Stelara ustekinumab: Phase III data
Top-line data from the double-blind Phase III PSUMMIT II trial in 312 adults 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 (43.7% and 43.8%, respectively, vs. 20.2%, p<0.001 for both). In a subset of patients previously treated with tumor necrosis factor (TNF) inhibitors, Stelara led to ACR20 response rates at week 24 of 36.7% in the low-dose arm and 34.5% in the high-dose dose arm vs. 14.5% for placebo (p=0.006 and p=0.011, respectively).
Additionally, Stelara met the secondary endpoint of improving ACR50 response rate at week 24 in both the low-dose arm (17.5%, p=0.018) and high-dose arm (22.9%, p=0.001) vs. 6.7% for placebo. Both doses of Stelara non-significantly improved ACR70 response rates at week 24 vs. placebo. Furthermore, Stelara produced a PASI 75 response in 51.3% of patients in the low-dose group and 55.6% in the high-dose group vs. 5% for placebo (p<0.001 for both). Low- and high-dose Stelara also met the secondary endpoint of improving HAQ-DI scores vs. placebo (p=0.001 and p<0.001, respectively). There were no cases of tuberculosis, opportunistic infections or major adverse cardiovascular events or deaths reported. There was 1 case of squamous cell carcinoma (SCC) in situ in the 90 mg Stelara arm. Data were presented at the American College of Rheumatology meeting in Washington. ...