FDA Approves Ixekizumab for Treatment of Active Psoriatic Arthritis in Adults
Findings from both studies showed that Taltz-treated patients achieved significant improvement in joint symptoms vs placebo.
The Food and Drug Administration (FDA) has approved Taltz (ixekizumab; Lilly) for the treatment of adults with active psoriatic arthritis (PsA), either as monotherapy or in combination with a conventional disease-modifying antirheumatic drug (DMARD).
The safety and efficacy of Taltz was established in two Phase 3 randomized, double-blind, placebo-controlled studies (SPIRIT-P1 and SPIRIT-P2) involving >670 adults with active PsA. In SPIRIT-P1, Taltz was compared to placebo in biologic-naive patients; SPIRIT-P2 compared Taltz to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed 1 or 2 TNF inhibitors. The primary efficacy endpoint was the proportion of patients at 24 weeks achieving ACR20 response (a 20% reduction in a composite measure of disease activity as defined by ACR).
Findings from both studies showed that Taltz-treated patients achieved significant improvement in joint symptoms vs placebo at Week 24: SPIRIT-P1 (58% vs 30%) and SPIRIT-P2 (53% vs 20%).
Taltz, an interleukin-17A antagonist, is already indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is available as an 80mg/mL strength injection for subcutaneous (SC) injection.
Lilly's Taltz® (ixekizumab) Receives US FDA Approval for the Treatment of Active Psoriatic Arthritis [press release]. Indianapolis, IN: Lilly. Accessed December 5, 2017.