Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Cadernos de Saúde Pública |
Texto Completo: | https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/5164 |
Resumo: | We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible. |
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Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trialsPsoriasisBiological AgentsEfficacySafetyHealth Technology EvaluationWe conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.Se realizó una revisión sistemática y metaanálisis de ensayos controlados aleatorios en pacientes con psoriasis moderada a severa tratados con biológicos o placebo por 10-14 semanas. Se incluyeron 41 estudios con una puntuación de Jadad de 4,4, un total de 15.586 pacientes. Para variables de eficacia PASI 50, 75 y 90, los resultados no son concluyentes para definir cuál es el mejor agente biológico en el corto plazo. No hubo diferencia estadística entre el placebo y la ocurrencia biológica de las infecciones y los eventos adversos graves. Ustequinumabe 45mg fue el biológico con una menor incidencia de la interrupción debido a eventos adversos. Basado en la evidencia disponible hasta el momento, no es posible determinar qué agente biológico es lograr la mejor respuesta PASI 50, 75 y 90 después de 10-14 semanas de tratamiento. Para el mismo período, la seguridad global parece ser el mismo para todos los tratamientos y ustequinumabe 45mg el mejor tolerado. Para comprender mejor la eficacia y seguridad, es necesario un metaanálisis indirecto comparando medicamento a medicamento.Conduziu-se uma revisão sistemática e metaanálise de ensaios clínicos randomizados em pacientes com psoríase moderada a grave, tratados com biológicos ou placebo por 10 a 14 semanas. Foram incluídos 41 estudos, com escore de Jadad médio de 4,4, totalizando 15.586 pacientes. Para os desfechos de eficácia PASI 50, 75 e 90 os resultados não são conclusivos para definir qual é o melhor agente biológico no curto prazo. Não houve diferença estatística entre placebo e biológicos para ocorrência de infecções e eventos ad-versos sérios. Ustequinumabe 45mg foi o biológico com menor ocorrência de descontinuação por conta de eventos adversos. Baseado na evidência até então disponível, não é possível determinar qual agente biológico é o melhor para se atingir resposta PASI 50, 75 e 90 após 10-14 semanas de tratamento. Para o mesmo intervalo, a segurança global parece ser a mesma para todos os biológicos e ustequinumabe 45mg o tratamento melhor tolerado. Para melhor compreender a eficácia e segurança, meta-análise indireta comparando droga-a-droga são necessárias já que ensaios clínicos randomizados podem não ser viáveis.Reports in Public HealthCadernos de Saúde Pública2013-11-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlapplication/pdfhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/5164Reports in Public Health; Vol. 29 No. 13 (2013): Supplement 1Cadernos de Saúde Pública; v. 29 n. 13 (2013): Suplemento 11678-44640102-311Xreponame:Cadernos de Saúde Públicainstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZenghttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/5164/10577https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/5164/10578Correr, Cassyano JanuárioRotta, InajaraTeles, Thaís de SouzaGodoy, Rangel RayRiveros, Bruno SalgadoGarcia, Mariana MartinsGonçalves, Patrícia RodriguesOtuki, Michel Fleithinfo:eu-repo/semantics/openAccess2024-03-06T15:28:34Zoai:ojs.teste-cadernos.ensp.fiocruz.br:article/5164Revistahttps://cadernos.ensp.fiocruz.br/ojs/index.php/csphttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/oaicadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br1678-44640102-311Xopendoar:2024-03-06T13:05:57.424848Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ)true |
dc.title.none.fl_str_mv |
Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials |
title |
Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials |
spellingShingle |
Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials Correr, Cassyano Januário Psoriasis Biological Agents Efficacy Safety Health Technology Evaluation |
title_short |
Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials |
title_full |
Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials |
title_fullStr |
Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials |
title_full_unstemmed |
Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials |
title_sort |
Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials |
author |
Correr, Cassyano Januário |
author_facet |
Correr, Cassyano Januário Rotta, Inajara Teles, Thaís de Souza Godoy, Rangel Ray Riveros, Bruno Salgado Garcia, Mariana Martins Gonçalves, Patrícia Rodrigues Otuki, Michel Fleith |
author_role |
author |
author2 |
Rotta, Inajara Teles, Thaís de Souza Godoy, Rangel Ray Riveros, Bruno Salgado Garcia, Mariana Martins Gonçalves, Patrícia Rodrigues Otuki, Michel Fleith |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
Correr, Cassyano Januário Rotta, Inajara Teles, Thaís de Souza Godoy, Rangel Ray Riveros, Bruno Salgado Garcia, Mariana Martins Gonçalves, Patrícia Rodrigues Otuki, Michel Fleith |
dc.subject.por.fl_str_mv |
Psoriasis Biological Agents Efficacy Safety Health Technology Evaluation |
topic |
Psoriasis Biological Agents Efficacy Safety Health Technology Evaluation |
description |
We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible. |
publishDate |
2013 |
dc.date.none.fl_str_mv |
2013-11-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/5164 |
url |
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/5164 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/5164/10577 https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/5164/10578 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html application/pdf |
dc.publisher.none.fl_str_mv |
Reports in Public Health Cadernos de Saúde Pública |
publisher.none.fl_str_mv |
Reports in Public Health Cadernos de Saúde Pública |
dc.source.none.fl_str_mv |
Reports in Public Health; Vol. 29 No. 13 (2013): Supplement 1 Cadernos de Saúde Pública; v. 29 n. 13 (2013): Suplemento 1 1678-4464 0102-311X reponame:Cadernos de Saúde Pública instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Cadernos de Saúde Pública |
collection |
Cadernos de Saúde Pública |
repository.name.fl_str_mv |
Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
cadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br |
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1798943373603635200 |