AT AAD 2017
ORLANDO (FRONTLINE MEDICAL NEWS) – The interleukin-17A inhibitor ixekizumab was associated with superior efficacy and safety when compared with ustekinumab at 24 weeks, a head-to-head trial of the two monoclonal antibodies in plaque psoriasis has shown.
The 24-week data from the IXORA-S trial were presented during a late-breaking clinical trial session at the annual meeting of the American Academy of Dermatology by Kristian Reich, MD, PhD , a founder of SCIderm in Hamburg, Germany.
Investigators randomly assigned 302 adults with moderate to severe plaque psoriasis to either ustekinumab (Stelara) or ixekizumab (Taltz), which was approved by the Food and Drug Administration in March 2016 for treating this patient population. A total of 136 patients received a starting subcutaneous dose of 160 mg ixekizumab, then 80 mg every other week for 12 weeks, followed by 80 mg every 4 weeks. Another 166 patients in the ustekinumab group were treated according to the drug’s label: between 45 mg and 90 mg per dose, depending upon patient weight.
At 24 weeks, 49% in the ixekizumab arm achieved a Psoriasis Area and Severity Index (PASI) 100 level of skin clearance, compared with 24% in the ustekinumab arm (P = .001). Ixekizumab treatment also reached significantly higher skin clearances than ustekinumab at 24 weeks at the level of PASI 90 (83% vs. 59%; P less than .001) and PASI 75 (91% vs. 82%; P = .015).
Treatment with ixekizumab produced a Static Physician’s Global Assessment (sPGA) score of 0 in 54% at 24 weeks, compared with 24% with ustekinumab (P less than .001). A sPGA score of 0 or 1 occurred in 87% of patients who took ixekizumab and in 59% of the ustekinumab group.
An improvement of 4 or more points in the pruritus Numeric Rating Scale was reported by 86% of ixekizumab patients at 24 weeks, compared with 72% of those who took ustekinumab (P = .018).
Dr. Reich reported that there were no deaths or any significant differences in overall treatment-related adverse events across both arms, although he cautioned against putting too much stock in 24-week safety data. “I hesitate to show safety data for only 300 patients at 24 weeks, but it’s good to see here that there doesn’t seem to be a difference. I still would want to see larger patient numbers and more long-term data,” he said.
Dr. Reich had numerous disclosures, including honoraria for serving as a speaker for Eli Lilly, the sponsor of this trial.
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