• Karel Pavelka, Nurullah Akkoç, Mustafa Al-Maini, Zerbini Cristiano A F CAF Department of Rheumatology, Centro Paulista de Investigação Clinica, São Paulo, Brazil., Dmitry E Karateev, Evgeny L Nasonov, Mahboob U Rahman, Ronald Pedersen, Andrew Dinh, Qi Shen, Radu Vasilescu, Sameer Kotak, Ehab Mahgoub, and Bonnie Vlahos.
• Institute and Clinic of Rheumatology 1st Medical Faculty, Charles University, Prague, Czech Republic. Pavelka@revma.cz.
• Rheumatol. Int. 2017 Sep 1; 37 (9): 1469-1479.

AbstractIn this transglobal, randomized, double-blind, placebo-controlled, treat-to-target study, the maintenance of efficacy was compared between biologic-and biologic-free-disease-modifying antirheumatic drug (DMARD) combination regimens after low disease activity (LDA) was achieved with biologic DMARD induction therapy. Patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy received open-label etanercept 50 mg subcutaneously once weekly plus methotrexate with or without other conventional synthetic (cs) DMARDs for 24 weeks. Patients achieving LDA [disease activity score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) <3.2] at week 24 were randomized to receive etanercept-methotrexate combination therapy or placebo-methotrexate combination therapy, with or without other csDMARDs, for 28 weeks. In the open-label period, 72% of patients achieved DAS28-ESR LDA at week 24. Patients enrolled in the double-blind period had long-standing rheumatoid arthritis and high disease activity at baseline (mean duration, 8.1 years; DAS28-ESR, 6.4). In the etanercept and placebo combination groups, 44% versus 17% achieved DAS28-ESR LDA and 34 versus 13% achieved DAS28-ESR remission at week 52 (p < 0.001). Adverse events were reported in 37 and 43%, serious adverse events in 0 and 4%, and serious infections in 0 and 2% in these groups, respectively, in the double-blind period. After induction of response with etanercept combination therapy following a treat-to-target approach in patients with long-standing rheumatoid arthritis and high disease activity at baseline, the etanercept combination regimen was significantly more effective in maintaining LDA and remission than a biologic-free regimen. ClinicalTrials.gov identifier. NCT01578850.

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