RESUMO
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.
Assuntos
Produtos Biológicos , Psoríase , Prescrições de Medicamentos , Humanos , Psoríase/tratamento farmacológico , Sistema de Registros , Inibidores do Fator de Necrose TumoralRESUMO
Recent publication of the results of clinical trials in which lymph node dissection was not associated with any survival benefit in patients with sentinel node metastasis makes it necessary to reconsider the treatment of patients with melanoma. This article provides an update on the available evidence on the diverse factors (routes of metastatic spread, predictors, adjuvant therapy, etc.) that must be considered when treating patients with sentinel node-positive melanoma. The authors propose a decision-making algorithm for use in this clinical setting. The current evidence no longer supports lymph node dissection in patients with low-risk sentinel node metastasis (sentinel node tumor load ≤1mm).
Assuntos
Algoritmos , Excisão de Linfonodo , Melanoma/secundário , Melanoma/cirurgia , Linfonodo Sentinela , Neoplasias Cutâneas/patologia , Neoplasias Cutâneas/cirurgia , Tomada de Decisão Clínica , Medicina Baseada em Evidências , Humanos , Metástase Linfática , Guias de Prática Clínica como AssuntoRESUMO
Polymorphisms at genes encoding proteins involved in the pathogenesis of psoriasis (Psor) or in the mechanism of action of biological drugs could influence the treatment response. Because the interleukin (IL)-17 family has a central role in the pathogenesis of Psor, we hypothesized that IL17RA variants could influence the response to anti-TNF drugs among Psor patients. To address this issue we performed a cross-sectional study of Psor patients who received the biological treatments for the first time, with a follow-up of at least 6 months. All of the patients were Caucasian, older than 18 years old, with chronic plaque Psor, and had completed at least 24 weeks of anti-TNF therapy (adalimumab, etanercept or infliximab). The treatment response to anti-TNF agents was evaluated according to the achievement of PASI50 and PASI75 at weeks 12 and 24. Those who achieved PASI75 at week 24 were considered good responders. All patients were genotyped for the selected single-nucleotide polymorphisms (SNPs) at IL17RA gene. A total of 238 patients were included (57% male, mean age 46 years). One hundred and five patients received adalimumab, 91 patients etanercept and 42 infliximab. The rs4819554 promoter SNP allele A was significantly more common among responders at weeks 12 (P=0.01) and 24 (P=0.04). We found a higher frequency of AA versus AG+GG among responders, but the difference was only significant at week 12 (P=0.03, odd ratio=1.86, 95% confidence of interval=1.05-3.27). Thus, in the study population, the SNP rs4819554 in the promoter region of IL17RA significantly influences the response to anti-TNF drugs at week 12.
Assuntos
Polimorfismo de Nucleotídeo Único/genética , Psoríase/genética , Receptores de Interleucina-17/genética , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/uso terapêutico , Alelos , Estudos Transversais , Etanercepte/uso terapêutico , Feminino , Genótipo , Humanos , Infliximab/uso terapêutico , Interleucina-17/genética , Masculino , Pessoa de Meia-Idade , Psoríase/tratamento farmacológicoRESUMO
BACKGROUND: Therapeutic decisions in psoriasis are influenced by disease factors (e.g., severity or location), comorbidity, and demographic and clinical features. OBJECTIVE: We aimed to assess the reliability of a mobile telephone application (MDi-Psoriasis) designed to help the dermatologist make decisions on how to treat patients with moderate to severe psoriasis. METHOD: We analyzed interobserver agreement between the advice given by an expert panel and the recommendations of the MDi-Psoriasis application in 10 complex cases of moderate to severe psoriasis. The experts were asked their opinion on which treatments were most appropriate, possible, or inappropriate. Data from the same 10 cases were entered into the MDi-Psoriasis application. Agreement was analyzed in 3 ways: paired interobserver concordance (Cohen's κ), multiple interobserver concordance (Fleiss's κ), and percent agreement between recommendations. RESULTS: The mean percent agreement between the total of 1210 observations was 51.3% (95% CI, 48.5-54.1%). Cohen's κ statistic was 0.29 and Fleiss's κ was 0.28. Mean agreement between pairs of human observers only, excluding the MDi-Psoriasis recommendations, was 50.5% (95% CI, 47.6-53.5%). Paired agreement between the recommendations of the MDi-Psoriasis tool and the majority opinion of the expert panel (Cohen's κ) was 0.44 (68.2% agreement). CONCLUSIONS: The MDi-Psoriasis tool can generate recommendations that are comparable to those of experts in psoriasis.
