Low and high doses of secukinumab were associated sustained skin clearance for up to 1 year in children and adolescents with severe chronic plaque psoriasis, according to study findings published in the Journal of the European Academy of Dermatology Venereology.
This study included 162 patients between the ages of 6 and 18 years (mean age, 13.5 years) with chronic plaque psoriasis. Patients were randomly assigned to low-dose 75/75/150 mg secukinumab (n=40), high-dose 75/150/300 mg secukinumab (n=40), 0.8 mg/kg etanercept (n=41), or placebo (n=41). Treatment allocation was based on participants’ weight and age.
The primary objective was to show a superiority of low- and high-dose secukinumab compared with placebo at week 12, as determined by the percentage of patients who achieved PASI 75 and IGA mod 2011 of 0 or 1 response. A secondary objective was to demonstrate the superiority of secukinumab compared with placebo at week 12, determined by the percentage of patients who achieved PASI 90. In addition, the investigators evaluated the efficacy of secukinumab vs placebo with respect to PASI 75/90/100 and IGA mod 2011 of 0/1 up to week 52.
Both the low and high doses of secukinumab demonstrated superior efficacy compared with placebo in terms of PASI 75 response (80.0% and 77.5% vs 14.6%, respectively) and IGA mod 2011 of 0 or 1 response (70% and 60% vs 4.9%) at week (P <.0001).
The low and high doses of secukinumab were also superior to placebo in terms of PASI 90 response at week 12 (72.5% and 67.5% vs 2.4%) at week 12 (P <.0001). Efficacy of both secukinumab doses was sustained to week 52, with secukinumab-treated patients achieving higher responses compared with patients treated with etanercept (PASI 75/90/100: 87.5%/75.0%/40.0% [low-dose group] and 87.5%/80.0%/47.5% [high-dose group] vs 68.3%/51.2%/22.0% [etanercept]; IGA 0 or 1: 72.5% [low-dose group] and 75.0% [high-dose group] vs 56.1% [etanercept]).
According to the investigators, secukinumab’s safety profile in this study was consistent with that observed in adult phase 3 studies. No new safety signals were identified.
Although the study included 52-week follow-up data, the researchers noted that longer-term follow up is needed to determine longer-term efficacy and safety outcomes with secukinumab in the pediatric population.
The study investigators added that their findings are important for clinical care, writing that “freeing children of the burden of psoriasis is especially important in this vulnerable patient population to ensure an optimal chance for physical and psychosocial development during childhood.”
Disclosure: This clinical trial was supported by Novartis Pharma. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomised, controlled trial. Published online October 17, 2020. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.17002