Phase 2 Results of Brodalumab for Psoriatic Arthritis
(HealthDay News) — The monoclonal antibody brodalumab significantly improves response rates among patients with psoriatic arthritis, according to a phase 2 study published in the June 12 issue of the New England Journal of Medicine.
Philip J. Mease, MD, from the University of Washington in Seattle, and colleagues randomly assigned patients with active psoriatic arthritis to receive brodalumab (140mg [57 patients] or 280mg [56 patients] subcutaneously) or placebo (55 patients) on day one and at weeks one, two, four, six, eight, and 10. Open-label brodalumab (280mg) every two weeks was offered at week 12 to patients who were still participating in the study.
The researchers based their analysis on the 159 patients completing the double-blind phase and 134 patients completing 40 weeks of the open-label extension. At week 12, both brodalumab groups had higher rates of improvement (20%) in American College of Rheumatology response criteria (ACR 20) compared to the placebo group (P=0.03 and 0.02 for 140mg and 280mg, respectively). At week 24, ACR 20 response rates in the brodalumab 140mg and 280mg groups were 51 and 64%, respectively, vs. 44% among patients who switched from placebo to open-label brodalumab, with responses sustained through week 52. Serious adverse events at 12 weeks occurred in 3% of the brodalumab patients and in 2% of those in the placebo group.
"Larger studies of longer duration are necessary to assess adverse events," the authors write.
Several authors disclosed financial ties to Amgen, which funded the study and manufactures brodalumab.