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OBJECTIVE: While clinical trials provide invaluable evidence, real-world data can offer further insight on the efficacy and safety of biologic drugs. This report aims to analyze the long-term efficacy and safety of ixekizumab in real-world clinical practice in our facility. PATIENTS AND METHODS: Patients with a diagnosis of psoriasis and who started treatment with ixekizumab were included in this retrospective study and followed for 156 weeks. The severity of cutaneous manifestations was evaluated using the PASI score at several time points and clinical efficacy was evaluated using PASI 75, -90 and -100 responses. RESULTS: Not only PASI 75, but also PASI 90 and 100 responses showed a favorable outcome after treatment with ixekizumab. Responses at week 12 were sustained through the following three years in the majority of patients. No statistically significant difference was found between bio-naive and bioswitch patients and weight and disease duration had no impact on the efficacy of the drug. Ixekizumab had a favorable safety profile, as we observed no major adverse events. Two cases of eczema were observed and led to drug discontinuation. CONCLUSIONS: This study confirms the efficacy and safety of ixekizumab in real-world clinical practice. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Heterogeneous real-world evidence can complement the more strictly regulated clinical trial data. A benefit of this is the wide range of backgrounds, comorbidities and characteristics that can give additional insights into treatments. Observational, retrospective studies can help to fill in the mosaic that makes up a treatments landscape. Tildrakizumab, an interleukin 23p19 inhibitor, is approved for the treatment of plaque psoriasis and has been shown to be a safe and efficacious therapy in clinical trials and emerging real-world evidence. We aimed at confirming the efficacy of tildrakizumab in patients with plaque psoriasis in a dual center setting and identifying patients' characteristics leading to better treatment response. PATIENTS AND METHODS: Patients with moderate to severe plaque psoriasis, eligible for systemic biological treatment, and treated with tildrakizumab were included in the study and the routine clinical parameters - Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and safety - were retrospectively analyzed. RESULTS: The combined cohorts included 89 patients, of which 64% were naïve to biologic therapies. At the time of analysis efficacy assessment was available for 39 patients after 12 months of treatment, 73 patients after 36 weeks, 79 patients after 16 weeks and 82 patients after 4 weeks. PASI and DLQI decreased significantly over time, with 52/73 (71.2%) patients achieving PASI 100 after 36 weeks. No severe side-effects were recorded in association with tildrakizumab. CONCLUSIONS: We confirmed the safety and efficacy of tildrakizumab in a real-world clinical setting. A higher proportion of patients naïve to biologics achieved a greater PASI response than patients who had previously been treated with biologics. The same was true for older patients and patients with a shorter history of disease. [ABSTRACT FROM AUTHOR]

Background: As one of the main goals of hip and knee replacements is to improve patients' health-related quality of life, a meaningful evaluation can be achieved by calculating minimal important changes (MICs) for improvements in patient-reported outcome measures (PROMs). This study aims at providing MICs adjusted for patient characteristics for EQ-5D-3L index score improvements after hip and knee replacements. It adds to existing literature by relying on a large national sample and precise clustering algorithms, and by employing a state-of-the-art methodology for the calculation of improved adjusted MICs., Methodology: A retrospective observational study was conducted using the publicly available National Health Service (NHS) PROMs dataset for primary hip and knee replacements. We used information on 252,331 hip replacements and 279,668 knee replacements from all NHS-funded providers in England between 2013 and 2020. Clusters of patients were created based on pre-operative EQ-VAS, depression status, and sex. Unstratified and stratified estimates for meaningful EQ-5D-3L improvements were obtained through anchor-based predictive MICs corrected for the proportion of improved patients and the reliability of transition ratings., Results: Stratifying patients showed that MICs varied across subgroups based on pre-operative EQ-VAS, depression status, and sex. MICs were larger for patients with worse pre-operative EQ-VAS scores, while patients with better pre-operative scores required smaller MICs to achieve a meaningful change. We show how after stratification the percentage of patients achieving their stratified MIC was better in line with the actual share of improved patients. Larger MICs were found for patients with depression and for female patients. MICs calculated for knee replacements were consistently lower than those for hip replacements., Conclusions: Our findings show the importance of adjusting MICs for patients' characteristics and should be considered for quality-related choices and policy initiatives., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors have no relevant financial or non-financial interests to disclose., (© 2024. The Author(s).)

