ABSTRACT
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.
Subject(s)
Biosimilar Pharmaceuticals/administration & dosage , Dermatologic Agents/administration & dosage , Psoriasis/drug therapy , Adalimumab/administration & dosage , Adalimumab/adverse effects , Biosimilar Pharmaceuticals/adverse effects , Biosimilar Pharmaceuticals/therapeutic use , Dermatologic Agents/adverse effects , Dermatologic Agents/pharmacokinetics , Dermatology , Drug Approval , Etanercept/administration & dosage , Etanercept/adverse effects , Humans , Infliximab/administration & dosage , Infliximab/adverse effects , Mexico , PharmacovigilanceABSTRACT
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.
Subject(s)
Dermatitis, Atopic , Practice Guidelines as Topic , Adolescent , Adult , Biological Products/therapeutic use , Combined Modality Therapy , Comorbidity , Dermatitis, Atopic/diagnosis , Dermatitis, Atopic/psychology , Dermatitis, Atopic/therapy , Dermatologic Agents/classification , Dermatologic Agents/therapeutic use , Dermatology/methods , Diagnosis, Differential , Disease Management , Female , Humans , Immunotherapy/methods , Lactation , Male , Mexico , Phototherapy/methods , Pregnancy , Pregnancy Complications/therapy , Randomized Controlled Trials as Topic , Severity of Illness Index , Skin Diseases, Infectious/complications , Surveys and Questionnaires , Therapeutic Irrigation , Transition to Adult CareABSTRACT
A case about a male patient 31 years with a history of non-healing suppurative lesion on his left index finger that finally required amputation is reported. A year later he developed two ulcers, one of them on the abdominal wall had been present for almost one year reaching a big size (18±6.5 cm); the second one was smaller and located on the left proximal arm. Histopathology study showed non-caseating granulomas with positive stain for acid-fast bacillus, and a PCR test was positive for Mycobacterium tuberculosis. Patient was treated with combined treatment against tuberculosis during a year, achieving complete healing. The most outstanding feature of this case report is the clinical expression with an uncommon huge ulcer.
Subject(s)
Skin Ulcer/microbiology , Skin Ulcer/pathology , Tuberculosis, Cutaneous/pathology , Adult , Humans , MaleABSTRACT
A 39 years old man with a long-standing disseminated dermatophytosis even with several antifungal treatments is presented. From lesions, Trichophyton rubrum var. typical downy, T. tonsurans and Candida albicans were isolated and showed sensivity to azolic compounds in vitro. The phagocytic activity in vitro compared with normal control was depressed. Treatment with itraconazole and immunomodulation using a bacterial antigen was indicated. During the last two years the patient has been clinical and mycologically healthy, and his phagocytosis activity has become normal. In patients with chronic and relapsing dermatophytosis, the immune response evaluation is recommended, and immunomodulation could be useful as a rational measure in patients with a particular immunodeficiency.
Subject(s)
Antifungal Agents/therapeutic use , Dermatomycoses/drug therapy , Immunotherapy/methods , Adult , Dermatomycoses/immunology , Humans , Male , Treatment OutcomeABSTRACT
Se presenta el caso de un hombre de 39 años de edad con dermatofitosis crónica diseminada. De las lesiones se aislaron Trichophyton rubrum var. vellosa típica, T. tonsurans y Candida albicans, todos sensibles in vitro a compuestos azólicos. La actividad fagocítica in vitro comparada con un control normal mostró deficiencia en la misma. Se indicó tratamiento con itraconazol e inmunoestimulación con antígeno bacteriano. Durante los dos últimos años el paciente se ha mantenido clínica y micológicamente sano y su actividad fagocitaria es normal. En los pacientes con dermatofitosis crónica recidivante es recomendable la valoración de la respuesta inmune y la inmunomodulación puede ser útil como parte del tratamiento.
A 39 years old man with a long-standing disseminated dermatophytosis even with several antifungal treatments is presented. From lesions, Trichophyton rubrum var. typical downy, T. tonsurans and Candida albicans were isolated and showed sensivity to azolic compounds in vitro. The phagocytic activity in vitro compared with normal control was depressed. Treatment with itraconazole and immunomodulation using a bacterial antigen was indicated. During the last two years the patient has been clinical and mycologically healthy, and his phagocytosis activity has become normal. In patients with chronic and relapsing dermatophytosis, the immune response evaluation is recommended, and immunomodulation could be useful as a rational measure in patients with a particular immunodeficiency.
Subject(s)
Humans , Male , Adult , Antifungal Agents/therapeutic use , Dermatomycoses , Immunotherapy/methods , Dermatomycoses , Treatment OutcomeABSTRACT
El actinomicetoma es un síndrome de localización subcutánea de evolución crónica. Se presenta el caso de un paciente con micetoma abdominal causado por Nocardia brasiliensis, que había sido resistente a diferentes esquemas terapéuticos durante varios años y que, además, presentaba deficiencia en la función fagocitaria. En este caso, la curación se obtuvo con la administración de dos ciclos (con duración de 23 días cada uno); se administró cefotaxima (1g cada 8 horas) y amikacina (50 mg cada 12 horas). La inmunomodulación se llevó a cabo mediante la administración de una dosis semanal de levamisol de 300 mg, durante cuatro semanas, y la aplicación dos veces por semana de 1 ml de antígeno bacteriano a una concentración 600,000,000 de bacterias por ml durante 20 meses. Se discute la utilidad del antibiograma en estos pacientes y la importancia de la investigación de la función inmunológica en pacientes con resistencia a los tratamientos convencionales
