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Background: Scant information from clinical practice is available on the effectiveness and safety of ustekinumab (UST) 90 mg in patients with psoriasis weighing 100 kg or less. Objectives: To assess the effectiveness and safety at weeks 16 and 24 of UST 90 mg in patients with psoriasis weighing

The objective of the study was to evaluate efficacy and safety of ixekizumab in psoriasis patients under clinical practice conditions. Observational, retrospective, multicentre study that included patients with ixekizumab from March 2017 to March 2019. >= 90% reduction in the Psoriasis Area and Severity Index (PASI 90) and absolute PASI

Background Ixekizumab (anti-IL17A) is effective as treatment for moderate-to-severe plaque psoriasis, but real-life data on effectiveness and safety are currently very limited. Objective To evaluate the efficacy and safety of ixekizumab in a cohort of real-life plaque psoriasis patients. Methods Retrospective chart review of 100 patients with moderate-to-severe plaque psoriasis treated with ixekizumab at seven Spanish dermatological centres. Results According to the as observed analysis, the percentage of patients achieving a 75% and 90% of reduction from the baseline score of Psoriasis Area and Severity Index (PASI) was 87.5%-50.0% at week 12-16; 88.3%-58.4% at week 24 and 82.9%-58.5% at week 52, respectively. The mean +/- standard deviation (SD) score of PASI at baseline was 12.9 +/- 9.2, and it declined rapidly after ixekizumab administration to 1.9 +/- 4.0 (P < 0.001) at week 12-16 and was maintained at 1.7 +/- 4.1 and 1.8 +/- 2.9 at week 24 and 52, respectively. Ixekizumab response was not affected by clinical variables like body mass index, disease duration or the presence of psoriatic arthritis. However, the bio-naive group showed significantly higher PASI 75 response rate at week 12-16 compared to patients previously exposed to biologic agents (P = 0.037). Twenty-six (26%) patients experienced adverse events (AEs) during the follow-up period, being most of them of mild-to-moderate intensity. The most common AE was local reaction at the site of injection (14/26; 53.8%). At the end of the observational period, 15 (15%) patients discontinued ixekizumab treatment due to limited clinical improvement (n = 11), adverse events (n = 3) or lost to follow-up (n = 1) within a mean +/- SD time of 6.0 +/- 3.9 months. Conclusion The present study illustrates the initial experience with ixekizumab in real-world clinical practice confirming its usefulness and safety in the management of plaque psoriasis patients.

Although several randomized clinical trials and observational studies have evaluated the effectiveness, safety and drug survival of etanercept (ETN) in the treatment of psoriatic arthritis (PsA), long-term data regarding these aspects are currently scarce. For this reason, we sought to investigate the long-term survival and safety of ETN in PsA patients in 4 tertiary care Spanish hospitals over a 13-year observation period (from 2004 to 2017). The records of 85 PsA patients were reviewed. ETN showed an excellent survival profile, with rates of treatment discontinuation at 1, 3, 5 and 10 years of 15, 37, 46 and 59%, respectively. In our cohort, a trend toward longer drug survival in patients with shorter disease duration and those who were treated with ETN as their first biologic agent was observed. On the other hand, combination therapy with conventional disease-modifying antirheumatic drugs did not provide greater improvement on the long-term drug survival. Only 12% of the patients reported adverse events (AEs) during therapy, being most of them of mild to moderate intensity, and in only 7% AEs led to drug discontinuation. To the best of our knowledge, the present study shows the largest follow-up period of ETN-treated population analyzed in a real-life setting, and these results demonstrate the positive safety profile and long-term effectiveness of this biologic agent in the management of PsA patients.

