Phase III VOLTAIRE-RA1 study shows BI 695501 (adalimumab biosimilar) similar to Humira in rheumatoid arthritis- Boehringer

Boehringer announced results from the pivotal Phase III VOLTAIRE-RA1 study, confirming that its adalimumab biosimilar candidate BI 695501 and HUMIRA have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis. These data confirm the clinical efficacy equivalence of BI 695501 to HUMIRA. The safety and immunogenicity data in the study were also similar between BI 695501 and HUMIRA.

In the VOLTAIRE-RA1 study 645 patients aged between 18 and 80 years old with moderate-to-severely active rheumatoid arthritis on stable treatment with methotrexate were randomised to receive HUMIRA or BI 695501 at 40 mg every two weeks for 48 weeks. The co-primary endpoints, which measured the proportion of patients achieving an ACR20 (American College of Rheumatology 20) improvement at weeks 12 and 24, were met. The one year results will be presented at a future medical congress. The 24 week results will be presented at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid.