This article is part of the Arthritis Archives.
Editor note: In November 1999, the FDA approved the use of Remicade (infliximab) with methotrexate for the treatment of rheumatoid arthritis.
Dateline: June 15, 1999
Remicade ATTRACT Trial Results
Results from ATTRACT, one of the largest clinical studies ever done with advanced rheumatoid arthritis patients, has revealed very favorable results for the use of Remicade (infliximab).
The 54-week results from the phase III clinical trial "Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy" (ATTRACT) was recently presented at the European League Against Rheumatism meeting (EULAR) in Scotland. The 30 week results from this study were previously presented in November 1998 at the meeting of the American College of Rheumatology in San Diego, California.
About The Trial
The ATTRACT trial is a double-blind, placebo-controlled, randomized trial of 428 patients at 34 clinical sites in North America and Europe. The study was designed to assess efficacy and safety of Remicade, used in combination with methotrexate, in patients with active rheumatoid arthritis who have failed treatment with methotrexate alone.
The one-year trial results revealed that 52 percent of all patients treated with Remicade experienced significantly reduced signs and symptoms of rheumatoid arthritis compared to 17% of patients receiving only methotrexate. The standard assessment of disease activity known as ACR20 was utilized. ACR20 is indicative of a 20 percent reduction in the number of tender and swollen joint counts, other criteria from physician and patient global assessments, and a laboratory indicator of pain and inflammation.
There are also two other assessments, ACR50 and ACR70, which correspond to 50 and 70 percent reduction of symptoms. 33% of all patients treated with Remicade attained a ACR50 response compared to 9% on a placebo. 18% of patients on Remicade attained ACR70 compared to 3% on a placebo. Swollen joints decreased 64 percent from baseline in Remicade patients compared to 18 percent on a placebo. Tender joint counts were reduced by 69 percent from baseline in patients receiving Remicade compared to 28 percent on a placebo.
The trial results are significant since evidence shows that improved symptoms remain after one year. The majority of patients who responded to Remicade did so within two weeks. 90% responded within 6 weeks. Such information indicates that Remicade provokes a rapid response.
Remicade was FDA approved for the treatment of Crohn's disease in August 1998.
EULAR: Remicade Shows Positive Results in Rheumatoid Arthritis at One Year. Doctor's Guide. June 7, 1999.
Remicade Rapidly Reduces Signs and Symptoms of Rheumatoid Arthritis. Doctor's Guide. Nov. 9, 1998.