Patients with psoriasis treated with ixekizumab showed sustained results for more than five years, according to results of the UNCOVER-3 trial published in the Journal of the American Academy of Dermatology.
During the trial, patients were randomized to receive subcutaneous injections of either placebo, 50 mg of etanercept twice weekly, or 80 mg of ixekizumab every two or four weeks after an initial dose of 160 mg. After the first 12 weeks of the study, patients were enrolled in a long-term extension study. These patients were treated with ixekizumab every four weeks and could be escalated every two weeks after week 60.
The authors noted that excluding the every 2-week dosing escalation, 97.4% and 90.7% of patients achieved PASI 75 using the as-observed and multiple imputation (MI) methods, respectively. They also noted that 90.2% and 75.9% of patients achieved PASI 90, and 66.5% and 51.9% achieved PASI 100 at week 264. When the researchers included the every-2-weeks dosing escalation, the proportions of patients in the every two weeks/4 weeks group reaching PASI 75, 90, and 100 after week 264 using the modified non-responder imputation (mNRI) method were 81.0%, 67.2%, and 44.6%, respectively. The mean improvements at week 264 from baseline PASI were 96.8% with the as-observed method and 82.4% with the MI method.
The authors also noted that the response rates were consistent using the static Physician’s Global Assessment (sPGA) for a score of 0/1 and 0 throughout the treatment period. Excluding the dose escalations, the responses were 90.7% using the as-observed method, 79.4% using the MI method, and 69.2% for the mNRI for an sPGA of 0/1. For a score of 0, the rates were 66.5%, 50.9%, and 45.3%, respectively using the three statistical analyses. Including the dose escalation group, the rates for achieving a score of 0/1 and 0 at week 264 with the mNRI method were 65.8% and 44.1%, respectively.
Further review of the data showed complete resolution during the treatment period was observed in patients with baseline nail, scalp, and palmoplantar involvement. Just over 57% of patients reported no itch at week 264 using the as-observed method, compared to 50.8% in the MI method, and 44.1% with the mNRI method, excluding the escalations.
Safety results from the UNCOVER-3 trial were previously published. The authors noted that treatment-emergent adverse events were reported in 323 patients during the long-term extension period, with most events considered mild or moderate. The most frequent were nasopharyngitis and upper respiratory tract infections. Serious adverse events were reported in 55 patients during the extension period. Thirty-three patients discontinued the study due to an adverse event during the extension phase of the study.
The authors noted that sustainability and safety results like the ones reported during the trial are “crucial factors” when considering treatments for chronic use during the treatment of a condition like psoriasis.
“The results reported here illustrate the consistency of the safety profile for the approved dosing regimen of ixekizumab as well as sustained long-term efficacy through 5 years of treatment in patients with moderate to severe plaque psoriasis,” the authors concluded.