Eli Lilly reported that Taltz (ixekizumab) achieved primary and secondary endpoints in SPIRIT-P2, a Phase 3 clinical trial evaluating the treatment in psoriatic arthritis (PsA). These results were announced in the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.
SPIRIT-P2, a randomized, double-blind, placebo-controlled study, evaluated the efficacy of Taltz in patients (n=363) with psoriatic arthritis who either exhibited inadequate response to one or two TNF inhibitors or were intolerant to TNF inhibitors. Patients were randomized to two treatment groups of Taltz or placebo for 24 weeks. The dosing regimens for Taltz treatment arms consisted of starting doses of subcutaneous (SC) Taltz 160mg then either 80mg SC once every 2 weeks or once every 4 weeks.
The primary endpoint of the study was the percentage of patients achieving at least a 20% reduction in disease activity as defined by the American College of Rheumatology (ACR20). Secondary endpoints measured included ACR50, ACR70, skin clearance defined by the Psoriasis Area Severity Index (PASI), and physical function assessed as change in HAQ-DI scores.
Both Taltz treatment arms showed significant superiority to placebo in achieving the primary endpoint of ACR20 (53% in patients treated every 4 weeks vs. 48% in patients treated every 2 weeks vs. 19% placebo; P<0.0001). Similar results of superiority were seen in comparison of ACR50 (35% and 33% vs. 5%, respectively; P<0.0001) and ACR70 (22% and 12% vs. 0%, respectively; P<0.0001).
Additionally, both Taltz regimens demonstrated significant improvements in skin clearance and HAQ-DI scores at Week 12 and Week 24 compared with placebo.
Treatment with Taltz resulted in greater treatment-emergent adverse events, which included injection site reaction, upper respiratory infection, nasopharyngitis and sinusitis. Other common adverse reactions established in previous trials were nausea and tinea infections.
Ixekizumab is a monoclonal antibody that selectively inhibits interleukin 17A (IL-17A), a cytokine responsible for inflammatory and immune responses. By inhibiting IL-17A, ixekizumab helps control excess inflammation.
“Many patients with psoriatic arthritis have tried a variety of therapies and have either lost response over time, had an inadequate response or been intolerant of therapy,” stated lead author of the study, Peter Nash, Associate Professor of the University of Queensland. “If approved, ixekizumab may provide physicians with a new option in this difficult-to-treat patient population.”
Taltz is filed under a supplemental Biologics License Application for the treatment of active PsA in adults. It is currently approved for the treatment of moderate to severe plaque psoriasis in patients who are eligible for systemic therapy or phototherapy.
The SPIRIT-P2 trial will continue to evaluate long-term efficacy and safety of Taltz in PsA for up to 3 years.
For more information visit Taltz.com.