Experiences with Long-term Treatment of Psoriasis with Interleukin 17A Inhibitor
The current publication of the long-term extension of the UNCOVER-3 study, which focused on the treatment of psoriasis with ixekizumab, describes the efficacy and safety of 4 years of use of this drug.
Ixekizumab in the Treatment of Psoriasis
Psoriasis is a chronic disease that requires long-term treatment. Among the medications approved for use in patients with more severe forms of this condition is ixekizumab (IXE), a high-affinity monoclonal antibody against interleukin 17A (IL-17A). The randomized UNCOVER-3 study investigated the efficacy and safety of IXE in patients with moderate to severe psoriasis over 4 years of use.
Study Design
The study included patients with moderate to severe psoriasis, who were randomly divided into 4 groups. In the individual arms, they either used a placebo, or IXE at a dose of 80 mg every 2 weeks (Q2W), or IXE at a dose of 80 mg every 4 weeks (Q4W; both groups receiving IXE had an initial dose of 160 mg), or 50 mg of etanercept twice a week. After 12 weeks, all patients were switched to the IXE Q4W regimen in long-term extension (LTE) observation.
The presented study focused on patients who took IXE at the recommended dosing of Q2W/Q4W (initial dose of 160 mg, followed by 80 mg Q2W for 12 weeks, then 80 mg Q4W). A total of 385 patients were randomized into the analyzed arm, of which 285 completed 204 weeks of treatment.
Results
The efficacy of IXE persisted throughout the 4-year duration of the study. In the IXE Q2W/Q4W group, using the mNRI method (modified non-responder imputation), at week 204, 48.3% of patients achieved a PASI 100 score (Psoriasis Area Severity Index), indicating 100% improvement in psoriasis symptoms. 82.8% achieved at least PASI 75.
67% of patients who had nail psoriasis at the start of the study, 73% with scalp involvement, and 77% with palmoplantar lesions achieved complete clearance of these disease symptoms by week 204. Almost half of the patients (48.6%) reported relief from itching.
No new safety signals were observed during the long-term extension of the study, and the safety of IXE therapy was confirmed.
Conclusion
The presented study demonstrates high efficacy and a sustained treatment response after 4 years of continuous treatment with ixekizumab in patients with moderate to severe psoriasis. The safety profile remains consistent with previous studies, and no new treatment risks were identified.
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Source: Lebwohl M. G., Gordon K. B., Gallo G. et al. Ixekizumab sustains high level of efficacy and favourable safety profile over 4 years in patients with moderate psoriasis: results from UNCOVER-3 study. J Eur Acad Dermatol Venereol 2020 Feb; 34 (2): 301–309, doi: 10.1111/jdv.15921.
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