Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis
Authors
Discussion
Loading...
Member takes
Implication
Randomized double-blind trial demonstrates significant skin clearance with oral TYK2 inhibition in adults with moderate-to-severe psoriasis, indicating therapeutic potential of targeted pathways.
Key Points
- To evaluate the efficacy and safety of the oral selective TYK2 inhibitor BMS-986165 across multiple dosing regimens in adults with moderate-to-severe psoriasis.
- Conducted a phase 2, double-blind trial (NCT02931838) involving 267 adults with moderate-to-severe psoriasis who received at least one dose of study intervention.
- Randomly assigned patients to receive oral BMS-986165 at 3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, 12 mg daily, or placebo.
- Evaluated the primary endpoint of achieving a 75% or greater reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) score at week 12.
- Week 12 PASI 75 rates were 7% (3/45) with placebo vs. 9% (4/44, P=0.49) with 3 mg every other day, 39% (17/44, P<0.001) with 3 mg daily, 69% (31/45, P<0.001) with 3 mg twice daily, 67% (30/45, P<0.001) with 6 mg twice daily, and 75% (33/44, P<0.001) with 12 mg daily.
- Safety analyses identified three serious adverse events in the active-drug treatment groups and one case of malignant melanoma detected 96 days after initiating therapy.
Cite This Study
Papp et al. (2018) studied this question.