The findings are exciting in part because patients in this age group have limited treatment options, the study’s lead author Dr. Ian Landells, of Memorial University of Newfoundland, Canada, told Reuters Health by email.
In the CADMUS trial, the researchers randomized 110 patients 12 to 17 years old to a standard dose or a half dose of ustekinumab, or a placebo, for 12 weeks. A standard dose is .75 mg/kg for patients that weigh 60 kg or less, 45 mg for those weighing more than 60 up to 100 kg, and 90 mg for those weighing more than 100 kg, taken at baseline, four weeks later and then every 12 weeks.
The placebo group crossed over to ustekinumab after 12 weeks.
After 12 weeks, 69.4% of the standard-dose group were cleared according to the Physician’s Global Assessment, as were 67.6% of the half-dose group. Only 5.4% of the placebo group was cleared, however, according to an article online Aug. 7 in the Journal of the American Academy of Dermatology.
Similarly, 80.6% of the standard-dose group achieved at least 75% improvement in Psoriasis Area and Severity Index, as did 78.4% of the half-dose group, compared to only 10.8% of the placebo group.
By week 12, 56.8% of the placebo patients reported at least one adverse event, which was more than either of the treatment groups. Sixty weeks after starting the trial, 81.8% of the patients reported side effects.
“Both dosages resulted in robust and sustainable efficacy. However, efficacy was generally higher with the standard dosage across all endpoints, responses were also better sustained over each 12-week dosing interval with the standard dosage, and both dosages had acceptable safety profiles with no new adverse events identified in this adolescent population,” Dr. Landells said.
One of the trial’s limitations is its small size. Even so, Dr. Landells said he hopes the drug gains approval for adolescents in Canada based on the findings.
Janssen Research and Development funded this research and employed four coauthors. Janssen Biotech is manufacturer of Stelara, ustekinumab’s brand name. Six coauthors reported relationships with pharmaceutical companies, some including Janssen.