Brodalumab: Phase II data

A double-blind, U.S. and Canadian Phase II trial in 159 evaluable adults with psoriatic arthritis showed that 140 and 280 mg subcutaneous brodalumab given once every 2 weeks each met the primary endpoint of improving ACR20 response rate at week 12 vs. placebo (37% and 39%, respectively, vs. 18%, p<0.05 for both). In biologic-naïve patients, ACR20 response rates were 36% for low-dose brodalumab, 37% for high-dose brodalumab and 20% for placebo. In patients with prior biologic exposure, ACR20 response rates were 37% for low-dose brodalumab, 42% for high-dose brodalumab and 16% for placebo. At week 12, both doses of brodalumab led to an ACR50 response rate of 14% vs. 4% for placebo (p=0.051 for low-dose arm vs. placebo and p=0.047 for high-dose arm vs. placebo).

The most common adverse events reported were upper respiratory tract infection, headache, nasopharyngitis, psoriatic arthropathy, injection site erythema, injection-site pain, fatigue, diarrhea, nausea, dizziness and arthralgia. There were 4 serious adverse events reported, including cellulitis in the placebo arm, abdominal pain in the low-dose brodalumab arm and cellulitis and cholecystitis in the high-dose brodalumab arm. No >=grade 2 neutropenia, deaths or mycobacterial or fungal/opportunistic infections were reported. Data were presented at the European League Against Rheumatism meeting in Madrid. ...