Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis

Abstract

Introduction: To compare etanercept (ETN) and placebo (PBO) for maintaining low disease activity (LDA) achieved with ETN in patients with rheumatoid arthritis (RA) from Africa and the Middle East.

Methods: In this subset analysis of the Treat-to-Target trial (ClinicalTrials.gov identifier NCT01981473), 53 adult patients with moderate-to-severe RA nonresponsive to methotrexate were treated with 50 mg ETN/week for 24 weeks (Period 1). Patients achieving LDA were randomized to continue ETN treatment or switched to PBO for an additional 28 weeks (Period 2). The proportion of patients maintaining LDA or remission in each arm at the end of Period 2 was determined. Additional efficacy and patient-reported outcomes (PROs) were also evaluated.

Results: During Period 1, 51 patients achieved LDA according to the disease activity score-28 joints-erythrocyte sedimentation rate (DAS28-ESR LDA) and 30 achieved remission. At week 52, nine of 22 and eight of 29 in the ETN and PBO groups, respectively, remained in DAS28-ESR LDA without experiencing a flare. Additionally, six of 14 and five of 16 in the ETN and PBO groups, respectively, remained in remission. Among patients experiencing a flare during Period 2, 13 of 22 and 21 of 29 received ETN or PBO, respectively. The median time to flare was 193 and 87 days in the ETN and PBO groups, respectively. At week 52, consistently more patients in the ETN group than in the PBO group achieved predetermined efficacy and PRO endpoints.

Conclusions: These data suggest continuing ETN maintenance therapy is beneficial to patients after they have achieved their treatment target. However, this subset analysis is limited by the small patient population and must be interpreted with caution.

Funding: Pfizer.

Trial registration: ClinicalTrials.gov identifier, NCT0198147.

Keywords: Africa; Efficacy; Etanercept; Maintenance therapy; Middle East; Rheumatoid arthritis.

Figures

Fig. 1

Proportion of patients at week 52 remaining with (a) Disease Activity Score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) low disease activity (LDA) without experiencing a flare, and (b) DAS28-C-reactive protein (CRP) LDA. ETN Etanercept, PBO placebo

Fig. 2

Proportion of patients at week 52 remaining in DAS28-ESR remission

Fig. 3

Proportion of patients achieving various endpoints at week 52. ACR20, -50, -70, -90 American College of Rheumatology-based criteria for 20, 50, 70 and 90% improvement from baseline, respectively, EULAR European League Against Rheumatism, HAQ-DI Health Activity Questionnaire-Disability Index,