- Sticherling M, et al. Pooled safety analysis from two phase 3 studies of secukinumab in paediatric patients for up to week 52 with moderate to severe plaque psoriasis. P49, Psoriasis from Gene to Clinic 2021, 9–11 December.
Approximately 1% of all children and adolescents suffer from psoriasis. Although children are less likely to develop the disease than adults, their suffering is particularly severe as the condition negatively impacts their quality of life. In addition, it affects their long-term psychological well-being. Last year, the IL-17 blocker secukinumab was approved for children aged between 6 and <18 years with moderate-to-severe psoriasis following 2 phase 3 studies.
In these studies, children (aged 6 to <12 years) and adolescents (aged 12 to <18 years) received either 75 mg or 150 mg of secukinumab, depending on their body weight (<50 kg or ≥50 kg). The biologic improved skin symptoms and quality of life at all doses studied. The issue of safety is of particular interest when it comes to children and adolescents. To explore this further, pooled safety analyses of the 2 phase 3 studies (NCT02471144 and NCT03668613) evaluated all patients who received at least 1 dose of secukinumab.
Dr Michael Sticherling (University Erlangen–Nürnberg, Germany) presented 2 analyses: one on the safety data up to week 12, the second included data up to week 52. The safety profile of secukinumab was comparable in both studies and was consistent with that seen in adults with plaque psoriasis. In the 12-week analysis, infections (particularly nasopharyngitis) were most common. Infections occurred in 31.7% of children treated with the low dose of secukinumab and 35.4% with the high dose of secukinumab compared with 39% with placebo.
In addition, gastrointestinal disturbances occurred in 8.5% of patients treated with the low secukinumab dose and 14.6% treated with the high secukinumab dose. By week 52, 74.2% of children in both secukinumab groups reported adverse events (compared with 82.9% of children treated with etanercept). The incidence of serious adverse events was 6.6% in secukinumab-treated children compared with 12.12% of those treated with etanercept. Infections were also most common at one year (in 58.1% of all patients treated with secukinumab compared with 65.9% on etanercept therapy).
More paediatric patients in the etanercept group (34.1%) had gastrointestinal problems compared with children treated with secukinumab (18.4% in the low-dose group compared with 25% in the high-dose group), and 2% of children treated with secukinumab had candida infections. In general, the safety profile of secukinumab-treated paediatric patients was comparable to that of the placebo group. There was also no significant difference between the 2 doses. In addition, no new and unexpected safety signals were identified in children and adolescents. The frequency of adverse events was comparable to those seen in an adult population. The proportion of patients with infections was also similar between the 2 paediatric age subgroups.