Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: A multicenter study.
Adalimumab
Biosimilar
Efficacy
Inflammatory bowel disease
Safety
Journal
Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology
ISSN: 0975-0711
Titre abrégé: Indian J Gastroenterol
Pays: India
ID NLM: 8409436
Informations de publication
Date de publication:
Feb 2019
Feb 2019
Historique:
received:
07
09
2018
accepted:
27
11
2018
pubmed:
16
1
2019
medline:
20
8
2019
entrez:
16
1
2019
Statut:
ppublish
Résumé
Adalimumab has emerged as a useful drug for treating patients with Crohn's disease (CD) and ulcerative colitis (UC), not responding to conventional therapy. There is limited data on effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease (IBD). Patients with IBD who received at least one dose of adalimumab biosimilar from October 2015 to February 2018 were retrospectively included in this multicenter data analysis. Its effectiveness in inducing and maintaining clinical remission at 8, 26, and 52 weeks for CD and UC and safety profile of the drug was studied. Seventy patients (49 CD; 21 UC) with a median age of 39 (range 13-73) years, male predominance (64.3%), and median (IQR) disease duration of 72 (33-104) months were included. Adalimumab biosimilar was effective in inducing remission (at 8 weeks) in 46.9% and 52.4% patients with CD and UC, respectively, of whom 32.7% and 33.3% (three fourths of remitters) maintained remission over 1 year, respectively. Twenty (28.6%) patients experienced adverse events; seven (10%) were serious of whom three had developed tuberculosis. Adalimumab biosimilar in usual clinical practice is safe and effective in inducing and maintaining remission in Indian patients with IBD. Steroid-free clinical remission was observed in one third of patients with UC and CD at 1 year of therapy. Graphical Abstract.
Sections du résumé
BACKGROUND
BACKGROUND
Adalimumab has emerged as a useful drug for treating patients with Crohn's disease (CD) and ulcerative colitis (UC), not responding to conventional therapy. There is limited data on effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease (IBD).
METHODS
METHODS
Patients with IBD who received at least one dose of adalimumab biosimilar from October 2015 to February 2018 were retrospectively included in this multicenter data analysis. Its effectiveness in inducing and maintaining clinical remission at 8, 26, and 52 weeks for CD and UC and safety profile of the drug was studied.
RESULTS
RESULTS
Seventy patients (49 CD; 21 UC) with a median age of 39 (range 13-73) years, male predominance (64.3%), and median (IQR) disease duration of 72 (33-104) months were included. Adalimumab biosimilar was effective in inducing remission (at 8 weeks) in 46.9% and 52.4% patients with CD and UC, respectively, of whom 32.7% and 33.3% (three fourths of remitters) maintained remission over 1 year, respectively. Twenty (28.6%) patients experienced adverse events; seven (10%) were serious of whom three had developed tuberculosis.
CONCLUSIONS
CONCLUSIONS
Adalimumab biosimilar in usual clinical practice is safe and effective in inducing and maintaining remission in Indian patients with IBD. Steroid-free clinical remission was observed in one third of patients with UC and CD at 1 year of therapy. Graphical Abstract.
Identifiants
pubmed: 30645725
doi: 10.1007/s12664-018-0922-1
pii: 10.1007/s12664-018-0922-1
doi:
Substances chimiques
Anti-Inflammatory Agents
0
Adalimumab
FYS6T7F842
Types de publication
Journal Article
Multicenter Study
Langues
eng
Pagination
44-54Références
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