Long-term secukinumab proven safe, effective in kids with chronic plaque psoriasis

Long-term treatment with secukinumab, either at low or high dose, results in sustained efficacy and better health-related quality of life up to 4 years in children and adolescents with moderate-to-severe chronic plaque psoriasis, as shown in a phase III study presented at EADV 2024.

With regard to safety, no new signals have been observed, and both doses of secukinumab are well tolerated by patients.

“Growth and development data did not show any notable adverse effects with secukinumab treatment in the paediatric population,” said lead author Dr Kulli Kingo from Tartu University Hospital and University of Tartu in Tartu, Estonia.

Kingo and colleagues conducted this randomized phase III, open-label trial in 84 paediatric patients (aged 6 to <18 years), who were randomly assigned to receive either low-dose (75/75/150 mg; n=42) or high-dose (75/150/300 mg; n=42) secukinumab based on their weight (<25 kg, 25 to <50 kg, or ≥50 kg) and disease severity (moderate or severe).

The trial had three phases, namely screening (up to 4 weeks), treatment (208 weeks), and post-treatment follow-up (16 weeks).

Kingo and her team then assessed the long-term efficacy of secukinumab via Psoriasis Area and Severity Index (PASI) 75/90/100 response, Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0/1 response, and PASI score. They also evaluated the Children’s Dermatology Life Quality (CDLQI) 0/1 response, impact of treatment on physical development, and safety over 4 years.

Of the patients, 67 (79.8 percent) completed the treatment. Both treatment groups maintained high PASI 75/90/100 and IGA 0/1 responses from week 12 until end of treatment. [EADV 2024, abstract 5915]

At week 208, patients on secukinumab demonstrated sustained PASI 75/90/100 (low dose: 96.3 percent/88.9 percent/51.9 percent; high dose: 87.9 percent/81.8 percent/51.9 percent) and IGA mod 2011 0/1 responses (low dose: 85.2 percent; high dose: 84.8 percent).

From week 12 to week 208, both treatment groups had low mean PASI score. At week 208, the mean percentage change in PASI scores from baseline was ‒95.7 percent (mean absolute score 0.76) with low-dose secukinumab and ‒94.5 percent (mean absolute score 1.07) with high-dose secukinumab.

Additionally, both the low- and high-dose groups showed high CDLQI 0/1 response from week 12 up to week 208 (low dose: 75.0 percent; high dose: 88.2 percent).

Safety

No new safety signals were identified by Kingo and her team in this paediatric population with long-term exposure to secukinumab (approx. 313.9 patient-years). Both dose groups also had similar incidence of treatment-emergent adverse events (low dose: 78.6 percent; high dose: 83.3 percent).

The most common safety concerns were infections and infestations, gastrointestinal disorders, and skin and subcutaneous tissue disorders. Moreover, the most frequent adverse events were acne, COVID-19, and nasopharyngitis.

“Secukinumab did not have any adverse effect on the growth and development of patients or on their sexual maturation, as evaluated by Tanner score,” Kingo said.

In addition, antidrug antibody (ADA) development with secukinumab therapy for 208 weeks was low, with seven patients (8.3 percent) having positive treatment-emergent ADAs and six showing positive ADAs only during follow-up.

“Secukinumab is a fully human monoclonal antibody that selectively neutralizes interleukin-17A, a key cytokine involved in the pathogenesis of plaque psoriasis,” Kingo said. [N Engl J Med 2014;371:326-338]

“Efficacy and safety of secukinumab up to week 52 have been reported previously for the present pivotal phase III study in children and adolescents with moderate-to-severe chronic plaque psoriasis,” she added. [Paediatr Drugs 2022;24:377-387]