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Background: The limited therapies available for treating Merkel cell carcinoma (MCC), a highly aggressive skin neoplasm, still pose clinical challenges, and novel treatments are required. Targeting retinoid signalling with retinoids, such as all‐trans retinoic acid (ATRA), is a promising and clinically useful antitumor approach. ATRA drives tumour cell differentiation by modulating retinoid signalling, leading to anti‐proliferative and pro‐apoptotic effects. Although retinoid signalling is dysregulated in MCC, ATRA activity in this tumour is unknown. This study aimed to evaluate the impact of ATRA on the pathological phenotype of MCC cells. Methods: The effect of ATRA was tested in various Merkel cell polyomavirus‐positive and polyomavirus‐negative MCC cell lines in terms of cell proliferation, viability, migration and clonogenic abilities. In addition, cell cycle, apoptosis/cell death and the retinoid gene signature were evaluated upon ATRA treatments. Results: ATRA efficiently impaired MCC cell proliferation and viability in MCC cells. A strong effect in reducing cell migration and clonogenicity was determined in ATRA‐treated cells. Moreover, ATRA resulted as strongly effective in arresting cell cycle and inducing apoptosis/cell death in all tested MCC cells. Enrichment analyses indicated that ATRA was effective in modulating the retinoid gene signature in MCC cells to promote cell differentiation pathways, which led to anti‐proliferative and pro‐apoptotic/cell death effects. Conclusions: These results underline the potential of retinoid‐based therapy for MCC management and might open the way to novel experimental approaches with other retinoids and/or combinatorial treatments. [ABSTRACT FROM AUTHOR]

Background: Pemphigus, an autoimmune blistering disease that affects the skin and mucous membranes, significantly impairs the quality of life (QoL) of affected individuals. While there are a variety of QoL measurement tools available for assessing this disease, there is a lack of studies that specifically evaluate the sexual QoL of patients with pemphigus. Objectives: This case–control study aims to investigate the impact of the disease on sexual activity as well as its overall effect on QoL. Materials and Methods: Fifty pemphigus patients, who were referred to the Dermatology Department at the University Hospital of Brescia in the period March 2019–September 2021, completed several QoL surveys, including the 36‐item Short Form Health survey (SF‐36), the 12‐Item General Health Questionnaire (GHQ‐12), the Autoimmune Bullous Disease Quality of Life (ABQOL) and either the International Index of Erectile Function (IIEF) or the Female Sexual Function Index (FSFI). The severity of the disease was assessed using the Pemphigus Disease Area Index (PDAI). Differences in QoL surveys between the case and control groups were analysed using either the t‐test or the Wilcoxon–Mann–Whitney test. The correlation between QoL surveys in pemphigus patients and disease severity were analysed using Spearman's coefficient (r). Results: The results revealed a marked impairment in overall QoL among patients with pemphigus compared to the healthy control subjects. Significant differences were observed in various domains of QoL, including physical health, mental well‐being, social functioning and, notably, sexual health. Furthermore, disease severity as evaluated by the PDAI showed correlations with specific aspects of health status, and disease‐specific QoL demonstrated associations with nearly all domains of health status. No significant correlations were found between sexual activity, mucosal involvement or steroid therapy and PDAI scores or disease‐specific QoL measures. Conclusion: These findings emphasize the significant impact of pemphigus on patients' well‐being, with particular attention to the impaired sexual activity. [ABSTRACT FROM AUTHOR]

This article discusses the use of line-field confocal optical coherence tomography (LC-OCT) as a new tool for assessing cutaneous mycosis fungoides (MF), the most common variant of cutaneous T-cell lymphoma. The early diagnosis of MF is challenging and often results in a therapeutic delay. LC-OCT allows for the visualization of various features of MF, such as epidermal architectural disarray, atypical lymphocytes, and dermal changes. The study demonstrates that LC-OCT has a high correlation with histology and can provide valuable information for the diagnosis and follow-up of MF. [Extracted from the article]

