Drug nearly clears psoriasis in more than half of patients
Editor's note: As of May 2015, Amgen has stopped developing brodalumab, due to reports of suicidal thoughts and behavior in patients taking the drug in clinical trials.
Psoriasis symptoms nearly disappeared in more than half of the patients trying a new treatment for the disease.
Two Phase III clinical trials for secukinumab, a biologic medication, suggest that the drug can significantly improve the skin of a majority of patients. Results from the trials, published last week in the New England Journal of Medicine, also show that most patients maintained these improvements throughout the year-long trials.
Together, the trials involved more than 2,000 people with moderate to severe psoriasis. Both trials, called ERASURE and FIXTURE, randomly assigned patients to take 300-milligram (mg) or 150-mg doses of the drug, or a placebo. FIXTURE also included a group of patients assigned to take Enbrel (etanercept), another biologic medication, to compare the two drugs.
Patients taking secukinumab got injections once a week for the first five weeks of the study, and every four weeks after that. Enbrel patients received 50-mg injections twice weekly for 12 weeks, and then once a week for the rest of the study.
Almost 82 percent of patients in the ERASURE study who took the 300-mg dose experienced a 75-percent improvement in their skin, as measured by the Psoriasis Area and Severity Index (also known as PASI 75), while almost 72 percent in the 150-mg group experienced PASI 75.
More than half of the patients in both groups experienced clear or almost clear skin, with nearly two-thirds of the 300-mg group showing this level of improvement.
Additional observations show that almost 29 percent of patients on the 300-mg dose, and almost 13 percent on the 150-mg dose, achieved PASI 100, which is complete skin clearance.
A large percentage of patients on both secukinumab doses saw continued improvement over the year, with 80.5 percent in the 300-mg group, and 72.4 percent in the 150-mg group, maintaining PASI 75 throughout the entire study.
Results were similar for patients taking secukinumab in the FIXTURE study, with 24.1 percent of patients taking 300-mg doses, and 14.4 percent of patients taking 150-mg doses, achieving PASI 100.
Among patients taking Enbrel, 44 percent achieved PASI 75. In addition, 27.2 percent experienced clear or almost clear skin, and 4.3 percent achieved PASI 100. Almost 73 percent of the patients who experienced PASI 75 maintained these results throughout the year.
More than half of the patients taking secukinumab experienced at least one side effect, with headache, upper respiratory tract infection, the common cold and diarrhea being among the most common, according to the study results. Infections occurred in 29.4 percent of the 300-mg group, and 26.9 percent of the 150-mg group.
The researchers note that incidences of side effects in patients taking secukinumab were similar to those taking Enbrel.
Secukinumab is a biologic medication being developed by Novartis Pharmaceuticals. Unlike other biologics on the market, it targets interleukin-17A (IL-17A), which is a protein, or cytokine, that triggers inflammation. IL-17 is a key cytokine in psoriasis, and, according to the researchers, may even be a “master cytokine,” responsible for a series of inflammatory reactions.
Trial results for another IL-17-based drug, brodalumab, were recently published. Brodalumab works by binding to the IL-17 receptor, which prevents the receptor from receiving the signals that set an inflammatory response into motion.