GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis

Bibliographic Details
Main Author: Vieira De Sousa, Elsa Cristina
Publication Date: 2020
Other Authors: Alves, Pedro, Rodrigues, Ana M., Teixeira, Filipa, Tavares Costa, José, Bernardo, Alexandra, Pimenta, Sofia, Pimentel-Santos, Fernando M., Gomes, João Lagoas, Aguiar, Renata, Pinto, Patrícia, Videira, Taciana, Catita, Cristina, Santos, Helena, Borges, Joana, Sequeira, Graça, Ribeiro, Célia, Teixeira, Lídia, Ávila-Ribeiro, Pedro, Martins, Fernando M., Canhao, Helena, McInnes, Iain B., Ribeiro, Ruy M., Fonseca, João Eurico
Format: Article
Language: eng
Source: Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
Download full: http://hdl.handle.net/10451/45110
Summary: © author(s) (or their employer(s)) 2020. Re-use permitted under CC BY- nC. no commercial re-use. see rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license.
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spelling GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritisAnti-TNFMethotrexateOutcomes researchPsoriatic arthritis© author(s) (or their employer(s)) 2020. Re-use permitted under CC BY- nC. no commercial re-use. see rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license.Objectives: To assess the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy in psoriatic arthritis (PsA) dactylitis. Methods: Multicentre, investigator-initiated, randomised, double-blind, placebo-controlled, parallel-design phase 3b trial in 11 Portuguese rheumatology centres. Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) were randomly assigned to golimumab or placebo, both in combination with MTX. The primary endpoint was Dactylitis Severity Score (DSS) change from baseline to week 24. Key secondary endpoints included DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score. Analysis was by intention-to-treat for the primary endpoint. Results: Twenty-one patients received golimumab plus MTX and 23 MTX monotherapy for 24 weeks. One patient from each arm discontinued. Patient inclusion was halted at 50% planned recruitment due to a favourable interim analysis. Median baseline DSS was 6 in both arms. By week 24, patients treated with golimumab plus MTX exhibited significantly greater improvements in DSS relative to MTX monotherapy (median change of 5 vs 2 points, respectively; p=0.026). In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy. Conclusions: The combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy for the treatment of PsA dactylitis.BMJ Publishing Group Ltd.Repositório da Universidade de LisboaVieira De Sousa, Elsa CristinaAlves, PedroRodrigues, Ana M.Teixeira, FilipaTavares Costa, JoséBernardo, AlexandraPimenta, SofiaPimentel-Santos, Fernando M.Gomes, João LagoasAguiar, RenataPinto, PatríciaVideira, TacianaCatita, CristinaSantos, HelenaBorges, JoanaSequeira, GraçaRibeiro, CéliaTeixeira, LídiaÁvila-Ribeiro, PedroMartins, Fernando M.Canhao, HelenaMcInnes, Iain B.Ribeiro, Ruy M.Fonseca, João Eurico2020-12-03T14:39:45Z20202020-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/45110engAnn Rheum Dis 2020;79:490–4980003-496710.1136/annrheumdis-2019-2165001468-2060info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2025-03-17T14:25:14Zoai:repositorio.ulisboa.pt:10451/45110Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-29T03:11:24.155031Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse
dc.title.none.fl_str_mv GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
title GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
spellingShingle GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
Vieira De Sousa, Elsa Cristina
Anti-TNF
Methotrexate
Outcomes research
Psoriatic arthritis
title_short GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
title_full GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
title_fullStr GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
title_full_unstemmed GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
title_sort GO-DACT : a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
author Vieira De Sousa, Elsa Cristina
author_facet Vieira De Sousa, Elsa Cristina
Alves, Pedro
Rodrigues, Ana M.
Teixeira, Filipa
Tavares Costa, José
Bernardo, Alexandra
Pimenta, Sofia
Pimentel-Santos, Fernando M.
Gomes, João Lagoas
Aguiar, Renata
Pinto, Patrícia
Videira, Taciana
Catita, Cristina
Santos, Helena
Borges, Joana
Sequeira, Graça
Ribeiro, Célia
Teixeira, Lídia
Ávila-Ribeiro, Pedro
Martins, Fernando M.
Canhao, Helena
McInnes, Iain B.
Ribeiro, Ruy M.
Fonseca, João Eurico
author_role author
author2 Alves, Pedro
Rodrigues, Ana M.
Teixeira, Filipa
Tavares Costa, José
Bernardo, Alexandra
Pimenta, Sofia
Pimentel-Santos, Fernando M.
Gomes, João Lagoas
Aguiar, Renata
Pinto, Patrícia
Videira, Taciana
Catita, Cristina
Santos, Helena
Borges, Joana
Sequeira, Graça
Ribeiro, Célia
Teixeira, Lídia
Ávila-Ribeiro, Pedro
Martins, Fernando M.
Canhao, Helena
McInnes, Iain B.
Ribeiro, Ruy M.
Fonseca, João Eurico
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório da Universidade de Lisboa
dc.contributor.author.fl_str_mv Vieira De Sousa, Elsa Cristina
Alves, Pedro
Rodrigues, Ana M.
Teixeira, Filipa
Tavares Costa, José
Bernardo, Alexandra
Pimenta, Sofia
Pimentel-Santos, Fernando M.
Gomes, João Lagoas
Aguiar, Renata
Pinto, Patrícia
Videira, Taciana
Catita, Cristina
Santos, Helena
Borges, Joana
Sequeira, Graça
Ribeiro, Célia
Teixeira, Lídia
Ávila-Ribeiro, Pedro
Martins, Fernando M.
Canhao, Helena
McInnes, Iain B.
Ribeiro, Ruy M.
Fonseca, João Eurico
dc.subject.por.fl_str_mv Anti-TNF
Methotrexate
Outcomes research
Psoriatic arthritis
topic Anti-TNF
Methotrexate
Outcomes research
Psoriatic arthritis
description © author(s) (or their employer(s)) 2020. Re-use permitted under CC BY- nC. no commercial re-use. see rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license.
publishDate 2020
dc.date.none.fl_str_mv 2020-12-03T14:39:45Z
2020
2020-01-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10451/45110
url http://hdl.handle.net/10451/45110
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Ann Rheum Dis 2020;79:490–498
0003-4967
10.1136/annrheumdis-2019-216500
1468-2060
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group Ltd.
publisher.none.fl_str_mv BMJ Publishing Group Ltd.
dc.source.none.fl_str_mv reponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron:RCAAP
instname_str FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
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institution RCAAP
reponame_str Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
collection Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
repository.name.fl_str_mv Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
repository.mail.fl_str_mv info@rcaap.pt
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