Back to Journals » Open Access Rheumatology: Research and Reviews » Volume 11

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

Authors Guerra Bautista G, Xavier RM, de la Vega M, Simón-Campos JA, Solano G, Pedersen RD, Vlahos B, Borlenghi C

Received 28 August 2019

Accepted for publication 13 November 2019

Published 12 December 2019 Volume 2019:11 Pages 275—281


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Chuan-Ju Liu

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, Argentina

Correspondence: Generoso Guerra Bautista
Consultorios Royal Center, Calle 53 Marbella, Panamá, República de Panamá
Tel +507-263-3283

Background: 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:, NCT00848354.

Keywords: etanercept, rheumatoid arthritis, clinical outcome, patient-reported outcome, predictor

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]