Stelara ustekinumab: Phase III data

The double-blind Phase III PSUMMIT I trial in 615 patients with active psoriatic arthritis showed that 45 and 90 mg subcutaneous Stelara each met the primary endpoint of improving ACR20 response rates at week 24 vs. placebo (42.4% and 49.5%, respectively, vs. 22.8%, p<0.0001 for both). Low- and high-dose Stelara also met the secondary endpoints of improving ACR50 (24.9% and 27.9%, respectively, vs. 8.7%, p<0.0001 for both) and ACR70 (12.2% and 14.2%, respectively, vs. 2.4%, p<0.0001 for both) response rates at week 24 vs. placebo (p<0.0001 for all). Additionally, a significantly greater proportion of patients receiving low- and high-dose Stelara achieved a >=0.3 point change from baseline in HAQ-DI score at week 24. Low- and high-dose Stelara also significantly improved DAS28-CRP responses at week 24 vs. placebo (65.9% and 67.6, respectively, vs. 34.5%, p<0.001 for both).

In patients affected with enthesitis (n=425), median enthesitis scores improved by 42.9% with low-dose Stelara and by 50% with high-dose Stelara compared to 0% for placebo (p<0.001 for both). In patients affected with dactylitis (n=286), median dactylitis scores improved by 75% with low-dose Stelara and by 70.8% with high-dose Stelara compared to 0% for placebo (p<0.001 for both). In 440 patients with >=3% body surface area involvement at baseline, 57.2% of patients receiving low-dose Stelara and 62.4% of patients receiving high-dose Stelara achieved a PASI 75 response compared to 11% for placebo (p<0.001 for placebo). ...