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Sonidegib is an antagonist of the transmembrane protein Smoothened in the Hedgehog signaling pathway. It is indicated for the treatment of locally advanced basal cell carcinoma (BCC) that is not amenable to curative surgery or radiotherapy. Sonidegib's efficacy and safety were demonstrated in the phase 2 BOLT trial, where 61% (95% CI, 48-72%) of patients with locally advanced BCC treated with sonidegib 200 mg achieved an objective response to treatment with a mean time to response of 4 months. The median duration of response was 26.1 months and the median progression-free survival was 22.1 months. The most common adverse events were muscle spasms (54.4%), hair loss (49.4%), and loss of taste (44.3%); most events were grade 1 or 2. In this review, we summarize the main findings on the efficacy, safety, and tolerability of sonidegib and discuss the management of locally advanced BCC with this drug., (Copyright © 2020 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background and Objectives: Current psoriasis guidelines do not usually include recommendations about first line classical or biologic treatment. The objectives of this study were: to describe shifts in the prescription of the first biological treatment, and to compare treatment withdrawal and rates of adverse events over ten years., Material and Methods: Biobadaderm registry was analyzed to describe: first biological prescription in bio-naïve patients, adverse events rate and reasons for drug withdrawal comparing three periods of time (2008-2010, 2011-2014, 2015-2018)., Results: Anti-TNF drugs were the most prescribed biological drug from 2008 to 2010. Ustekinumab has become the most prescribed first biologic since 2014. The main reasons for drug discontinuation were adverse events, lack of efficacy and remission. In each period any treatment was less likely to be discontinued due to any of these three reasons comparing to the previous period., Conclusions: The present study identifies trends in prescription of the first biological antipsoriatic drug in clinical practice from 2008 to 2018. It suggests that we have become more comfortable with the safety profile and more exigent with the efficacy of the drugs., (Copyright © 2020. Publicado por Elsevier España, S.L.U.)

Introduction and Objectives: Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy., Material and Method: We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology., Results: The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects., Conclusions: No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis., (Publicado por Elsevier España, S.L.U.)

Background and Objective: We now have considerable experience in the use of biologic agents to treat psoriasis, but doubts about management arise in certain clinical settings. Surgery is one of them. Although treatment guidelines advise that biologics be suspended before major surgery, data about actual clinical practices and associated complications are lacking. We aimed to analyze current practice in the clinical management of these cases., Methods: Retrospective study of cases in the Biobadaderm database. We analyzed the management of biologic therapy in patients with psoriasis who underwent surgical procedures., Results: Forty-eight of the 2113 patients registered in Biobadaderm underwent surgery. The largest percentage of procedures (31%) involved skin lesions. Biologic treatment was interrupted in 42% of the cases. No postsurgical complications were significantly related to treatment interruption. Likewise we detected no associations between treatment interruption and other variables, such as sex, age, or duration or severity of psoriasis., Conclusion: Continuity of biologic treatment and the risk of postsurgical complications were not associated in this study, although conclusions are limited by the small sample size., (Copyright © 2016 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: With the advent of biologic drugs in the management of moderate to severe psoriasis, there may have been a shift in therapeutic approach from rotational strategies to a unidirectional progression from topical treatments to the highest rung of the therapeutic ladder. We studied the frequency of switching from classic to biologic therapy and vice versa in a cohort of patients with psoriasis over a period of up to 5 years., Methods: Patients are included in the BIOBADADERM prospective registry when they are first prescribed any specific conventional or biologic systemic treatment. The data for each patient refer to the follow-up period from the time they entered the cohort until October 2013. To describe the pattern of switches from classic to biologic therapy and vice versa, we used the data in the registry on the first day of every 365-day period following the date each patient was included in the cohort., Results: In total, 47.3% of the patients (926/1956) were prescribed a classic systemic drug and 52.7% (1030/1956) a biologic agent on entry into the study. Of the 741 patients who accumulated 5 years of follow-up, 21.9% (155) were receiving nonbiologic drugs and 78.1% (553) were on biologic therapy on the first day of their 5th year of follow-up., Conclusions: The proportion of patients receiving biologic therapy increased with longer follow-up., (Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.)

