Zasocitinib meets proof of concept in plaque psoriasis
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Key takeaways:
- Patients treated with 15 mg and 30 mg of zasocitinib had significantly greater changes in mean PASI score compared with placebo.
- Results were evident as early as week 2 and continued through week 12.
Patients with psoriasis treated with higher doses of oral zasocitinib experienced greater improvement than those treated with placebo, according to a phase 2b study.
The results were presented at the International Federation of Psoriasis Associations Conference.
“We measure absolute PASI improvements from people who participated in the phase 2 proof-of-concept study for zasocitinib [Takeda]. Absolute PASI measurements are another way of calculating PASI improvement, without a baseline PASI score needed,” Lawrence J. Green, MD, FAAD, clinical professor of dermatology at George Washington University School of Medicine and the study’s lead investigator, told Healio.
The randomized, multicenter, double blind, placebo-controlled trial enrolled patients aged 18 to 70 years with moderate to severe plaque psoriasis who were subsequently randomly assigned to receive daily doses of 2 mg, 5 mg, 15 mg or 30 mg or oral zasocitinib, a tyrosine kinase 2 inhibitor, or placebo. The results presented included data from the 15 mg and 30 mg cohorts, as well as the placebo group.
The 53 patients in the 15 mg and 52 in the 30 mg group experienced a mean change in absolute PASI scores of –13.7% and –14.1%, respectively, compared with –5% in the placebo group (n = 52) at week 12.
Results were also measurable as early as week 2 with a mean change of –4.2% in the 15 mg group, –5% in the 30 mg group and –2.3% in the placebo group.
Additionally, 56.6% and 55.8% of subjects in the 15 mg and 30 mg cohorts achieved a PASI score of 2 or less, 32.1% and 32.7% achieved a PASI score of 1 or less and 15.1% and 32.7% achieved PASI 0, compared with zero patients in the placebo cohort.
“There are two take-home messages,” Green said. “The rapid onset of action of zasocitinib, with significant reduction in absolute PASI scores as early as week 2 for both the 15 mg and 30 mg doses and the percent of people who were completely clear at the 12-week mark in the zasocitinib 30 mg dose.”
Phase 3 trials are currently ongoing to evaluate the efficacy of zasocitinib across multiple endpoints in a larger population.