This article reports on a study that investigated the long-term efficacy and safety of tralokinumab, a treatment for moderate-to-severe atopic dermatitis (AD), in adult patients. The study followed 171 AD patients for up to 52 weeks and found that 96.5% of patients were still using tralokinumab at the end of the study. There was a significant improvement in AD symptoms, including a decrease in Eczema Area and Severity Index (EASI) scores, itch, sleep loss, and improvement in quality of life. Adverse events were generally mild, with conjunctivitis being the most common. The study suggests that tralokinumab is a well-tolerated and effective long-term treatment option for AD. [Extracted from the article]

This article discusses the treatment of dermatofibrosarcoma protuberans (DFSP), a rare type of skin cancer. DFSP mainly affects young and middle-aged adults and appears as a flat plaque that slowly progresses into a raised nodule. The most effective treatment for DFSP is Mohs micrographic surgery (MMS) or conventional surgery with wide margins. The study compared the efficacy of slow MMS to wide margin excision (WLE) in 83 DFSP patients and found that slow MMS required fewer interventions and had no relapses, suggesting its effectiveness in achieving surgical radicality. The authors plan to continue using slow MMS for DFSP treatment. [Extracted from the article]

Pyoderma gangrenosum triggered by COVID-19 vaccination in a patient with ulcerative colitis: a case report. Given the absence of any other significant medical history, the patient's relapse was believed to be triggered by the COVID-19 vaccination, and the patient chose not to receive the scheduled third dose. In this case report, we describe a patient with a history of PG, which had been in remission for several years prior to vaccination that experienced a recurrence of PG at the same sites as the previous involvement. [Extracted from the article]

Given these premises, LC-OCT appears to be very useful in the differential diagnosis of MCC. RCM en-face (c) and LC-OCT horizontal sections (d) showing hyporeflective nests (red circle) of monomorphous cells (red asterisks) outlined by bright collagen septa (yellow arrows). Line-field confocal optical coherence tomography, thanks to its cellular resolution, its depth of penetration and its tridimensional view, seems to be very useful for the early diagnosis of MCC, allowing it to be differentiated from other clinically and dermoscopically similar tumours. [Extracted from the article]

Atopic dermatitis (AD) represents the most common dermatosis in humans with a lifetime prevalence of up to 20% and a significant impact on health-related quality of life.[1] Several systemic treatments are available for moderate-to-severe AD, including cyclosporin, methotrexate, glucocorticoids, azathioprine, mycophenolate mofetil and dupilumab.[2] Dupilumab, a fully human monoclonal antibody that binds interleukin (IL)-4Ra, because of its very favourable efficacy and safety profile is rapidly replacing the traditional systemics.[[3]] Real-life data on dupilumab long-term survival and the associated predictors are scarce,[[5], [7]] and no studies have analysed dupilumab drug survival for longer than 3 years yet. By the data lock, 319 patients (87.9%) were still using dupilumab, 44 patients (12.1%) had discontinued dupilumab treatment, 11 of whom due to ineffectiveness, 20 due to adverse effects, 5 owing to pregnancy, 8 owing to AD remission and 5 patients (1.3%) were lost to follow up. [Extracted from the article]

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 paediatric 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. [ABSTRACT FROM AUTHOR]

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 paediatric, adolescent, pregnant and breastfeeding patients. [ABSTRACT FROM AUTHOR]

This article discusses a case of isolated cutaneous crystal-storing histiocytosis (CSH) and its dermatoscopic findings. CSH is a rare condition where crystalline material accumulates within macrophages. It is usually associated with a lymphoplasmacytic neoplasm or inflammatory diseases. The article presents the case of a 60-year-old man with a plaque on his elbow, which was excised and found to have histopathological features consistent with CSH. Dermoscopy was found to be valuable in diagnosing the condition. The article concludes that considering CSH in the differential diagnosis of orange-yellowish lesions is important. [Extracted from the article]

This article discusses the efficacy of upadacitinib in treating a case of resistant lupus erythematosus tumidus (LET). LET is a rare variant of cutaneous lupus erythematosus characterized by erythematous, non-scarring plaques and photosensitivity. The patient in this case study had previously tried various treatments, including steroids, with limited success. However, after starting upadacitinib treatment, the patient achieved complete remission of the disease within two months. Upadacitinib is an orally administered Janus kinase inhibitor that targets the JAK-STAT pathway involved in immune-mediated inflammatory diseases. This case suggests that upadacitinib may be a promising treatment option for LET when standard therapies are ineffective. Further research is needed to validate these findings. [Extracted from the article]

