Oral zasocitinib presents high potential as new psoriasis treatment
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Key takeaways:
- PASI 100 was achieved by one-third of patients receiving zasocitinib 30 mg at week 12.
- While more adverse events occurred in the treatment vs. placebo group, zasocitinib was well tolerated.
Zasocitinib, a potent and selective tyrosine kinase 2 inhibitor, safely and effectively cleared psoriasis in a high proportion of patients, according to a study.
“We as a field are really looking at targeting tyrosine kinase 2 (TYK2) because this is highly important in the pathogenesis of psoriasis,” April W. Armstrong, MD, MPH, professor and chief of dermatology at University of California, Los Angeles, told Healio. “What this study does is it highlights the impact of this novel oral medication that has been shown to be very efficacious in this phase 2 study.”
A total of 259 patients (mean age, 47 years; 32% women) in the study were randomly assigned to receive one of four doses of oral zasocitinib — 2 mg, 5 mg, 15 mg or 30 mg — or placebo once daily for 12 weeks.
Results showed that PASI 75 was achieved by 18%, 44%, 68% and 67% of patients receiving zasocitinib 2 mg, 5 mg, 15 mg or 30 mg, respectively. In contrast, only 6% of patients taking placebo achieved the same.
While PASI 90 responses were consistent with PASI 75 across doses, PASI 100 was achieved by one-third of patients (33%) receiving zasocitinib 30 mg at the primary endpoint of week 12.
“This is a noteworthy result because now we are seeing that an oral therapy can have such a high efficacy that a third of the patients can be cleared of their psoriasis by 3 months,” Armstrong said. “This shows that the TYK2 pathway continues to be a very important pathway for psoriasis pathogenesis and, therefore, a key pathway to target with our oral therapeutics.”
Zasocitinib also demonstrated a favorable safety profile. Treatment-emergent adverse events occurred in 44% of the placebo group and 53% to 62% of patients in the zasocitinib groups. Adverse events were not dose dependent and were mild, with the most comment events being COVID-19, acne/acneiform dermatitis and diarrhea.
Two serious adverse events were reported in a single patient and included severe pleural effusion and severe pericardial effusion; however, these were deemed unrelated to the study drug. No events commonly associated with Janus kinase inhibitors such as major adverse cardiovascular events, thromboembolic events or opportunistic infections were observed.
“As clinicians, it’s important that we have oral therapies that are efficacious and safe for treating our patients with moderate to severe plaque psoriasis,” Armstrong said. “What we saw was similar to what we would expect from TYK2 inhibition which was, overall, very well tolerated.”
According to Armstrong, a phase 3 study evaluating zasocitinib for the treatment of psoriasis is currently underway.
“We look forward to seeing the results that come out of the phase 3 study which will consist of not only the primary endpoints, but also key secondary endpoints involving special areas and quality of life,” Armstrong concluded.