Background: A clinical dashboard is a data-driven clinical decision support tool visualizing multiple key performance indicators in a single report while minimizing time and effort for data gathering. Studies have shown that including patient-reported outcome measures (PROMs) in clinical dashboards supports the clinician's understanding of how treatments impact patients' health status, helps identify changes in health-related quality of life at an early stage, and strengthens patient-physician communication., Objective: This study aims to determine design components for clinical dashboards incorporating PROMs to inform software producers and users (ie, physicians)., Methods: We conducted interviews with software producers and users to test preselected design components. Furthermore, the interviews allowed us to derive additional components that are not outlined in existing literature. Finally, we used inductive and deductive coding to derive a guide on which design components need to be considered when building a clinical dashboard incorporating PROMs., Results: A total of 25 design components were identified, of which 16 were already surfaced during the literature search. Furthermore, 9 additional components were derived inductively during our interviews. The design components are clustered in a generic dashboard, PROM-related, adjacent information, and requirements for adoption components. Both software producers and users agreed on the primary purpose of a clinical dashboard incorporating PROMs to enhance patient communication in outpatient settings. Dashboard benefits include enhanced data visualization and improved workflow efficiency, while interoperability and data collection were named as adoption challenges. Consistency in dashboard design components is preferred across different episodes of care, with adaptations only for disease-specific PROMs., Conclusions: Clinical dashboards have the potential to facilitate informed treatment decisions if certain design components are followed. This study establishes a comprehensive framework of design components to guide the development of effective clinical dashboards incorporating PROMs in health care practice., (©Anja Yvonne Bischof, David Kuklinski, Irene Salvi, Carla Walker, Justus Vogel, Alexander Geissler. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 02.10.2024.)

Background: Healthcare workers have a fundamental role in providing care and education on sexually transmitted infections (STIs). However, their knowledge is often worryingly limited. This study aimed to assess the real knowledge and attitude regarding STIs among healthcare workers of the IRCCS Ospedale Policlinico San Martino, Genoa, Italy., Methods: The recruited subjects were asked to complete a 31-item questionnaire, divided into 3 sections: socio-demographic context, knowledge about STIs, and personal sexual behavior., Results: We enrolled 140 subjects, employed as nurses (52.9%), physicians (12.9%), laboratory technicians (7.1%), or other workers (27.1%). Despite the generalized erroneous belief of having a good level of knowledge on the matter, only one-third of the subjects could correctly identify STIs among a list of diseases, and less than one-third correctly recognize all possible ways of transmission. Human immunodeficiency virus (HIV) was the most frequently recognized STI (97%), but only 39.2% of healthcare workers were correctly informed about the body fluids that can transmit the virus. Most participants (93.5%) correctly identified condoms as effective in preventing STIs but did not indicate complete abstinence as the only way to guarantee protection against STIs. Most participants were informed on the oncogenic potential of human papillomavirus (HPV) infections (82%), the usefulness of the Pap test (85.7%), and the existence of vaccines against some STIs (63.5%)., Conclusions: Overall, healthcare workers have limited knowledge about STIs. Creating specific educational programs aimed at healthcare providers should become a priority.

