OBJECTIVE: Tumor necrosis factor (TNF) and interleukin-17A (IL-17A) may independently contribute to the pathophysiology of rheumatoid arthritis (RA). The objective of this study was to evaluate the safety and efficacy of ABT-122, a novel dual variable domain immunoglobulin (DVD-Ig ) targeting human TNF and IL-17A in patients with RA with inadequate response to methotrexate.METHODS: Patients with active RA receiving methotrexate and no prior exposure to biologic agents (N=222) were enrolled in a 12-week phase 2, randomized, double-blind, active-controlled, parallel-group study (NCT02141997). Patients were randomized to receive ABT-122 60 mg every other week (EOW), 120 mg EOW, or 120 mg every week (EW), or adalimumab 40 mg EOW subcutaneously. The primary efficacy endpoint was American College of Rheumatology (ACR) 20 response at week 12.RESULTS: Treatment-emergent adverse events were similar across all treatment groups, with no serious infections or systemic hypersensitivity reactions reported with ABT-122. ACR20 response rates at week 12 were 62%, 75%, and 80% with ABT-122 60 mg EOW, 120 mg EOW, and 120 mg EW, respectively, compared with 68% with adalimumab. Corresponding ACR50 and ACR70 response rates were, respectively, 35%, 46%, 47%, and 48% and 22%, 18%, 36%, and 21%.CONCLUSIONS: Dual inhibition of TNF and IL-17A with ABT-122 produced a safety profile consistent with inhibition of TNF alone with adalimumab over the 12-week study period. The efficacy of ABT-122 120 mg EOW and 120 mg EW was not meaningfully differentiated from that of adalimumab 40 mg EOW over 12 weeks in patients with RA receiving concomitant methotrexate. This article is protected by copyright. All rights reserved.
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