Maintenance of low disease activity and remission with etanercept-disease-modifying antirheumatic drug (DMARD) combination therapy compared with treatment with DMARDs alone in Latin American patients with active rheumatoid arthritis: Subset analysis of a randomized trial

Abstract

Background: Current guidelines on the treatment of rheumatoid arthritis (RA) recommend early therapy targeting the achievement of low disease activity (LDA) or clinical remission. Little published information is available on the success of this treatment strategy in Latin America. In a subset analysis of patients from Latin America, we compared efficacy maintenance with etanercept 50 mg once weekly (ETN50) versus placebo (PBO), on a background of methotrexate (MTX) ± other non-biologic, disease-modifying antirheumatic drugs, in patients with moderate-to-severe RA who had achieved LDA with ETN50.

Methods: In the Treat-to-Target trial, adult patients with active RA nonresponsive to MTX were treated with ETN50 for 24 weeks (Period 1). Patients achieving LDA were randomized to receive ETN50 or PBO for 28 additional weeks (Period 2). The proportion of patients maintaining LDA at week 52 and other efficacy and quality-of-life measures were assessed. Descriptive statistics are presented using last observation carried forward imputation of data.

Results: Of the 64 patients from Latin America treated in Period 1, 61 (95.3%) achieved LDA. Among patients receiving ETN50, 13/34 remained in LDA and 6/14 maintained remission at week 52 versus 6/27 and 4/10 patients receiving PBO. The median time to flare was 113 days and 33 days for the ETN50 and PBO groups, respectively. In the overall population, adverse events were reported in 37% and 43%, serious adverse events in 1% and 4%, and serious infections in 0% and 2% of patients in the ETN50 and PBO groups, respectively.

Conclusions: In patients with RA from Latin America, continuing treatment with ETN50 after achieving LDA appears to result in a higher proportion of patients maintaining LDA and remission compared with switching to PBO. CLINICALTRIALS.

Gov registration: NCT01578850.

Figure 1

Patient disposition with respect to primary endpoints. DAS28 = Disease Activity Score-28 joints, ESR = erythrocyte sedimentation rate, ETN = etanercept, LDA = low disease activity, PBO = placebo.

Figure 2

Proportion of patients at week 52 remaining in (A) DAS28-ESR LDA, (B) DAS28-ESR remission, and (C) DAS28-CRP LDA. CRP = C-reactive protein, DAS28 = Disease Activity Score-28 joints, ESR = erythrocyte sedimentation rate, ETN = etanercept, LDA = low disease activity, PBO = placebo.

Figure 3

Proportion of patients achieving various endpoints at week 52. ACR = American College of Rheumatology, ETN = etanercept, EULAR = European League Against Rheumatism, HAQ-DI = Health Activity Questionnaire-Disability Index, PBO = placebo.