Biosimilar medicines for psoriasis. Positioning of the Mexican Academy of Dermatology.

The development and marketing of biosimilars opens a new scenario in the treatment of many pathologies, including psoriasis. This article reflects the position of the Mexican Academy of Dermatology (AMD) on the use of biosimilar medicines for the treatment of psoriasis in Mexico. In summary, the AMD estates that there is sufficient evidence to accept comparability of pharmacokinetics and pharmacodynamics of some biosimilar medicines to adalimumab, infliximab and etanercept; this evidence does not sufficiently support interchangeability or indication extrapolation. It is essential to establish a close pharmacovigilance not only to guarantee compliance with the Cofepris rules in Mexico, but also to facilitate the effective monitoring of the adverse effects of biosimilar medicines. Although the goal of biotechnological drugs is to achieve substantial savings for patients and public institutions, no economic criteria should prevail over rigorous scientific criteria that guarantee maximum therapeutic efficacy and optimum safety for patients.

El desarrollo y comercialización de biocomparables abre un nuevo escenario en el tratamiento de muchas patologías, entre ellas la psoriasis. El presente artículo recoge la postura de la Academia Mexicana de Dermatología (AMD) respecto al uso de medicamentos biocomparables para el tratamiento de la psoriasis en México. En resumen, la AMD establece que existe suficiente evidencia para aceptar la comparabilidad farmacocinética y farmacodinámica entre algunos medicamentos biocomparables al adalimumab, el infliximab y el etanercept; esta evidencia no sustenta suficientemente su intercambiabilidad ni la extrapolación de indicaciones; es fundamental establecer una farmacovigilancia estrecha no solo para garantizar el cumplimiento de las reglas de la Comisión Federal para la Protección contra Riesgos Sanitarios en México, sino para facilitar un seguimiento efectivo de los efectos adversos de los medicamentos biocomparables. Si bien la meta de los medicamentos biotecnológicos es lograr un ahorro sustancial para los pacientes y las instituciones públicas, los criterios económicos no deben anteponerse a criterios científicos rigurosos que garanticen la máxima eficacia terapéutica y la óptima seguridad para los pacientes.

Consenso mexicano en el manejo clínico de la hidradenitis supurativa / Mexican consensus on the clinical management of hidradenitis suppurativa

Resumen ANTECEDENTES: La hidradenitis supurativa es una enfermedad inflamatoria, crónica y recurrente con gran repercusión en la calidad de vida de los pacientes, específicamente en los aspectos psicológicos y sexuales, así como también en la productividad laboral. OBJETIVO: Generar un documento de consenso sobre el manejo clínico de los pacientes con hidradenitis supurativa en México que sirva para homologar el diagnóstico y tratamiento de estos pacientes. MÉTODO: Se convocó a un grupo multidisciplinario (dermatólogos, ginecólogos, cirujanos, infectólogos, proctólogos) para analizar la evidencia en el tratamiento integral de la hidradenitis supurativa (calidad de vida, clinimetría, diagnóstico y tratamiento), localizada mediante una revisión sistemática de la bibliografía. El grupo discutió sobre los temas y se generaron las recomendaciones por acuerdo unánime de los participantes. RESULTADOS: Con frecuencia los pacientes con hidradenitis supurativa pueden tardar mucho tiempo en obtener el diagnóstico y manejo correctos, principalmente debido a la falta de evidencia sobre la enfermedad, así como a la falta de criterios para referir al paciente con un especialista. Se emitieron 22 recomendaciones para el tratamiento de pacientes con hidradenitis supurativa, que comprenden el diagnóstico, estadificación y clinimetría, así como el manejo clínico en el primer, segundo y tercer nivel de atención. CONCLUSIONES: Se emitieron las recomendaciones con base en la mejor evidencia disponible, así como la experiencia del grupo multidisciplinario de expertos en el tratamiento de hidradenitis supurativa.