Introduction: The efficacy and safety of tildrakizumab for the treatment of plaque psoriasis were demonstrated by randomized clinical studies, but the reappraisal of prolonged experiences in the clinical practice helps to optimize the use of this biologic drug. The aim of this study was to evaluate the long-term efficacy of tildrakizumab in patients with moderate-to-severe psoriasis in the real world., Methods: This is a long-term retrospective observational study in a real-life setting. Overall, 136 adult patients with moderate-to-severe plaque psoriasis and treated with tildrakizumab were included., Results: One hundred percent reduction of Psoriasis Area Severity Index (PASI100) was reached by 21.7% of patients at 4 weeks of therapy and by 51.2% at week 16, and the proportion of patients with this improvement was between 66.9% and 64.5% from 36 weeks to 3 years. The mean PASI of the cohort progressively improved from 12.6 at baseline to 1.8 at week 36 and was stable at 1 year, 2 years and 3 years. We could not confirm a previous observation that patients naïve to biologic had a better response, but we observed that those with a short history of psoriasis had a higher probability of 90% PASI reduction (PASI90) or PASI 100 within 36 weeks, suggesting that early treatment could be useful., Conclusion: This long-term observation in the real life of patients with moderate-to-severe plaque psoriasis receiving tildrakizumab 100 mg showed that PASI100 can be obtained in a high proportion of patients by week 36 and be maintained for up to 3 years., (© 2024. The Author(s).)

Immune-mediated comorbidities in patients with psoriasiform eczema are common. It can be challenging to manage multiple immune-mediated diseases, especially considering that biologic treatments are prone to causing paradoxical effects. The aim of this retrospective observational case series was to describe the course of both psoriasiform eczema and immune-mediated comorbidities in five patients treated with upadacitinib for psoriasiform dermatitis. Five patients, all male, were included. All the patients suffered from psoriasiform eczema. Moreover, two of the patients suffered from alopecia areata, two from vitiligo, one from ulcerative colitis and one from hidradenitis suppurativa. In all cases, the treatment with upadacitinib was rapidly effective on the eczema. The effectiveness on alopecia areata was good in both cases, while the results on vitiligo were only partial. The only case of ulcerative colitis achieved complete remission, while the case of hidradenitis suppurativa experience partial improvement. In conclusion, upadacitinib was effective in treating not only psoriasiform eczema, but also several immune mediated comorbidities. Additional studies are necessary to determine the efficacy of upadacitinib in alopecia areata, vitiligo and hidradenitis suppurativa., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Salvi, Parodi, Cozzani and Burlando.)

Background: The increased proliferation of Demodex mites in the pilosebaceous unit can be the cause of rosacea flare-ups on the face. Signs and symptoms of the scalp (e.g., itching, dandruff) have sometimes been reported in patients with papulopustular rosacea of face; they may be due to a proliferation of Demodex mites on the scalp., Methods: To study the Demodex mites count, a standardized skin surface biopsy was performed on the cheek and on the scalp. Microscopic examination and molecular identification of Demodex were performed. Pearson's χ 2 Test or Fisher's Exact Test were used to test for any association between categorical variables and outcome., Results: Patients affected by papulopustular rosacea had a greater frequency of Demodex-positive standardized skin surface biopsy than controls at the scalp (35.0% vs. 0%, P=0.033), at the face and/or at the scalp (50% vs. 10%, P=0.032). Demodex positive patients with a Demodex-positive face sample were more frequently found to have a Demodex-positive scalp sample (P=0.035). The predominant species was found to be Demodex folliculorum (92.6% of samples); the species Demodex brevis was identified only in 7.4% of samples., Conclusions: Demodex folliculorum is more frequently found on the scalp and face of patients with rosacea than controls, even though it is not statistically associated with scalp symptoms. The scalp may be a reservoir area for Demodex mites which could migrate on the face again after an acaricidal treatment.

