Switching From Originator Adalimumab to the Biosimilar SB5 in Patients With Inflammatory Bowel Disease: Short-term Experience From a Single Tertiary Clinical Centre
Language English Country Great Britain, England Media print
Document type Journal Article
PubMed
31905382
DOI
10.1093/ecco-jcc/jjaa001
PII: 5697282
Knihovny.cz E-resources
- Keywords
- Adalimumab, biosimilar, inflammatory bowel disease,
- MeSH
- Adalimumab blood immunology therapeutic use MeSH
- Biosimilar Pharmaceuticals blood therapeutic use MeSH
- C-Reactive Protein metabolism MeSH
- Tertiary Care Centers MeSH
- Crohn Disease blood drug therapy MeSH
- Adult MeSH
- Feces chemistry MeSH
- Gastrointestinal Agents blood immunology therapeutic use MeSH
- Leukocyte L1 Antigen Complex analysis MeSH
- Middle Aged MeSH
- Humans MeSH
- Drug Substitution MeSH
- Antibodies blood MeSH
- Retrospective Studies MeSH
- Severity of Illness Index MeSH
- Colitis, Ulcerative blood drug therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Adalimumab MeSH
- Biosimilar Pharmaceuticals MeSH
- C-Reactive Protein MeSH
- Gastrointestinal Agents MeSH
- Leukocyte L1 Antigen Complex MeSH
- Antibodies MeSH
BACKGROUND AND AIMS: Patients' perspectives after switching from originator to biosimilar adalimumab have yet to be assessed. We evaluated the efficacy of switching from the originator adalimumab to a biosimilar compound [SB5] in patients with inflammatory bowel disease [IBD]. METHODS: Data on IBD patients who were switched from the originator to biosimilar adalimumab [SB5] at IBD Center ISCARE were analysed. Disease activity was assessed using standard clinical indices (Harvey-Bradshaw index [HBI] for Crohn's disease [CD] and partial Mayo score for ulcerative colitis [UC]), and laboratory parameters (C-reactive protein [CRP] and faecal calprotectin [FC]). Trough levels and anti-drug antibodies were measured. Patients were evaluated 10 weeks [W10] after the switch, and results were compared with the control group of patients on originator compound. RESULTS: A total of 93 patients switched to biosimilar adalimumab were included [CD 86%] and were matched to 93 controls for age, gender, diagnosis, and disease activity. There was no difference in the disease activity in either SWITCH or ORIGINATOR cohorts between Weeks 0 and 10. Similarly, no difference was found between cohorts at both prespecified time points. Moreover, no significant differences in CRP or FC concentrations were seen between W0 and W10 either in the SWITCH, or in the ORIGINATOR cohort [p >0.05]. Adalimumab serum trough levels remained stable after the switch. No new safety signals were detected. CONCLUSIONS: Our study confirmed that switching IBD patients from the originator adalimumab to a biosimilar compound [SB5] does not affect treatment efficacy.
Clinical and Research Centre for Inflammatory Bowel Disease ISCARE Prague Czech Republic
Institute of Animal Physiology and Genetics Czech Academy of Sciences Libechov Czech Republic
Institute of Pharmacology 1st Faculty of Medicine Charles University Prague Czech Republic
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