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Efficacy, safety of psoriasis drug Taltz sustained over 4 years

Taltz demonstrated high levels of efficacy and safety for the treatment of psoriasis over 4 years, according to research presented at the American Academy of Dermatology Annual Meeting.

“[Taltz (ixekizumab, Eli Lilly)] a high-affinity monoclonal antibody that selectively targets IL-17A, has shown sustained high efficacy response over 3 years with consistent safety profile in moderate-to-severe psoriasis patients,” Mark G. Lebwohl, MD, professor and system chair of dermatology at Mount Sinai Hospital, and colleagues wrote.

Lebwohl and colleagues conducted a study to determine if ixekizumab had sustained efficacy and safety over 4 years of treatment. They enrolled 1,346 patients with psoriasis. Participants were randomly assigned to one of four treatment groups during a 12-week induction period:

• an initial dose of 160 mg of ixekizumab followed by 80 mg of ixekizumab every 2 weeks;
• an initial dose of 160 mg of ixekizumab followed by 80 mg of ixekizumab every 4 weeks;
• 50 mg of Enbrel (etanercept, Amgen) twice weekly; or
• placebo.

At week 12, 1,274 patients entered the long-term extension phase of the study and received ixekizumab every 4 weeks and after week 60, dosing could be modified to every 2 weeks at the researchers’ discretion.

The researchers used several measurements to determine efficacy, including 75%, 90% or

100% improvement from baseline in the Psoriasis Area and Severity Index (PASI), a static Physician’s Global Assessment (sPGA) score of 0/1 or 0, complete resolution based on the Psoriasis Scalp Severity Index (PSSI = 0) and Palmoplantar Psoriasis Area and Severity Index (PPASI = 100).

They assessed treatment-emergent adverse events in patients who received at least one dose during the long-term extension period to evaluate safety.

About three-quarters of participants completed 4 years of the efficacy assessment.

Most patients taking ixekizumab every 2 or 4 weeks demonstrated improvement on all of the efficacy assessments (PASI 75: 82.9%; PASI 90: 68.9%; PASI 100: 49%; sPGA 0/1: 69.2%; sPGA 0: 50.3%; PSSI = 0: 73.4%; and PPASI = 100: 76.1%).

Of the 19.9% of patients who had their ixekizumab dose adjusted to every 2 weeks between week 60 and year 4, 59.8% showed 75% improvement in PASI before dose adjustment.

The overall safety profile of ixekizumab was consistent to year 4. Most treatment-emergent adverse events were mildly or moderately severe. The most common adverse event was infections (67.2%). There were eight (0.6%) deaths, according to the researchers.

“High efficacy response was demonstrated with ixekizumab treatment that sustained over 4 years in patients with moderate-to-severe plaque psoriasis,” Lebwohl and colleagues wrote. “The safety profile remained consistent with prior findings, with no or unexpected new safety concerns.” – by Alaina Tedesco

Reference:

Lebwohl MG, et al. Abstract 10011. Presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, D.C.

Disclosure: Lebwohl is a consultant for Allergan, Aqua, Arcutis, Boehringer Ingelheim, Leo Pharma, Menlo, Promius and Verrica.