Data Show Bristol-Myers Squibb's BMS-188667 (CTLA4Ig), An Investigational Costimulation Blocker, Provided Improvement in Rheumatoid Arthritis Activity When Added to Methotrexate Therapy
Saturday October 26, 9:30 am ET
NEW ORLEANS, Oct. 26 /PRNewswire/ -- Results from a 12-month Phase II study presented today at the American College of Rheumatology (ACR) scientific meeting, showed that targeting the T-cell via costimulation blockade with the investigational biologic agent CTLA4Ig, provided improvement in rheumatoid arthritis activity when added to methotrexate therapy.
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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 CTLA4Ig, added to the background therapy methotrexate in people with active rheumatoid arthritis, resulted in significant clinical improvements in disease activity as measured by ACR 20, 50 and 70 response rates compared with methotrexate alone over a 12-month period.
"The findings from these data presented at ACR are important and support further study of the potential role of costimulation blockade in the treatment of rheumatoid arthritis," said Joel Kremer, M.D., professor of medicine, Albany Medical College in New York, who presented the study findings. "It is encouraging that clinical response continued with CTLA4Ig over one year."
The primary endpoints of the study were the proportion of subjects meeting the ACR 20, 50 and 70 criteria, a way of measuring improvement in patients by using ACR guidelines. By achieving ACR 70, a patient has at least a 70 percent improvement in multiple measures of disease activity.
In the study, 339 people with rheumatoid arthritis were divided into three groups -- those receiving a 2 milligram per kilogram (mg/kg) dose of CTLA4Ig, those receiving a 10 mg/kg dose of drug and those receiving a placebo; all patients received methotrexate therapy. CTLA4Ig demonstrated an effect over time, through one year at the 10 mg/kg dose.
Among patients receiving the 10 mg/kg dose of CTLA4Ig and methotrexate, 63 percent of patients achieved ACR 20, while 36 percent of patients taking placebo and methotrexate achieved ACR 20 (p<0.05). ACR 50 and 70 were achieved in 42 percent and 21 percent, respectively, in the 10 mg/kg CTLA4Ig plus methotrexate treatment arm, compared to 20 percent and 8 percent, respectively, in the placebo plus methotrexate treatment arm (p<0.05). Efficacy at the 2 mg/kg dose of CTLA4Ig was not statistically significantly different compared to placebo at 12 months.
The overall incidence of adverse events in patients taking CTLA4Ig was similar to the placebo group. The overall incidence of adverse events -- upper respiratory infections, headache and nausea/vomiting -- in patients taking CTLA4Ig was similar to the placebo group.
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. |
