Why carry out this study?

ABP 501 (Amgevita®) was the first European Medicines Agency (EMA)- and US Food and Drug Administration (US FDA)-approved biosimilar to the adalimumab reference product (Humira®).

Comparative clinical trials have demonstrated biosimilarity between ABP 501 and the reference product regarding efficacy, safety, and immunogenicity in patients with rheumatoid arthritis and in patients with psoriasis, while indications of Crohn’s disease and ulcerative colitis were approved for ABP 501 on the basis of the principle of extrapolation.

In the absence of comparative clinical trial data, we sought to describe the real-world use of ABP 501 in patients with inflammatory bowel disease (IBD), to provide additional useful information to healthcare providers and patients.

What was learned from the study?

This real-world study showed that patients with IBD and their treating physicians both reported high levels of satisfaction with ABP 501 treatment, regardless of their prior exposure to adalimumab reference product.

Patient self-assessment data suggested minimally impaired health-related quality of life for both ABP 501 initiators and switchers from the reference product.