Positive results have been reported from a pivotal phase 3 trial of BI 695501 (Boehringer Ingelheim), a biosimilar candidate to U.S.-licensed Humira (adalimumab, AbbVie). BI 695501 met the study’s primary efficacy endpoint by establishing equivalence with Humira in patients with active rheumatoid arthritis (RA). Secondary endpoints comparing the efficacy, safety, and immunogenicity of BI 695501 with that of Humira were also met.
The randomized, double-blind, parallel-arm, multiple-dose, active-comparator study included 645 patients diagnosed with moderate-to-severe active RA who were treated with methotrexate. The subjects were randomly assigned to receive either BI 695501 or Humira every two weeks for 48 weeks. The primary objective was to establish statistical equivalence in efficacy between BI 695501 and Humira in patients with active RA, as measured by the proportion of patients meeting ACR20 (an American College of Rheumatology 20% improvement) criteria at week 12 and at week 24 compared with baseline.
RA is a chronic inflammatory autoimmune disease affecting the lining of synovial joints, causing pain, stiffness, swelling, and limited motion and function of joints. In many patients, the progressive destruction of joints may ultimately result in disability. RA affects three times more women than men. The disease affects approximately 1.6 million people in the United States. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.
Source: Boehringer Ingelheim; October 26, 2016.