Bristol-Myers Squibb Releases Study Results that Support Orencia

Oct 23, 2009 (Close-Up Media via COMTEX) -- BMY | Quote | Chart | News | PowerRating -- Bristol-Myers Squibb Company has announced two-year results of a study that supports use of Orencia (abatacept) for methotrexate-naive patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

In a release, the Company noted:

The data from the Agree study, which compared patients treated with Orencia plus methotrexate versus patients treated with methotrexate alone, show that patients taking Orencia in combination with methotrexate achieved sustained low disease activity scores at 24 months. Of note, 55.2 percent of patients treated with Orencia plus methotrexate achieved low disease activity scores (DAS28-CRP less than 2.6, which is a combined index that measures disease activity). Of these patients, more than half had no active joints. The data also showed that Orencia plus methotrexate can inhibit radiographic progression of rheumatoid arthritis and improve physical function in addition to relieving pain, swelling and fatigue. The safety profile for the open-label period was similar to the double-blind period of the study.

The data were presented recently at the American College of Rheumatology Annual Scientific Meeting in Philadelphia.

"Treating moderate to severe rheumatoid arthritis patients earlier with a biologic such as Orencia, in combination with methotrexate in patients with poor prognostic factors, may help some patients return to common everyday activities," said AGREE study lead investigator Rene Westhovens, M.D., Ph.D., Department of Rheumatology, Katholieke Universiteit Leuven, Belgium. "The data help rheumatologists to better understand when and whether Orencia is a treatment option for appropriate new-to-biologic adult patients with moderate to severe rheumatoid arthritis."

Orencia is indicated for reducing the signs and symptoms, inducing clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis, Orencia may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. Orencia should not be administered concomitantly with TNF antagonists. Orencia is not recommended for use concomitantly with other biologic rheumatoid arthritis therapy, such as anakinra.

The U.S. Food and Drug Administration approved on August 25, an update in the labeling for Orencia (abatacept) to include data from the Agree trial (Abatacept study to Gauge Remission and joint damage progression in methotrexate-naive patients with Early Erosive rheumatoid arthritis). Patients were required to be methotrexate naive, have moderate to severe rheumatoid arthritis of less than two years disease duration, have erosive disease and had to be positive for RF and/or anti-CCP-2 to enter the trial.

The co-primary endpoints of the double-blind period (Year 1) of the Agree trial were the proportion of patients achieving a DAS28-CRP of less than 2.6 and assessment of structural damage using the Genant-modified Total Sharp Score. At year 1, 41.4 percent versus 23.3 percent of patients achieved a DAS28-CRP of less than 2.6 (P less than .001) in the Orencia plus methotrexate group compared with the group treated with methotrexate alone. Of patients treated with Orencia plus methotrexate who achieved a DAS28-CRP of less than 2.6, there were 54 percent with no active joints, 17 percent had one active joint, 7 percent had two active joints and 22 percent had 3 or more active joints, where an active joint was tender and/or swollen. Mean change from baseline in Genant-modified Total sharp Score was lower for patients in the group treated with Orencia plus methotrexate versus the group treated with methotrexate alone, 0.6 versus 1.1, (P=0.040) respectively. Of the 256 Orencia and 253 placebo-treated patients who completed the one year, randomized, double-blind active control period, 232 Orencia and 227 placebo-treated patients entered the open-label period, receiving approximately 10 mg/kg of Orencia plus methotrexate. Of these patients, 94.3 percent completed the open-label period.

Of patients treated with Orencia plus methotrexate who achieved a DAS28-CRP of less than 2.6, there were 63.5 percent with no active joints, 11.9 percent with one active joint, and 24.6 percent with two or more active joints, where an active joint was tender or swollen.

Joint damage progression was also measured using the Total Sharp Score (TS), which uses X-rays to measure change at Year 1. Non-progression was defined as a TS of less than or equal to 0.0. Radiographic data read in a blinded manner demonstrated that 56.8 percent of patients treated with Orencia plus methotrexate for 24 months were non-progressors.

Overall, incidence rates (per 100 patient years of exposure to Orencia) of serious adverse events (8.4 vs 6.4 percent) and serious infections (2.0 vs 1.7 percent) were similar in the double-blind and open-label periods, respectively. Autoimmune events occurred at a similar rate in the double-blind and open-label periods (2.5 vs 1.3 percent respectively). A total of eight deaths occurred during the 24 months of the study, four Orencia plus methotrexate patients and four methotrexate-alone patients. A total of one malignancy was reported during the 24 months of the study, and this occurred during the double-blind period in the Orencia plus methotrexate arm. Safety experience in the Agree study was consistent with the Orencia rheumatoid arthritis clinical studies.

Orencia is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Orencia may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. Orencia should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with other biologic rheumatoid arthritis therapy, such as anakinra.

Full Prescribing Information:

www.orencia.com or www.bms.com.

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