Phase 2 Study of ABT-122, a TNF- and IL-17A-Targeted Dual Variable Domain Immunoglobulin, in Psoriatic Arthritis With Inadequate Methotrexate Response.
TNF-blocking antibody; adalimumab; interleukins; psoriatic arthritis
OBJECTIVE: This study investigated the safety and efficacy of ABT-122, a TNF- and IL-17A-targeted dual variable domain immunoglobulin, in patients with active psoriatic arthritis (PsA) with an inadequate response to methotrexate.
METHODS: Patients (N=240) were randomized to receive ABT-122 (120 or 240 mg every week), adalimumab (40 mg every other week), or placebo in a 12-week, double-blind, parallel-group study (NCT02349451). The primary efficacy endpoint was ≥20% improvement in American College of Rheumatology criteria (ACR20 response) at week 12. Secondary and exploratory 12-week endpoints included ACR50, ACR70, and Psoriasis Area and Severity Index (PASI75 and PASI90 skin scores) in patients with ≥3% body surface affected.
RESULTS: For both ABT-122 dose groups, ACR20 responses at week 12 (64.8% to 75.3%) were superior to placebo (25.0%; P
CONCLUSIONS: Dual neutralization of TNF and IL-17A with ABT-122 had efficacy and safety that was similar to and not broadly differentiated from adalimumab over 12 weeks in patients with PsA. This article is protected by copyright. All rights reserved.
Orthopedics & Sports Medicine
Mease, Philip; Genovese, Mark C; Weinblatt, Michael E; Peloso, Paul M; Chen, Kun; Othman, Ahmed A; Li, Yihan; Mansikka, Heikki T; Khatri, Amit; Wishart, Neil; and Liu, John, "Phase 2 Study of ABT-122, a TNF- and IL-17A-Targeted Dual Variable Domain Immunoglobulin, in Psoriatic Arthritis With Inadequate Methotrexate Response." (2018). Articles, Abstracts, and Reports. 267.