BMS Reports Results from the P-III (POETYK PSO) Long-Term Extension Study of Sotyktu for Treating Plaque Psoriasis
Shots:
- The P-III (POETYK PSO-1; n=666 & POETYK PSO-2; n=1,020) studies assessed Sotyktu's (6mg, QD) safety & efficacy vs PBO & Otezla (30mg, BID) to treat moderate-to-severe plaque psoriasis
- The efficacy evaluable patients (n=513), progressed from both trials to the POETYK PSO-LTE study, showed 71.7% PASI 75 (yr.1: 72.0%; yr.3: 73.8%) at yr.4, 47.5% PASI 90 (yr.1: 45.6%; yr.3: 49.0%) & 57.2% sPGA 0/1 (yr.1: 57.7%; yr.3: 55.2%)
- The safety evaluable patients (n=1,519) with cumulative exposure to Sotyktu of 4,392.8 PYs showed reduced or same EAIRs/100 PYs from yr.1 to 4 for AEs (229.2 to 131.7), SAEs (5.7 to 5.0), discontinuation due to AEs (4.4 to 2.2), herpes zoster (0.8 to 0.6), malignancies (1.0 to 0.9), major cardiovascular AEs (0.3), venous thromboembolism (0.2 to 0.1) & deaths (0.2 to 0.3)
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