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Researchers report that patients diagnosed with moderate to severe plaque psoriasis who were treated with ixekizumab, an investigational anti-interleukin-17A monoclonal antibody, have maintained a favorable clinical response over a year-long course of treatment.
Researchers report that patients diagnosed with moderate to severe plaque psoriasis who were treated with an investigational anti-interleukin-17A monoclonal antibody have maintained a favorable clinical response over a year-long course of treatment.
The authors of “A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis,” published in The Journal of the American Academy of Dermatology, evaluated the long-term efficacy and safety of ixekizumab in the treatment of patients with moderate to severe plaque psoriasis.
For the study, patients with moderate to severe plaque psoriasis were randomized to receive 10, 25, 75, or 150 mg of ixekizumab or placebo for up to 19 weeks. Patients with less than 75% improvement from baseline on the Psoriasis Area and Severity Index score (PASI75) were assigned to an open-label extension arm. Patients with PASI75 or higher were enrolled in a treatment-free period for weeks 20-32 and then entered into the open-label extension arm after meeting response criteria.
Patients in the open-label extension received subcutaneous ixekizumab 120 mg every 4 weeks.
In their summary of the trial results, the researchers noted that “120 patients entered OLE; 103 completed 52 weeks or more of treatment. Overall, 77% of patients achieved PASI75 at week 52 (nonresponder imputation). Patients who responded to treatment in the randomized, placebo-controlled trial maintained a high-level response by week 52 of OLE (PASI75 = 95%; 90% improvement from baseline on the PASI score = 94%; 100% improvement from baseline on the PASI score = 82%). Irrespective of dose in the randomized, placebo-controlled trial, each group had similar response rates at week 52 of OLE. The exposure-adjusted incidence rate for adverse events was 0.47 and for serious adverse events was 0.06 per patient-year during OLE.”
Based on these results, the authors concluded that “a high proportion of patients responded to ixekizumab therapy and maintained clinical responses over 1 year of treatment with no unexpected safety signals.”