Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis

Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis

Generoso Guerra Bautista,1 Ricardo Machado Xavier,2 Maria de la Vega,3 J Abraham Simón-Campos,4 Gastón Solano,5 Ronald D Pedersen,6 Bonnie Vlahos,6 Cecilia Borlenghi7 1Centro de Investigación Marbella, Paitilla Panamá, Panamá; 2Hospital de Cl&am...

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Autores principales: Guerra Bautista G, Xavier RM, de la Vega M, Simón-Campos JA, Solano G, Pedersen RD, Vlahos B, Borlenghi C
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2019
Materias:
etanercept
rheumatoid arthritis
clinical outcome
patient-reported outcome
predictor
Diseases of the musculoskeletal system
RC925-935
Acceso en línea:https://doaj.org/article/c4943f7c47134a46984caa97ba8347ed
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spelling oai:doaj.org-article:c4943f7c47134a46984caa97ba8347ed2021-12-02T04:45:54ZClinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis1179-156Xhttps://doaj.org/article/c4943f7c47134a46984caa97ba8347ed2019-12-01T00:00:00Zhttps://www.dovepress.com/clinical-improvements-as-predictors-of-improvements-in-patient-reporte-peer-reviewed-article-OARRRhttps://doaj.org/toc/1179-156XGeneroso Guerra Bautista,1 Ricardo Machado Xavier,2 Maria de la Vega,3 J Abraham Simón-Campos,4 Gastón Solano,5 Ronald D Pedersen,6 Bonnie Vlahos,6 Cecilia Borlenghi7 1Centro de Investigación Marbella, Paitilla Panamá, Panamá; 2Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; 3CEIM Investigaciones Medicas, Buenos Aires, Argentina; 4Köhler & Milstein Research, Mérida, México; 5Pfizer, San José, Costa Rica; 6Pfizer, Collegeville, PA, USA; 7Pfizer, Buenos Aires, ArgentinaCorrespondence: Generoso Guerra BautistaConsultorios Royal Center, Calle 53 Marbella, Panamá, República de PanamáTel +507-263-3283Email generosoguerra@icloud.comBackground: In rheumatoid arthritis (RA), little is known about clinical responses to treatment as predictors of patient-reported outcome (PRO) changes. In this post hoc analysis, we examined the relationship between clinical outcomes at week 12 and PRO changes at week 24 in patients with RA.Methods: In an open-label study, Latin American patients with moderate-to-severe RA and an inadequate response to methotrexate (MTX) were randomized to receive etanercept 50 mg/week plus MTX (ETN+MTX; n=281) or an additional conventional disease-modifying anti-rheumatic drug (DMARD) plus MTX (DMARD+MTX; n=142) for 24 weeks. The PROs included Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form (SF-36), Physician and Patient Global Assessment scores (PGA, PtGA), Physician and Patient Satisfaction, and an activity impairment assessment. PRO changes at week 24 were calculated by week-12 improvements using the American College of Rheumatology criteria (ACR <20, ≥20 to <50, ≥50 to <70, and ≥70) and the 28-joint Disease Activity Scores (DAS28 ≥3.2, ≥2.6 to <3.2, and <2.6). Observed-cases data were analyzed using an ANCOVA model with linear contrast, adjusted for baseline PRO and ACR/DAS28 values.Results: For both ETN+MTX- and DMARD+MTX-treated patients, there was a significant linear trend between week-12 changes in ACR and DAS28 responses and week-24 changes in HAQ-DI (P<0.001 for all), with numerical improvements generally favoring ETN+MTX. Similar relationships were observed for SF-36, PGA, PtGA, Physician Satisfaction, Patient Satisfaction, and activity impairment. Conclusions: In patients with RA, clinical response after 12 weeks of treatment with ETN+MTX or DMARD+MTX could be a predictor of week-24 response for several PROs.Trial registration: ClinicalTrials.gov, NCT00848354.Keywords: etanercept, rheumatoid arthritis, clinical outcome, patient-reported outcome, predictorGuerra Bautista GXavier RMde la Vega MSimón-Campos JASolano GPedersen RDVlahos BBorlenghi CDove Medical Pressarticleetanerceptrheumatoid arthritisclinical outcomepatient-reported outcomepredictorDiseases of the musculoskeletal systemRC925-935ENOpen Access Rheumatology: Research and Reviews, Vol Volume 11, Pp 275-281 (2019)
