A new biologic medication for psoriasis scored positive results in a Phase III clinical trial.
Patients taking brodalumab experienced significant skin improvement after three months on the drug, according to a statement released by the drug's manufacturer. The placebo-controlled trial, which involved 661 participants, evaluated the safety and effectiveness of taking 210-milligram and 140-milligram doses to treat psoriasis.
At the end of 12 weeks, more than 83 percent of patients taking the 210-milligram (mg) dose experienced a 75 percent reduction in psoriasis severity, with almost 42 percent experiencing complete clearing.
Of the patients who took the 140-mg dose, approximately 60 percent experienced a 75 percent reduction in severity. Approximately 23 percent of patients in this group experienced complete skin clearing.
"When we look at these results, we see a very profound level of response," said Dr. Kim Papp, the coordinating investigator for the trial.
The trial will extend for five years to explore the long-term efficacy of the drug, Papp said. "That will tell us how well this effect will stand up over the years."
Amgen and AstraZeneca, the makers of brodalumab, reported that 1.8 percent of patients in the 210-mg group and 2.7 percent of patients in the 140-mg group experienced serious side effects. The statement did not specify what these serious side effects were, although it listed colds, headaches and upper respiratory tract infections as the most common side effects.
Unlike other drugs on the market, brodalumab targets interleukin-17 (IL-17), a protein, or cytokine, that triggers inflammatory response. Biologics that are currently available target other cytokines.
IL-17 is one of the key drivers of inflammation in psoriasis. Brodalumab, delivered by injection, binds to the IL-17 receptor, which blocks the receptor from receiving the signals that promote inflammation.
Phase III trials comparing brodalumab with Stelara (ustekinumab), a biologic drug targeting IL-12 and IL-23, for the treatment of psoriasis are ongoing. In addition, a Phase III trial testing brodalumab for psoriatic arthritis is currently recruiting.
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