Introduction The Psoriasis Area Severity Index (PASI) is the most widely used scale for assessing the severity of psoriasis and for therapeutic decision making. On the basis of the PASI score, patients have been stratified into 2 groups: mild disease and moderate-to-severe disease. Objective To draft a proposal for the definition and characterization of moderate psoriasis based on PASI and Dermatology Life Quality Index (DLQI) scores. Material and methods A group of 6 dermatologists with experience in the treatment of psoriasis undertook a critical review of the literature and a discussion of cases to draft a proposal. Results In order of priority, PASI, DLQI, and body surface area (BSA) are the parameters to be used in daily practice to classify psoriasis as mild, moderate, or severe. Severity should be assessed on the basis of a combined evaluation and interpretation of the PASI and DLQI. And 3, PASI and DLQI should carry equal weight in the determination of disease severity. On this basis, psoriasis severity was defined using the following criteria: mild, PASI 15, independently of the DLQI score. Conclusions A more precise classification of psoriasis according to disease severity will improve the risk-benefit assessment essential to therapeutic decision making in these patients.

Resumen Introduccion El Psoriasis Area Severity Index (PASI) es la escala de medida mas utilizada para la valoracion de la gravedad de la psoriasis y la toma de decision para la indicacion de tratamiento. Atendiendo a su valor se han diferenciado 2 grupos de pacientes: psoriasis leve y moderada-grave. Objetivo Elaborar una propuesta para la definicion y caracterizacion de la psoriasis moderada mediante el PASI y el DLQI. Material y metodos Un grupo de 6 dermatologos con experiencia en tratar psoriasis planteo la revision critica de la literatura y discusion de casos clinicos para elaborar una propuesta. Resultados 1) PASI, DLQI y BSA son, en orden de prioridad, los parametros a emplear en la practica clinica para la clasificacion de la psoriasis leve, moderada y grave; 2) la evaluacion de la gravedad debe incluir la evaluacion e interpretacion conjunta del PASI y del DLQI; y 3) la evaluacion del PASI y del DLQI deberia tener igual relevancia a la hora de determinar la gravedad de la psoriasis. Conforme a esto, se definieron los siguientes criterios de caracterizacion de psoriasis: a) leve: PASI 15, independientemente de la puntuacion DLQI. Conclusiones Una mejor caracterizacion de los pacientes en funcion de su gravedad permitira una mejora del balance de riesgos y beneficios en el que se fundamente la toma de decisiones terapeuticas.

Background: The efficacy and safety of secukinumab in patients with plaque psoriasis (PsO) have been demonstrated in randomized clinical trials (RCTs). However, data regarding its efficacy and safety in real-life settings are scarce. Objectives: To evaluate the efficacy and safety of secukinumab in clinical practice in patients with PsO attending 10 dermatology centers in Spain. Methods: Data from 136 patients consecutively treated with secukinumab for at least 52 weeks were collected in a retrospective observational study. Results: After 52 weeks of treatment, 69% and 46% of patients achieved a PASI-75, PASI-90, respectively. PASI-score = 30 and those previously treated with other biologic agents.

After approval of the use of ustekinumab for treatment of moderate to severe psoriasis, patients with psoriatic arthritis have treated with this drug in daily clinical practice. The aims of this study were to describe baseline characteristics and evolution of a cohort of patients with psoriasis and psoriatic arthritis treated with ustekinumab and to compare differences between patients who discontinued treatment and those who maintained. A retrospective multicenter observational study including patients who had received ustekinumab for a minimum of 3 months from 2009 to 2015 was performed. The baseline characteristics of the cohort of patients, the main indication for treatment, number and percentage of patients who maintained and discontinued treatment, reasons for discontinuation and differences between patients who discontinued and maintained ustekinumab were evaluated. Fifty-eight patients were included. The main indication was dermatological (72.4% of cases), and treatment with ustekinumab was maintained in most patients (62.1% of cases) with low discontinuation by side effects and rheumatological lack of efficacy. Discontinuation of ustekinumab was correlated with more number of obese patients, less presence of plaque psoriasis and more number of previous biological therapies. Ustekinumab demonstrated efficacy and safety in the management of patients with psoriasis and psoriatic arthritis in daily clinical practice in our cohort of patients.

