Síntesis amplia / Living FRISBEE

No clasificado

¿Es efectivo el ustekinumab para la artritis psoriásica que no responde a tratamiento inicial?

Traducción oficial
Año 2018
Revista Medwave
Enlaces Virtual Health Library , Pubmed , DOI

Sin referencias

Cargando información sobre las referencias
Mostrar resumen

INTRODUCCIÓN:

La artritis psoriásica es una artritis inflamatoria sin una clara etiología, con el tratamiento biológico como un pilar fundamental en pacientes más complejos. Existen varias alternativas para tratamiento biológico, debido a su alto costo, es importante evaluar la real efectividad de estos para un buen tratamiento.

MÉTODOS:

Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud a nivel mundial, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE.

RESULTADOS Y CONCLUSIONES:

Identificamos 12 revisiones sistemáticas que en conjunto incluyen tres ensayos aleatorizados. Concluimos que el ustekinumab logra una mejoría clínica en pacientes con psoriasis, y probablemente no se asocia a efectos adversos graves.

Mostrar resumen

Revisión sistemática

No clasificado

Systematic review and meta-analysis of ustekinumab for moderate to severe psoriasis.

Año 2014
Autores Meng Y , Dongmei L , Yanbin P , Jinju F , Meile T , Binzhu L - Más
Revista Clinical and experimental dermatology
Enlaces Pubmed , DOI

Este artículo incluye 9 Estudios primarios 6 Estudios primarios (9 referencias)

Cargando información sobre las referencias
Mostrar resumen

BACKGROUND:

Psoriasis is a chronic, recurrent skin disease that affects approximately 2-3% of the world's population, and can significantly impair patients' wellbeing and their physical and mental functioning.

AIM:

To systematically evaluate the efficacy and safety of ustekinumab versus placebo for psoriasis.

METHODS:

We performed a systematic review of all the relevant published literature relating to randomized controlled trials (RCTs) of ustekinumab from 1990 to August 2013. Relative ratios (RRs) and 95% confidence intervals (CIs) were calculated, and meta-analysis was conducted with Revman5.2.6 software, while GRADE Profile 3.6 was used to evaluate the quality of the evidence.

RESULTS:

In total, 9 RCTs involving 11 381 patients were included. The meta-analysis results were as follows. (i) At the end of 12 weeks, the ustekinumab group had a larger number of patients with improvement in Psoriasis Area and Severity Index (PASI) of at least 50% (PASI50), at least 75% (PASI75) and at least 90% (PASI90); a larger number with improvement in Physician's Global Assessment (PGA), and a larger number with improvement in Dermatology Life Quality Index (DLQI) to a score of 0 or 1 (no effect at all on patient's life). (ii) There was no significant difference in efficacy between 45 mg and 90 mg ustekinumab at the end of 12 weeks. (iii) There was no obvious difference between the ustekinumab and placebo groups in the incidence of adverse events over 5 years. There was also no obvious difference between the two doses of ustekinumab after 5 years.

CONCLUSION:

Our results indicate that ustekinumab is safe for patients with moderate to severe plaque psoriasis over a period of 5 years, and it is effective after 12 weeks. There was no significant superiority in efficacy between the 45 mg and 90 mg doses for short-term therapy. Results of the long-term safety evaluation are consistent with short-term reports of ustekinumab safety. More long-term studies and RCTs are needed to validate these results.

Mostrar resumen

Estudio primario

No clasificado

Ustekinumab in the treatment of severe paediatric psoriasis.

Año 2013
Autores Dixit S , Shumack S , Fischer G
Revista The Australasian journal of dermatology
Enlaces Pubmed , DOI

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

Cargando información sobre las referencias
Mostrar resumen

Este artículo no tiene resumen

Mostrar resumen

Estudio primario

No clasificado

Ustekinumab. Análisis de efectos adversos infecciosos

Traducción oficial
Año 2012
Revista Actas dermo-sifiliogr. (Ed. impr.)
Enlaces Virtual Health Library

Este artículo no está incluido en ninguna revisión sistemática

Cargando información sobre las referencias
Mostrar resumen

Ustekinumab es el primer representante de un nuevo grupo de fármacos biológicos, cuyo mecanismo de acción principal es la inhibición selectiva de la actividad de las interleucinas 12 y 23. A pesar de ser la terapia de uso más reciente en dermatología, es el fármaco que mayor número de pacientes ha aportado en su desarrollo clínico en psoriasis. Gracias a esta experiencia acumulada, se ha confirmado que el perfil de seguridad de ustekinumab frente a eventos infecciosos demuestra un riesgo similar a placebo y equiparable a la población general en cuanto a incidencia absoluta, infecciones severas y requerimientos de antibioterapia adicional. Este comportamiento inicial se confirma durante el seguimiento a 3 y 4 años en pacientes con psoriasis moderada a severa. A pesar de este perfil favorable de seguridad, el carácter inmunosupresor selectivo de ustekinumab aconseja mantener un seguimiento estricto de los pacientes en tratamiento, como el despistaje de infecciones activas o latentes, similar a los aplicados en el caso de los fármacos anti factor de necrosis tumoral (AU)

Mostrar resumen

Resumen estructurado de revisiones sistemáticas

No clasificado

Ustekinumab (Stelara) for plaque psoriasis in adolescents

Año 2013
Autores NIHR HSC
Revista HTA Database
Enlaces
Cargando información sobre las referencias
Mostrar resumen

RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

NIHR HSC. Ustekinumab (Stelara) for plaque psoriasis in adolescents Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2013

