Biosimilar BI 695501 Effective, Safe in Moderate to Severe RA
Boehringer Ingelheim announced data from the Phase 3 VOLTAIRE-RA study demonstrating that BI 695501, an adalimumab biosimilar, and Humira had similar safety, efficacy, and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis. The full findings were presented at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid, Spain.
The VOLTAIRE-RA study enrolled 645 adults aged 18–80 years with moderately-to-severely active rheumatoid arthritis on stable therapy with methotrexate. Patients were randomized to Humira or BI 69501 40mg every 2 weeks for 48 weeks. The primary endpoints measuring the proportion of patients achieving ACR20 improvements at Weeks 12 and 24 were met. Study data for Week 52 will be announced at a future medical conference.
Findings from the VOLTAIRE-AI study were also presented at EULAR 2017, which showed similar pharmacokinetic profiles between BI 695501 prefilled syringes and auto-injector dosage forms.
Humira (adalimumab; AbbVie), a tumor necrosis factor (TNF) blocker, is indicated to treat various chronic inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis.
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