Ustekinumab in paediatric patients with moderately to severely active Crohn's disease: UniStar study long-term extension results.
J Pediatr Gastroenterol Nutr
; 79(2): 315-324, 2024 Aug.
Article
en En
| MEDLINE
| ID: mdl-38801079
ABSTRACT
OBJECTIVES:
To assess the efficacy, safety, immunogenicity, and pharmacokinetics through 240 weeks of ustekinumab treatment in paediatric patients from the long-term extension (LTE) of the phase 1, double-blind UniStar trial.METHODS:
Paediatric patients with moderately to severely active Crohn's disease (CD) were randomised 11 and stratified by body weight (<40 or ≥40 kg) to low- or high-dose intravenous ustekinumab followed by a subcutaneous maintenance dose at Week 8. At Week 16, patients were eligible to enter the LTE at the discretion of the investigator and continued maintenance dosing every 8 weeks up to Week 240.RESULTS:
Of the 34 patients who entered the LTE, 25 patients with evaluable data completed Week 48, and 41.2% (14/34) achieved clinical remission at Week 48. Among the 24 patients with Week-0 C-reactive protein (CRP) levels ≥3 mg/L, 29.2% (7/24) achieved normalisation of CRP at Week 48, while imputing missing data as failures. Through Week 240, the most common adverse events were infections (n = 28) and gastrointestinal disorders (n = 26). The most common serious adverse event was worsening of CD (n = 6). Only one patient had detectable antibodies to ustekinumab. Median serum ustekinumab concentrations remained consistent through Week 48, were detectable through Week 224, and trended lower in patients <40 kg.CONCLUSIONS:
Efficacy and pharmacokinetics through 1 year and safety and immunogenicity through 4 years of ustekinumab treatment in paediatric patients with CD were generally comparable to those previously reported in adults.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Enfermedad de Crohn
/
Ustekinumab
Límite:
Adolescent
/
Child
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
J Pediatr Gastroenterol Nutr
/
J. pediatr. gastroenterol. nutr
/
Journal of pediatric gastroenterology and nutrition
Año:
2024
Tipo del documento:
Article
País de afiliación:
Israel