Nonmedical switch of anti-TNF-α biosimilars has no major clinical, pharmacokinetic and psychological impact on patients with IBD - the SAFER Study.

Abstract

Background: Data on nonmedical switching from one anti-Tumor Necrosis Factor (TNF)-α biosimilar to another in inflammatory bowel disease (IBD) are relatively sparse. We aimed to study the effects of nonmedical switch from infliximab biosimilar CT-P13 to SB2 and from adalimumab biosimilar ABP 501 to SB5.

Methods: In this observational study, consecutive IBD patients receiving nonmedical switch were prospectively followed-up for 12 months. The primary outcome was treatment persistence; other outcomes included: secondary effectiveness outcomes, safety, immunogenicity, inflammatory makers levels and psychometric assessments.

Results: A total of 119 and 76 patients were enrolled in the SB2 and SB5 cohorts. Persistence on treatment at 12 months was 84.0 % in the SB2 cohort and 78.9 % in the SB5 cohort. No clinically meaningful changes in other secondary effectiveness outcomes were recorded. Rates of 0.38 and 0.63 adverse events of interest per 100 patient-years were observed in the SB2 and SB5 cohorts. The pharmacokinetics and immunogenicity of either drug were unaffected by nonmedical switch; similarly, levels of inflammatory cytokines remained largely unchanged. No changes in psychometric assessments were recorded.

Conclusion: Nonmedical switch of infliximab and adalimumab biosimilars does not significantly affect treatment effectiveness, safety and pharmacokinetics, nor does it have major psychological implications for patients.