Deferred time of delivery of biologic therapies in patients with stabilized psoriasis leads to a 'perceived satisfaction': a multicentric study.

OBJECTIVE: Thanks to their specificity of action, biologic drugs often lead to complete clearance of psoriatic lesions. In order to maintain its effectiveness, biological therapies cannot be discontinued. The aim of the study was to investigate the effect of widening the administration window of four biologic drugs, thus improving the quality of life of psoriatic patients and satisfying their desire to feel free from the disease, without loss of effectiveness. METHODS: We performed a multicentric cohort study considering patients with moderate-severe plaque psoriasis and/or arthropathic psoriasis treated with infliximab, adalimumab, etanercept or ustekinumab. The study group included patients with stabilized psoriasis in which the administration regimen of the biologic drug was deferred. The control group included psoriatic patients treated according the product monograph. RESULTS: The percentage of relapses in case of deferred administration intervals was comparable to that of standard administration intervals. The delayed administration modality got a good psychological consensus from the patients themselves, that reported a greater 'perceived satisfaction'. A consistent economic advantage was reported in case of prolonged administration intervals. CONCLUSIONS: The administration of biologic drugs with prolonged intervals maintains the same effectiveness as standard administration and produces a 'perceived satisfaction' in psoriatic patients.

Biological therapy in patients with psoriasis: What we know about the effects on renal function.

Psoriasis is a chronic inflammatory dermatosis affecting 2%-3% of the general population. The link between psoriasis and renal dysfunction has been investigated, demonstrating a common pro-inflammatory pathogenesis. This study is aimed at evaluating renal function in patients with moderate-to-severe chronic plaque psoriasis treated with biological therapy. We analyzed 92 patients, correlating PASI and serum creatinine levels at baseline, after 6 months and after 1 year of continuous treatment with biological therapy. Data were analyzed using paired t-test and the linear mixed model for PASI and serum creatinine levels correlation, whereas the analysis of variances (ANOVA) was used for creatinine levels assessment between the baseline, the 6-months and, 1-year later evaluation. We observed a significant mean decrease in comparing serum creatinine levels after 1 year of biological therapy (p < 0.001). Interestingly, PASI reduction is correlated with creatinine decrease, and the renal function improvement is greater when complete psoriasis remission is attained. Our data suggest that a drop in systemic inflammation, secondary to biological therapy administration, might improve renal function. Future research is needed to confirm and expand our findings.

Management of patients with atopic dermatitis undergoing systemic therapy during COVID-19 pandemic in Italy: Data from the DA-COVID-19 registry.

BACKGROUND: Few and small studies have described the management of immunomodulant/immunosuppressive therapies or phototherapy in atopic dermatitis (AD) patients during coronavirus disease 2019 (COVID-19) pandemic. METHODS: A national registry, named DA-COVID-19 and involving 35 Italian dermatology units, was established in order to evaluate the impact of COVID-19 pandemic on the management of adult AD patients treated with systemic immunomodulant/immunosuppressive medications or phototherapy. Demographic and clinical data were obtained at different timepoints by teledermatology during COVID-19 pandemic, when regular visits were not allowed due to sanitary restrictions. Disease severity was assessed by both physician- and patient-reported assessment scores evaluating itch intensity, sleep disturbances, and AD severity. RESULTS: A total of 1831 patients were included, with 1580/1831 (86.3%) continuing therapy during pandemic. Most patients were treated with dupilumab (86.1%, 1576/1831) that was interrupted in only 9.9% (156/1576) of cases, while systemic immunosuppressive compounds were more frequently withdrawn. Treatment interruption was due to decision of the patient, general practitioner, or dermatologist in 39.9% (114/286), 5.6% (16/286), and 30.1% (86/286) of cases, respectively. Fear of increased susceptibility to SARS-CoV-2 infection (24.8%, 71/286) was one of the main causes of interruption. Sixteen patients (0.9%) resulted positive to SARS-CoV-2 infection; 3 of them (0.2%) were hospitalized but no cases of COVID-related death occurred. CONCLUSIONS: Most AD patients continued systemic treatments during COVID pandemic and lockdown period, without high impact on disease control, particularly dupilumab-treated patients.

Helicobacter pylori infection in psoriatic patients during biological therapy.

