Secukinumab Safely Treats Severe Chronic Plaque Psoriasis in Children Regardless of Age or Weight

Secukinumab use for up to 1 year has proven safe at both high and low doses across body weight and age subgroups in pediatric patients with severe or moderate to severe chronic plaque psoriasis, according to authors of a study published in the American Journal of Clinical Dermatology.

Researchers sought to analyze the pooled safety of secukinumab using data from 2 phase 3 trials in which pediatric patients were stratified by age and body weight. They subsequently compared these data with pooled safety data from adult trials of secukinumab with high- and low-dose treatment arms. The included phase 3 trials (ClinicalTrials.gov Identifier: NCT03668613 [open-label]; NCT02471144 [double-blind]) confirmed the efficacy and safety of secukinumab in pediatric patients with severe or moderate to severe chronic plaque psoriasis.

Pooled assessment of safety included 198 pediatric patients (overall exposure, 184.6 patient-years [PY]) with severe or moderate to severe chronic plaque psoriasis treated with secukinumab, stratified by age and dose. Patients between 6 and 12 years of age were divided into low-dose (n=25) and high-dose (n=25) groups. Patients between 12 and 18 years of age were also divided into low-dose (n=57) and high-dose (n=57) groups. The dosages were determined as follows: Patients weighing between 25 kg and 50 kg received low-dose (n=30; 75 mg) or high-dose (n=27; 150 mg) therapy; those weighing 50 kg or more received low-dose (n=46; 150 mg) or high-dose (n=48 300 mg) therapy; and all patients weighing less than 25kg (n=13) received low-dose therapy (75 mg), regardless of grouping.

There were 41 pediatric patients with severe chronic plaque psoriasis who received etanercept (ETN) (0.8 mg/kg) and 41 patients who received placebo. Investigators compared this analysis with pooled data from 4 adult secukinumab studies (ClinicalTrials.gov Identifiers: NCT01365455, NCT01636687, NCT01358578, and NCT01555125) that included treatment arms of 150-mg and 300-mg doses.

The pediatric studies were comparable in the secukinumab treatment groups in terms of demographics and baseline characteristics. The average age of pediatric patients treated with secukinumab was 13 years, 60% were girls, participants were predominantly White, and the average body weight was 54 kg. In the pooled adult studies, the average participant age was 45 years, 30% were women, participants were predominantly White, and the average body weight was 87 kg.

At week 52, the incidence of adverse events (AEs) was lower among younger patients and those with lower body weight. The secukinumab-treated pediatric pool had lower exposure-adjusted incident rates (EAIRs) for treatment emergent AEs, compared with the etanercept pool and the adult pool (198.8 per 100 PY vs 266.3 per 100 PY vs 256.1 per 100 PY, respectively).

The authors noted that the most commonly affected system organ classes (based on incidence of infections and infestations) were similar in pediatric and adult populations treated with secukinumab. Upper respiratory tract infections were a common AE.

In subgroup analysis, the AE incident rate in patients aged 6 to 12 years treated with secukinumab was 167.7 per 100 PY and for patients aged 12 to  18 years was 214.7 per 100 PY. By weight, the AE incident rate in patients weighing less than 25 kg was 177.3 per 100 PY, in patients 25 kg to 50 kg was 192.5 per 100 PY, and in patients weighing 50 kg or more was 206.8 per 100 PY.

The neutropenia AEs were mostly mild and none led to treatment discontinuation. Among 198 secukinumab-treated pediatric patients, 2 reported vulvovaginal Candida, 1 reported skin Candida, and 1 reported nail Candida. In this patient population, the most frequently reported AE was nasopharyngitis across age (<12 years, 11.8 per 100 PY; 12 to <18 years, 42.4 per 100 PY), and across body weight (<25 kg, 22.8 per 100 PY; 25 kg to <50 kg, 19.0 per 100 PY; ≥ 50kg, 43.0 per 100 PY). In all groups, the second most frequent AE was headache. The incident rate of suicidal ideation was 0.5 per 100 PY in the secukinumab group and 0. per 100 PY in the etanercept group.

There was no treatment-emergent incidence of anti-drug antibodies among pediatric patients treated with secukinumab, nor were there any clinically meaningful between-subgroup (age or body weight) differences in reported AEs. The latter was consistent with the overall population. The authors noted that there were no new or unexpected safety indications and that secukinumab was well tolerated in patients as young as 6 years of age.

Study limitations include underpowered sample sizes in some subgroups in both pediatric studies, particularly the under 25 kg subgroup.

“Secukinumab was well tolerated in pediatric patients with moderate to severe and severe plaque psoriasis across age and body weight subgroups,” the authors concluded.  In addition, they noted, “The overall safety profile of secukinumab in pediatric patients was consistent with that of adult patients.”

Disclosure: This research was supported by Novartis Pharma AG, Basel, Switzerland. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

This article originally appeared on Dermatology Advisor