Patients on DMF had used systemic therapies for psoriasis, including biologics, more frequently than patients under other systemic treatments (73.4% vs. 50.7%, I P i = 0.003). DMF may be the preferred choice for multi-failure psoriasis patients with treatment-emergent side-effects, due to its favourable long-term safety profile. When comparing patients on DMF versus patients under other systemic treatments through cumulative PASI75 up to the first therapy discontinuation, we found, from month 9 onwards, a slightly superior improvement in the DMF group, although without any statistically significant difference (Figure 1). [Extracted from the article]

Most reactions consist in injection site adverse events, although reports about generalized exanthemas, urticaria, chilblain-like lesions, autoimmune diseases and severe acute adverse reactions are growing.[[1]] We report a case of interstitial granulomatous dermatitis developed after the (m-RNA)-1273 vaccine and recurring after booster. Dear Editor, Cutaneous reactions to messenger RNA (mRNA)-1273 SARS-CoV-2 vaccine had an important impact on dermatology practice, posing diagnostic and therapeutic challenges. BNT162b2 mRNA COVID-19 vaccine-induced chilblain-like lesions reinforces the hypothesis of their relationship with SARS-CoV-2. [Extracted from the article]

Background: The efficacy for actinic keratosis (AK) clearance of field‐directed treatments has been investigated in randomized studies against placebo, but the comparison of results is difficult for several methodological reasons. Objectives: The present study aims to compare efficacy of MAL‐photodynamic therapy (MAL‐PDT), ingenol mebutate gel (IMB) and diclofenac plus hyaluronate gel (DHA) on multiple AKs assessing a new performance index of efficacy, the cumulative AK area and evaluating dermoscopical and high‐frequency ultrasound (HFUS) changes. Methods: Patients with ≥5 Olsen II AKs in a 25 cm2 area of the scalp and face were enrolled and randomized to one of the treatment choices. Number of AKs and cumulative area were assessed before and after treatment. Dermoscopy and HFUS were performed on a single AK and surrounding photo‐damaged skin in the treatment area. Results: Cumulative AKs area reduced significantly more with PDT compared to other treatment options and with IMB in comparison to DHA. PDT was also the only treatment option that increased at a significant level the dermal density in both target AK and the surrounding skin and decreased significantly the SLEB thickness in the perilesional skin at HFUS. Conclusions: MAL‐PDT is more effective than IMB and DHA for reducing the cumulative AK area which is calculated digitally from 3D pictures and should be the preferred performance index for the evaluation of the efficacy of treatments for AKs, rolling out clinical and dermoscopy evaluation. MAL‐PDT improves all HFUS features of chronic photodamages of the dermis of the skin underlying and surrounding the AK spots. [ABSTRACT FROM AUTHOR]

Background: Psoriasis has important physical and psychosocial effects that extend beyond the skin. Understanding the impact of treatment on health‐related quality of life (HRQoL) and patient‐perceived symptom severity in psoriasis is key to clinical decision‐making. Objectives: This post hoc analysis of the PSO‐LONG trial data assessed the impact of long‐term proactive or reactive management with fixed‐dose combination calcipotriene 50 µg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) foam on patient‐reported outcomes (PROs) in patients with psoriasis vulgaris. Methods: Five hundred and twenty‐one patients from the Phase 3, randomized, double‐blind PSO‐LONG trial were included. An initial 4‐week, open‐label phase of fixed‐dose combination Cal/BD foam once daily (QD) was followed by a 52‐week maintenance phase, at the start of which patients were randomized to a proactive management arm (Cal/BD foam twice weekly) or reactive management arm (vehicle foam twice weekly). Patient‐perceived symptom severity and HRQoL were assessed using the Psoriasis Symptom Inventory (PSI), the Dermatology Life Quality Index (DLQI) and the EuroQol‐5D for psoriasis (EQ‐5D‐5L‐PSO). Results: Statistically and clinically significant improvements were observed across all PRO measures. The mean difference (standard deviation) from baseline to Week 4 was −8.97 (6.18) for PSI, −6.02 (5.46) for DLQI and 0.11 (0.15) for EQ‐5D‐5L‐PSO scores. During maintenance, patients receiving reactive management had significantly higher DLQI (15% [p = 0.007]) and PSI (15% [p = 0.0128]) and a numerically lower EQ‐5D‐5L‐PSO mean area under the curve score than patients receiving proactive management (1% [p = 0.0842]). Conclusions: Cal/BD foam significantly improved DLQI, EQ‐5D‐5L‐PSO and PSI scores during the open‐label and maintenance phases. Patients assigned to proactive management had significantly better DLQI and PSI scores and numerically better EQ‐5D‐5L‐PSO versus reactive management. Additionally, baseline flare was associated with worse PROs than the start of a relapse, and patients starting a relapse also had worse PROs than patients in remission. [ABSTRACT FROM AUTHOR]