BACKGROUND: Psoriasis is a relapsing inflammatory disease exacerbated by many triggers. Helicobacter pylori (H. pylori) is a Gram-negative bacterium causing the liberation of many cytokines and having a role in systemic inflammation. We assessed over a period of 12 months the presence of H. pylori in psoriatic patients undergoing biologic therapy and how PASI improved after its eradication. METHODS: We performed an interventional, prospective, cohort, exploratory and mono-centric study in patients affected by moderate-severe psoriasis during biological therapy to assess the correlation between psoriasis (moderate to severe forms), and H. pylori infection. We also checked if the bacterial eradication could improve the severity of psoriasis throughout the variation of PASI over a 12-month period. RESULTS: The prevalence of H. pylori was 35%. The average of PASI improved in H. pylori positive patients after the eradication (confidence interval: 33-44; P=0.023). H. pylori positive patients were more likely to have psoriatic arthropathy (P=0.049). Gastrointestinal symptoms (such as epigastric pain, postprandial heaviness, pyrosis) were found in only 31.3% of H. pylori positive patients. CONCLUSIONS: Since the H. pylori infection is often asymptomatic, it can be useful to perform the 13C-Urea breath test, and to eradicate it before to start the psoriasis therapy in order to decrease the level of inflammation.

Cutaneous carcinogenic risk evaluation in 375 patients treated with narrowband-UVB phototherapy: A 15-year experience from our Institute.

BACKGROUND: Narrowband-ultraviolet B (NB-UVB) is widely used for the treatment of several dermatological diseases. A cutaneous carcinogenic effect has been hypothesized, but not proved. METHODS: We retrospectively reviewed the data of patients treated with NB-UVB between January 1998 and December 2013 at the Dermatology Unit of our University Hospital, to evaluate the cutaneous carcinogenic risk of NB-UVB. RESULTS: In all, 375 patients were included, each receiving a mean follow-up of 6.9 years. Vitiligo and psoriasis were the most common diseases. In total, 19 non-melanoma skin cancers (NMSCs) were diagnosed in eight patients, after a mean latency of 5.2 years after the first radiation. No malignant melanoma (MM) was observed. The incidence rates of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) were 620.2/100 ̇000 p/y and 116.3/100 ̇000 p/y. NMSCs were more frequent in patients affected by psoriasis (P = .0232), with older age at the first radiation (mean = 68.8 years, P = .0001). CONCLUSION: Despite the small number of patients and limited follow-up, our data suggest that NB-UVB may trigger cutaneous carcinogenesis, mainly in patients at risk for NMSCs, increasing their personal risk for single and multiple neoplasms, usually superficial BCCs. MM risk does not seem to be enhanced.

Safety and Efficacy of Phototherapy in the Management of Eczema.

Atopic Dermatitis (AD), a common skin disease, can occur in patients of all age, gender and ethnicity. It is an inflammatory affection, characterized by chronic and highly debilitating behavior. First-line interventions against AD include environmental measures and topical emollients, corticosteroids or calcineurin inhibitors. When these measures are not sufficient, phototherapy represents an efficient second-line option of treatment; it can be administered on its own, or in the most severe cases combined with systemic medicaments such as corticosteroids.Different types of light therapy, including photochemotherapy, have been tested in the past and in recent years for AD: in particular, ultraviolet A1 (UVA1) and narrow band ultraviolet B (NB-UVB) have been reported in the literature as the most effective resources, respectively for acute and chronic AD. However, to date, no guidelines have been realized concerning the use of phototherapy for AD, as no light form has been defined superior to the others. The most reliable protocols and dosimetry are standardized within the American Academy of Dermatology (AAD) psoriasis guidelines.In adults and children over 12 years (8 years for NB-UVB) phototherapy is recommended with strength B and level of evidence II (excluding home phototherapy, which is recommended with strength C and level of evidence III). It is usually safe and well tolerated; however its short- and long-term adverse effects are the same as those observed when light therapy is performed for other pathologic conditions. Erythema and photodamage are in particular quite frequent; moreover it has not been clarified whether UV radiation may induce neoplastic cellular transformation. For all these reasons, the use of phototherapy must be chosen only after a comprehensive and careful evaluation of the patient's features and compliance, as well as of the limitations of the procedure due to costs and availability.

Treatment of severe psoriasis in children: recommendations of an Italian expert group.

This article provides comprehensive recommendations for the systemic treatment of severe pediatric psoriasis based on evidence obtained from a systematic review of the literature and the consensus opinion of expert dermatologists and pediatricians. For each systemic treatment, the grade of recommendation (A, B, C) based on the treatment's approval by the European Medicines Agency for childhood psoriasis and the experts' opinions is discussed. The grade of recommendation for narrow-band-ultraviolet B phototherapy, cyclosporine, and retinoids is C, while that for methotrexate is C/B. The use of adalimumab, etanercept, and ustekinumab has a grade A recommendation. No conventional systemic treatments are approved for pediatric psoriasis. Adalimumab is approved by the European Medicines Agency as a first-line treatment for severe chronic plaque psoriasis in children (≥ 4 years old) and adolescents. Etanercept and ustekinumab are approved as second-line therapy in children ≥ 6 and ≥ 12 years, respectively. CONCLUSION: A treatment algorithm as well as practical tools (i.e., tabular summaries of differential diagnoses, treatment mechanism of actions, dosing regimens, control parameters) are provided to assist in therapeutic reasoning and decision-making for individual patients. These treatment recommendations are endorsed by major Italian Pediatric and Dermatology Societies. What is Known: • Guidelines for the treatment of severe pediatric psoriasis are lacking and most traditional systemic treatments are not approved for use in young patients. Although there has been decades of experience with some of the traditional agents such as phototherapy, acitretin, and cyclosporine in children, there are no RCTs on their pediatric use while RCTs investigating new biologic agents have been performed. What is New: • In this manuscript, an Italian multidisciplinary team of experts focused on treatment recommendations for severe forms of psoriasis in children based on an up-to-date review of the literature and experts' opinions.

Randomized, controlled, double-blind clinical study evaluating the safety and efficacy of MD2011001 cream in mild-to-moderate atopic dermatitis of the face and neck in children, adolescents and adults.

INTRODUCTION: This mono-center randomized, controlled, double-blind study evaluates the safety and efficacy of MD2011001 cream versus placebo, in mild-to-moderate atopic dermatitis (AD). MD2011001 is a nonsteroidal topical cream containing vitamin E, epigallocatechin gallate and grape seed procyanidins. METHODS: Patients with AD (corresponding to an IGA score of 2 or 3), involving the face, the perioral/periocular area and/or the neck, were enrolled. Patients were randomized 1:1 ratio to receive MD2011001 or placebo before the start of the study (D0), then evaluated after 7 days, and after 28 days. The study was approved by the Local Independent Ethics Committee and conducted according to the Declaration of Helsinki and local regulations. The statistical tests used were the Wilcoxon test and the Mann-Whitney U-test. RESULTS: Forty-four patients (29F and 15M) were enrolled. The IGA values showed a statistically significant reduction during the treatment period obtaining a favorable safety profile and local tolerance for both the products. The reduction in the surface area affected by AD was significantly faster with MD2011001. DISCUSSION: This study focuses on very sensitive areas known to be particularly susceptible to local complications. CONCLUSIONS: These results suggest the usefulness of an emollient treatment for mild/moderate AD.

Management of atopic dermatitis: safety and efficacy of phototherapy.

