Patients with psoriasis treated with the targeted agent ixekizumab appear to have better outcomes at 24 weeks than those treated with ustekinumab, according to the 24-week data of the ongoing IXORA-S trial presented at the 2017 Annual Meeting of the American Academy of Dermatology (AAD).
"This study demonstrated the continued superiority of ixekizumab when compared with ustekinumab after 24 weeks of treatment," said lead author Kristian Reich, MD, PhD, Dermatologikum Hamburg, Hamburg, Germany, speaking at an oral, late-breaker presentation here on March 4.
After 24 weeks, 83.1% of patients with psoriasis treated with ixekizumab had achieved a Psoriasis Area and Severity Index 90 (PASI90) -- clear to almost clear skin, compared with 59% of the patients on ustekinumab (P < .001).
The investigators randomised166 patients with psoriasis to treatment with ustekinumab and 136 patients to treatment with ixekizumab. Patients were treated with ustekinumab 45 mg/90 mg depending on body weight. The patients on ixekizumab were treated every other week for the first 12 weeks and then every 4 weeks in an extension trial that will continue for 52 weeks.
In presenting the 24-week data of the IXORA-S trial, Dr. Reich said that treatment with ixekizumab allowed 49.3% of patients to achieve a PASI 100 -- completely clear skin -- compared with 23.5% (P < .001) of patients who were treated with ustekinumab.
Ixekizumab patients achieved better scores on the Physician's Global Assessment (PGA) scale. About 86.6% of patients on ixekizumab achieved scores of 0 to 1 on that assessment tool compared with 69.3% of patients on ustekinumab (P < .001). About 53.7% of patients ixekizumab achieved PGA scores of 0 compared with 24.1% of patients on ustekinumab at week 24 (P < .001).
Treatment with ixekizumab was also superior to ustekinumab when measured on the Dermatology Quality of Life Index. About 66% of patients on ixekizumab achieved a 0 to 1 score on that measure compared with 53% of patients on ustekinumab (P < .03).
Ixekizumab was not significantly better than ustekinumab in reducing the itchiness or skin pain often associated with psoriasis.
Patients in this study were approximately 43 years old; two-thirds of the subjects in the trial were male. About 60% of the patients in the trial were from Western Europe; about 20% were from Eastern Europe; and the rest were from North America. At baseline, the mean PASI score was 20; the mean PGA was 3.6.
The safety profile was consistent with published reports for both ixekizumab and ustekinumab. "There were no deaths in the trial, and no significant difference in overall adverse events in the treatment groups," Dr. Reich reported. Five patients (3%) on ustekinumab experienced what were classified as serious adverse events compared with 3 (2.2%) of the patients receiving ixekizumab (P = .735). One individual on ustekinumab and 2 on ixekizumab discontinued their assigned drugs due to adverse events.
Funding for this study was provided by Eli Lilly and Company, Indianapolis, Indiana.
[Presentation title: Efficacy and Safety of Ixekizumab Compared to Ustekinumab After 24 Weeks of Treatment in Patients With Moderate-to-Severe Plaque Psoriasis: Results From IXORA-S, a Randomized Head-to-Head Trial. Abstract 5174]