New Treatment for Rheumatoid Arthritis Shows Promise in Trial Phase

May 20, 2009

A recently completed Phase II proof-of-concept trial demonstrated that patients with rheumatoid arthritis given methotrexate were more likely to report an improvement in signs and symptoms than those given a placebo.

A recently completed Phase II proof-of-concept trial has shown that patients with rheumatoid arthritis (RA) given methotrexate (MDX-1100) were more likely to report an improvement in RA signs and symptoms than those given a placebo.

Medarex, Inc., the company that developed the drug, said that “three times the number of patients treated with 10 mg/kg of MDX-1100 every two weeks achieved at least a 20% improvement” in their RA symptoms after 12 weeks, which was the primary endpoint of the study. Results were measured in accordance with the American College of Rheumatology’s (ACR) 20 measurements of response.

The patients with active RA who participated in the study were given either the drug every two weeks over the course of 12 weeks for a total of six doses or placebo.

In addition to the primary endpoints, secondary endpoints included “other clinical response assessments, pharmacokinetics of MDX-1100, and potential biomarkers of activity.”

"These results show that by targeting the chemokine IP-10 with our MDX-1100 antibody, we may be able to offer a potentially important and novel treatment option for rheumatoid arthritis and potentially other inflammatory indications," said Howard H. Pien, Chairman and CEO of Medarex.

The results showed that “the antibody combination with methotrexate was generally safe and well tolerated.” The researchers also said that the full results of the trial will be presented at an upcoming scientific meeting.

In addition to its use in RA, methotrexate is being explored as a treatment for ulcerative colitis.

"Based on these positive results with a novel pro-inflammatory target, we are actively preparing for the next stage of clinical development for MDX-1100 in RA, including the potential for subcutaneous dosing," said Geoffrey M. Nichol, MBChB, senior vice president of product development at Medarex. "We also look forward to exploring the broader potential of MDX-1100 in a range of inflammatory diseases, including ulcerative colitis in an ongoing companion Phase 2 study."