Ixekizumab Shows Efficacy and Safety in Patients Who Failed Biweekly Etanercept Therapy: Analysis From UNCOVER-2, a Phase 3 Randomized Clinical Trial in Psoriasis
April 2016
in “
Journal of The American Academy of Dermatology
”
TLDR Ixekizumab is effective and safe for patients who did not improve with etanercept treatment for psoriasis.
The document presents findings from a study that evaluated the efficacy and safety of ixekizumab (IXE), an anti-IL17A monoclonal antibody, in patients with moderate-to-severe psoriasis who did not respond to biweekly etanercept (ETN) therapy. In the UNCOVER-2 phase 3 clinical trial, 358 patients were initially treated with ETN, and 200 (56%) were nonresponders at week 12. These nonresponders were then treated with IXE every 4 weeks (Q4W) for up to 60 weeks. Results showed significant improvement after switching to IXE: at week 28, 83.5% achieved PASI 75, 57.0% achieved PASI 90, and 22.0% achieved PASI 100; at week 60, these numbers were 82.5%, 68.5%, and 43.5%, respectively. Additionally, 45.5% of ETN-nonresponders achieved an SPGA score of 0/1 after 4 weeks of IXE Q4W, which increased to 73% after 12 weeks. Quality of life also improved, with 58.0% of patients achieving a DLQI score of 0/1 at week 60. The safety profile of IXE was similar to that of patients switching from placebo to IXE, with 79% of ETN-nonresponders experiencing at least one treatment-emergent adverse event (TEAE), which were mostly mild or moderate. There were 4.5% serious adverse events (SAEs) and 4% discontinuations due to AEs. The study concluded that IXE is highly effective and has a comparable safety profile for patients who failed to respond to biweekly ETN therapy.