Adverse events increase with age, body weight in pediatric patients with plaque psoriasis
Click Here to Manage Email Alerts
Key takeaways:
- Secukinumab was well tolerated across age and body weight subgroups of pediatric patients with chronic plaque psoriasis.
- There was a lower incidence rate of adverse events in lower age and body weight subgroups.
As age and body weight increased among secukinumab-treated pediatric patients with chronic plaque psoriasis, so did the incidence rate of adverse events, according to pooled safety data from two phase 3 studies.
“In two studies, secukinumab was found to be efficacious and well tolerated in pediatric patients with moderate to severe and severe chronic plaque psoriasis,” Michael Sticherling, MD, of the department of dermatology at Friedrich-Alexander-University of Erlangen-Nürnberg in Germany, and colleagues wrote. “However, an assessment of safety data from the larger pool of pediatric patients with plaque psoriasis across the two studies and across different age and body weight subgroups has not yet been reported.”
As age and body weight increased among secukinumab-treated pediatric patients with chronic plaque psoriasis, so did the incidence rate of adverse events. Image: Adobe Stock.
In this analysis, the researchers pooled safety data from the two phase 3 trials to assess the safety profile of secukinumab in pediatric patients in this indication according to age and weight.
In the phase 3 studies, 198 pediatric patients were randomly assigned to receive a low dose of secukinumab, a high dose of secukinumab, placebo or etanercept (0.8 mg/kg) for 52 weeks.
Patients were separated into age groups (6-11 years and 12-17 years) and body weight (< 25 kg, 25-50 kg and 50 kg). From lightest to heaviest, those in the low dose group received 75 mg, 75 mg or 150 mg, respectively. Those in the high dose group received 75 mg, 150 mg or 300 mg, respectively.
The findings from the pediatric patients were compared with 1,989 adult patients that were also treated with secukinumab for 52 weeks.
Results showed that the incidence of adverse events was much lower in the lower age, lower body weight and secukinumab-treated groups compared with the higher age, higher body weight and etanercept-treated groups.
Exposure-adjusted incidence rates for treatment-emergent adverse events were 198.8 per 100 patient-years (PY) in the secukinumab-treated pediatric groups, 266.3 per 100 PY in the etanercept group and 256.1 per 100 PY in the adult groups.
Pediatric patients aged 6 to 11 years saw lower incidence rates (167.7 per 100 PY) compared with patients aged 12 to 17 years (214.7 per 100 PY).
Incidence rates of adverse events increased as weight increased, with the rate of incidence being 177.3 per 100 PY in the less than 25 kg group, 192.5 per 100 PY in the 25 kg to less than 50 kg group and 206.8 per 100 PY in the greater than or equal to 50 kg group.
Nevertheless, the authors concluded that secukinumab was well tolerated across all age and body weight groups regardless of incidence rate fluctuation.
“The results from this analysis further demonstrate the favorable safety profile of secukinumab in pediatric patients with moderate to severe and severe chronic plaque psoriasis,” the authors wrote.