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Tomada de Decisão Clínica , Fármacos Dermatológicos/uso terapêutico , Dermatologia/métodos , Aplicativos Móveis , Psoríase/tratamento farmacológico , Adulto , Telefone Celular , Contraindicações de Medicamentos , Estudos Transversais , Prova Pericial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Terapia PUVA , Psoríase/radioterapia , Reprodutibilidade dos Testes , Terapia UltravioletaRESUMO
BACKGROUND: There are a limited number of studies comparing psoriasis patients without psoriatic arthritis (PsA) to those with arthritis. Previous results are controversial. OBJECTIVES: To perform a comparative analysis of the phenotype, baseline comorbidities, therapeutic profile and incidence of adverse events (particularly overall adverse events, infections and infestations, malignancies and psychiatric disorders) among psoriatic patients with/without PsA. METHODS: All the patients on the Biobadaderm registry, a prospective inception cohort of psoriasis patients on systemic therapy, were included. Patients were divided into two groups: those with psoriasis without arthritis at the time of entry into the cohort (Pso group) and those with psoriasis and psoriatic arthritis (PsA group) at entry. Patients were followed until the censorship date (last visit in a lost-to-follow-up patient, or 10 November 2015, whichever occurred first). We excluded all the patients who developed any kind of signs and/or symptoms of joint involvement during the follow-up. A descriptive analysis was performed. We estimated incidence ratios (IRR) of adverse events during systemic treatment using a mixed-effects Poisson regression. RESULTS: We included 2120 patients: 1871 (88%) patients with psoriasis without arthritis and 249 (12%) with psoriasis and PsA. The follow-up time was 5020 patients-year in the Pso group and 762 patients-year in the PsA group. Patients with PsA had more comorbidities, particularly hypertension and liver disease; used a higher number of systemic therapies, particularly anti-TNFα drugs and combination therapy; and presented more adverse events (IRR adjusted = 1.29; 95% CI: [1.05-1.58]), particularly serious adverse events (IRR adjusted = 1.51; 95% CI: [1.01-2.26]) and infections/infestations (IRR adjusted = 1.88; 95% CI: [1.27-2.79]), independently of the associated comorbidities and present/past therapies. CONCLUSIONS: Given the differences between patients with psoriasis alone or with psoriasis associated with PsA, patients with psoriasis and PsA should be followed and managed more closely and with specific attention.
Assuntos
Artrite Psoriásica/fisiopatologia , Fenótipo , Sistema de Registros , Adulto , Idoso , Artrite Psoriásica/complicações , Feminino , Humanos , MasculinoRESUMO
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.
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Antirreumáticos/administração & dosagem , Fatores Biológicos/administração & dosagem , Imunossupressores/administração & dosagem , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios , Psoríase/tratamento farmacológico , Adulto , Idoso , Anestesia/métodos , Antibioticoprofilaxia , Antirreumáticos/efeitos adversos , Fatores Biológicos/efeitos adversos , Contraindicações de Medicamentos , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Imunossupressores/efeitos adversos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/induzido quimicamente , Psoríase/complicações , Sistema de Registros , Estudos Retrospectivos , Espanha/epidemiologia , Procedimentos Cirúrgicos Operatórios , Resultado do TratamentoRESUMO
Methotrexate (MTX) is the most frequently used conventional systemic drug in the treatment of psoriasis. Despite over 50years of experience in this setting, certain aspects of the use of this drug in clinical practice are still little standardized and poorly understood. For this reason, a group of 15 experts took part in a consensus development conference to achieve consensus on a series of recommendations on the use of MTX in psoriasis. The guidelines, which were developed on the basis of a systematic review of the literature, were validated by 2 rounds of voting and categorized by level of evidence and grade of recommendation. Before MTX can be used to treat moderate to severe psoriasis, the patient must be evaluated to assess the suitability of the treatment, including consideration of vaccination status and screening for tuberculosis and pregnancy. The recommended starting dose for a patient with no risk factors is 10 to 20mg/wk, the therapeutic dose for most patients is 15mg/wk, and the maximum dose is 20mg/wk. Most patients who respond to treatment will show improvement within 8weeks. Parenteral administration of MTX is desirable when there is a risk of erroroneous dosing, nonadherence, gastrointestinal intolerance, or inadequate response to the therapeutic dose taken orally. Noninvasive methods are preferred for monitoring hepatotoxicity. MTX is a good treatment option for patients with a history of cancer, but is not recommended in patients with chronic hepatitisB infection or individuals who are seropositive for human immunodeficiency virus.
