The investigational tyrosine kinase 2 (TYK2) inhibitor ESK-001 was well tolerated and displayed promising efficacy data in a phase 2 including patients with moderate-to-severe plaque psoriasis. A phase 3 study has been launched to further assess this agent in over 600 patients with this skin condition.
The STRIDE study previously showed that the TYK2 inhibitor ESK-001 was associated with high PASI75 rates in patients with plaque psoriasis at week 12. At this time, 64.1% of the patients treated at the highest dose level (ie 40 mg, twice daily) reached this endpoint, compared with 0.0% of the patients on placebo1. Andrew Blauvelt, MD, Blauvelt Consulting LLC, Maryland, presented the first results of the subsequent open-label extension study2. “Today, I will present efficacy data from the patients who received the highest dose in the induction study and continued on this dose level during the open-label extension study [n=82], and safety data from a broader population of patients [n=164],” Dr. Blauvelt explained.
The drug was well tolerated throughout 52 weeks, with most side effects being mild or moderate in severity and self-limiting. “Acne was only reported in 3.7% of the patients, and there were just two cases of herpes zoster and one case of herpes simplex,” highlighted Dr. Blauvelt. Moving to efficacy, PASI rates increased with longer-term use of ESK-001, with PASI75, PASI90, and PASI100 rates of 77.5%, 61.3%, and 38.8% at week 52, respectively. “This PASI100 rate is the highest we have seen for a TYK2 inhibitor,” emphasized Dr. Blauvelt.
“We observed that responses improved over time with high-dose ESK-001 without causing serious safety issues,” decided Dr. Blauvelt. “The ONWARD study will test this agent in another 600+ patients with plaque psoriasis.”
Medical writing support was provided by Robert van den Heuvel.
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