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Open-Label Observation of Addition of Etanercept Versus a Conventional Disease-Modifying Antirheumatic Drug in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy in the Latin American Region

Machado, Daniel A. MD*; Guzman, Renato M. MD†‡; Xavier, Ricardo M. MD§; Simon, J. Abraham MD∥¶; Mele, Linda MA#; Pedersen, Ronald MS#; Ferdousi, Tahmina PhD**; Koenig, Andrew S. DO#; Kotak, Sameer MS, MBA#; Vlahos, Bonnie MBA, BSN, RN#

Journal of Clinical Rheumatology: January 2014 - Volume 20 - Issue 1 - p 25–33
doi: 10.1097/RHU.0000000000000055
Original Articles

Background Previous global studies examined etanercept (ETN) + methotrexate (MTX) for treatment of rheumatoid arthritis (RA), but included few subjects from Latin America.

Objective The objective of this study was to compare the safety and efficacy of ETN + MTX versus a standard-of-care disease-modifying antirheumatic drug (DMARD) + MTX in Latin American subjects with moderate to severe active RA despite MTX therapy.

Methods This open-label, active-comparator study (NCT00848354) randomized subjects 2:1 to ETN 50 mg/wk + MTX or investigator-selected DMARD (sulfasalazine or hydroxychloroquine) + MTX (ETN + MTX, n = 281; DMARD + MTX, n = 142). The primary end point was the proportion achieving American College of Rheumatology (ACR) 50 at week 24. Secondary end points included ACR20/70, disease activity score (DAS) 28 measures, and mean change in modified total Sharp score. Patient-reported outcomes were the Health Assessment Questionnaire, 36-item Short-Form, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment: RA (WPAI:RA), and Caregiver Burden and Resource Utilization. Statistical analyses were stratified by country; χ2 test and analysis of covariance were used. Adverse events were monitored.

Results More subjects achieved ACR50 at week 24 with ETN + MTX versus DMARD + MTX (62% vs 23%, respectively), in addition to secondary end points (P < 0.0001 for all); mean change in modified total Sharp score was lower for the ETN + MTX group (0.4 vs 1.4, respectively; P = 0.0270). Improvements in patient-reported outcomes favored ETN + MTX for Health Assessment Questionnaire, 36-item Short-Form, Hospital Anxiety and Depression Scale for depression, WPAI:RA, and Caregiver Burden and Resource Utilization emergency department visits for RA (P < 0.01). Overall, adverse events were similar between the groups (69% vs 68%,); serious adverse events were also similar (4% vs 1%). The rate of overall infections was higher with ETN + MTX (38%) than DMARD + MTX (22%, P ≤ 0.001).

Conclusions Consistent with published global data among RA patients with inadequate response to MTX, adding ETN to MTX demonstrated better efficacy than adding one other conventional DMARD to MTX. No new safety issues were observed. ETN + MTX provided favorable benefit-risk profile among RA patients from LA region.

From *CAICI Instituto, Rosario, Santa Fe, Argentina; †IDEARG and ‡Saludcoop Clínica, Bogotá, Colombia; §Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil; ∥BIOCEM and ¶Universidad Marista de Mérida, Mérida, Yucatán, Mexico; #Pfizer Inc and**Formerly of Pfizer Inc, Collegeville, PA.

The Latin American RA study was designed and funded by Wyeth, which was acquired by Pfizer Inc in October 2009. Medical writing support was provided by Patricia McChesney, PhD, CMPP, of Engage Scientific Solutions and was funded by Pfizer Inc.

D.A.M., R.M.X., and J.A.S. have received compensation for advisory boards and speaker fees from Pfizer Inc. R.M.G. has received consulting fees from Pfizer Inc. L.M., R.P., T.F., A.S.K., S.K., and B.V. were employees of Pfizer Inc during this study and manuscript preparation.

Correspondence: Daniel A. Machado, MD, CAICI Instituto, Mendoza 2612, Rosario, Santa Fe, S2000 Argentina. E-mail:

© 2014 by Lippincott Williams & Wilkins, Inc.