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Metotrexato/uso terapêutico , Psoríase/tratamento farmacológico , Contraindicações , Infecções por HIV , Hepatite B Crônica , Humanos , Neoplasias , Guias de Prática Clínica como Assunto , Fatores de RiscoRESUMO
The first biosimilar version of a biologic agent used to treat psoriasis (infliximab) entered the Spanish market on February 16 of this year, and more biosimilars can be expected to follow in the coming months and years. Logically, this new situation will have economic repercussions and alter prescribing patterns among dermatologists. In this second part of the review, we will look at several somewhat contentious issues, such as the extrapolation of indications, interchangeability, and automatic substitution. We will also review the biosimilars with indications for psoriasis currently in the clinical development pipeline and assess their potential to offer comparable efficacy and safety to the reference product while contributing to the sustainability of the public health care system.
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Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas/legislação & jurisprudência , Psoríase/tratamento farmacológico , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/farmacocinética , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/farmacocinética , Ensaios Clínicos como Assunto , Substituição de Medicamentos , União Europeia , Humanos , Infliximab/efeitos adversos , Infliximab/uso terapêutico , Farmacovigilância , Espanha , Espondilite Anquilosante/tratamento farmacológico , Equivalência TerapêuticaRESUMO
INTRODUCTION AND OBJECTIVES: A 5% risk of reactivation of hepatitis B virus (HBV) infection has been reported in patients with diseases other than psoriasis treated with tumor necrosis factor inhibitors. The aim of this study was to investigate the risk of HBV reactivation in patients with a past history of HBV infection who were receiving biologic therapy for psoriasis. MATERIAL AND METHODS: This was a multicenter study of 20 patients with psoriasis who were treated with at least 1 biologic agent. All the patients had serologic evidence of past HBV infection (positive total hepatitis B core antibody and negative hepatitis B surface antibody). We analyzed the clinical, serological, and liver function variables recorded before, during, and at the end of follow-up. The viral load at the end of follow-up was also analyzed for all patients. RESULTS: None of the patients fulfilled the criteria for HBV reactivation at the end of a median follow-up period of 40 months. Combining our data with data from other studies of psoriasis patients with a past history of HBV infection who were treated with a biologic, we calculated a maximum estimated risk of HBV reactivation for a mean follow-up period of 30 months of 2.7 reactivations per 100 patients. CONCLUSIONS: Biologic therapy did not cause HBV reactivation in our series of patients. Nonetheless, because of the potentially serious complications associated with HBV reactivation, it is important to measure viral load in patients with a history of HBV infection prior to initiation of biologic therapy to rule out occult carriage. These patients should also be monitored regularly in conjunction with a hepatologist.