The diagnosis of adult-onset Still's disease (AOSD) can be very difficult. There are no specific tests available, and diagnosis is usually based on a symptom complex and the well-described typical evanescent rash seen in the majority of patients. However, in recent years, other atypical cutaneous manifestations of AOSD have been reported. These atypical skin eruptions often present in addition to the typical evanescent rash but may also be the only skin manifestation, resulting in delayed diagnosis because of under-recognition. In this study, we present 3 new cases of AOSD with atypical cutaneous manifestations diagnosed during a 30-year period in our department and review 78 additional cases previously reported (PubMed 1990–2016). These 81 patients form the basis of the present analysis. The overall prevalence of atypical cutaneous manifestations in our AOSD population was 14%. These manifestations may appear at any time over the course of the disease, and usually occur in patients who have persistent and severe disease, with a considerable frequency of clinical complications (23%), including serositis, myopericarditis, lung involvement, abdominal pain, neurologic involvement, and reactive hemophagocytic syndrome. The most representative and frequent lesion among the nonclassical skin rashes is the development of persistent pruritic papules and/or plaques. Interestingly, these lesions show a distinctive histological pattern. Other, less frequently observed lesions include urticaria and urticaria-like eruptions, generalized or widespread non-pruritic persistent erythema, vesiculopustular eruptions, a widespread peau d’orange appearance of the skin, and edema of the eyelids mimicking dermatomyositis without any accompanying skin lesion. The great majority of these patients required medium or high doses of glucocorticoids (including intravenous methylprednisolone pulse therapy in some cases) and, in nearly 40%, a more potent or maintenance immunotherapy with immunosuppressant drugs and/or biologic agents (mainly anakinra or tocilizumab) to control or manage symptoms because of a polycyclic or chronic course. The development of atypical cutaneous manifestations seems to be associated with a potentially worse prognosis, with a mortality rate reaching 8% primarily because of infectious complications related to immunosuppressive therapy. In conclusion, the appearance of atypical cutaneous manifestations is not uncommon in AOSD. Recognition of this clinical variant is crucial for the early diagnosis of AOSD, as it might imply persistent disease activity and the need for more aggressive treatment.

Background Normally, percutaneous absorption tests are carried out using skin biopsies for an apparent and acceptable physiological condition. However, under different pathological conditions, the stratum corneum (SC) barrier function is impaired. Methods The barrier function of the SC was assessed by correlation between the number of repeated applications of tape strips on the skin and its transepidermal water loss (TEWL), as well as by in vitro percutaneous absorption studies of different compounds, using Franz diffusion cells and porcine skin previously stripped. Results A progressive diminution of the skin barrier function has been detected by TEWL both in vitro and in vivo as the number of skin tape strips increases. On the other hand, the percutaneous absorption of the compounds tested increases in a different way as the number of strips increases. Salicylic acid increases linearly depending on the barrier disturbance. However, percutaneous absorption of caffeine exponentially increased with barrier disturbance. Our results indicate that the barrier impairment of skin always increases the penetration behavior of a given compound; however, the hydrophilic–lipophilic balance of the compounds or formulations used could greatly modify its penetration profile, especially when a modified skin is used. Conclusions This in vitro protocol may be useful to simulate the percutaneous absorption profile of some drugs applied onto skin with an impaired SC barrier function and could be used to avoid, to some extent, the use of in vivo experimental animal models in the dermopharmaceutical field.

Environmental risks, particularly UV radiation, provide a challenge to the function of the skin barrier. Protective measures such as the use of antioxidant products represent a possible method of providing protection to the skin. This paper reports the development of a non-invasive ex vivo method using tape strips of the outermost layers of stratum corneum (SC) from human volunteers in order to determine the effectiveness of an antioxidant emulsion topically applied to prevent lipid peroxidation (LPO) in the horny layer after an UV irradiation exposure. Two different formulations were used: formulation (A), containing Vitamin A, E and C, and formulation (B) containing fish extract. Both formulations were topically applied in vivo on volunteer forearms; then, a tape stripping of the SC of each volunteer was carried out. The lipid peroxidation was measured ex vivo after an UV irradiation of the SC samples. The amount of SC stripped to evaluate differences in lipid peroxidation, the UV irradiation intensity to form lipid peroxides and the accuracy of lipid peroxide analysis were optimized in this methodology using formulation (A). After an exposure application of seven days, a group of three strips of the outermost layers of SC of volunteers was irradiated with an intensity of 182.7 J/cm(2) to quantify the LPO inhibition. The percentage of LPO inhibition obtained after topical application of both formulations was in the range of 40-58% demonstrating the effectiveness of the formulations topically applied against lipid peroxidation on human SC. This methodology may be used as a quality control tool to determine ex vivo the percentage of the LPO inhibition on human SC for a variety of antioxidants topically applied.

