Real-world effectiveness of ustekinumab and vedolizumab in TNF-exposed pediatric patients with ulcerative colitis.
J Pediatr Gastroenterol Nutr
; 78(5): 1126-1134, 2024 May.
Article
en En
| MEDLINE
| ID: mdl-38482890
ABSTRACT
OBJECTIVES:
Vedolizumab (VDZ) and ustekinumab (UST) are second-line treatments in pediatric patients with ulcerative colitis (UC) refractory to antitumor necrosis factor (anti-TNF) therapy. Pediatric studies comparing the effectiveness of these medications are lacking. Using a registry from ImproveCareNow (ICN), a global research network in pediatric inflammatory bowel disease, we compared the effectiveness of UST and VDZ in anti-TNF refractory UC.METHODS:
We performed a propensity-score weighted regression analysis to compare corticosteroid-free clinical remission (CFCR) at 6 months from starting second-line therapy. Sensitivity analyses tested the robustness of our findings to different ways of handling missing outcome data. Secondary analyses evaluated alternative proxies of response and infection risk.RESULTS:
Our cohort included 262 patients on VDZ and 74 patients on UST. At baseline, the two groups differed on their mean pediatric UC activity index (PUCAI) (p = 0.03) but were otherwise similar. At Month 6, 28.3% of patients on VDZ and 25.8% of those on UST achieved CFCR (p = 0.76). Our primary model showed no difference in CFCR (odds ratio 0.81; 95% confidence interval [CI] 0.41-1.59) (p = 0.54). The time to biologic discontinuation was similar in both groups (hazard ratio 1.26; 95% CI 0.76-2.08) (p = 0.36), with the reference group being VDZ, and we found no differences in clinical response, growth parameters, hospitalizations, surgeries, infections, or malignancy risk. Sensitivity analyses supported these findings of similar effectiveness.CONCLUSIONS:
UST and VDZ are similarly effective for inducing clinical remission in anti-TNF refractory UC in pediatric patients. Providers should consider safety, tolerability, cost, and comorbidities when deciding between these therapies.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Fármacos Gastrointestinales
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Colitis Ulcerosa
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Anticuerpos Monoclonales Humanizados
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Ustekinumab
Límite:
Adolescent
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Child
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Female
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Humans
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Male
Idioma:
En
Año:
2024
Tipo del documento:
Article