Atopic dermatitis (AD) is a common chronic inflammatory skin disease that can affect all age groups. It is characterized by a relapsing course and a dramatic impact on quality of life for patients. Environmental interventions together with topical devices represent the mainstay of treatment for AD, in particular emollients, corticosteroids, and calcineurin inhibitors. Systemic treatments are reserved for severe cases. Phototherapy represents a valid second-line intervention in those cases where non-pharmacological and topical measures have failed. Different forms of light therapy are available, and have showed varying degrees of beneficial effect against AD: natural sunlight, narrowband (NB)-UVB, broadband (BB)-UVB, UVA, UVA1, cold-light UVA1, UVA and UVB (UVAB), full-spectrum light (including UVA, infrared and visible light), saltwater bath plus UVB (balneophototherapy), Goeckerman therapy (coal tar plus UVB radiation), psoralen plus UVA (PUVA), and other forms of phototherapy. In particular, UVA1 and NB-UVB have gained importance in recent years. This review illustrates the main trials comparing the efficacy and safety of the different forms of phototherapy. No sufficiently large randomized controlled studies have been performed as yet, and no light modality has been defined as superior to all. Parameters and dosing protocols may vary, although clinicians mainly refer to the indications included in the American Academy of Dermatology psoriasis guidelines devised by Menter et al in 2010. The efficacy of phototherapy (considering all forms) in AD has been established in adults and children, as well as for acute (UVA1) and chronic (NB-UVB) cases. Its use is suggested with strength of recommendation B and level of evidence II. Home phototherapy can also be performed; this technique is recommended with strength C and level of evidence III. Phototherapy is generally considered to be safe and well tolerated, with a low but established percentage of short-term and long-term adverse effects, with the most common being photodamage, xerosis, erythema, actinic keratosis, sunburn, and tenderness. A carcinogenic risk related to UV radiation has not been excluded. Phototherapy also has some limitations related to costs, availability, and patient compliance. In conclusion, phototherapy is an optimal second-line treatment for AD. It can be used as monotherapy or in combination with systemic drugs, in particular corticosteroids. It must be performed conscientiously, especially in children, and must take into account the patient's features and overall condition.

Pruritic papular eruption in HIV: a case successfully treated with NB-UVB.

Pruritic papular eruption (PPE) is a skin disease characterized by the eruption of itching papules on the extremities, face, and trunk; it is quite frequent in HIV-positive patients especially during the advanced immunosuppressive stage. PPE usually improves or heals when antiretroviral therapy restores the immune system function, but in some cases, it can take several months, and a symptomatic treatment for PPE is required. Systemic antihistamines, topical steroids, topical tacrolimus, itraconazole, pentoxyphilline, and ultraviolet B phototherapy have been proposed in cases of persisting PPE, but an elective treatment has not yet been found. We describe the case of a black patient affected by PPE, nonimproving with antiretroviral treatment, and resistant to topical steroids and oral antihistamines; a satisfactory and speedy result was achieved with narrow-band ultraviolet B phototherapy.

A novel HPLC-electrochemical detection approach for the determination of D-penicillamine in skin specimens.

D-penicillamine is a thiol drug mainly used for Wilson's disease, rheumatoid arthritis and cystinuria. Adverse effects during normal use of the drug are frequent and may include skin lesions. To evaluate its toxic effects in clinical cases an original method based on high performance liquid chromatography coupled to amperometric detection in a specific biological matrix such as skin has been developed. The chromatographic analysis of D-penicillamine was carried out on a C18 column using a mixture of acid phosphate buffer and methanol as the mobile phase. Satisfactory sensitivity was obtained by oxidizing the molecule at +0.95 V with respect to an Ag/AgCl reference electrode. A chemical reduction of D-penicillamine-protein disulphide bonds using dithioerythritol combined with microwaves was necessary for the determination of the total amount of D-penicillamine in skin specimens. A further solid-phase extraction procedure on C18 cartridges was implemented for the sample clean-up. The whole analytical procedure was validated: high extraction yield (>91.0%) and satisfactory precision (RSD<6.8%) values were obtained. It was successfully applied to skin samples from a patient who was previously under a long-term, high-dose treatment with the drug and presented serious D-penicillamine-related dermatoses. Thus, the method seems to be suitable for the analysis of D-penicillamine in skin tissues.

Dermasilk briefs in vulvar lichen sclerosus: an adjuvant tool.

OBJECTIVE: : The purpose of our study was to evaluate whether briefs made of Dermasilk fabric could be an adjuvant tool in the management of vulvar lichen sclerosus (LS). MATERIALS AND METHODS: : A controlled, randomized, double-blind study versus placebo was conducted, comparing Dermasilk versus standard cotton briefs in patients affected by LS during treatment with clobetasol propionate 0.05% ointment and vitamin E moisturizer. For each patient, an evaluation of objective genital signs and subjective symptoms typical of LS was recorded before the start of treatment, after 1 month, and after 6 months of the study. Statistical analysis was performed with SPSS 17.0 for Windows. RESULTS: : Forty-two women affected by LS were recruited and divided into those wearing Dermasilk or cotton briefs. Patients wearing Dermasilk briefs showed a better improvement in the clinical symptoms of burning sensation, skin irritation, and pain (Fisher test, p < .0001) compared with the cotton placebo group. The improvement in itching was also faster in the Dermasilk group (Fisher exact test, p < .05). Erythema also showed a better improvement in the Dermasilk group (Fisher test, p < 0.05). CONCLUSIONS: : Dermasilk fabric seems to be a useful adjunct to topical treatment in producing a better and more rapid control of symptoms in patients with LS.