Background: Trypanophobia or "needle phobia" represents a potential hindrance to the effective management of chronic diseases whenever an injectable therapy might be required, especially in case of frequent administrations. Psoriasis, a chronic dermatologic disease, can be effectively treated with biologic drugs administered subcutaneously. Thankfully, anti-IL-23 drugs require few administrations per year and are available in prefilled pens that hide the needle, thus representing a convenient option in patients with trypanophobia., Methods: An observational multicentric study was conducted on patients with moderate-to-severe psoriasis who were treated with 75 mg × 2 risankizumab prefilled syringe therapy for more than 6 months and reported a loss of efficacy measured by the Psoriasis Area and Severity Index (PASI) from PASI 90 to PASI 75 attributed to a reduction of adherence due to trypanophobia. The patients were switched to 1 prefilled pen of risankizumab 150 mg and asked to fill out the Self-Injection Assessment Questionnaire (SIAQ) before and after the injection at week 0 and at the following administration after 12 weeks. Subjects scored each item of the SIAQ on a 5-point scale, scores were later transformed from 0 (worst experience) to 10 (best experience)., Results: Twenty-two patients were enrolled. The mean SIAQ predose domain scores were 5.5 for feelings about injection, 6.2 for self-confidence, and 6.4 for satisfaction with self-injection. After dose scores were higher (> 8.5) for each of the six domains at Week 0 and even higher after 12 weeks (> 9.0)., Conclusions: User-friendly devices, such as prefilled pens, and a lower number of injections improved patient satisfaction in a group of patients with psoriasis on treatment with biologic drugs. We believe that treatment adherence could be positively influenced by such changes in the way of administration of a biologic treatment., (© 2024 The Author(s). Skin Research and Technology published by John Wiley & Sons Ltd.)

Demodex mite proliferation is frequently involved in the pathogenesis of rosacea. The gold standard for Demodex identification is microscopic examination on a standardized skin surface biopsy. However, this method of sampling can be distressing and painful, especially when performed on hairy sites. In this case-control study, we compared the sensitivity of PCR and microscopic examination in diagnosing a Demodex infestation. Moreover, we investigated the possible correlations between the presence of Demodex mites and clinical characteristics. In total, 20 patients affected by papulopustular rosacea and 10 controls were included. At both microscopic examination and PCR, patients with rosacea presented a greater prevalence of positive samples than controls at the scalp and at the face. Microscopy had sensitivity of 50% at the face and of 46.7% at the scalp. PCR had sensitivity of 93.75% at the face and of 86.7% at the scalp. The positivity of PCR was associated to a higher frequency of facial papules and pustules. Patients with positivity at the face had a more frequent positivity at the scalp. The scalp could represent a reservoir for the Demodex mites, and should be investigated by sensitive and painless methods. PCR performed on painlessly collected samples should be further investigated., (© 2024. The Author(s).)

Background: Conventional photodynamic therapy (c-PDT) is an effective treatment for actinic keratoses (AKs) and nonmelanoma skin cancer which exploits the photosensitizing properties of methyl aminolaevulinate (MAL). Daylight photodynamic therapy (DL-PDT) is an alternative to c-PDT which does not require the application of MAL in occlusion and that is better tolerated by patients. The impact of occlusion on the efficacy of DL-PD has not been investigated by previous studies., Objective: To compare the efficacy and tolerability of occlusive and non-occlusive DL-PDT., Methods: We conducted a prospective intraindividual left/right comparison study. AKs of the face or scalp were marked in two symmetrical treatment areas. The two target areas were randomly assigned to DL-PDT with occlusive and non-occlusive application of MAL. The efficacy and cosmetic outcome were determined by a "blinded" investigator., Results: Lesions in occluded areas showed a better response in the clearance rate of the lesions (65.5% vs 35.0 %, p < 0.001 %), and cosmetic outcome (P < 0.001). There was no difference in phototoxicity or pain between occluded and non-occluded areas., Conclusion: The occlusive application of MAL improves the efficacy of DL-PDT in clearing AKs and does not increase the incidence of side effects., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Introduction: During the COVID-19 pandemic, personal protective equipment, particularly face masks, became an essential requirement to engage in various activities. Several articles reported an increase of recurrences of dermatologic facial diseases (ie, acne, rosacea) related to mask use., Objectives: To evaluate the number of recurrences of rosacea related to face mask use., Methods: This prospective study was conducted on adult patients with a pre-pandemic diagnosis of mild and moderate papulopustular rosacea. All patients had previously achieved either partial or complete remission after a 4-month treatment with topical ivermectin in 2019. We collected data in two different phases characterized by different intensity of mask use during the pandemic and post-pandemic period. We collected data through clinical assessment of the disease, questionnaires on personal habits and standardized skin surface biopsy to study the Demodex mites count., Results: We enrolled a total of 30 patients. In the pandemic period, 5/30 patients had a relapse of mild papulopustular rosacea; the Demodex sample resulted positive in 4/5 relapsed patients. In the post-pandemic period, 4/30 patients reported a relapse of mild rosacea (3 patients) and moderate papulopustular rosacea (1 patient). At the Demodex exam, 1/4 relapsed patients resulted positive., Conclusions: We did not find a significant increase in relapses of papulopustular rosacea during the pandemic. An appropriate anti-parasitic treatment may reduce the number of recurrences due to mask use.

