Effectiveness of adalimumab for ulcerative colitis: A multicentre, retrospective study of clinical practice in Italy.
Adalimumab
Effectiveness
Real-world evidence
Safety
Ulcerative colitis
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
Mar 2022
Mar 2022
Historique:
received:
05
06
2021
revised:
12
08
2021
accepted:
25
08
2021
pubmed:
21
9
2021
medline:
11
3
2022
entrez:
20
9
2021
Statut:
ppublish
Résumé
Adalimumab is used to treat ulcerative colitis, but additional effectiveness and safety data are needed. This retrospective study considered adults with ulcerative colitis treated with adalimumab at 19 hospitals. Clinical data were collected from the start of treatment, after 2, 6 and 12 months, and at the last visit. Outcome measures of effectiveness were treatment duration, reasons for discontinuation and colectomy. We studied 381 patients treated with adalimumab for a median of 12.1 months. Disease activity at the start of treatment was moderate to severe in 262 cases (68.8%) and endoscopic activity was moderate to severe in 339 cases (89.0%). At week 8, clinical responses were observed in 177 cases (46.5%) and clinical remission in 136 cases (35.7%). At 12 months, remission was observed in 128 cases (33.6%). Overall, 44 patients required colectomy, and 170 patients (44.6%) were still taking adalimumab when data were collected. Variables associated with adalimumab discontinuation were concomitant steroid treatment, severe clinical-endoscopic activity at baseline, need for adalimumab intensification and drug-related adverse events. Variables associated with colectomy were concomitant steroid treatment and high baseline C-reactive protein. Adalimumab is safe and effective for the treatment of ulcerative colitis.
Sections du résumé
BACKGROUND
BACKGROUND
Adalimumab is used to treat ulcerative colitis, but additional effectiveness and safety data are needed.
PATIENTS AND METHODS
METHODS
This retrospective study considered adults with ulcerative colitis treated with adalimumab at 19 hospitals. Clinical data were collected from the start of treatment, after 2, 6 and 12 months, and at the last visit. Outcome measures of effectiveness were treatment duration, reasons for discontinuation and colectomy.
RESULTS
RESULTS
We studied 381 patients treated with adalimumab for a median of 12.1 months. Disease activity at the start of treatment was moderate to severe in 262 cases (68.8%) and endoscopic activity was moderate to severe in 339 cases (89.0%). At week 8, clinical responses were observed in 177 cases (46.5%) and clinical remission in 136 cases (35.7%). At 12 months, remission was observed in 128 cases (33.6%). Overall, 44 patients required colectomy, and 170 patients (44.6%) were still taking adalimumab when data were collected. Variables associated with adalimumab discontinuation were concomitant steroid treatment, severe clinical-endoscopic activity at baseline, need for adalimumab intensification and drug-related adverse events. Variables associated with colectomy were concomitant steroid treatment and high baseline C-reactive protein.
CONCLUSION
CONCLUSIONS
Adalimumab is safe and effective for the treatment of ulcerative colitis.
Identifiants
pubmed: 34538764
pii: S1590-8658(21)00761-1
doi: 10.1016/j.dld.2021.08.020
pii:
doi:
Substances chimiques
Tumor Necrosis Factor Inhibitors
0
Adalimumab
FYS6T7F842
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
352-357Informations de copyright
Copyright © 2021. Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
Conflict of Interest None declared.