TYK-2 inhibitor effective over 7 months for treatment of plaque psoriasis
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Key takeaways:
- Among those treated twice daily with ESK-001 40 mg, 93% of patients reached PASI 75.
- Similarly, sPGA 0/1 was achieved by 76.1% of patients treated with twice-daily dosing in the same time frame.
ESK-001 demonstrates continued efficacy for the treatment of moderate to severe plaque psoriasis over the span of 7 months, according to a late-breaker presentation at the European Academy of Dermatology and Venereology Congress.
“Similar to deucravacitinib, ESK-001 binds allosterically and inhibits [tyrosine kinase 2 (TYK2)] active domain by allosteric inhibitions,” Andrew Blauvelt, MD, MBA, founder of Blauvelt Consulting, explained in the late-breaker presentation concerning the characteristics of ESK-001.
According to Blauvelt, 40 mg twice daily is the optimal dose that inhibits TYK2 in vitro and in vivo. These late-breaking data describe the efficacy and safety of ESK-001 40 mg for the treatment of moderate to severe plaque psoriasis over the span of 7 months.
Blauvelt and colleagues conducted an open-label extension trial consisting of 165 subjects with plaque psoriasis from the phase 2 STRIDE study who were treated with ESK-001 40 mg once daily (n = 82) or twice daily (n = 82) for 28 weeks.
Among those treated twice daily, 93% of patients reached PASI 75, 71.8% reached PASI 90 and 35.2% reached PASI 100 by week 28. Similarly, static Physician Global Assessment (sPGA) 0/1 and sPGA 0 was achieved by 76.1% and 39.4% of patients treated with twice-daily dosing in the same time frame, respectively.
In comparison, those treated once daily achieved lower efficacy results with 72.9%, 47.1% and 20% reaching PASI 75, PASI 90 and PASI 100, respectively.
Blauvelt explained that the safety of ESK-001 was very “quiet” and “clean” with 52.4% of patients experiencing one or more treatment-emergent adverse event, four of which were serious.
Overall, the STRIDE study and its open-label extension showed that ESK-001 is a promising treatment for moderate to severe plaque psoriasis, with efficacy that increased over time and a safety profile that showed favorable benefit vs. risk outcomes.
“What I’ve showed you here today is a drug that a company has put a particular emphasis in in vitro and in vivo pharmacodynamics to optimize the dosing of their TYK2 inhibitor,” Blauvelt said. “TYK2 inhibition over time continues to improve in efficacy in particular over the first 6 to 7 months.”