Genital psoriasis (GenPs) leads to numerous symptoms such as itch, pain, burning and dyspareunia; however, it is often neglected by patients and physicians.1,2 Recently, two double-blind, placebo-controlled phase IIIb studies demonstrated superiority of ixekizumab over placebo for the treatment of moderate-to-severe GenPs,3 but there are few data on anti-IL-23. Sixty percentage of patients had severe psoriasis with PASI between 18 and 25; the remaining 40% of patients had moderate psoriasis with PASI between 10 and 12, the mean sPGA-G was 3.5. Genital psoriasis awareness program: physical and psychological care for patients with genital psoriasis. [Extracted from the article]

Background: Following the first investigational study on the use of extracorporeal photopheresis for the treatment of cutaneous T‐cell lymphoma published in 1983, this technology has received continued use and further recognition for additional earlier as well as refractory forms. After the publication of the first guidelines for this technology in the JEADV in 2014, this technology has maintained additional promise in the treatment of other severe and refractory conditions in a multidisciplinary setting. It has confirmed recognition in well‐known documented conditions such as graft‐vs.‐host disease after allogeneic bone marrow transplantation, systemic sclerosis, solid organ transplant rejection including lung, heart and liver and to a lesser extent inflammatory bowel disease. Materials and methods: In order to further provide recognized expert practical guidelines for the use of this technology for all indications, the European Dermatology Forum (EDF) again proceeded to address these questions in the hands of the recognized experts within and outside the field of dermatology. This was done using the recognized and approved guidelines of EDF for this task. All authors had the opportunity to review each contribution as it was added. Results and conclusion: These updated 2020 guidelines provide at present the most comprehensive available expert recommendations for the use of extracorporeal photopheresis based on the available published literature and expert consensus opinion. The guidelines were divided into two parts: PART I covers Cutaneous T‐cell lymphoma, chronic graft‐vs.‐host disease and acute graft‐vs.‐host disease, while PART II will cover scleroderma, solid organ transplantation, Crohn's disease, use of ECP in paediatric patients, atopic dermatitis, type 1 diabetes, pemphigus, epidermolysis bullosa acquisita and erosive oral lichen planus. [ABSTRACT FROM AUTHOR]

Molluscum contagiosum is a benign viral epidermal infection associated with high risk of transmission. The guideline is focused on the sexually transmitted molluscum contagiosum. The diagnosis is clinical with characteristic individual lesions, termed 'mollusca', seen as dome‐shaped, smooth‐surfaced, pearly, firm, skin‐coloured, pink, yellow or white papules, 2 ‐ 5 mm in diameter with central umbilication. Dermoscopy may facilitate diagnosis. Therapeutic options are numerous, including physical treatments (cautery, curettage and cryotherapy), topical chemical treatments (e.g. podophyllotoxin and imiquimod) or waiting for spontaneous resolution in immunocompetent patients. In pregnancy, it is safe to use physical procedures (e.g. cryotherapy). Immunosuppressed patients develop severe and recalcitrant molluscum lesions that may require treatment with cidofovir, imiquimod or interferon. Patients with molluscum contagiosum infection should be offered to be screened for other sexually transmitted infections. [ABSTRACT FROM AUTHOR]

