麻豆传媒

ORLANDO -- Ixekizumab (Taltz) proved superior to ustekinumab (Stelara) for several outcomes after 24 weeks of treatment in patients with psoriasis, researchers reported here.

After 24 weeks, 83.1% of psoriasis patients treated with injectable ixekizumab achieved a Psoriasis Area and Severity Index 90 (PASI90) -- clear to almost clear skin -- versus 59% of the patients on ustekinumab (P<0.001), said of the Dermitologikum Hamburg in Germany, and colleagues.

Treatment with ixekizumab allowed 49.3% of patients to achieve a PASI100 -- completely clear skin -- compared with 23.5% (P<0.001) of patients who were treated with ustekinumab, they stated in a presentation at the American Academy of Dermatology (AAD) annual meeting.

Ixekizumab was approved by the FDA for the treatment of in adults in March 2016, while ustekinumab gained FDA approval in 2009 in the same patient population.

Results from the IXORA-S trial also demonstrated that patients getting ixekizumab had better scores on the physician's global assessment (PGA) for scores of 0-1, with 86.6% of patients reaching that goal compared with 69.3% of patients on ustekinumab (P<0.001). On the even more stringent PGA 0, 53.7% of patients ixekizumab achieved that rating compared with 24.1% of patients on ustekinumab at week 24 (P<0.001).

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 0-1 score on that measure compared with 53% of patients on ustekinumab (P<0.05), Reich said.

However, ixekizumab was not significantly better than ustekinumab in reducing itchiness, or in reducing skin pain often associated with psoriasis, he noted.

The study assigned 136 patients with psoriasis to treatment with ixekizumab (160-mg starting dose, then 80-mg every 2 weeks for 12 weeks, followed by 80-mg every 4 weeks). The remaining patients (n=166) were assigned to ustekinumab (45 mg/90 mg depending on weight-based dosing). Patients on ixekizumab are in an extension trial that will continue for 52 weeks, Reich said.

The patients were about 43-years-old and two-thirds were men. The majority of patients were from Western Europe, with patients from Eastern Europe and North America making up the rest of the study population. At baseline the mean PASI score was about 20, and the mean PGA was 3.6.

Reich said there were no deaths in the trial, and no significant difference in overall adverse events in the treatment groups. Five (3%) of the patients on ustekinumab experienced serious adverse events compared with three patients (2.2%) taking ixekizumab (P=0.735). One individual on ustekinumab and two people on ixekizumab discontinued their assigned drugs because of adverse events.

Treatment-emergent adverse events occurred among 75% of the patients on ustekinumab and 70% of the patients treated with ixekizumab (P=0.299), while serious treatment-emergent adverse events occurred in 10 (6%) of patients taking ustekinumab versus six (4.4%) of patients taking ixekizumab (P=0.613).

"I have already changed my practice, and have been using ixekizumab because it shows the highest efficacy of any biologic, as the primary result of the trial showed. This work reinforces that earlier convincing evidence," commented AAD session moderator of Oregon Medical Research Center in Portland.