Plain language summary of the VOLTAIRE-CD study in people with moderate-to-severe active Crohn's disease

Summary This is a summary of the VOLTAIRE-CD study originally published in The Lancet Gastroenterology and Hepatology. BI 695501 is a medicine being developed to treat people with moderately to severely active Crohn's disease, a chronic inflammatory condition that usually affects the small bowel and colon. BI 695501 is a biosimilar, which means that it is designed to be highly similar to the original drug. The VOLTAIRE-CD study aimed to show whether BI 695501 is just as effective and safe as the original drug, adalimumab (Humira®) in treating Crohn's disease. Participants in the VOLTAIRE-CD study took either the original adalimumab product for 24 weeks followed by BI 695501 for the next 22 weeks, or just the biosimilar BI 695501 for the entire 46-week treatment period. Similar improvements in Crohn's disease symptoms and the number of participants with side effects were similar, regardless of whether they received the original drug or BI 695501. These results show that both drugs could be used in the treatment of people with Crohn's disease, with similar efficacy and safety.