Potential Psoriasis Therapy Associated With Improved Outcomes
The investigational p19-directed Interleukin-23 (IL-23) antibody mirikizumab improved the quality of life and skin clearance among patients with moderate to severe psoriasis, according to a study presented by Phoebe Rich, MD, and colleagues at the 2018 American Academy of Dermatology Annual Meeting.
The phase 2 randomized, double-blind, placebo-controlled trial assessed the safety and efficacy of various doses of mirikizumab compared with placebo among participants with moderate to severe psoriasis. Fifty-two participants were randomly assigned to receive placebo, 51 were randomly assigned to receive 30 mg of mirikizumab, 51 were randomly assigned to receive 100 mg of mirikizumab, and 51 were randomly assigned to receive 300 mg of mirikizumab at weeks 0 and 8. The primary outcome included the proportion of patients achieving a 90% improvement on the Psoriasis Area Severity Index (PASI 90). Secondary outcomes included evaluation of the superiority of mirikizumab compared with placebo at achieving static Physician’s Global Assessment (sPGA) of 0 and 0/1 and dermatology life quality index (DLQI) of 0/1 at week 16.
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Compared with participants who received placebo (0%), 29.4% of those who received 30 mg of mirikizumab, 58.8% of those who received 100 mg of mirikizumab, and 66.7% of those who received 300 mg of mirikizumab achieved PASI 90. At week 16, sPGA 0/1 and 0 responses were observed among were 37.3% and 15.7% of participants who received 30 mg of mirikizumab, 70.6% and 31.4% of participants who received 100 mg of mirikizumab, and 68.6% and 31.4% of participants who received 300 mg of mirikizumab, respectively, compared with 1.9% and 0% of those who received placebo.
Participants who received 30 mg, 100 mg, or 300 mg of mirikizumab experienced 35.3%, 49%, and 47.1% improvements in DLQI responses at week 16, respectively, compared with 3.8% of those who received placebo.
The most common treatment-emergent adverse events (AEs) were upper respiratory tract infections, with 2 participants discontinuing treatment. Two participants who received mirikizumab experienced serious AEs compared with 1 in the placebo group.
“Mirikizumab demonstrated clinical efficacy and improved quality of life after 16 weeks of treatment,” the researchers concluded. “The overall frequency of AEs was similar for mirikizumab and placebo-treatment participants.”
Rich P, Maari C, Leonardi C, et al. Efficacy, safety, and quality of life in patients with moderate to severe plaque psoriasis treated with mirikizumab. Presented at: American Academy of Dermatology Annual Meeting; February 16-20, 2018; San Diego, CA.