Bristol-Myers Squibb Company announced results from an exploratory phase II study of 56 individuals that suggested that Orencia (abatacept), a prescription drug for adults with moderate to severe rheumatoid arthritis (RA), may delay the development of RA in people with undifferentiated inflammatory arthritis (UA).

Orencia is not indicated for people with UA. In addition, further studies in larger patient populations of UA are required to validate these findings. The results were presented at the Annual Congress of the European League Against Rheumatism (EULAR).

In this small, randomized, double-blind, phase II, multicenter, placebo-controlled, exploratory study, researchers investigated whether monotherapy with Orencia, administered for six months and then withdrawn, was more effective than placebo in delaying the development of RA in adult patients with UA who were positive for anti-cyclic citrullinated peptide (anti-CCP2) antibodies, a serum biomarker associated with increased risk of progression to erosive RA.

"Undifferentiated inflammatory arthritis is a common disease that, in some cases, may evolve into other rheumatic conditions, such as rheumatoid arthritis," said the study's lead investigator, Paul Emery, MD, F.R.C.P., University of Leeds. "The results of this proof-of-concept study in a poor prognosis subset of UA patients support further study on the potential of Orencia to alter the course of disease towards RA".

"Bristol-Myers Squibb is committed to helping patients in their fight against rheumatoid arthritis," said Brian Daniels, MD, rheumatologist and senior vice president, global development and medical affairs, Bristol-Myers Squibb. "We are excited by the potential of Orencia and will continue our efforts to help patients suffering from early forms of rheumatoid arthritis".

In this study, 56 individuals with UA who were positive for anti-CCP2 antibodies were randomized to receive either monotherapy with Orencia (abatacept) for six months, after which treatment was discontinued.

The primary endpoint of this study was the proportion of patients who developed RA as measured by the American College of Rheumatology (ACR) criteria at Month 12, six months after treatment was ended.

Orencia is a prescription medicine that is used to treat adults with moderate to severe rheumatoid arthritis including those who have not been helped enough by other medicines for RA.