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| |  DG DISPATCH - EULAR: Remicade Shows Efficacy And Safety Benefits In Active RA By David Jack Special to DG News GLASGOW, SCOTLAND -- June 9, 1999 -- Researchers presented the results of a clinical trial with Centocor’s Remicade™ (infliximab) in the treatment of active rheumatoid arthritis today at the European League Against Rheumatism (EULAR) congress in Glasgow. R.N. Maini, director of the Kennedy Institute of Rheumatology, London, England, made the first public announcement of the 54-week results from the phase III double-blind, placebo-controlled, randomised trial called "Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy" (known as ATTRACT). The 30-week results were presented last year at the American College of Rheumatology meeting in San Diego. TNF (tissue necrosis factor)-alpha is an important inflammatory cytokine and Remicade acts at a molecular level by binding to, and neutralising, TNF-alpha on the cell membrane and blood. The ATTRACT study is being carried out at 34 sites in North America and Europe and is designed to evaluate the safety and efficacy of Remicade in combination with methotrexate in patients with active rheumatoid arthritis who have not responded to methotrexate monotherapy. In the study, 428 patients were randomly assigned to five Remicade treatment groups: 3 mg/kg every eight weeks, three mg/kg every four weeks, 10 mg/kg every eight weeks and 10 mg/kg every four weeks, and placebo. All patients are maintained on methotrexate throughout the study. Outcome measures were ACR-20, which represents a 20 percent reduction in the number of tender and swollen joints, as well as physician and patient global assessments and laboratory markers of inflammation and pain such as C-reactive protein. Two other, more stringent, key assessments to establish efficacy of treatment were ACR-50 and ACR-70, which represent 50 percent and 70 percent reductions in the same benchmarks. At one year, 52 percent of patients treated with Remicade exhibited significant reductions in signs and symptoms of RA as reflected in the ACR-20 compared to 17 percent of patients on methotretaxe monotherapy. Maini said that 33 percent of patients treated with Remicade achieved an ACR-50 response compared with nine percent of the placebo group. In addition, 18 percent of patients in the Remicade group achieved an ACR-70 response compared with three percent of the placebo group. Swollen joints were reduced by 64 percent from baseline with Remicade compared with 18 percent for the placebo group. Tender joints were reduced by 69 percent in the Remicade group compared with 28 percent in the placebo group. "The rapid and marked improvement in signs and symptoms of RA after treatment with infliximab is impressive because patients have now been controlled for one year," Dr. Maini said. Even the lowest tested dose, 3 mg/kg every eight weeks, led to improved function, relief of joint tenderness and reduced joint swelling in a significant number of patients. Safety of Remicade Professor Josef Smolen, from the department of medicine, Rheumatic Disease Center, University of Vienna, Austria, presented the safety findings on Remicade in his presentation at EULAR. After one year, Remicade is generally well tolerated with very few side effects. The most common side effects include upper respiratory tract infection, headache, nausea, sinusitis, rash and cough, Dr. Smolen explained. However, there was no difference in the incidence of serious adverse events between the Remicade group and the placebo group (17 percent versus 21 percent) or in serious infections (six percent versus eight percent). There were no serious infusion reactions in any of the groups. Researchers are still analysing the results of the study to determine the rates of human antichimeric antibodies (HACA) in the two treatment groups, Dr. Smolen said. However, he added, only one patient was found to be HACA positive out of the 32 patients who discontinued treatment.
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