Data Suggest Bristol-Myers Squibb Investigational Costimulation Blocker, BMS-188667 (CTLA4Ig), May Have Potential in Rheumatoid Arthritis Patients Inadequately Responding to Etanercept Alone
Saturday October 26, 9:30 am ET
NEW ORLEANS, Oct. 26 /PRNewswire/ -- According to results from a Phase II study presented today at the American College of Rheumatology (ACR) scientific meeting, the novel investigational biologic agent, CTLA4Ig, may have potential for treating rheumatoid arthritis patients who do not respond adequately to etanercept alone.
CTLA4Ig is the first in a new class of treatments called costimulation blockers and is being developed by Bristol-Myers Squibb Company (NYSE: BMY - News)
Researchers found that people who inadequately responded to etanercept alone showed significant improvement from baseline in ACR 20 and 70 response rates with the addition of once monthly infusions of CTLA4Ig compared with placebo plus etanercept over a 6-month period.
The primary endpoint of the study was the proportion of patients meeting the ACR 20 criteria, a way of measuring patient improvement using ACR guidelines. By achieving ACR 20, a patient has at least a 20 percent improvement in multiple measures of disease activity.
In this study of people with active rheumatoid arthritis despite treatment with etanercept, 85 people received a once-monthly infusion of a 2 milligram per kilogram (mg/kg) dose of CTLA4Ig and twice-weekly injections of etanercept. Another 36 people studied received a placebo in addition to the twice-weekly etanercept injections.
Of the 85 patients receiving CTLA4Ig 2 mg/kg plus etanercept, 41 (48.2 percent) achieved ACR 20 (p=0.037). Of the 36 patients receiving placebo and etanercept, only 10 (27.8 percent) achieved ACR 20.
Also, researchers found that 9 of the 85 patients (10.6 percent) receiving CTLA4Ig 2 mg/kg achieved ACR 70 (p=0.042) -- a 70 percent improvement in symptoms. No patient receiving placebo plus etanercept achieved ACR 70.
The overall incidence and severity of adverse events in the trial was similar in both treatment arms. Headache, nausea and vomiting, and musculo-skeletal pain were more common in the CTLA4Ig plus etanercept arm. No opportunistic infections were observed.
Bristol-Myers Squibb plans to initiate CTLA4Ig phase III development in rheumatoid arthritis later this year.
One percent of the world's population suffers from rheumatoid arthritis, resulting in more than 9 million physician visits and 250,000 hospitalizations in the United States annually. The condition, which leads to joint swelling, pain, and often disfigurement, is more common in women than in men. Three out of four patients diagnosed with rheumatoid arthritis are women.
Bristol-Myers Squibb Company is a $19 billion pharmaceutical and related care products company whose mission is to extend and enhance human life. |