Abstract BACKGROUND: Hidradenitis suppurativa is an inflammatory, chronic and recurrent disease with a high impact on patients quality of life, specifically in psychological and sexual aspects, as well as in labor productivity. OBJECTIVE: To generate a consensus document on the clinical management of patients with hidradenitis suppurativa in Mexico, that serves to standardize the diagnosis and treatment of these patients. METHOD: A multidisciplinary group was convened (dermatologists, gynecologists, surgeons, infectologists, proctologists) to analyze the evidence on the integral treatment of hidradenitis suppurativa (quality of life, clinimetry, diagnosis and treatment), located through a systematic review of the literature. The group discussed the issues and the recommendations were generated by unanimous agreement of the participants. RESULTS: Frequently, patients with hidradenitis suppurativa can take a long time to obtain the correct diagnosis and management, mainly due to the lack of evidence about the disease, as well as the lack of criteria to refer the patient to a specialist. Twenty-two recommendations were issued for the treatment of patients with hidradenitis suppurativa, which include diagnosis, staging and clinimetry, as well as clinical management in the first, second and third levels of care. CONCLUSIONS: The recommendations were issued based on the best available evidence, as well as the experience of the multidisciplinary group of experts in the treatment of hidradenitis suppurativa.

Second joint position paper: Use of isotretinoin in severe acne / Segunda declaración de posición conjunta: uso de isotretinoína en acné severo

Background: The use of isotretinoin is indicated in the treatment of severe acne; however, its adverse effects are important. Objective: To update the first Mexican Consensus on the use of isotretinoin in severe acne vulgaris, which took place in 2009. Methods: It was carried out a literature search between June 2009, and February 2015, in order to evaluate topics to be discussed; materials were sent to the experts to promote the debate among participants. The topics of interest were analyzed during the consensus with the Delphi modified method, using an instrument previously validated. 15 certified dermatologists with experience in handling acne with isotretinoin took part in the study; seven of them were involved in the previous consensus. Results: Several cases of isolated adverse events were identified. Neither systematic reviews, meta-analyses nor comparative, randomized, controlled clinical trials were published during the observation period. Conclusions: Isotretinoin is still the best treatment for severe nodulocystic acne. However, it must be taken into consideration its teratogenic effect on pregnant women and its association with inflammatory bowel disease, depression and suicidal ideas. Monitoring with laboratory tests is a tool for identifying possible adverse events.

Introducción: el uso de la isotretinoína está indicado en el tratamiento del acné severo; sin embargo, sus efectos adversos son importantes. Objetivo: actualizar el primer Consenso Mexicano sobre el uso de isotretinoína en acné vulgar severo. Métodos: se realizó una búsqueda de la literatura especializada entre junio de 2009 y febrero de 2015, con el fin de evaluar los temas que se iban a discutir; el material fue enviado a los expertos con el objetivo de promover el debate entre los participantes. Los temas de interés fueron analizados durante el consenso mediante el método Delphi modificado, utilizando un instrumento previamente validado. Participaron 15 dermatólogos certificados y con experiencia en el manejo de acné con isotretinoína; siete de los especialistas intervinieron en el primer consenso. Resultados: se identificaron múltiples reportes de caso de eventos adversos aislados. Ninguna revisión sistemática o metaanálisis fueron publicados en el periodo de observación. Tampoco se identificaron estudios comparativos clínicos aleatorios controlados. Conclusiones: la isotretinoína todavía es el mejor tratamiento para el acné noduloquístico severo. Sin embargo, se debe considerar su potencial teratogénico sobre el feto en mujeres embarazadas y la asociación con enfermedad inflamatoria intestinal, depresión e ideas suicidas. La monitorización con exámenes de laboratorio es el instrumento para identificar posibles eventos adversos.

[Mexican consensus on the diagnosis and treatment of atopic dermatitis in adolescents and adults]. / Consenso mexicano para el diagnóstico y tratamiento de la dermatitis atópica en adolescentes y adultos.

BACKGROUND: The diagnostic approaches and therapeutic strategies of atopic dermatitis (AD) are generally inconsistent among physicians and health institutions. OBJECTIVE: To develop a consensus statement among experts to reduce the variations in practice regarding the diagnosis and treatment of patients ≥ 12 years with AD to improve their care. METHODS: Systematic literature search in PubMed and GREAT. With methodological support and using the Delphi method, a formal consensus was developed among 16 experts in Dermatology and Allergology, based on the current evidence and its applicability in the Mexican context. Apart from intense electronic communication, several issues of disagreement were discussed in two face-to-face meetings. RESULTS: The clinical experts reached consensus on 46 statements related to the definition, classification, diagnostic strategies and treatment of AD. For the diagnosis we suggest the Williams criteria and for severity scoring the SCORAD (by the doctor) and POEM (by the patient). In addition to general care and treatment education (workshops), we suggest four steps for treatment, depending on severity: 1. Topical treatment with anti-inflammatory agents (and systemic: antihistamines/antileukotrienes -low level evidence-) 2. Phototherapy, 3. Cyclosporin A and 4. Dupilumab, with the possibility of managing this biological earlier on if a fast effect is needed. In extrinsic AD we suggest evaluating the addition of allergen immunotherapy or an elimination diet, if there is an IgE-mediated respiratory or food allergy, respectively. CONCLUSION: The panel of experts reached consensus on relevant aspects of AD with a focus on the transcultural adaptation of recent evidence.