Background: Following the first investigational study on the use of extracorporeal photopheresis for the treatment of cutaneous T‐cell lymphoma published in 1983, this technology has received continued use and further recognition for additional earlier as well as refractory forms. After the publication of the first guidelines for this technology in the JEADV in 2014, this technology has maintained additional promise in the treatment of other severe and refractory conditions in a multi‐disciplinary setting. It has confirmed recognition in well‐known documented conditions such as graft‐versus‐host disease after allogeneic bone marrow transplantation, systemic sclerosis, solid organ transplant rejection including lung, heart and liver and to a lesser extent inflammatory bowel disease. Materials and methods: In order to further provide recognized expert practical guidelines for the use of this technology for all indications, the European Dermatology Forum (EDF) again proceeded to address these questions in the hands of the recognized experts within and outside the field of dermatology. This was done using the recognized and approved guidelines of EDF for this task. All authors had the opportunity to review each contribution as it was added. Results and conclusion: These updated 2020 guidelines provide at present the most comprehensive available expert recommendations for the use of extracorporeal photopheresis based on the available published literature and expert consensus opinion. The guidelines are divided in two parts: PART I covers cutaneous T‐cell lymphoma, chronic graft‐versus‐host disease and acute graft‐versus‐host disease while PART II will cover scleroderma, solid organ transplantation, Crohn's disease, use of ECP in paediatrics practice, atopic dermatitis, type 1 diabetes, pemphigus, epidermolysis bullosa acquisita and erosive oral lichen planus. [ABSTRACT FROM AUTHOR]

In addition to approved indications in non‐melanoma skin cancer in immunocompetent patients, topical photodynamic therapy (PDT) has also been studied for its place in the treatment of, as well as its potential to prevent, superficial skin cancers in immune‐suppressed patients, although sustained clearance rates are lower than for immune‐competent individuals. PDT using a nanoemulsion of ALA in a daylight or conventional PDT protocol has been approved for use in field cancerization, although evidence of the potential of the treatment to prevent new SCC remained limited. High‐quality evidence supports a strong recommendation for the use of topical PDT in photorejuvenation as well as for acne, refractory warts, cutaneous leishmaniasis and in onychomycosis, although these indications currently lack approvals for use and protocols remain to be optimized, with more comparative evidence with established therapies required to establish its place in practice. Adverse events across all indications for PDT can be minimized through the use of modified and low‐irradiance regimens, with a low risk of contact allergy to photosensitizer prodrugs, and no other significant documented longer‐term risks with no current evidence of cumulative toxicity or photocarcinogenic risk. The literature on the pharmacoeconomics for using PDT is also reviewed, although accurate comparisons are difficult to establish in different healthcare settings, comparing hospital/office‐based therapies of PDT and surgery with topical ointments, requiring inclusion of number of visits, real‐world efficacy as well as considering the value to be placed on cosmetic outcome and patient preference. This guideline, published over two parts, considers all current approved and emerging indications for the use of topical photodynamic therapy in Dermatology prepared by the PDT subgroup of the European Dermatology Forum guidelines committee. It presents consensual expert recommendations reflecting current published evidence. [ABSTRACT FROM AUTHOR]

Topical photodynamic therapy (PDT) is a widely approved therapy for actinic keratoses, Bowen's disease (squamous cell carcinoma in situ), superficial and certain thin basal cell carcinomas. Recurrence rates when standard treatment protocols are used are typically equivalent to existing therapies, although inferior to surgery for nodular basal cell carcinoma. PDT can be used both as lesional and field therapies and has the potential to delay/reduce the development of new lesions. A protocol using daylight to treat actinic keratoses is widely practised, with conventional PDT using a red light after typically a 3‐h period of occlusion employed for other superficial skin cancer indications as well as for actinic keratoses when daylight therapy is not feasible. PDT is a well‐tolerated therapy although discomfort associated with conventional protocol may require pain‐reduction measures. PDT using daylight is associated with no or minimal pain and preferred by patient. There is an emerging literature on enhancing conventional PDT protocols or combined PDT with another treatment to increase response rates. This guideline, published over two parts, considers all current approved and emerging indications for the use of topical PDT in dermatology, prepared by the PDT subgroup of the European Dermatology Forum guidelines committee. It presents consensual expert recommendations reflecting current published evidence. [ABSTRACT FROM AUTHOR]

