Nonmedical switch of anti-TNF-α biosimilars has no major clinical, pharmacokinetic and psychological impact on patients with IBD - the SAFER Study
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View abstract on PubMed
Summary
This summary is machine-generated.Nonmedical switching between anti-Tumor Necrosis Factor-alpha (TNF) biosimilars in inflammatory bowel disease (IBD) is safe and effective. Treatment persistence, effectiveness, and patient well-being remain largely unchanged after switching infliximab and adalimumab biosimilars.
Area Of Science
- Gastroenterology
- Pharmacology
- Immunology
Background
- Limited data exist on nonmedical switching between anti-Tumor Necrosis Factor-alpha (TNF) biosimilars in inflammatory bowel disease (IBD).
- This study investigated nonmedical switches from infliximab biosimilar CT-P13 to SB2 and adalimumab biosimilar ABP 501 to SB5.
Purpose Of The Study
- To evaluate the effects of nonmedical switching between anti-TNF biosimilars in IBD patients.
- To assess treatment persistence, effectiveness, safety, immunogenicity, and psychological impact.
Main Methods
- Observational study of consecutive IBD patients undergoing nonmedical biosimilar switch.
- Prospective 12-month follow-up assessing primary outcome of treatment persistence and secondary outcomes including effectiveness, safety, immunogenicity, inflammatory markers, and psychometric assessments.
Main Results
- Treatment persistence at 12 months was 84.0% for SB2 and 78.9% for SB5.
- No clinically significant changes in effectiveness, safety, pharmacokinetics, or immunogenicity were observed.
- Inflammatory cytokine levels and psychometric assessments remained largely unchanged post-switch.
Conclusions
- Nonmedical switching of infliximab and adalimumab biosimilars is safe and effective in IBD.
- Switching does not significantly impact treatment effectiveness, safety, pharmacokinetics, or patient psychological well-being.
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