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Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis

In ASTRAEA (NCT01860976), abatacept significantly increased American College of Rheumatology criteria 20% (ACR20) responses at Week 24 versus placebo in patients with psoriatic arthritis (PsA). This post hoc analysis explored relationships between prospectively identified baseline characteristics [p...

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Autores principales: Mease, Philip J., McInnes, Iain B., Strand, Vibeke, FitzGerald, Oliver, Ahmad, Harris A., Elbez, Yedid, Banerjee, Subhashis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256096/
https://www.ncbi.nlm.nih.gov/pubmed/32356115
http://dx.doi.org/10.1007/s00296-020-04564-x
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author Mease, Philip J.
McInnes, Iain B.
Strand, Vibeke
FitzGerald, Oliver
Ahmad, Harris A.
Elbez, Yedid
Banerjee, Subhashis
author_facet Mease, Philip J.
McInnes, Iain B.
Strand, Vibeke
FitzGerald, Oliver
Ahmad, Harris A.
Elbez, Yedid
Banerjee, Subhashis
author_sort Mease, Philip J.
collection PubMed
description In ASTRAEA (NCT01860976), abatacept significantly increased American College of Rheumatology criteria 20% (ACR20) responses at Week 24 versus placebo in patients with psoriatic arthritis (PsA). This post hoc analysis explored relationships between prospectively identified baseline characteristics [poor prognostic factors (PPFs) ] and response to abatacept. Patients were randomized (1:1) to receive subcutaneous abatacept 125 mg weekly or placebo for 24 weeks; those without ≥ 20% improvement in joint counts at Week 16 switched to open-label abatacept. Potential predictors of ACR20 response were identified by treatment arm using multivariate analyses. Likelihood of ACR20 response to abatacept versus placebo was compared in univariate and multivariate analyses in subgroups stratified by the PPF, as defined by EULAR and/or GRAPPA treatment guidelines. Odds ratios (ORs) were generated using logistic regression to identify meaningful differences (OR cut-off: 1.2). 424 patients were randomized and treated (abatacept n = 213; placebo n = 211). In abatacept-treated patients, elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and ≥ 3 joint erosions were identified as predictors of response (OR > 1.2). In placebo-treated patients, only dactylitis was a potential predictor of response. In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding. Response to abatacept versus placebo is more likely in patients with features indicative of high disease activity and progressive disease; these characteristics are recognized as PPFs in treatment guidelines for PsA.
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spelling pubmed-72560962020-06-08 Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis Mease, Philip J. McInnes, Iain B. Strand, Vibeke FitzGerald, Oliver Ahmad, Harris A. Elbez, Yedid Banerjee, Subhashis Rheumatol Int Clinical Trials In ASTRAEA (NCT01860976), abatacept significantly increased American College of Rheumatology criteria 20% (ACR20) responses at Week 24 versus placebo in patients with psoriatic arthritis (PsA). This post hoc analysis explored relationships between prospectively identified baseline characteristics [poor prognostic factors (PPFs) ] and response to abatacept. Patients were randomized (1:1) to receive subcutaneous abatacept 125 mg weekly or placebo for 24 weeks; those without ≥ 20% improvement in joint counts at Week 16 switched to open-label abatacept. Potential predictors of ACR20 response were identified by treatment arm using multivariate analyses. Likelihood of ACR20 response to abatacept versus placebo was compared in univariate and multivariate analyses in subgroups stratified by the PPF, as defined by EULAR and/or GRAPPA treatment guidelines. Odds ratios (ORs) were generated using logistic regression to identify meaningful differences (OR cut-off: 1.2). 424 patients were randomized and treated (abatacept n = 213; placebo n = 211). In abatacept-treated patients, elevated C-reactive protein (CRP), high Disease Activity Score based on 28 joints (CRP), presence of dactylitis, and ≥ 3 joint erosions were identified as predictors of response (OR > 1.2). In placebo-treated patients, only dactylitis was a potential predictor of response. In the univariate analysis stratified by PPF, ACR20 response was more likely (OR > 1.2) with abatacept versus placebo in patients with baseline PPFs than in those without; multivariate analysis confirmed this finding. Response to abatacept versus placebo is more likely in patients with features indicative of high disease activity and progressive disease; these characteristics are recognized as PPFs in treatment guidelines for PsA. Springer Berlin Heidelberg 2020-04-30 2020 /pmc/articles/PMC7256096/ /pubmed/32356115 http://dx.doi.org/10.1007/s00296-020-04564-x Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Clinical Trials
Mease, Philip J.
McInnes, Iain B.
Strand, Vibeke
FitzGerald, Oliver
Ahmad, Harris A.
Elbez, Yedid
Banerjee, Subhashis
Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis
title Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis
title_full Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis
title_fullStr Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis
title_full_unstemmed Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis
title_short Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis
title_sort poor prognostic factors in predicting abatacept response in a phase iii randomized controlled trial in psoriatic arthritis
topic Clinical Trials
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256096/
https://www.ncbi.nlm.nih.gov/pubmed/32356115
http://dx.doi.org/10.1007/s00296-020-04564-x
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