Atopic dermatitis and psoriasis are traditionally considered diseases that cannot coexist, since they are described as the result of the activation of opposing inflammatory pathways. However, this belief has been debunked, and numerous cases of psoriasis induced by dupilumab, a biologic treatment for atopic dermatitis, have been reported. We report three cases of dupilumab-induced psoriasis and we present a literature review including cases of "de novo" psoriasis and of the relapse of psoriasis that occurred during treatment with dupilumab. In total, 39 publications met the inclusion criteria, including 112 AD patients, 101 of whom developed "de novo" psoriasis, and 11 with a flare of pre-existent psoriasis. In the first group, patients more frequently developed plaque psoriasis on the scalp and extremities, after an average latency period from the initiation of dupilumab of 5 months. In the second group, the incidence of dupilumab-induced relapses of psoriasis was 43%, after an average of 4 months since the first administration. The most common psoriasis type was plaque psoriasis, with the involvement of the scalp and upper extremities. Dupilumab was interrupted in 38% of patients with "de novo" psoriasis and in 50% of relapsed patients, leading, in most cases, to an improvement of psoriasis. In conclusion, atopic dermatitis and psoriasis can definitely co-exist, and biologic drugs used to treat the former can promote the latter. It is thus crucial to perform a careful personal and familiar anamnesis before prescribing any biologic treatment. Moreover, a study of cytokine expression and blood proteomic markers could be considered in these patients.

Facial follicular scales, dandruff, scalp itching and ocular alterations are lesser-known signs of rosacea and demodicosis. The aim of this prospective original study was to investigate the presence of these signs and symptoms in patients with almost-clear, mild and moderate papulopustular rosacea (PPR) and to study the differences between Demodex-positive (D+) and Demodex-negative (D-) rosacea. Twenty-seven out of 60 patients (45%) presented follicular scales, 24 (40%) ocular involvement and 22 (36.67%) scalp involvement. Follicular scales were more frequently observed in mild and moderate than in almost-clear rosacea (P<0.001). Itching of the scalp was more frequently reported in patients with moderate rosacea than in those with mild disease (P=0.05). Follicular scales (P=0.002) and scalp itching (P=0.05) were more frequently reported in D+ than in D- patients. Among D+ patients, scalp itching was more frequently reported in mild than in almost clear rosacea (P=0.01) and ocular symptoms associated to scalp itching were more frequently reported in moderate than in almost-clear rosacea (P=0.05). We suggest looking for these signs and symptoms in all patients with PPR, because they can be a sign of a more severe form of rosacea or of demod-icosis., Competing Interests: Conflict of interest: the authors declare no potential conflict of interest., (Copyright © 2024, the Author(s).)

Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: Xerosis is an extremely common condition, especially in the elderly population. It is the most common cause of pruritus in the older adult. Since xerosis is generally caused by a lack of epidermal lipids, the use of leave-on skin care products is the mainstay treatment. The aim of this open prospective analytical observational study was to investigate the clinical and self-reported hydrating efficacy of a moisturizer formulation containing a synergy between amino-inositol and urea (INOSIT-U 20) in patients with psoriasis and xerosis., Methods: Twenty-two patients with psoriasis successfully treated with biologic therapy, and who presented xerosis, were recruited. Each patient was instructed to apply the topical with a frequency of two applications per die on the identified skin area. Corneometry values and a VAS itch questionnaire were measured at baseline (T0) and after 28 days (T4). To evaluate the cosmetic efficacy, the volunteers also completed a self-assessment questionnaire., Results: Comparing Corneometry values at T0 and T4, a statistically significant increase value was observed in the area subjected to topical treatment (P<0.0001). A significant decrease in itch (P=0.001) was also observed. Moreover, the patients' ratings of the cosmetic properties of the moisturizer showed significant confirmation rates., Conclusions: This study provides preliminary evidence that INOSIT-U20 provides a good hydrating effect on xerosis, further reducing self-reported itch.

