Bristol-Myers Squibb has presented promising results from two studies of its rheumatoid arthritis drug Orencia at the European Congress of Rheumatology (EULAR) meeting in Copenhagen.
The first study analysed the safety and efficacy profile of Orencia (abatacept) over seven years of treatment in RA patients who have had an inadequate response to methotrexate (MTX). During the trial, treatment with Orencia and MTX in combination was generally well tolerated, and the cumulative incidence of adverse events (AEs) was 366.1 per 100 patient years, Serious AEs was 17.4 per 100 patient years and the rate of serious infections was 3.18.
After seven years, over half (52.1%) of Orencia patients (85) entering the study period remained on treatment. Discontinuations due to lack of efficacy and AEs were 11.0% and 19.2%, respectively.
The second study, called AIM (Abatacept in Inadequate responders to Methotrexate) reinforces the long-term safety and efficacy profile the drug, B-MS said. 70.4% of patients (266 out of 378) remained on treatment with Orencia plus MTX at year five. Of these, 33.7% achieved clinical remission and ACR 20, 50 and 70 response rates (improvement in percentage terms of tender and swollen joints) were 83.6%, 61.1% and 39.6%, respectively, after five years.
B-MS cited Rene Westhovens of the University Hospital Leuven, Belgium as saying that “the relevance of these long-term data should not be underestimated for a chronic and progressive disease such as RA”. The professor added that patients who have to live with the disease, and in many cases, undergo treatment, for the rest of their lives. need a drug that has “a proven long-term safety and efficacy profile”.
There will be much more from the EULAR meeting in Monday’s PharmaTimes World News elert.
