Phase III PSUMMIT 1 study of Stelara (J&J Janssen Cilag) for patients with Active Psoriatic Arthritis reaches primary endpoint

Data from the 615-patient Phase III PSUMMIT 1 trial showed patients with Active Psoriatic Arthritis receiving Stelara (ustekinumab), from J&J Janssen Cilag, achieved the primary endpoint of the study, a significant reduction in Arthritis signs and symptoms at week 24. At the primary endpoint, 42 percent and 50 percent of patients receiving Stelara (45 mg and 90 mg, respectively) achieved at least an ACR (American College of Rheumatology criteria) 20 response, compared with 23 percent of patients receiving placebo. Significantly higher proportion of patients in the Stelara 45 mg and 90 mg groups also achieved a 50 percent improvement in signs and symptoms (ACR 50) and a 70 percent improvement in signs and symptoms (ACR 70) versus patients receiving placebo. Investigators reported Stelara-treated patients also achieved significant improvements in physical function, including dactylitis (inflammation of the finger or toe) and enthesitis (inflammation of the entheses, the sites where tendons or ligaments attach to bone), as well as in plaque psoriasis. Stelara is currently being investigated in a Phase III programme for the treatment of active Psoriatic Arthritis and is approved for the treatment of moderate to severe plaque psoriasis in 65 countries. Results were presented at the European League Against Rheumatism Annual Congress.