Boehringer Ingelheim‘s BI 695501 has been deemed effectively equivalent to Humira (adalimumab) in patients with active rheumatoid arthritis (RA), according to the results of a crucial Phase 3 clinical trial comparing the two drugs. BI 695501 also met high safety and immunogenicity standards set by the study.
BI 695501 is a biosimilar of Humira, a therapy already approved and prescribed for RA patients in Europe the U.S. Humira is a biologic tumor necrosis factor (TNF) blocking agent — an immunosuppressant that lowers the responses of the immune system. Side effects can include allergic reactions, liver problems, heart failure, and the development of autoimmune disorders such as lupus and psoriasis.
The Phase 3 clinical trial (NCT02137226) was a parallel-arm, multiple-dose study comparing the safety, effectivenes, and immunogenicity of BI 695501 and Humira in 645 patients with moderate to severe active RA while undergoing treatment with methotrexate.
Each RA patient participant was randomized to receive BI 695501 or Humira every two weeks for 48 weeks. “Statistical equivalence” in effectiveness was calculated by identifying the proportion of patients meeting American College of Rheumatology 20 criteria at three and six months compared to the start of the study. ACR2o represents an improvement equal or higher than 20 percent in disease activity.
Based in Germany, Boehringer Ingelheim is now considering publishing and presenting summaries of the trial results at future medical conferences and meetings. Pending regulatory approval, the company will move ahead with commercializing Bi 695501 in markets worldwide.
“This milestone paves the way for submitting BI 695501 for regulatory approval in key markets such as the USA and Europe,” Sandeep Athalye, MD, vice president and head of Clinical Development and Medical Affairs Biosimilars for Boehringer Ingelheim, said in a press release.
RA is a chronic inflammatory autoimmune disease that affects synovial joint lining leading to pain, stiffness, swelling, and limited motion. Most patients eventually become disabled. The disease affects approximately 23.7 million people worldwide; 1.6 million people in the U.S. alone.
”With our focus on BI 695501 and other biosimilar candidates, we recognize biosimilars as playing an increasing role in providing patients and doctors with high quality therapeutic options while contributing to the long-term sustainability of healthcare systems” Athalye said.