According to data presented Monday at the American Academy of Dermatology meeting in San Francisco, Stelara (ustekinumab), a biologic used to treat adults with psoriasis, could be an effective treatment for teenagers, too.
Although more and more children and adolescents are developing psoriasis—with as many as a third of all psoriasis patients developing symptoms before the age of 20—there are not a lot of treatments available for this age group. On top of that, few rigorous trials have tested psoriasis treatments, especially biologic drugs and other systemic therapies, in children and adolescents, according to the researchers.
“There is a medical need for safe, systemic therapies for pediatric psoriasis,” said Dr. Lawrence Eichenfield, who presented the data. Eichenfield is a dermatologist at the University of California, San Diego and a co-author of the study.
The year-long, placebo-controlled Phase III trial tested Stelara in teenagers between the ages of 12 and 18, with 73 patients on Stelara and 37 patients on placebo. The Stelara patients received a range of doses according to their weight. The highest dose of 90 milligrams (mg) was given to patients weighing more than 100 kilograms (kg), or about 200 pounds.
Patients received injections of the drug three times during the first three months of the study, and then about every three months for the rest of the year, according to the data.
At the start of the study, about 60 percent of patients had moderate psoriasis and the rest had severe disease, as measured by the Physician’s Global Assessment (PGA), according to the data.
After three months on Stelara, about 70 percent of patients had clear or almost clear skin, as measured by the PGA. The PGA measures psoriasis severity on a scale of zero to five, with zero being completely clear and five being the most severe. Patients with clear or almost clear skin scored a zero or one. Within this group, as many as 47.2 percent had completely clear skin, according to the findings. Two patients on placebo also had clear or almost clear skin after three months.
About 60 percent of patients on Stelara still had clear or almost clear skin after a year, according to the data.
Among the patients on Stelara, 62 experienced some kind of side effect during the year, with six patients experiencing serious side effects, researchers reported.
Stelara is a biologic drug that targets two cytokines involved in psoriatic disease, interleukin-12 and interleukin-23. Cytokines are proteins produced by the body that can trigger the inflammation seen in psoriasis and psoriatic arthritis.
Researchers plan to publish more details of the study, including information on specific side effects, in an upcoming article in a medical journal, Eichenfield said.
Editor's note: In December 2016, Janssen, the makers of Stelara, announced that they submitted an application asking the U.S. Food and Drug Administration to approve Stelara for the treatment of moderate-to-severe plaque psoriasis in adolescents.
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