institution DOAJ
collection DOAJ
language EN
topic etanercept
rheumatoid arthritis
clinical outcome
patient-reported outcome
predictor
Diseases of the musculoskeletal system
RC925-935
spellingShingle etanercept
rheumatoid arthritis
clinical outcome
patient-reported outcome
predictor
Diseases of the musculoskeletal system
RC925-935
Guerra Bautista G
Xavier RM
de la Vega M
Simón-Campos JA
Solano G
Pedersen RD
Vlahos B
Borlenghi C
Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis
description Generoso Guerra Bautista,1 Ricardo Machado Xavier,2 Maria de la Vega,3 J Abraham Simón-Campos,4 Gastón Solano,5 Ronald D Pedersen,6 Bonnie Vlahos,6 Cecilia Borlenghi7 1Centro de Investigación Marbella, Paitilla Panamá, Panamá; 2Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; 3CEIM Investigaciones Medicas, Buenos Aires, Argentina; 4Köhler & Milstein Research, Mérida, México; 5Pfizer, San José, Costa Rica; 6Pfizer, Collegeville, PA, USA; 7Pfizer, Buenos Aires, ArgentinaCorrespondence: Generoso Guerra BautistaConsultorios Royal Center, Calle 53 Marbella, Panamá, República de PanamáTel +507-263-3283Email generosoguerra@icloud.comBackground: In rheumatoid arthritis (RA), little is known about clinical responses to treatment as predictors of patient-reported outcome (PRO) changes. In this post hoc analysis, we examined the relationship between clinical outcomes at week 12 and PRO changes at week 24 in patients with RA.Methods: In an open-label study, Latin American patients with moderate-to-severe RA and an inadequate response to methotrexate (MTX) were randomized to receive etanercept 50 mg/week plus MTX (ETN+MTX; n=281) or an additional conventional disease-modifying anti-rheumatic drug (DMARD) plus MTX (DMARD+MTX; n=142) for 24 weeks. The PROs included Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form (SF-36), Physician and Patient Global Assessment scores (PGA, PtGA), Physician and Patient Satisfaction, and an activity impairment assessment. PRO changes at week 24 were calculated by week-12 improvements using the American College of Rheumatology criteria (ACR <20, ≥20 to <50, ≥50 to <70, and ≥70) and the 28-joint Disease Activity Scores (DAS28 ≥3.2, ≥2.6 to <3.2, and <2.6). Observed-cases data were analyzed using an ANCOVA model with linear contrast, adjusted for baseline PRO and ACR/DAS28 values.Results: For both ETN+MTX- and DMARD+MTX-treated patients, there was a significant linear trend between week-12 changes in ACR and DAS28 responses and week-24 changes in HAQ-DI (P<0.001 for all), with numerical improvements generally favoring ETN+MTX. Similar relationships were observed for SF-36, PGA, PtGA, Physician Satisfaction, Patient Satisfaction, and activity impairment. Conclusions: In patients with RA, clinical response after 12 weeks of treatment with ETN+MTX or DMARD+MTX could be a predictor of week-24 response for several PROs.Trial registration: ClinicalTrials.gov, NCT00848354.Keywords: etanercept, rheumatoid arthritis, clinical outcome, patient-reported outcome, predictor
format article
author Guerra Bautista G
Xavier RM
de la Vega M
Simón-Campos JA
Solano G
Pedersen RD
Vlahos B
Borlenghi C
author_facet Guerra Bautista G
Xavier RM
de la Vega M
Simón-Campos JA
Solano G
Pedersen RD
Vlahos B
Borlenghi C
author_sort Guerra Bautista G
title Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis
title_short Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis
title_full Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis
title_fullStr Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis
title_full_unstemmed Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis
title_sort clinical improvements as predictors of improvements in patient-reported outcomes: post hoc analysis of a randomized, open-label study of etanercept in latin american patients with rheumatoid arthritis
publisher Dove Medical Press
publishDate 2019
url https://doaj.org/article/c4943f7c47134a46984caa97ba8347ed
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