Causal relationship between exposure to chemicals and malignant melanoma? A review and study proposal.

Malignant melanoma (MM) is a significant cause of morbidity and mortality worldwide. The MM-related incidence and mortality have been increasing at an alarming rate over at least the past four decades. Malignant melanoma has been thought to be related mainly to exposure to the sun or UV radiation. A review of the scientific literature reveals many significant correlations between chemical exposure in the workplace and the occurrence of malignant melanoma, particularly in cutaneous areas that have never been exposed to sunlight. Discrepant findings are reported by independent studies concluding that MM is causally related to employment-related chemical exposures and to investigators with industry affiliations. More studies are needed to define a correlation of chemical exposure as a co-factor on the pathogenesis in some melanoma patients. We propose further investigation by dermatologists working in Melanoma Centers, using a simple questionnaire on chemical exposure among patients, that have previously been diagnosed and are followed up for melanoma comparing with appropriate matched controls. Collecting the data and results from the questionnaire will help us understand the initiation events in melanoma and prevention health issues.

A double-blind, randomized, vehicle-controlled clinical study to evaluate the efficacy and safety of MAS063DP (ATOPICLAIR) in the management of atopic dermatitis in paediatric patients.

A multicenter, randomized, double-blind, vehicle-controlled clinical study was conducted to evaluate the efficacy and safety of MAS063DP in 60 paediatric patients affected by atopic dermatitis (AD), aged between 2 and 17 years. Using the Investigator's Global Assessment (IGA) score for AD, patients with a score of 2 (mild) or 3 (moderate) were enrolled in the study. Patients were randomly selected to receive MAS063DP (20 patients), MAS060 (20 patients, a similar formulation with lower key ingredients' concentration and no preservatives) or vehicle (20 patients).The study consisted in a treatment period of 43 days, with clinical evaluations at baseline (day 1), days 8, 15, 22, 29 and 43, at which time the treatment was stopped. MAS063DP showed nearly 80% improvement in IGA score at day 22, compared with 16.6% and 26.3% with the MAS060 and vehicle respectively. A statistically significant difference was found by comparing MAS063DP with MAS060 (p < 0.0001); a similar result was evidenced comparing MAS063DP and vehicle (p = 0.001). By contrast, no significant difference was found between MAS060 and vehicle. A statistically significant difference was sustained until the end of the study. MAS063DP may therefore be considered as one of the available regimens effective in the treatment of mild-to-moderate AD in children and adolescents.

Evaluation of the antibacterial activity of a special silk textile in the treatment of atopic dermatitis.

BACKGROUND: Increased skin Staphylococcus aureus colonization is frequently found in atopic patients. The reduction of local overinfection decreases skin inflammation and improves the flares. OBJECTIVE: To evaluate the effectiveness of the antimicrobial activity of a silk fabric (MICROAIR DermaSilk) coated with alkoxysilane quaternary ammonium with durable antimicrobial properties (AEGIS AEM 5572/5) in children affected by atopic dermatitis (AD). METHODS: Sixteen children, 12 affected by AD with symmetric eczematous lesions on the antecubital areas and 4 without any cutaneous disease, used, for 7 days, tubular arm covers made of this special silk fabric but only one of each pair was coated with AEGIS AEM 5572/5. Microbiological examinations were done with standard cultural swabs and by means of quantification of bacterial agents using agar plates at baseline, after 1 h and after 7 days. RESULTS: After 7 days a significant improvement in the mean value of the 'local SCORAD' index was observed in both the covered areas compared to the values obtained at baseline. The reduction in the mean number of colony forming units per square centimetre was similar in both areas. CONCLUSIONS: Although this special silk fabric seems to be able to improve skin lesions in AD, we were unable to demonstrate that such silk fabrics coated with AEGIS AEM 5572/5 have an antibacterial activity in vivo, as shown in vitro.