The aim of our study was to determine the influence of several types of liposomes with a different lipid composition on the percutaneous absorption of one conventional sun filter with a lipophilic character (ethyl hexyl methoxycinnamate) using both in vitro and in vivo methodologies. Three different liposomes were prepared with unsaturated and saturated phosphatidylcholine (PC, HPC), and with a wool lipid mixture (IWL) with a composition similar to that of the stratum corneum lipids. Results showed that the liquid crystalline state associated with PC liposomes plays a key role in enhancing skin penetration. when liposomes with a composition and structural organization similar to that of the stratum corneum lipids (HPC and IWL) are used, the skin penetration is retarded, suggesting a certain reinforcement of the stratum corneum barrier. These two types of liposomes could be regarded as alternatives to conventional oil/water emulsions in the formulations of lipidic sun filters. Finally, an acceptable correlation was obtained using both in vitro and in vivo methodologies to evaluate the corresponding skin absorption profile.

Introduction Hidradenitis suppurativa (HS) is a chronic skin disease which causes a great impact in the quality of life.Multiple therapeutic options have been proposed, and recently the potential use of biological drugs in severe cases hasbeen postulated.Material and Methods A retrospective study from seven tertiary Spanish centers reviewing the charts of patients withHS treated with biological drugs was performed. Retrieved information included epidemiological data, clinical features,pain intensity, Hurley stage, laboratory data and therapeutic outcomes.Results Nineteen patients were included in the study; 10 men (52.6%) and 9 women. Eight patients (42%) showed aHurley severity stage II and 11 a stage III (57.8%). Adalimumab was prescribed as the first biological treatment in nineout of 19 cases (47.3%), whereas infliximab was prescribed in seven cases (36.8%), ustekinumab in two cases (10.5%)and etanercept in one (5.2%). A complete response was observed in three patients (two cases with infliximab and onecase with ustekinumab), a partial improvement in 10 patients and in six patients no clinical improvement was noted. Onepatient referred worsening of the skin symptoms. In 6 cases, a second biological treatment was prescribed. In three ofsuch cases, a partial improvement was noted, whereas in three cases no clinical improvement was observed. In twocases a switch to a third biological drug was indicated, with a partial improvement in one case.Discussion and Conclusions Biological drugs could be a potential and effective therapeutic option for patients withsevere HS. Complete and persistent clinical responses are rarely obtained (15%) and partial responses are achieved inapproximately 50% of patients. No specific markers for a therapeutic response have been identified. No definitive con-clusions regarding the most effective biological drug for HS could be drawn. Higher dosage schedules seem to be asso-ciated with higher response rates. The lack of response of one particular drug does not preclude a potential efficacy toanother biological treatment.Received: 4 December 2013; Accepted: 31 January 2014

Normally, percutaneous absorption tests are carried out using skin biopsies for an apparent and acceptable physiological condition. However, under different pathological conditions, the stratum corneum (SC) barrier function is impaired.The barrier function of the SC was assessed by correlation between the number of repeated applications of tape strips on the skin and its transepidermal water loss (TEWL), as well as by in vitro percutaneous absorption studies of different compounds, using Franz diffusion cells and porcine skin previously stripped.A progressive diminution of the skin barrier function has been detected by TEWL both in vitro and in vivo as the number of skin tape strips increases. On the other hand, the percutaneous absorption of the compounds tested increases in a different way as the number of strips increases. Salicylic acid increases linearly depending on the barrier disturbance. However, percutaneous absorption of caffeine exponentially increased with barrier disturbance. Our results indicate that the barrier impairment of skin always increases the penetration behavior of a given compound; however, the hydrophilic-lipophilic balance of the compounds or formulations used could greatly modify its penetration profile, especially when a modified skin is used.This in vitro protocol may be useful to simulate the percutaneous absorption profile of some drugs applied onto skin with an impaired SC barrier function and could be used to avoid, to some extent, the use of in vivo experimental animal models in the dermopharmaceutical field.