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Taltz meets primary, secondary endpoints in head-to-head trial
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Taltz met the primary and secondary endpoints at week 12 in a phase 4 head-to-head study comparing its efficacy and safety vs. Tremfya in patients with moderate to severe plaque psoriasis, according to an announcement from Eli Lilly and Company.
The IXORA-R trial represents the first completed head-to-head trial between an interleukin-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint, according to the press release.
Patients with moderate to severe plaque psoriasis (n = 1,027) were randomly assigned to receive Taltz (ixekizumab) or Tremfya (guselkumab, Janssen). Taltz patients received 160 mg at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10 and 12, and then 80 mg every 4 weeks. Tremfya patients received 100 mg at weeks 0 and 4 and every 8 weeks thereafter. Treatments were administered via subcutaneous injection for a total of 24 weeks.
Taltz showed superiority in the proportion of patients achieving complete skin clearance compared with Tremfya as measured by PASI 100 at 12 weeks.
The treatment also met all major secondary endpoints up to week 12, including superiority over Tremfya in the proportion of patients achieving PASI 75 at week 2, PASI 90 at weeks 4 and 8, PASI 100 at weeks 4 and 8, static Physician’s Global Assessment at week 12 and PASI 50 at week 1, according to the release.
"While other head-to-head studies have used lower measures of success, IXORA-R was the first head-to-head trial between a selective IL-17A (Taltz) and a selective IL-23 inhibitor (Tremfya) to use PASI 100 – complete skin clearance – as the primary endpoint," Andrew Blauvelt, MD, MBA, lead study investigator and president of Oregon Medical Research Center in Portland told Healio Dermatology. "The results indicate that Taltz is more effective than Tremfya in achieving completely clear skin and in providing rapid relief of symptoms associated with moderate-to-severe plaque psoriasis. Speed and magnitude of response are two important treatment goals for patients. Data from head-to-head trials like IXORA-R should help psoriasis patients and doctors have more informed conversations around these important treatment goals."
The company plans to share results on the proportion of patients achieving PASI 100 at 24 weeks in 2020.
The safety profile for Taltz was consistent with previous results, with no new safety signals identified.
Taltz is currently approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis.
Disclosures: Blauvelt is lead study investigator for IXORA-R and president of Oregon Medical Research Center.