Etanercept Treatment for Children and Adolescents with Plaque Psoriasis

Paller, Amy S.; Siegfried, Elaine C.; Langley, Richard; Gottlieb, Alice B.; Pariser, David M.; Landells, Ian; Hebert, Adelaide A.; Eichenfield, Lawrence F.; Patel, Vaishali; Creamer, Kara; Jahreis, Angelika

doi:10.1056/nejmoa066886

Cited by 358 publications

(337 citation statements)

References 24 publications

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“…Durante el primer ensayo clínico en niños y adolescentes con psoriasis en placas moderada-grave, no se notificaron casos de muerte, cán-cer, infecciones oportunistas, tuberculosis (TB) ni enfermedades desmielinizantes 5,6 . En adultos, ha demostrado el mismo perfil de seguridad favorable en tratamientos de hasta 4,2 años 7,9-11,17,26,27 .…”

Section: Datos De Seguridad De Los Tratamientos Biológicosunclassified

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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Section: Datos De Seguridad De Los Tratamientos Biológicosunclassified

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

Guerra¹

2012

Más Dermatol.

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“…The effects of etanercept remained constant during the 24 weeks open label phase, whereas PASI values in the original placebo group gradually approached those in the etanercept group during these 24 weeks. A gradual loss of efficacy was seen in the placebo group during the second double-blind phase, whereas PASI-75 was reached in 75% of patients in the etanercept group [29].…”

Section: Efficacy Etanerceptmentioning

confidence: 99%

Biologicals in the Treatment of Plaque Psoriasis: Drug Selection by Means of the SOJA Method

Janknegt¹

2016

J Pharma Care Health Sys

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The treatment of plaque psoriasis is changing because of the introduction of new treatment options. The goal of this article is to allow a transparent and rational choice of medicines by means of the System of Objectified Judgement Analysis. The following selection criteria (relative weight) were applied: approved indications (40), drug interactions (60), clinical efficacy (400), safety (300), dosage frequency (100) and documentation (100). Acquisition cost was not taken into consideration to allow a preselection on quality aspects only. Adalimumab, etanercept, infliximab and ustekinumab were compared on these criteria. Infliximab and ustekinumab showed the highest scores and are the most suitable medicines for the treatment of severe plaque psoriasis. Of course, cost will play a key role in the final selection in individual hospitals. Weight Approved indications 40 Drug Interactions 60Clinical efficacy 400Safety 300Dosage frequency 100 Documentation 100Total 1000 Selection Criteria Approved IndicationsThe number of licensed indications is a good measure of the applicability and documentation of the drugs. Although this analysis is limited to the treatment of plaque psoriasis, the fact that a drug is approved for (almost) all indications listed below is, from a formulary point of view, advantageous to another drug, which is approved for only one or two applications.The percentage of the maximum score for approved indications was obtained as follows (Table 2): IndicationMaximum Score (%)Plaque psoriasis 50% Psoriatric arthritis 20%Rheumatoid arthritis 10% Spondylitis ankylopoetica 10%Inflammatory bowel disease 10% Drug interactionsInteractions play a role only in patients who use other drugs which may interact with biologicals. However, it is a relevant criterion from a formulary point of view.The score for each drug was dependent on the frequency and severity of observed drug interactions. Clinical efficacyClinical efficacy is always a very important selection criterion for any group of drugs. The score for each drug was derived from the results of double-blind comparative studies. SafetyThe extent and the severity of adverse effects is another important selection criterion for drugs. A distinction was made between "minor" side effects, such as gastrointestinal disturbances or skin reactions, occurring in clinical trials and severe or even life-threatening adverse reactions observed with large scale use of the drugs. The evaluation of the "minor" adverse effects was based on results of double blind comparative clinical studies.

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“…Regarding long-term efficacy, etanercept response has been demonstrated to last up to 96 weeks, resulting in a statistically significant improvement (Tyring et al, 2007;Esposito et al, 2010). Etanercept is the only biological drug that has shown efficacy and safety in pediatric patients with moderate to severe plaque psoriasis (Paller et al, 2008). Paller et al reported a PASI 75 response in 57% of children and adolescents treated with etanercept (0.8 mg/kg body weight) compared with 11% in placebo patients after 12 weeks.…”

Section: Clinical Efficacymentioning

confidence: 99%