One-year effectiveness and safety of ustekinumab in ulcerative colitis: a multicenter real-world study from Italy.
Ulcerative colitis
anti-interleukin (IL)-12/23
efficacy
mucosal healing
persistence
safety
Journal
Expert opinion on biological therapy
ISSN: 1744-7682
Titre abrégé: Expert Opin Biol Ther
Pays: England
ID NLM: 101125414
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
pubmed:
16
9
2021
medline:
2
2
2022
entrez:
15
9
2021
Statut:
ppublish
Résumé
Efficacy and safety of ustekinumab for the treatment of ulcerative colitis (UC) has been demonstrated in clinical trials, but few real-world data are available so far. The aim of this study was to assess effectiveness and safety of ustekinumab in a cohort of refractory UC patients. Data of patients with moderate to severe UC treated with ustekinumab were retrospectively collected. Primary endpoint was steroid-free clinical remission at weeks 24 and 52 of therapy. Secondary endpoints were treatment response, endoscopic remission, treatment persistence at 12 months and safety. A total of 68 patients [males 63%; median (range) age 42 (16-72) years] were included. Almost all patients (97%) were biologics experienced. At weeks 24 and 52, 31% and 50% of patients achieved steroid-free clinical remission, 84% and 82% had clinical response, respectively. At the end of follow-up, there was a significant reduction of pMS from baseline (p < 0.001) and of steroid use (p < 0.001). At week 52, 22% of the available endoscopies (18/38) showed mucosal healing. The probability to persist in therapy at week 52 was 87%. Only one adverse event occurred. Data from our real-life cohort of refractory UC patients suggest satisfactory effectiveness and a good safety of ustekinumab.
Sections du résumé
BACKGROUND
Efficacy and safety of ustekinumab for the treatment of ulcerative colitis (UC) has been demonstrated in clinical trials, but few real-world data are available so far. The aim of this study was to assess effectiveness and safety of ustekinumab in a cohort of refractory UC patients.
METHODS
Data of patients with moderate to severe UC treated with ustekinumab were retrospectively collected. Primary endpoint was steroid-free clinical remission at weeks 24 and 52 of therapy. Secondary endpoints were treatment response, endoscopic remission, treatment persistence at 12 months and safety.
RESULTS
A total of 68 patients [males 63%; median (range) age 42 (16-72) years] were included. Almost all patients (97%) were biologics experienced. At weeks 24 and 52, 31% and 50% of patients achieved steroid-free clinical remission, 84% and 82% had clinical response, respectively. At the end of follow-up, there was a significant reduction of pMS from baseline (p < 0.001) and of steroid use (p < 0.001). At week 52, 22% of the available endoscopies (18/38) showed mucosal healing. The probability to persist in therapy at week 52 was 87%. Only one adverse event occurred.
CONCLUSIONS
Data from our real-life cohort of refractory UC patients suggest satisfactory effectiveness and a good safety of ustekinumab.
Identifiants
pubmed: 34521307
doi: 10.1080/14712598.2021.1981855
doi:
Substances chimiques
Ustekinumab
FU77B4U5Z0
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM