Envudeucitinib Improves Itch by Week 2 in Phase 3 Plaque Psoriasis Trials
Key Takeaways
- In two randomized phase 3 trials, investigational oral TYK2 inhibitor envudeucitinib was associated with clinically meaningful itch improvement as early as week 2 in patients with moderate-to-severe plaque psoriasis.
- At week 16, complete itch resolution was reported by 35.0% of envudeucitinib recipients in ONWARD1 and 36.3% in ONWARD2, compared with 6.7% and 7.7% receiving placebo, respectively.
- Itch responses continued to improve through week 24 among patients remaining on envudeucitinib, but the poster focuses on patient-reported itch rather than providing a full assessment of drug safety.
Investigational oral tyrosine kinase 2 (TYK2) inhibitor envudeucitinib produced clinically meaningful itch improvement as early as week 2 in patients with moderate-to-severe plaque psoriasis, according to 24-week results from the phase 3 ONWARD1 and ONWARD2 trials.
Jason E. Hawkes, MD, and colleagues evaluated worst pruritus using a patient-reported 0-to-10 numeric rating scale (NRS). The replicate, randomized, double-blind trials compared envudeucitinib 40 mg twice daily with placebo and apremilast 30 mg twice daily. ONWARD1 enrolled 912 participants, and ONWARD2 enrolled 859.
The itch analysis assessed a reduction of at least 4 NRS points among patients with baseline scores of 4 or higher, as well as complete or near-complete itch resolution among those with baseline scores of at least 1.
Complete Itch Resolution and Week 24 Responses
Approximately one-third of envudeucitinib-treated patients reported at least a 4-point itch improvement by week 2. By week 16, 68.6% in ONWARD1 and 62.3% in ONWARD2 achieved that threshold, compared with 18.9% and 12.3% receiving placebo, respectively.
Complete itch resolution (NRS 0 with at least a 1-point improvement) occurred at week 16 in 35.0% and 36.3% of envudeucitinib recipients in ONWARD1 and ONWARD2, compared with 6.7% and 7.7% receiving placebo. More than half of treated patients reported no or minimal itch at week 16.
Responses continued to improve through week 24, including among patients with moderate-to-severe scalp psoriasis.
The investigators concluded that “Envudeucitinib provided rapid, substantial, and sustained itch relief in patients with moderate-to-severe plaque psoriasis.”