FDA Approves Ixekizumab for Treatment of Active Psoriatic Arthritis in Adults

The FDA has approved ixekizumab for the treatment of adults with psoriatic arthritis.

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.

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Lilly’s Taltz® (ixekizumab) Receives US FDA Approval for the Treatment of Active Psoriatic Arthritis [press release]. Indianapolis, IN: Lilly. Accessed December 5, 2017.

This article originally appeared on MPR