Is SARS-CoV-2 screening test indicated for psoriasis patients candidate to biologic therapy? Patients and physicians may be concerned about starting a biologic treatment during the COVID-19 pandemic. Symptomatic patients In a patient with respiratory symptoms, fever or anosmia/ageusia a SARS-CoV-2 testing with RT-PCR test should be performed. [Extracted from the article]

In this period, we collected all LMs and LMMs of the face treated with staged micrographic/margin-controlled excision (SMEX).7,8 Subclinical spread of melanoma was measured relying on the number of surgical stages required to obtain clear margins. Remarkably, M1 macrophages seemed to possess pro-inflammatory and tumoricidal properties.9 Thus, melanophage/macrophage infiltration may act as a deterrent to the extension of LM along the dermo-epidermal junction of surrounding clinically unaffected skin. Lentigo maligna (LM) and lentigo maligna melanoma (LMM) are renown to present a subclinical spread that often extends widely in the surrounding photodamaged skin. [Extracted from the article]

Background: Ultrasound (US) is a real‐time non‐invasive technique that has been demonstrated to support an early diagnosis and a more precise assessment of hidradenitis suppurativa (HS). Objectives: To compare the clinical and US evaluation of a series of HS patients. Methods: 434 HS patients (259 F, 175 M; mean age 33.82 ±13.31 years) observed across 19 Italian dermatology centres [members of the Italian Ultrasound Working Group (IUWG)] were enrolled in a retrospective study. Clinical staging was obtained by the Hidradenitis Suppurativa Physician's Global Assessment score (HS‐PGA), while the ultrasonographic staging was determined by the US HS‐PGA, based on the same scores as clinical HS‐PGA but performed with the aid of US. Results: At the end of the study, the mean clinical and US HS‐PGA scores were 2.70 and 2.92, respectively. Direct comparison of clinical and ultrasonographic assessment revealed that a higher proportion of patients was classified as having moderate and very severe disease by US. In particular, 117 patients (26.96%) had a worse classification by US HS‐PGA compared to clinical assessment. Conclusion: Our findings confirm that the use of clinical grading only to assess HS severity may underestimate the real disease severity. US examination can be considered an essential non‐invasive imaging tool available to dermatologists for a more accurate diagnosis, staging, treatment planning and monitoring of HS and should be included in the pathway to an optimal standard of care of HS. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of topical therapies in psoriasis is dependent on, amongst other factors, patient adherence. Together with treatment effectiveness and reduction of symptoms, speed of onset and health‐related quality of life (HRQoL) are important influencers of adherence. Methods: This pooled analysis of three Phase II/III trials evaluated the efficacy of topical fixed‐dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) vs. foam vehicle at early timepoints in mild‐to‐severe psoriasis using clinically meaningful modified Psoriasis Area and Severity Index (mPASI) and Dermatology Life Quality Index (DLQI) targets. Results: A greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved absolute mPASI targets 0 (15.1% vs. 1.0%), ≤1 (41.4% vs. 5.2%), ≤3 (78.5% vs. 29.2%) and ≤5 (90.2% vs. 62.5%) at week 4 (P < 0.001; all targets). Significant differences between Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients were observed as early as week 1 in those achieving mPASI ≤1 (6.8% vs. 1.5%; P < 0.01), ≤3 (40.4% vs. 22.8%; P < 0.001) and ≤5 (69.7% vs. 50.8%; P < 0.001). In patients with more severe psoriasis (baseline mPASI >10), a greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved mPASI ≤1 (20.2% vs. 5.9%; P < 0.05), ≤3 (49.2% vs. 8.8%; P < 0.001) and ≤5 (63.7% vs. 26.5%; P < 0.001) at week 4. In patients with severely impaired HRQoL (baseline DLQI >10), a greater proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients achieved target DLQI ≤1 or 0 (week 4: DLQI ≤1, 25.0% vs. 4%; P = 0.001; DLQI 0, 17.4% vs. 2.0%; P = 0.006). Conclusion: We report rapid onset of action and greater efficacy with Cal/BD foam vs. foam vehicle, even in patients with more severe psoriasis, manageable with topical treatments. This may support physician management of patient expectations and improve patient adherence, translating into overall topical treatment effectiveness. [ABSTRACT FROM AUTHOR]

