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Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical
Michael Sticherling1, Arjen F Nikkels2, Ashraf M Hamza3
1Hautklinik, Friedrich-Alexander-University of Erlangen-Nürnberg (FAU) Department of Dermatology, University Hospital Erlangen, Ulmenweg 18, 91054, Erlangen, Germany. michael.sticherling@uk-erlangen.de.
Insights
Secukinumab demonstrated a favorable safety profile in pediatric patients with plaque psoriasis, with adverse events comparable to adult data. This IL-17A inhibitor is well-tolerated across various age and weight subgroups.
Area of Science:
- Immunodermatology
- Pediatric Dermatology
- Pharmacovigilance
Background:
- Plaque psoriasis affects approximately 1% of children, significantly impacting their quality of life.
- Previous trials established the efficacy and safety of secukinumab in pediatric patients with moderate-to-severe chronic plaque psoriasis.
Purpose of the Study:
- To report pooled safety data of secukinumab up to 52 weeks in pediatric subgroups stratified by age and body weight.
- To compare the safety profile of secukinumab in pediatric patients with pooled safety data from adult trials.
Main Methods:
- Pooled safety data from two pediatric trials (NCT03668613, NCT02471144) and four adult trials were analyzed.
- Pediatric patients were stratified by age (6 to <12 and 12 to <18 years) and body weight (<25 kg, 25 to <50 kg, ≥50 kg).
- Patients received secukinumab (low or high dose), placebo, or etanercept.
Main Results:
- 198 pediatric patients and 1989 adult patients were included in the 52-week safety analysis.
- Exposure-adjusted incidence rates for treatment-emergent adverse events were lower in secukinumab-treated pediatric patients (198.8/100 PY) compared to etanercept (266.3/100 PY) and adult pools (256.1/100 PY).
- Nasopharyngitis was the most frequent adverse event; transient neutropenia was observed, and no anti-drug antibodies emerged.
Conclusions:
- Secukinumab is well-tolerated in pediatric patients with moderate-to-severe plaque psoriasis across age and bodyweight subgroups.
- The safety profile of secukinumab in pediatric patients is consistent with that observed in adult patients.
Background:
Plaque psoriasis affects ~ 1% of the pediatric population, negatively impacting quality of life. The efficacy and safety of secukinumab in pediatric patients with moderate to severe or severe chronic plaque psoriasis have been established in two pivotal phase 3 trials (open-label, NCT03668613; double-blind, NCT02471144).
Objectives:
The aims were to report the pooled safety of secukinumab up to 52 weeks from two studies in subgroups of pediatric patients stratified by age and bodyweight, and to present, alongside the pediatric data, the pooled safety data from four pivotal adult secukinumab trials.
Methods:
The safety of secukinumab was evaluated in subgroups of pediatric patients defined by age (6 to < 12 and 12 to < 18 years) and bodyweight (< 25 kg, 25 to < 50 kg, and ≥ 50 kg) in the pooled population. Patients received secukinumab low dose (LD; 75/75/150 mg), secukinumab high dose (HD; 75/150/300 mg), placebo, or etanercept (0.8 mg/kg). For safety analyses, data were pooled from the pediatric studies NCT03668613 and NCT02471144, and presented alongside the pooled data from four adult pivotal studies (NCT01365455, NCT01636687, NCT01358578, NCT01555125).
Results:
A total of 198 pediatric patients (overall exposure: 184.6 patient-years [PY]) and 1989 adult patients (1749.5 PY) receiving secukinumab up to week 52 were included in this analysis. At week 52, the incidence of adverse events (AEs) was lower in the lower age and bodyweight subgroups. The AEs reported within these subgroups were consistent with the overall AEs reported in this analysis. Overall, exposure-adjusted incidence rates for treatment-emergent AEs were lower in the secukinumab-treated pediatric pool (198.8/100 PY) compared with the etanercept (266.3/100 PY) and adult pools (256.1/100 PY). Up to 52 weeks, the incidence rates of the AEs in the secukinumab-treated patients in the 6 to < 12 years subgroup and 12 to < 18 years subgroup were 167.7/100 PY and 214.7/100 PY, respectively. Similarly, incidence rates of the AEs in the secukinumab-treated patients in the < 25 kg, 25 kg to < 50 kg, and ≥ 50 kg subgroups were 177.3/100 PY, 192.5/100 PY, and 206.8/100 PY, respectively. Nasopharyngitis was the most frequently reported AE in secukinumab-treated pediatric patients across age (< 12 years: 11.8/100 PY; ≥ 12 years: 42.4/100 PY) and bodyweight (< 25 kg: 22.8/100 PY; 25 kg to < 50 kg: 19.0/100 PY; ≥ 50 kg: 43.0/100 PY). Of the 198 secukinumab-treated pediatric patients, one reported nail Candida, one reported skin Candida, and two reported vulvovaginal Candida. Transient and mostly mild events of neutropenia were observed with secukinumab, none leading to study treatment discontinuation. No incidence of treatment-emergent anti-drug antibodies was reported in pediatric patients treated with secukinumab.
Conclusions:
Secukinumab was well tolerated in pediatric patients with moderate to severe and severe plaque psoriasis across age and bodyweight subgroups. The overall safety profile of secukinumab in pediatric patients was consistent with that of adult patients.
Gov Identifier:
NCT03668613 (Novartis Study Code CAIN457A2311, referred to as A2311), actual study start date: August 29, 2018; actual primary completion date: September 19, 2019; estimated study completion date: September 14, 2023. NCT02471144 (Novartis Study Code CAIN457A2310, referred to as A2310), study start date: September 29, 2015; primary completion date: December 13, 2018; estimated study completion date: March 31, 2023.
