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Non-medical switch from the originator to biosimilar and between biosimilars of adalimumab in inflammatory bowel disease – a prospective, multicentre study.
- Source :
- Digestive & Liver Disease; Dec2022, Vol. 54 Issue 12, p1639-1645, 7p
- Publication Year :
- 2022
-
Abstract
- Clinical data on the efficacy and safety of non-medical switch between adalimumab(ADA) biosimilars are limited. The aim of this study was to evaluate medium-term clinical efficacy, drug sustainability and safety comparing non-medical switches from the originator to biosimilar ADA, and between ADA biosimilars. 276 consecutive patients on maintenance ADA therapy (n = 205 Crohn's disease, n = 71 ulcerative colitis) were included. Data on clinical efficacy, biomarkers and adverse events were collected at four time points: 8–12 weeks prior switch, at baseline/switch, 8–12 weeks and 20–24 weeks after switch. Drug survival was evaluated after a median 40(IQR:35–42) weeks follow-up. A total 174 patients underwent a non-medical switch from the originator to a biosimilar, and 102 patients had a biosimilar-to-biosimilar switch. No significant difference was found in clinical remission rates at any time point in patients switching from originator to biosimilar(87.3%/88.5%/86.5%/85.7%) or biosimilar to biosimilar(74.5%/78.4%/85.3%/79.8%). Mean C-reactive protein levels remained unchanged in both cohorts(p = 0.856 and p = 0.525). Drug survival was similar between the two cohorts with a probability of 91.6%(SE: 2.2) and 87.0%(SE:3.4) to stay on drug after 40 weeks(log-rank:0.96; p = 0.327). Five cases of injection related adverse events were reported. Clinical benefit was sustained following non-medical switch from originator to biosimilar, or between biosimilars in adalimumab treated IBD patients. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 15908658
- Volume :
- 54
- Issue :
- 12
- Database :
- Supplemental Index
- Journal :
- Digestive & Liver Disease
- Publication Type :
- Academic Journal
- Accession number :
- 160031903
- Full Text :
- https://doi.org/10.1016/j.dld.2022.07.004