Antecedentes: Los abordajes diagnósticos y las estrategias terapéuticas de la dermatitis atópica generalmente son inconsistentes entre los médicos y entre las instituciones de salud. Objetivo: Consensar las opiniones de expertos para reducir las variaciones en la práctica respecto al diagnóstico y tratamiento de pacientes ≥ 12 años con dermatitis atópica para mejorar su cuidado. Métodos: Búsqueda sistemática de la literatura en PubMed y GREAT. Con apoyo metodológico y utilizando el método Delphi se desarrolló un consenso formal entre 16 expertos en dermatología y alergología, basándose en la evidencia actual y su aplicabilidad en el contexto mexicano. A parte de una comunicación electrónica intensa, se discutieron los puntos en desacuerdo en dos reuniones presenciales. Resultados: Los expertos clínicos alcanzaron consenso en 46 declaraciones relacionadas con la definición, clasificación, estrategias de diagnóstico y tratamiento de la dermatitis atópica. Para el diagnóstico sugerimos se usan los criterios de Williams y el SCORAD (por parte del médico) y POEM (por parte del paciente) para definir la gravedad. Aunado a cuidados generales y educación terapéutica, sugerimos cuatro pasos para tratamiento, según gravedad: 1. Manejo tópico con antiinflamatorio (y sistémico: antihistamínico/antileucotrieno ­evidencia reducida­) 2. Fototerapia, 3. Ciclosporina A y 4. Dupilumab, con la posibilidad de manejarlo antes si se necesita efecto rápido. En la dermatitis atópica extrínseca sugerimos agregar inmunoterapia con alérgenos o una dieta de eliminación si existe una alergia IgE-mediada, inhalatoria o alimentaria, respectivamente. Conclusión: El panel de expertos realizó consenso en aspectos relevantes de la dermatitis atópica con enfoque en la adaptación transcultural de evidencia reciente.

Three cases of bullous morphea: histopathologic findings with implications regarding pathogenesis.

Bullous morphea is a rare variant and is not frequently reported. We present three cases of bullous morphea. Although lymphangiectases have been suggested as the most likely mechanism for the development of the bullae in cases of morphea, none of the cases presented with lymphangiectases. To the contrary, all of our cases showed hemorrhagic content in the bullae, which suggests local trauma as a mechanism involved in bulla formation.

An unusual presentation of Takayasu's arteritis in two Mexican siblings.

Takayasu's arteritis (TA) is an idiopathic vasculitis characterized by granulomatous arteritis of the aorta and its main branches. Here we describe two cases with atypical presentation of TA in Mexican siblings. Both patients had pyoderma gangrenosum and pulmonary nodules throughout the course of their disease. We discuss skin manifestations associated with TA, as well as parenchymal lung involvement, which is unusual in TA and can be related to pyoderma. These cases exemplify the protean manifestations of TA.

[Position paper about isotretinoin on acne vulgaris]. / Declaración de posición conjunta. Uso de isotretinoína en acné común.

Isotretinoin was authorized since 1982 for the treatment of acne vulgaris associated to severe cutaneous lesions. It has been used in others clinical conditions in various plans of prescription. Since the Isotretinoin was launched, it caused controversies in our country and around the world, especially in relation with the security. Isotretinoin is proscribed in pregnant patient. As a security rule we must measure serum lipids and hepatic enzymes. The aim of the consensus was to spread information worked by a group of Mexican experienced dermatologists to the health professionals about the use and the specific indications about isotretinoin.

Response to hydralazine-valproate in a patient with mycosis fungoides.

