Does Ixekizumab Have Long-term Effects on Improving Psoriatic Arthritis Symptoms?

Ixekizumab in the Treatment of Psoriatic Arthritis

Ixekizumab (IXE) is a high-affinity antibody that selectively binds to interleukin 17A. In the SPIRIT-P2 study, it was observed at week 24 that its administration every 2 or 4 weeks (Q2W, Q4W) improves PsA symptoms in patients with an inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi).

Results of the Study Extension

310 patients entered the study extension. Participants receiving IXE remained on the same dose of the drug, and patients who were previously on placebo were reallocated in the same proportion to receive IXE Q2W or Q4W. Those who did not achieve ≥ 20% improvement in joint tenderness and swelling at week 32 (or at a later visit) were discontinued from the study. Of the 245 patients randomized to IXE, 64 discontinued treatment due to insufficient efficacy and 22 due to pre-established criteria for study discontinuation.

Effectiveness of Ixekizumab

Patients who took IXE for 156 weeks observed long-term improvements in American College of Rheumatology (ACR) criteria and PsA manifestations (enthesitis, dactylitis, and skin symptoms).

Minimal disease activity (MDA) was achieved by 30.8% of patients on IXE Q4W and 29.2% of those receiving IXE Q2W. Low disease activity or remission according to the Disease Activity in PsA (DAPSA) index was achieved by 47.7% of subjects treated with IXE Q4W and 40.7% of patients receiving IXE Q2W.

Safety Profile

Most treatment-emergent adverse events (TEAEs) were mild in nature, and 5.9% of patients discontinued the study due to adverse events. The most common TEAEs were infections (with an incidence rate [IR] of 33.1) and injection site reactions (IR 5.4).

Conclusion

Patients with previous inadequate response or intolerance to TNFi observed improvements in PsA signs and symptoms after IXE treatment, even after 3 years. During the study extension, no unexpected adverse effects were reported, and the safety profile of the drug was consistent with that demonstrated in previous studies.

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Source: Gratacos-Masmitja J., Turkiewicz A., Dokoupilová E. et al. SAT0411 Efficacy and safety of ixekizumab in patients with psoriatic arthritis and inadequate response to TNF inhibitors: three year results from a phase 3 study (SPIRIT-P2). Ann Rheum Dis 2020; 79: 1158, doi: 10.1136/annrheumdis-2020-eular.1482.