Competing Interests: None disclosed.

Objectives: Risk factors for acute respiratory infections (ARIs) in community settings are not fully understood, especially in low-income countries. We examined the incidence and risk factors associated with ARIs in under-two children from the Microbiota and Health study. Methods: Children from a peri-urban area of Dhaka (Bangladesh) were followed from birth to 2 years of age by both active surveillance of ARIs and regular scheduled visits. Nasopharyngeal samples were collected during scheduled visits for detection of bacterial facultative respiratory pathogens. Information on socioeconomic, environmental, and household conditions, and mother and child characteristics were collected. A hierarchical modeling approach was used to identify proximate determinants of ARIs. Results: Of 267 infants, 87.3% experienced at least one ARI episode during the first 2 years of life. The peak incidence of ARIs was 330 infections per 100 infant-years and occurred between 2 and 4 months of age. Season was the main risk factor (rainy monsoon season, incidence rate ratio [IRR] 2.43 [1.92-3.07]; cool dry winter, IRR 2.10 [1.65-2.67] compared with hot dry summer) in the first 2 years of life. In addition, during the first 6 months of life, young maternal age (<22 years; IRR 1.34 [1.01-1.77]) and low birth weight (<2,500 g; IRR 1.39 [1.03-1.89]) were associated with higher ARI incidence. Conclusions: Reminiscent of industrialized settings, cool rainy season rather than socioeconomic and hygiene conditions was a major risk factor for ARIs in peri-urban Bangladesh. Understanding the causal links between seasonally variable factors such as temperature, humidity, crowding, diet, and ARIs will inform prevention measures., Competing Interests: KV, AP, IS, MS, FF, HB, and OS are or were the employees of Société des Produits Nestlé S A at the time this work was performed. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Vidal, Sultana, Patron, Salvi, Shevlyakova, Foata, Rahman, Deeba, Brüssow, Ahmed, Sakwinska and Sarker.)

Brown widow spider (BrWS) (Latrodectus geometricus) venom produces intense systemic reactions such as cramps, harsh muscle nociceptive, nauseas, vomiting and hypertension. The proposed pathogenic mechanisms resulting in these accidents have principally been damages occurring at the nervous system. However, it is suspected that there is also damage of the adrenal glands, as a result of the experimental animal's clinical manifestations, which developed symptoms compatible with acute adrenal insufficiency. We have currently found that the adrenal gland is damaged by this venom gland homogenates (VGH) producing severe alterations on cortex cells resulting in death by acute adrenal insufficiency. In general, the ultrastructural study on the glands of mice under transmission electronic microscopy observations showed alterations in the majority of the intracellular membranes within 3 to 24h. BrWSVGH also showed specific actions on extracellular matrix proteins such as fibronectin, laminin and fibrinogen. In addition, zymogram experiments using gelatin as substrates detected gelatinolytic activity. The molecular exclusion fractionation of crude BrWSVGH resulted in 15 fractions, of which F1 and F2 presented alpha/beta-fibrinogenase and fibronectinolytic activities. Fractions F6, F14 and F15 showed only alpha-fibrinogenase activity; in contrast, the gelatinolytic action was only observed in fraction F11. Only metalloproteinase inhibitors abolished all these proteolytic activities. Our results suggest that adrenal cortex lesions may be relevant in the etiopathogenesis of severe brown widow spider envenoming. To our knowledge, this is the first report on adrenal gland damages, fibrinogenolytic activity and interrelations with cell-matrix adhesion proteins caused by L.geometricus VGH. The venom of this spider could be inducing hemostatic system damages on envenomed patients.