Germany-based Boehringer Ingelheim has released one-year data from VOLTAIRE-RA, a pivotal phase three clinical trial assessing Cyltezo (adalimumab-adbm) with reference product, Humira, it was reported yesterday.
The 48-week data indicated that the product is equivalent, with no clinically meaningful differences in efficacy, safety and immunogenicity to Humira in people with moderately-to-severely active rheumatoid arthritis (RA), including in patients who moved from Humira to Cyltezo at week 24.1.
In the European Union, the product recently received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for multiple chronic inflammatory diseases including, in adults with moderate to severely active rheumatoid arthritis, Psoriatic arthritis, moderate to severely active Crohn's disease, severe active ankylosing spondylitis, moderate to severely active ulcerative colitis, severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa and non-infectious intermediate, posterior and panuveitis.
The data will be presented at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in San Diego, California.
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