Assuntos
Antirreumáticos/efeitos adversos , Fármacos Dermatológicos/efeitos adversos , Vírus da Hepatite B/fisiologia , Hepatite B Crônica/complicações , Psoríase/tratamento farmacológico , Ustekinumab/efeitos adversos , Ativação Viral/efeitos dos fármacos , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/uso terapêutico , Antirreumáticos/uso terapêutico , Portador Sadio , DNA Viral/sangue , Bases de Dados Factuais , Fármacos Dermatológicos/uso terapêutico , Feminino , Seguimentos , Anticorpos Anti-Hepatite B/sangue , Antígenos da Hepatite B/sangue , Hepatite B Crônica/sangue , Hepatite B Crônica/virologia , Humanos , Masculino , Psoríase/complicações , Estudos Retrospectivos , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Ustekinumab/uso terapêutico , Carga ViralRESUMO
BACKGROUND: Biobadaderm is the Spanish registry of psoriasis patients receiving systemic treatment in clinical practice. OBJECTIVE: To compare the safety of biologics and classic systemic treatment. METHODS: Prospective cohort of patients receiving biologics and classic systemic therapies between 2008 and 2013 in 12 hospitals are included. We registered demographic data, diagnoses, comorbidities, treatments and adverse events (AE). We obtained raw relative risks (RR) for specific AE. Multivariate analysis consisted of Cox models adjusting for age, gender, chronic hepatic disease and previous cancer. RESULTS: A total of 1030 patients received biologics (2061 AE in 3681 person-years), 926 patients classic systemic drugs (1015 AE in 1517 person-years). Ninety-three per cent of AE in both groups were non-serious, 6% serious and 0.003% fatal. The age- and gender-adjusted hazard ratio of AE was lower in the biologics group [hazard ratio 0.6 (95% CI: 0.5-0.7)].We found no differences in rates of serious and mortal AE. Some system organ class AE rates differed between both groups. As limitations: Prescription bias might affect the incidence of AE in both groups. Association of drug and AE was based on timing: associations might not be causal. CONCLUSION: Patients receiving biologics had lower risk of AE. We did not find differences in the risk of serious or fatal AE.
Assuntos
Anti-Inflamatórios não Esteroides/efeitos adversos , Produtos Biológicos/efeitos adversos , Imunossupressores/efeitos adversos , Ceratolíticos/efeitos adversos , Psoríase/tratamento farmacológico , Acitretina/efeitos adversos , Adalimumab , Adulto , Idoso , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Ciclosporina/efeitos adversos , Etanercepte , Feminino , Humanos , Imunoglobulina G/efeitos adversos , Infliximab , Masculino , Metotrexato/efeitos adversos , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Receptores do Fator de Necrose Tumoral , Sistema de Registros , Medição de Risco , Espanha , UstekinumabAssuntos
Dermoscopia , Histiocitoma Fibroso Benigno/diagnóstico , Neoplasias Primárias Múltiplas/diagnóstico , Neoplasias Cutâneas/diagnóstico , Adenocarcinoma Mucinoso , Idoso , Biópsia , Neoplasias do Endométrio , Feminino , Células Gigantes/patologia , Histiocitoma Fibroso Benigno/classificação , Histiocitoma Fibroso Benigno/patologia , Humanos , Neoplasias Primárias Múltiplas/patologia , Segunda Neoplasia Primária/diagnóstico , Segunda Neoplasia Primária/patologia , Neoplasias Cutâneas/patologiaRESUMO
Novel treatment strategies and new information concerning the management of moderate to severe psoriasis justify a reassessment of the role of the classic therapies in this setting. This consensus statement evaluates narrowband UV-B therapy, which is currently considered the phototherapy option of choice in psoriasis because of its risk-to-benefit ratio. The role of excimer laser and photodynamic therapies are also discussed. These targeted therapies are still only available in a small number of centers in Spain and are used principally in the treatment of localized and recalcitrant forms of psoriasis. We discuss the efficacy and safety of phototherapy as well as treatment regimens, combination therapy, and clinical considerations relating to the characteristics of the patient or the disease.
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Lasers de Excimer/uso terapêutico , Terapia com Luz de Baixa Intensidade/métodos , Fotoquimioterapia/métodos , Psoríase/terapia , Terapia Ultravioleta/métodos , Acitretina/uso terapêutico , Corticosteroides/administração & dosagem , Corticosteroides/uso terapêutico , Adulto , Criança , Ensaios Clínicos como Assunto , Terapia Combinada , Comorbidade , Contraindicações , Eritema/etiologia , Feminino , Humanos , Lasers de Excimer/efeitos adversos , Terapia com Luz de Baixa Intensidade/efeitos adversos , Neoplasias Induzidas por Radiação/etiologia , Neoplasias Induzidas por Radiação/prevenção & controle , Terapia PUVA/efeitos adversos , Terapia PUVA/métodos , Fotoquimioterapia/efeitos adversos , Gravidez , Complicações na Gravidez/radioterapia , Psoríase/tratamento farmacológico , Psoríase/radioterapia , Dosagem Radioterapêutica , Terapia Ultravioleta/efeitos adversosRESUMO
INTRODUCTION: Although metastatic melanoma has a poor prognosis, cutaneous metastases represent a special case given their ready accessibility, making it possible for dermatologists to apply local treatment. We report our experience with intralesional treatment with interleukin (IL) 2 in 7 patients with cutaneous metastases from malignant melanoma. MATERIAL AND METHODS: A total of 244 lesions in 7 patients with satellitosis and/or cutaneous metastases from malignant melanoma were treated with intralesional IL-2 twice a week. The maximum dose in each patient ranged from 3 to 18 million units per session, according to the number and size of lesions. RESULTS: Complete or partial remission was achieved in almost all lesions (95.9 % and 3.7 %, respectively).Only 1 lesion (0.4 %) -the largest and located subcutaneously- did not respond to intralesional treatment and required alcoholization and subsequent surgical removal to achieve cure. All partial responses occurred in subcutaneous lesions larger than 2 cm. Treatment was well tolerated with only a few mild side effects (grade 1-2). CONCLUSIONS: IL-2 may be an effective and well-tolerated treatment option in patients with satellitosis and cutaneous metastases from melanoma. Lesions smaller than 2 cm and located in the epidermis or superficial dermis respond better than those larger than 2 cm or located in the subcutaneous cellular tissue. More studies are necessary to establish appropriate doses and regimens.
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Antineoplásicos/administração & dosagem , Interleucina-2/administração & dosagem , Melanoma/tratamento farmacológico , Melanoma/secundário , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/secundário , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Injeções Intralesionais , Masculino , Melanoma/patologia , Pessoa de Meia-Idade , Neoplasias Cutâneas/patologiaRESUMO
PURPOSE: This article is an analysis of the information derived from the determination of tumor-tissue concentration of CEA in patients with colorectal cancer. To ascertain the relationship between tumor marker content with the histologic aspects and serologic levels of CEA of this neoplam. MATERIALS AND METHODS: 136 patients with colorectal adenocarcinoma and 41 with colorectal benign processes are analyzed and followed during an average time of 27 months. The CEA of the serum were obtained preoperatively and postoperatively and measured by radioimmunoassay (RIA). Tissular CEA levels were determined with RIA. The histological characteristics are analyzed (Dukes classification, grade of differentiation, index of atypia, microscopic vascular and lymphatic involvement. RESULTS: 1) The cut off point of the tissular CEA with the best sensitivity and specificity for the diagnosis of normal mucosa is 386 ng/mg and for tumoral tissue is 1160 ng/mg. 2) There is no correlation between tissue and serologic CEA value. 3) The tissular level of CEA have a significant statistical correlation with Dukes stage (p < 0.003); other histological characteristics were no significative. 4) There are significant statistical correlations between serologic CEA and relapse but no with survival rates. CONCLUSIONS: 1) Serologic CEA levels depend on numerous factors. 2) There aren't correlations between preoperative serologic levels and tissular CEA levels. 3) Tissular CEA do not predict what patients will have an elevated serologic CEA level in relapse.
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Antígeno Carcinoembrionário/sangue , Neoplasias Colorretais/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores Tumorais , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Perianal condyloma acuminatum is a lesion rarely seen in children or babies. We report three new cases of this disease in children less than 3 years of age. There was no evidence of the mechanism of transmission in these cases. All patients underwent radical surgical excision. In one case, surgical treatment was needed on two different occasions due to the extension of the warts. None of the patients showed any recurrence of condyloma over a follow-up period of six years.