"These data provide important new insights into the efficacy of STELARA in the treatment of psoriatic arthritis across multiple disease measures," said Alice B. Gottlieb, M.D., Ph.D., Dermatologist-in-Chief and Chair of Dermatology, Tufts Medical Center, Harvey B. Ansell Professor of Dermatology, Tufts University School of Medicine, and study investigator. "For physicians who treat patients living with active psoriatic arthritis, the potential of STELARA, an IL-12/23 monoclonal antibody, for the treatment of this chronic, inflammatory disease is a promising development."
PSUMMIT I also assessed the efficacy of STELARA in the treatment of moderate to severe plaque psoriasis. Of 440 patients with at least three percent body surface involvement at the start of the study, 57 percent of patients receiving STELARA 45 mg and 62 percent of patients receiving STELARA 90 mg achieved at least a 75 percent improvement in psoriasis as measured by the Psoriasis Area Severity Index (PASI 75) score at week 24, compared with 11.0 percent of patients receiving placebo (P < 0.001).
Patients in the STELARA groups also reported statistically significant improvements in EULAR/Disease Activity Score (DAS) 28 C-reactive protein (CRP) responses. At week 24, 66 percent and 68 percent of patients receiving STELARA 45 mg and 90 mg, respectively, reported EULAR/DAS-CRP response compared with 34 percent of placebo patients (P < 0.001). The DAS 28 is a measure of disease activity in patients with arthritis that is calculated by assessing the number of tender and swollen joints (out of a total of 28), inflammation and the patient's assessment of global health. CRP is a type of protein produced in the liver and expressed during episodes of acute inflammation associated with arthritic conditions.
Treatment with STELARA was generally well-tolerated with similar proportions of patients experiencing at least one adverse event (AE) through week 16, the placebo-controlled period, among those receiving STELARA (42 percent) and placebo (42 percent). Serious AEs were reported in two percent of STELARA-treated patients and two percent of patients receiving placebo. No malignancies, cases of tuberculosis, serious infections, opportunistic infections, major adverse cardiovascular events (MACE) or deaths occurred through the placebo-controlled portion, week 16 of the study; one stroke occurred in the STELARA 45 mg group after the placebo-controlled period.
SOURCE Janssen Research & Development, LLC