Eli Lilly & Co. has announced that it will discontinue Phase 3 trials of the monoclonal antibody tabalumab for rheumatoid arthritis (RA), citing disappointing results. The experimental drug neutralizes B-cell activating factor (BAFF).
In a randomized trial published last month in Arthritis and Rheumatism, the drug achieved significantly higher ACR20 responses than placebo than among biologic-naive RA patients with an inadequate response to methotrexate(Drug information on methotrexate). However, in a trial published in the Annals of Rheumatic Diseases last December, 30 mg and 80 mg doses failed to achieve the primary outcome of ACR50 responses by 16 weeks among patients who had not responded to tumor necrosis factor inhibitors, although it showed an "indication of efficacy" at earlier time points.
"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Dr. Eiry Roberts, vice president of autoimmune product development at Lilly, in a press release.