Multicenter European Study to Look at Real-World Experience of Patients Switched to Imraldi

A hospital for rheumatological diseases in the United Kingdom is participating in an international study that is examining real-world evidence about patient experiences after they switch from reference adalimumab (Humira) to a biosimilar, Imraldi.

The Pan-EU Real-World Experience with IMRALDI: PROPER Research Study aims to recruit about 1200 to 1400 patients from 60 to 70 treatment centers in the European Union (EU). Patients with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, Crohn disease, and ulcerative colitis are eligible to participate.

The study is taking place at the Royal National Hospital for Rheumatic Diseases (RNHRD) in Bath, part of the Royal United Hospitals Bath NHS Foundation trust, which reported that it just recruited its first patient for the study.

“Randomized controlled trials have demonstrated excellent efficacy for patients to switch from the originator drug to the bio similar,” Raj Sengupta, MD, who is leading the study, said in a statement. “There are, however, very few studies that have looked at real-world evidence—data collected during an observational study—to demonstrate the evidence of the switches. We are very proud to participate in this global study looking at the effectiveness of switching axial spondyloarthritis and psoriatic arthritis patients from Humira, the originator medicine, to Imraldi, the biosimilar in a real-world setting."

In the United Kingdom, which was responsible for the most consumption of brand-name Humira in the European Union as of September 2018, a centralized tender broke the adalimumab market into 11 regions, and awarded shares of the market to multiple bidders. Imraldi took the greatest share, with nearly 45% of the English market.

Imraldi is made by Samsung Bioepis; other biosimilars available in the EU for the treatment of inflammatory diseases are Amgen’s Amgevita, Sandoz’s Hyrimoz, and Mylan’s Hulio.