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Efficacy and safety of continuous vs interrupted ixekizumab treatment in patients with plaque psoriasis: Results from a phase III trial
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A multicenter, randomized, phase III trial (NCT03364309) assessed ixekizumab vs placebo in patients with moderate-to-severe plaque psoriasis in China.1 Following 12-week induction, ixekizumab responders (n = 289) were re-randomized 2:1 to ixekizumab Q4W maintenance (IXE/IXE group; n = 192) or placebo Q4W (IXE/PBO group; n = 97), with patients who had disease worsening switching to ixekizumab Q4W (IXE/PBO + IXEQ4W group). Results were published in Advances in Therapy by Gao et al.1 |
| Key learnings |
| At Week 60, in the IXE/IXE group, PASI 75, PASI 90, PASI 100, sPGA (0,1), and sPGA (0) response rates were 75.0%, 70.3%, 53.1%, 68.2%, and 53.1%, respectively, compared with 6.2%, 3.1%, 0%, 2.1%, and 0%, respectively, in the IXE/PBO group (all p < 0.001). |
| In the IXE/PBO group, 90.7% of patients experienced disease relapse. After 24 weeks of re-treatment, patients in the IXE/PBO + IXEQ4W group had PASI 75 and sPGA (0,1) response rates of 97.2% and 76.4%, respectively. |
| No new safety signals were observed, and AEs were comparable between continuous treatment and re-treatment patients. |
| Results from this trial highlight the benefit of continuous ixekizumab treatment through 60 weeks in patients with moderate-to-severe plaque psoriasis. While the majority of patients who stopped ixekizumab treatment relapsed, re-treatment successfully restored response rates in most patients. |
Abbreviations: AE, adverse event; IXE, ixekizumab; PASI, Psoriasis Area and Severity Index; PBO, placebo; Q4W, every 4 weeks; sPGA, static Physician’s Global Assessment.
- Gao X, Pan W, Zheng M, et al. Efficacy and safety analysis in Chinese patients with moderate-to-severe psoriasis from a phase 3 trial: Impact of treatment withdrawal and retreatment of ixekizumab. Adv Ther. Online ahead of print. DOI: 10.1007/s12325-024-03030-5
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