Background: Plaque psoriasis has significant impact on patients' quality of life. Topical therapy is considered the treatment mainstay for mild‐to‐moderate disease according to guidelines. Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam is indicated for psoriasis vulgaris treatment in adults. Cal/BD foam trials demonstrated improved efficacy and similar safety in this population. Psoriasis treatment is complicated by the broad range of disease presentation, variability and therapeutic options; particularly decisions on transition from topical to non‐biologic systemic treatment are difficult. Assessing comparative effectiveness of treatment options provides meaningful value to treatment decisions. Objective: To compare efficacy of Cal/BD foam individual patient data from pooled trials with efficacy of non‐biologic systemic treatments based on aggregated patient characteristics and treatment outcomes. Methods: Individual data from four Cal/BD foam trials in 749 psoriasis patients were pooled to conduct matching‐adjusted indirect comparisons. Literature review identified non‐biologic systemic treatment trials where methods, populations and outcomes align with Cal/BD foam trials. Of 3090 screened publications, four studies of apremilast, methotrexate, acitretin or fumaric acid esters (FAE) were included. Results: After baseline matching, patients treated with 4 weeks of Cal/BD foam had greater Physician's Global Assessment 0/1 response compared to those treated with 16 weeks of apremilast (52.7% vs. 30.4%; P < 0.001). Patients treated with Cal/BD foam had significantly greater Psoriasis Area and Severity Index (PASI) 75 response at Week 4 compared to 16 weeks of apremilast treatment (51.1% vs. 21.6%; P < 0.001). Cal/BD foam patients demonstrated significantly greater PASI 75 response improvements at Week 4 vs. 12 weeks of methotrexate (50.8% vs. 33.5%; P < 0.001) or acitretin (50.9% vs. 31.7%; P = 0.009), and comparable response to FAE (42.4% vs. 47.0%; P = 0.451). Conclusions: Despite recent treatment advances, unmet needs for psoriasis patients remain. Cal/BD foam offers improved efficacy in baseline matched psoriasis patients compared to apremilast, methotrexate or acitretin, and comparable efficacy to FAE. [ABSTRACT FROM AUTHOR]

Background: Itch is common in psoriasis, adversely affecting health‐related quality of life (HRQoL) and sleep. Objective: We evaluated the efficacy of topical fixed‐dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch, itch‐related sleep loss and HRQoL vs. foam vehicle. Methods: We pooled data from three Phase II/III trials (NCT01536886/NCT01866163/NCT02132936) of Cal/BD foam vs. foam vehicle in adults with mild–severe psoriasis. For itch‐related analyses, patients with baseline itch visual analogue scale (VAS) >40 (range 0–100) were analysed. Outcomes included the following: itch VAS reduction >40, ≥70% improvement in itch (Itch70) or itch‐related sleep loss, 75% improvement in modified Psoriasis Area and Severity Index (excluding head; mPASI75) and Dermatology Life Quality Index (DLQI) scores 0/1 through 4 weeks. Results: Of 837 patients, 800 had baseline itch VAS >0 (Cal/BD foam, n = 610; foam vehicle, n = 190); 484 had baseline itch VAS >40. There was no correlation between itch VAS score and mPASI at baseline (R2 = 0.021). In patients with baseline itch VAS >40, more patients achieved itch VAS reduction >40 in the active vs. vehicle group from Day 5 onwards (Day 5: 57.5% vs. 40.2% [P < 0.05]; Week 4: 83.0% vs. 45.8% [P < 0.001]). More Cal/BD‐foam‐treated patients achieved Itch70 at Day 3 (34.2% vs. 22.5%; P < 0.05) through to Week 4 (79.3% vs. 38.1%; P < 0.001). In patients with baseline itch VAS >40 and sleep loss >20, improvements in itch‐related sleep loss occurred at Week 1 and continued through 4 weeks. Itch‐related improvements occurred before improvements in mPASI75. There were significant differences in the proportion of Cal/BD‐foam‐ vs. foam‐vehicle‐treated patients with baseline DLQI >10 (n = 172 vs. n = 50) achieving DLQI ≤1 (25.0% vs. 4.0%; P = 0.001) and DLQI 0 (17.4% vs. 2.0%; P = 0.006) at Week 4. Conclusion: Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI. [ABSTRACT FROM AUTHOR]