| Tóm tắt: | <p><strong>Introduction/Objectives:</strong> To evaluate the 3-year efficacy and safety of ixekizumab with and without concomitant conventional synthetic disease-modifying antirheumatic drug (csDMARD) use in patients with active psoriatic arthritis (PsA).</p>
<p><strong>Method:</strong> Patients with PsA who were biologic-naïve (SPIRIT-P1, NCT01695239) or had prior inadequate response to tumor necrosis factor inhibitors (SPIRIT-P2, NCT02349295) were randomized to receive 80-mg ixekizumab every 4 weeks after receiving 160-mg ixekizumab at baseline. Efficacy, safety, and immunogenicity were evaluated in this post-hoc analysis in 3 subgroups: (1) ixekizumab monotherapy, (2) ixekizumab and methotrexate (MTX), (3) ixekizumab and any csDMARD (including MTX). Missing data were imputed using multiple imputation for continuous variables and modified non-responder imputation for categorical variables.</p>
<p><strong>Results:</strong> Efficacy was similar across the 3 subgroups, including 59.1%, 67.0%, and 66.1% of ixekizumab-treated patients achieving 20% improvement in the American College of Rheumatology scale score at week 156. Radiographic progression of structural joint damage (SPIRIT-P1 only) was similarly inhibited across the 3 subgroups with several outliers. No new safety signals were reported, and 91.0%, 84.1%, and 83.2% in the 3 subgroups reported ≥1 treatment-emergent adverse event. At week 156, 15.9%, 13.1%, and 11.0% in the 3 subgroups had antidrug antibodies; most had low titer status.</p>
<p><strong>Conclusions:</strong> Ixekizumab showed sustained efficacy in treating patients with PsA up to 3 years in monotherapy or in combination with MTX or any csDMARD. The 3 groups had similar safety and immunogenicity profiles, which supports that the use of concomitant MTX or csDMARDs does not seem to impact the benefit/risk profile of ixekizumab.</p>
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