Objective: The main aim of this study was to identify predictors of sentinel lymph node (SN) metastasis in cutaneous melanoma., Patients and Methods: This was a retrospective cohort study of 818 patients in 2 tertiary-level hospitals. The primary outcome variable was SN involvement. Independent predictors were identified using multiple logistic regression and a classification and regression tree (CART) analysis., Results: Ulceration, tumor thickness, and a high mitotic rate (≥6 mitoses/mm(2)) were independently associated with SN metastasis in the multiple regression analysis. The most important predictor in the CART analysis was Breslow thickness. Absence of an inflammatory infiltrate, patient age, and tumor location were predictive of SN metastasis in patients with tumors thicker than 2mm. In the case of thinner melanomas, the predictors were mitotic rate (>6 mitoses/mm(2)), presence of ulceration, and tumor thickness. Patient age, mitotic rate, and tumor thickness and location were predictive of survival., Conclusions: A high mitotic rate predicts a higher risk of SN involvement and worse survival. CART analysis improves the prediction of regional metastasis, resulting in better clinical management of melanoma patients. It may also help select suitable candidates for inclusion in clinical trials., (Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.)

Introduction: Pemphigus comprises a group of autoimmune blistering diseases that affect the skin and mucous membranes. Its clinical and epidemiologic features vary according to geographic location and ethnic background., Objective: An exhaustive search of the literature reveals very few reports of the epidemiology of pemphigus in setting. Our aim, thus, was to conduct a retrospective study of the clinical and epidemiologic features of pemphigus at a secondary care hospital in Málaga, Spain., Material and Methods: We studied 20 patients diagnosed with pemphigus in our department over a period of 13 years (January 1995 to January 2008)., Results: We analyzed a large variety of clinical and epidemiologic parameters including sex; age; type of pemphigus; time since onset; associated symptoms; type, morphology, and location of lesions at the time of diagnosis; extent of skin and mucosal involvement; treatment received; treatment-related adverse effects and complications; number of hospital admissions; and patient outcome., Conclusions: Except for minor differences, our results are in agreement with published data on pemphigus regarding sex, age, and clinical presentation. According to our results, male sex is a predictor of poor prognosis as it is associated with poorer response to treatment and a higher rate of adverse effects and hospital admission.

Introduction: Nail biopsy is thought to be a useful technique for the diagnosis of diseases affecting the nail apparatus and may help avoid delays in the diagnosis of important mucocutaneous diseases. Furthermore, it has therapeutic value in its own right. It is not a difficult technique to perform but it requires an in-depth knowledge of the anatomy and physiology of the nail unit, as well as surgical experience and patient collaboration. In order to assess the diagnostic utility of this technique, we reviewed the nail biopsies performed in our department between June 2005 and May 2006., Patients and Methods: We identified 15 patients in whom nail biopsy had been performed. The clinical findings, type of biopsy performed, and histopathologic diagnosis were assessed., Results: Nail biopsy allowed diagnosis of a variety of skin disease in 13 out of 15 patients (psoriasis in 5, onychomycosis in 4, melanonychia in 2, melanoma in 1, and subungual hematoma in 1). None of the patients presented sequelae as a result of the intervention after several months of follow-up., Conclusion: Nail biopsy is a useful tool in cases in which the patient history, clinical presentation, and additional tests have not led to a definitive diagnosis. In our experience, it can be performed safely and with minimal scarring.

Introduction: Compared with other tumors, melanoma has displayed one of the largest increases in incidence in recent years, and it is known to have a high metastatic potential. In cases of metastasis, approximately two-thirds of patients have lymph-node metastases and one-third develop systemic metastases. However, few studies have been reported that analyzed different metastatic patterns according to the natural history of melanoma. The main aim of this study was to analyze the different metastatic pathways and patterns and to assess the time course of development of metastases from cutaneous melanoma., Material and Methods: A retrospective study was performed in 575 patients with onset of primary melanoma between 1990 and 2004. During follow-up, 67 patients developed metastases. Different pathways for metastasis were established and evaluated. We identified 4 metastatic pathways according to the metastatic pattern during progression of the melanoma. The time course of metastases was also evaluated. Finally, we analyzed melanomas with local recurrence in terms of whether or not systemic progression occurred., Results: Melanoma metastases first occurred in local lymph nodes in 55.2 % of the patients. Initial metastasis was systemic in 14.9 % of the patients. The anatomical location and tumor thickness influenced which metastatic pathway was followed. Distant metastases occurred after a mean of 25 months regardless of the pathway followed, Conclusions: The development of distant metastases displays a constant time course and the time to onset is independent of the metastatic pathway. This observation may explain why sentinel lymph node biopsy has a limited impact on overall survival of melanoma patients.