In a clinical trial pitting brodalumab, a new biologic drug for psoriasis, against Stelara (ustekinumab), more patients on brodalumab had completely clear skin after three months, according to a statement released earlier this week from Amgen and AstraZeneca, the makers of brodalumab.
Patients involved in the Phase III study were randomly assigned to take Stelara, a placebo, or 210 milligram (mg) or 140 mg doses of brodalumab, according to the statement, which reported results from the first three months of the study.
More patients taking brodalumab achieved completely clear skin than patients taking Stelara, as measured by the Psoriasis Area and Severity Index (PASI), the statement reports. More than 36 percent of patients taking the 210 mg dose of brodalumab and 27 percent of patients taking the 140 mg dose achieved PASI 100, compared with 18.5 percent of patients on Stelara. Less than 1 percent of patients on the placebo also achieved PASI 100, according to the statement.
Approximately 85 percent of patients on the 210 mg dose of brodalumab achieved 75 percent improvement, or PASI 75. Similar numbers of patients taking the lower brodalumab dose and Stelara achieved PASI 75, with about 69 percent of patients in both of these groups experiencing this level of improvement, as reported in the statement.
Only 6 percent of patients on the placebo achieved PASI 75, according to the statement.
Serious side effects occurred in about 1.5 percent of patients in the brodalumab groups, 0.6 percent of patients taking Stelara and 1 percent of patients on the placebo, the statement reports. The most common side effects experienced by people taking brodalumab were the common cold, joint pain, upper respiratory tract infection and headache, according to the statement.
The study will continue for up to five years, with all patients taking brodalumab after the first year.
Brodalumab targets the receptor for interleukin-17 (IL-17), which is a cytokine, or protein, involved in inflammation. Two other drugs currently in development for psoriasis, secukinumab and ixekizumab, also target IL-17.
According to additional data on brodalumab recently released, the drug can be an effective treatment for nail and scalp psoriasis, too. A Phase III trial testing brodalumab for psoriatic arthritis is currently recruiting.
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