BIOBADADERM: registro español de acontecimientos adversos de terapias biológicas en Dermatología. Primer informe

Rivera, R.; García‐Doval, I.; Carretero, G.; Daudén, E.; Sánchez‐Carazo, J.L.; Ferrándiz, Carlos; Herrera, Enrique; Alsina, M.; Ferrán, Marta; López-Estebaranz, J.L.; Gómez, Francisco Javier; Herranz, J.M.; Carrascosa, J.M.; Vanaclocha, F.

doi:10.1016/j.ad.2010.10.016

Cited by 48 publications

(3 citation statements)

References 9 publications

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“…Registry data can be used to assess the long-term risk of biological therapies, but most of the available information corresponds to patients with rheumatological diseases, and the information on psoriasis-specific registries is scarce [15,16]. Observational studies are a suitable source of information regarding the management of psoriasis with biologicals; they reflect ‘real life’ and provide useful information for clinical practice [17].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up

Puig

Martínez²,

Carpio³

et al. 2012

Dermatology

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Background: The efficacy of etanercept in the treatment of psoriasis has been demonstrated in several clinical trials, but information regarding results derived from prospective observational studies in clinical practice is scarce. Objectives: To evaluate the efficacy and safety of etanercept administration according to routine clinical use in moderate-to-severe plaque psoriasis. Materials and Methods: Postauthorization, prospective study, carried out at 59 dermatology units in Spain. Patients diagnosed with moderate-to-severe plaque psoriasis received etanercept during a 12-month period. Results: Altogether, 444 patients were enrolled. Overall, 325 patients (73.2%) initiated etanercept treatment at a dose of 50 mg twice weekly; 96 patients (21.6%) received etanercept as a continuous regimen for the entire study period, and 348 patients (79.4%) an intermittent regimen. Among these, 185 patients (41.6% overall) received one course of treatment, stopped at various study points and did not restart etanercept treatment, whereas the remaining 163 patients (36.7% overall) stopped etanercept treatment, lost response, relapsed and were retreated. Most patients who interrupted etanercept treatment did so at month 6. Altogether, 79.7% of patients completed the study period. Etanercept treatment resulted in significant improvement in disease activity. A Psoriasis Area and Severity Index (PASI) 75 response was achieved by 76.1% of patients at month 6. Out of 252 adverse events reported, 31 were considered severe. Three possibly treatment-related malignancies were detected during the study. No opportunistic infections, tuberculosis or demyelinating events were reported. Conclusion: The PASI 75 response rate at month 6 in this observational, naturalistic study is similar to those observed in recent published trials with etanercept, and within the range of those reported for other marketed biologicals.

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Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up

Puig

Martínez²,

Carpio³

et al. 2012

Dermatology

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“…Destacan las infecciones e infestaciones, los trastornos de la piel y el tejido subcutáneo y los trastornos de la sangre y del sistema linfático 25 .…”

Section: Datos De Seguridad De Los Tratamientos Biológicosunclassified

“…Se han observado más casos de linfomas entre los pacientes que recibieron un antagonista del TNF (infliximab, adalimumab y etanercept) en comparación con el grupo de control, en las partes controladas de los ensayos clínicos 25 . Aun así, la incidencia fue baja 25 . Con la administración de ustekinumab, no se ha observado aumento en las tasas de linfoma respecto a los pacientes tratados con placebo 47 .…”

Section: Contraindicaciones Absolutasunclassified

Elección de fármaco biológico en la psoriasis moderada-grave. Protocolo

Guerra¹

2012

Más Dermatol.

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RESUMENHasta la fecha, se han publicado diferentes guías clínicas acerca del tratamiento de la psoriasis en placas moderada-grave. Sin embargo, no se ha publicado un protocolo que recoja los puntos que deben considerarse en la elección de fármacos biológicos en la psoriasis moderada-grave.Las características basales de gravedad (PASI) de los pacientes no permiten por sí solas establecer a priori la selección del fármaco biológico. La presencia de caracterís-ticas individuales del paciente o de la enfermedad y la forma de administración a menudo determinan el perfil de eficacia y seguridad de cada fármaco en cada paciente. Valoraremos, por tanto, en el proceso de selección de un determinado fármaco biológico, los factores que permiten tomar una decisión terapéutica individualizada, como son eficacia, seguridad, contraindicaciones, precauciones y otros datos.Este protocolo debe ser revisado periódicamente, puesto que los datos recogidos a lo largo del tiempo sobre estas terapias aún jóvenes, el mayor número de pacientes en tratamiento, los datos de los registros (BIOBADADERM) todavía con escaso recorrido, los nuevos estudios y la incorporación de fármacos nuevos aportarán información que modificará la toma de decisión de tratamiento biológico en un futuro.Palabras clave: protocolo, terapia biológica, guías clínicas, etanercept, adalimumab, infliximab, ustekinumab. ABSTRACTTo date, various clinical guides have been published about the treatment of moderate-severe plaque psoriasis. However, no protocol has been published that summarizes the aspects to be considered when choosing the biologic drug for treatment of moderate-severe psoriasis.The Psoriasis Area and Severity Index (PASI) does not by itself allow making an a priori choice of biologic drug for patients. The individual characteristics of the patient or of the disease, as well as the form of administering the drug, often determine the efficacy and safety profile of each drug for each individual patient. Therefore, in the process of choosing a particular biologic drug, we will evaluate the factors that help decision making regarding individualized therapy, such as efficacy, safety, contraindications, precautions and other data.This protocol should be reviewed regularly because the data collected over time about these still novel therapies, the larger number of patients receiving treatment, the data from records (BIOBADADERM) that have only recently been implemented, the new studies and the incorporation of new drugs will all provide more information that will modify future decision making about biologic treatment.

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Riesgo de reactivación de hepatitis B pasada en pacientes con psoriasis tratados con biológicos. Análisis retrospectivo de 20 casos. Registro de BIOBADADERM

Sanz-Bueno

Vanaclocha

García‐Doval

et al. 2015

Actas Dermo-Sifiliográficas

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BIOBADADERM: registro español de acontecimientos adversos de terapias biológicas en Dermatología. Primer informe

Cited by 48 publications

References 9 publications

Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up

Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up

Elección de fármaco biológico en la psoriasis moderada-grave. Protocolo

Riesgo de reactivación de hepatitis B pasada en pacientes con psoriasis tratados con biológicos. Análisis retrospectivo de 20 casos. Registro de BIOBADADERM

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