Mostrar resumen

Resumen estructurado de revisiones sistemáticas

No clasificado

Ustekinumab for the treatment of moderate to severe psoriasis

Año 2013
Revista HTA Database
Enlaces DOI
Cargando información sobre las referencias
Mostrar resumen

RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

Gospodarevskaya E, Picot J, Cooper K, Loveman E, Takeda A. Ustekinumab for the treatment of moderate to severe psoriasis. Health Technology Assessment 2009; 13(Suppl 3 Article 10)

Mostrar resumen

Resumen estructurado de revisiones sistemáticas

No clasificado

Ustekinumab (Stelara) for psoriatic arthritis

Año 2012
Autores NIHR HSC
Revista HTA Database
Enlaces
Cargando información sobre las referencias
Mostrar resumen

RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

NIHR HSC. Ustekinumab (Stelara) for psoriatic arthritis Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2012

Mostrar resumen

Resumen estructurado de revisiones sistemáticas

No clasificado

Ustekinumab (Stelara) for Crohn's disease

Año 2014
Autores NIHR HSC
Revista HTA Database
Enlaces
Cargando información sobre las referencias
Mostrar resumen

RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

NIHR HSC. Ustekinumab (Stelara) for Crohn's disease Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2014

Mostrar resumen

Revisión sistemática

No clasificado

Therapeutic effect and safety of ustekinumab for plaque psoriasis: a meta-analysis.

Año 2014
Autores Liu Y , Gong JP , Li WF
Revista Chinese medical sciences journal = Chung-kuo i hsüeh k'o hsüeh tsa chih / Chinese Academy of Medical Sciences
Enlaces Pubmed , DOI

Este artículo incluye 6 Estudios primarios 6 Estudios primarios (6 referencias)

Cargando información sobre las referencias
Mostrar resumen

OBJECTIVE:

To evaluate the efficacy and safety of ustekinumab in the therapy of plaque psoriasis.

METHODS:

Literatures published up to November 2013 were collected from Cochrane library, MEDLINE, and PubMed which were related with ustekinumab for plaque psoriasis. The efficacy was estimated using relative risk of Psoriasis Area and Severity Index (PASI) 75 response rate at the week 12 endpoint in clinical trials, and adverse effects were also analyzed. Meta-analysis was carried out by using Review Manager 5.1.

RESULTS:

Six randomized control trials consistent with the inclusion criteria were selected and reviewed. Ustekinumab 45 mg group and 90 mg group could get better therapeutic effect compared with the placebo group (all P<0.00001). Furthermore, ustekinumab 90 mg group was more effective than ustekinumab 45 mg group (P=0.01). Adverse effects in the 6 trials were mentioned including headache, upper respiratory tract infection, nasopharyngtis, infection, serious infection, cardiovascular events, and malignant tumors. There were no statistically significant differences of these adverse effects among three groups (all P>0.05), except that infection rate in ustekinumab 45 mg group was higher than the placebo group (P=0.02).

CONCLUSIONS:

Ustekinumab is an effective and safe therapeutic method for plaque psoriasis. However, further longer time analysis of safety is needed.

Mostrar resumen

Revisión sistemática

No clasificado

Ustekinumab: Treatment of adult moderate-to-severe chronic plaque psoriasis

Año 2009
Revista The Annals of pharmacotherapy
Enlaces Pubmed , DOI

Sin referencias

Cargando información sobre las referencias
Mostrar resumen

OBJECTIVE:

To systematically review the pharmacology, pharmacokinetics, clinical efficacy, and safety profile of ustekinumab to inform pharmacists and other healthcare professionals of this new biologic therapy for psoriasis.

DATA SOURCES:

A search of PubMed/MEDLINE, EMBASE, and International Pharmaceutical Abstracts was performed through July 2009, limited to publications in English, using the search terms CNTO-1275, ustekinumab, interleukin-12, interleukin-23, and/or psoriasis to identify literature sources. References from the retrieved articles were also evaluated to identify relevant literature. An abstract from a Congress of the European Academy of Dermatology and Venereology and unpublished Phase 3 clinical trials in progress (using www.clinicaltrials.gov) were also reviewed. The Food and Drug Administration, European Medicines Agency, and Health Canada Web sites were used to retrieve product monographs, regulatory guidances, and advisory committee briefing packets.

STUDY SELECTION AND DATA EXTRACTION:

All available studies relevant to the pharmacology, pharmacokinetics, and clinical safety/efficacy of ustekinumab for the treatment of psoriasis were included, with preference for human data.

DATA SYNTHESIS:

Ustekinumab, an anti-interleukin-12/23 monoclonal antibody, achieved the primary endpoint of 75% reduction in the Psoriasis Area and Severity Index score in a large proportion of patients in the Phase 3 PHOENIX trials. Commensurate improvements were also seen in the Physician's Global Assessment and Dermatology Life Quality Index scores. These efficacy results were reproduced in the ACCEPT trial, demonstrating superiority of ustekinumab to etanercept. The frequency of adverse events was similar between ustekinumab and placebo; common adverse events reported included nasopharyngitis, upper respiratory tract infection, headache, arthralgia, cough, and injection site reactions. Phase 3 studies indicate that the optimal dosing appears to be 45 mg for patients weighing less than 100 kg or 90 mg for patients weighing more than 100 kg, with both doses administered subcutaneously. In these studies, the second dose was given 4 weeks after the first and then every 8-12 weeks thereafter, based upon response.

CONCLUSIONS:

Ustekinumab, a promising new therapy, reduces the extent and severity of psoriasis and was well tolerated in clinical trials. Ongoing clinical trials will allow clinicians to further assess the efficacy/safety profile of this novel biologic.

Mostrar resumen