A propensity score-weighted comparison between adalimumab originator and its biosimilars, ABP501 and SB5, in inflammatory bowel disease: a multicenter Italian study.
ABP501
Crohn’s disease
SB5
adalimumab
anti-TNF
biosimilar
inflammatory bowel disease
ulcerative colitis
Journal
Therapeutic advances in gastroenterology
ISSN: 1756-283X
Titre abrégé: Therap Adv Gastroenterol
Pays: England
ID NLM: 101478893
Informations de publication
Date de publication:
2021
2021
Historique:
received:
01
03
2021
accepted:
22
06
2021
entrez:
5
8
2021
pubmed:
6
8
2021
medline:
6
8
2021
Statut:
epublish
Résumé
Adalimumab is an effective and safe biological drug for the treatment of inflammatory bowel disease (IBD). Nowadays, several biosimilar agents are available, but data regarding their efficacy and safety in patients with IBD are still lacking. We aimed to compare the effectiveness and tolerability between adalimumab originator, ABP501 and SB5 biosimilars in patients with IBD in the short term (after induction and after 6 months of treatment) through a propensity score-weighted multicenter cohort study. We included 156 patients with IBD, 69 patients with ulcerative colitis and 87 patients with Crohn's disease (CD) receiving ABP501 or SB5 biosimilars from January 2019 to April 2020 for moderate-to-severe disease. For comparison, a group of age- and sex-matched patients treated with adalimumab originator was used. We collected clinical and biochemical data after induction and at 6 months of treatment. Endoscopic data were recorded only at baseline. Overall, clinical benefit was achieved by 86.4% and 85.3% after induction and at 6 months, respectively, without a statistically significant difference between the three treatment groups ( Adalimumab biosimilars seem to be as effective and safe as the originator in patients with IBD. Surely, they represent a great opportunity to reduce the costs of biological therapies, however larger and longer real-life studies are necessary.
Sections du résumé
BACKGROUND
BACKGROUND
Adalimumab is an effective and safe biological drug for the treatment of inflammatory bowel disease (IBD). Nowadays, several biosimilar agents are available, but data regarding their efficacy and safety in patients with IBD are still lacking. We aimed to compare the effectiveness and tolerability between adalimumab originator, ABP501 and SB5 biosimilars in patients with IBD in the short term (after induction and after 6 months of treatment) through a propensity score-weighted multicenter cohort study.
METHODS
METHODS
We included 156 patients with IBD, 69 patients with ulcerative colitis and 87 patients with Crohn's disease (CD) receiving ABP501 or SB5 biosimilars from January 2019 to April 2020 for moderate-to-severe disease. For comparison, a group of age- and sex-matched patients treated with adalimumab originator was used. We collected clinical and biochemical data after induction and at 6 months of treatment. Endoscopic data were recorded only at baseline.
RESULTS
RESULTS
Overall, clinical benefit was achieved by 86.4% and 85.3% after induction and at 6 months, respectively, without a statistically significant difference between the three treatment groups (
CONCLUSION
CONCLUSIONS
Adalimumab biosimilars seem to be as effective and safe as the originator in patients with IBD. Surely, they represent a great opportunity to reduce the costs of biological therapies, however larger and longer real-life studies are necessary.
Identifiants
pubmed: 34349836
doi: 10.1177/17562848211031420
pii: 10.1177_17562848211031420
pmc: PMC8295962
doi:
Types de publication
Journal Article
Langues
eng
Pagination
17562848211031420Informations de copyright
© The Author(s), 2021.
Déclaration de conflit d'intérêts
Conflict of interest statement: EVS has received lecture or consultancy fees from Takeda, Merck & Co, Bristol-Myers Squibb, Abbvie, Amgen, Novartis, Fresenius Kabi, Sandoz, Sofar and Janssen. FZ had received lecture fees from Takeda, Janssen and Norgine. The remaining authors declare no competing interests.
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