Histone deacetylase (HDAC) inhibitors have shown significant activity in the treatment of cutaneous T-cell lymphomas (CTCL). The epigenetic alterations of CTCL not only are limited to altered histone acetylation but also include aberrant DNA gene methylation hence, the combination of an HDAC inhibitor with a DNA demethylating agent is a promising therapy to be tested. Here we report a mycosis fungoides patient having a dramatic response to hydralazine and valproate, two repositioned drugs as HDAC and DNA methylation inhibitors, respectively.

Influence of skin color on the diagnostic utility of clinical acanthosis nigricans to predict insulin resistance in obese patients.

BACKGROUND: Skin color may influence the presence of acanthosis nigricans (AN) as predictor of insulin resistance (IR). The objective of this study was to determine how skin color influences the diagnostic utility of AN as a marker of IR. METHODS: We designed a cross-sectional study. Subjects were classified according to their skin color (phototypes I-VI of Fitzpatrick), presence, and severity of AN (Burke quantitative scale). Blood samples were taken for measurement of glucose and insulin to calculate the Matsuda insulin sensitivity index (ISI). RESULTS: Sixty two obese subjects with BMI of 39.6 +/- 8 were included. Males were more prone to AN (9/12, 75% vs. 24/50, 48%, p <0.085) than females. The neck was the most frequent affected body region (53/62, 85.5%), followed by the elbows (15/62, 24.2%), knuckles (6/62, 9.7%), and knees (4/62, 6.5%). No concordance was found among them. AN was more frequent in those with skin phototype IV (18/23, 78.3%, p = 0.001) than those with phototype III (12/23, 52.2%) and phototype II (3/16, 18.8%). The utility of AN on the neck to predict ISI <3.5 (surrogate of insulin resistance) was sensitivity, 66.7 (95% CI 40.9-79.5); specificity, 82.5 (95% CI 56-95); positive predictive value, 91%; negative predictive value, 48% (p <0.001 for all values). CONCLUSIONS: People with skin phototype IV have a high frequency of AN on the neck, compared with those with phototypes II and III. Those with AN and skin phototype II showed high specificity and positive predictive values for insulin resistance. Thus, AN is a good marker for IR only in lower phototypes.

Dermatological complications of obesity.

Obesity is a health problem of considerable magnitude in the Western world. Dermatological changes have been reported in patients with obesity, including: acanthosis nigricans and skin tags (due to insulin resistance); hyperandrogenism; striae due to over extension; stasis pigmentation due to peripheral vascular disease; lymphedema; pathologies associated with augmented folds; morphologic changes in the foot anatomy due to excess load; and complications that may arise from hospitalization. Acanthosis nigricans plaques can be managed by improved control of hyperinsulinemia; the vitamin D3 analog calcipitriol has also been shown to be effective. Skin tags can be removed by snipping with curved scissors, by cryotherapy or by electrodesiccation. Hyperandrogenism, a result of increased production of endogenous androgens due to increased volumes of adipose tissue (which synthesizes testosterone) and hyperinsulinemia (which increases the production of ovarian androgens) needs to be carefully assessed to ensure disorders such as virilizing tumors and congenital adrenal hyperplasia are treated appropriately. Treatment of hyperandrogenism should be centred on controlling insulin levels; weight loss, oral contraceptive and antiandrogenic therapies are also possible treatment options. The etiology of striae distensae, also known as stretch marks, is yet to be defined and treatment options are unsatisfactory at present; striae rubra and alba have been treated with a pulsed dye laser with marginal success. The relationship between obesity and varicose veins is controversial; symptoms are best prevented by the use of elastic stockings. Itching and inflammation associated with stasis pigmentation, the result of red blood cells escaping into the tissues, can be treated with corticosteroids. Lymphedema is associated with dilatation of tissue channels, reduced tissue oxygenation and provides a culture medium for bacterial growth. Lymphedema treatment is directed towards reducing the limb girth and weight, and the prevention of infection. Intertrigo is caused by friction between skin surfaces, combined with moisture and warmth, resulting in infection. This infection, most commonly candidiasis, is best treated with topical antifungal agents; systemic antifungal therapy may be required in some patients. Excess load on the feet can result in morphological changes that require careful diagnosis; insoles may offer some symptom relief while control of obesity is achieved. Obesity-related dermatoses associated with hospitalization, such as pressure ulcers, diminished wound healing, dermatoses secondary to respiratory conditions, and incontinence, must all be carefully managed with an emphasis on prevention where possible. Recognition and control of the dermatological complications of obesity play an important role in diminishing the morbidity of obesity.