO-2 receive deucravacitinib 6 mg once daily. Safety was assessed via adverse events (AEs) and laboratory parameter abnormalities. Efficacy endpoints, including ≥ 75% reduction from baseline Psoriasis Area and Severity Index score (PASI 75) and static Physician's Global Assessment (sPGA) score of 0/1 (clear/almost clear), were evaluated in patients originally randomized to deucravacitinib, patients who crossed over from placebo at week 16 and patients who achieved PASI 75 at week 24 (peak efficacy). RESULTS: At data cutoff (1 October 2021), 1519 patients had received at least one dose of deucravacitinib; 79.0% and 39.9% had ≥ 52 weeks and ≥ 104 weeks of total deucravacitinib exposure, respectively. Exposure-adjusted incidence rates (EAIRs) per 100 person-years were similar at 1 year and 2 years for any AEs (229.2 vs. 154.4, respectively), serious AEs (5.7 vs. 6.1), discontinuations (4.4 vs. 2.8), deaths (0.2 vs. 0.4), serious infections (1.7 vs. 2.6), herpes zoster (0.9 vs. 0.8), major adverse cardiovascular events (0.3 vs. 0.4), venous thromboembolic events (0.2 vs. 0.1) and malignancies (1.0 vs. 0.9). EAIRs for COVID-19 infections were higher at 2 years than at 1 year (5.1 vs. 0.5) owing to the peak of the global COVID-19 pandemic occurring during the LTE. No clinically meaningful changes from baseline or trends were observed over 2 years in haematological, chemistry or lipid parameters. Clinical responses were maintained in patients who received continuous deu-cravacitinib treatment from baseline [PASI 75: week 52, 72.4%; week 112, 79.7%; sPGA 0/1: week 52, 57.9%; week 112, 61.1% (as observed)]. Responses at week 52 were also maintained in placebo crossovers and in week-24 PASI-75 responders. CONCLUSIONS: Deucravacitinib maintained efficacy and demonstrated consistent safety with no new safety signals observed through 2 years.

Psoriasis is a chronic inflammatory skin condition. Many available treatments for psoriasis are injected, but can be inadequate in terms of effectiveness, and/or cause serious side-effects. Deucravacitinib is a recently approved oral medicine that interferes with an enzyme involved in inflammation called 'tyrosine kinase 2' (TYK2). Deucravacitinib has been shown to improve psoriatic patches and symptoms (such as itching) through 1 year in two global clinical trials in adults with moderate-to-severe plaque psoriasis (POETYK PSO-1 and PSO-2). This study was an analysis of the safety and efficacy of deu­cravacitinib for up to 2 years. To do this, the researchers used data from approximately 1500 people who completed both trials and continued into an ongoing, long-term extension trial (POETYK LTE). Overall, there were no new side-effects, and the number, type and severity of side-effects, as well as the number of patients who stopped treatment because of these side-effects, remained low. The most frequent side-effects included common cold symptoms and COVID-19. Rates of shingles and serious side-effects were comparable to rates reported in the real world. Improvements in psoriasis symptoms seen at 1 year were maintained for up to 2 years in patients receiving deucravacitinib treatment from the start of PSO-1 or PSO-2, or who crossed over from placebo to deucravacitinib at 4 months. Long-term treatment with deucravacitinib improved psoriasis symptoms and resulted in mostly mild side-effects. The study findings suggest that deucravacitinib could be a well-tolerated and effective treatment for people with psoriasis.

Hidradenitis Suppurativa Is Associated with Severe Sexual Impairment.

INTRODUCTION: Hidradenitis suppurativa (HS) is a chronic inflammatory disorder of the pilosebaceous unit, often affecting and deforming intimate regions. HS is associated with severe pain, pruritus, and constant, purulent, malodorous discharge expected to impair sexual health of patients. METHODS: We performed a cross-sectional, multicentric study involving 199 German patients from the health services research project "Epidemiology and Care in Acne inversa (EpiCAi)." The sexual health, HS severity, and quality of life of the studied group were evaluated using a specially designed questionnaire. RESULTS: Regardless of gender, HS has an enormous impact on patients' sexual health. The patients scored, on average, 28.8 ± 5.3 points on the Relation and Sexuality Scale (RSS). Multiple linear regression revealed that females and patients with Hurley III stage had higher sexual dysfunction (p = 0.012). Sexual dysfunction is associated with pain (ß = 0.25), the number of active lesions, the affected areas (ß = 0.14), and psychosocial aspects, including low quality of life (ß = 0.404), stigmatization (ß = 0.411), depression (ß = 0.413), and anxiety (ß = 0.300). Patients already see a substantial decrease in sexual frequency in the early stages of HS, while functional impairment and fear increase with the severity of the disease. CONCLUSION: Sexual health and management of its dysfunctions should be part of a holistic approach to HS patients.

Short-Term Clinical Assessment of Treating Female Androgenetic Alopecia with Autologous Stem Cells Derived from Human Hair Follicles.

BACKGROUND: Androgenetic alopecia (AGA) is the most common form of alopecia, but treatment options are limited. This study evaluated clinical improvement in hair condition in women with AGA six months after a single injection of autologous cell micrografts (ACMs) containing hair follicle stem cells and dermal papilla cells. METHODS: Twenty-three women with clinically and dermoscopy-confirmed AGA were included. Five 2.5 mm punch biopsies were taken from the skin of each patient with the Regenera device. The cell suspension was prepared with the Rigeneracons device and then injected into the hormone-dependent hairy zone of the scalp. RESULTS: A significant improvement was observed on the visual analog scale (VAS) when comparing pre- and post-procedure photos (p < 0.001). The change in VAS scores was moderately negatively correlated with baseline ferritin concentration and positively with iron concentration. Improved outcomes were associated with higher baseline levels of sex hormone-binding globulin and 17α-hydroxyprogesterone. Neither testosterone nor DHT showed a significant correlation with VAS scores. CONCLUSIONS: The ACM procedure was shown to be both safe and effective, yielding satisfying results six months after a single treatment session. Future investigations should aim to gather evidence that enables the development of a cost-effective approach while minimizing treatment burden and costs.