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| |  DG DISPATCH - ACR: Remicade Can Halt Rheumatoid Arthritis Damage By Maria Bishop Special to DG News BOSTON, MA -- November 16, 1999 -- Findings from a recent, controlled, clinical trial are among the first to suggest that a new class of drugs can halt the damage caused by rheumatoid arthritis (RA). According to radiographic data presented in Boston, MA, at a satellite symposium to the American College of Rheumatology meeting (ACR), Remicade (infliximab), in combination with methotrexate (the standard RA therapy), appeared to stop progression of advanced RA in trial participants.
Based on data from the Phase III ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy) trial, the FDA, on November 10, approved Remicade in combination with methotrexate for the purpose of reducing signs and symptoms of RA in patients who have had an inadequate response to methotrexate. Remicade is now under consideration simply for the prevention of joint damage in patients with RA; this approval would make Remicade the first agent in a new class of drugs known as joint-damage-arresting anti-rheumatic therapies (JDAARTs). At 34 clinical sites in North America and Europe, the ATTRACT trial randomized 428 patients to four dosing regimens of Remicade plus methotrexate as well as a control group that received methotrexate alone. More than one-third of all participants had had previous joint surgery and approximately half were classified as functional class 3 or 4 (progressive and advanced disease, respectively). The median duration of disease in trial patients was 8.4 year, and all patients were on methotrexate therapy (the majority for three or more years). All patients were on stable doses of concomitant methotrexate, corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs). In this one-year trial, says Dr. Peter Lipsky, co-director of the ATTRACT trial and director of the Harold C. Simmons Arthritis Research Center at the University of Texas Southwestern Medical Center, in Dallas, TX, x-rays were taken of each patient at baseline, at week 30 and at week 54. Modified Sharp scores (which evaluate a combination of bone erosion and joint-space narrowing on a scale of 0-4), were calculated upon blind presentation of each participant’s x-rays to two experienced x-ray readers. The primary endpoint was the median change from baseline for each patient (averaged between the two readers, who were presented the x-rays simultaneously and in random order). After one year, x-ray data in 348 patients were included in the primary analysis. No median progression of joint damage from baseline (0.0 score) was found among any of the 285 patients treated with a combination of Remicade and methotrexate, as compared to the 63 patients who received methotrexate alone (4.0 score). The control arm represented a seven to eight percent deterioration in radiographic scores, which is comparable to that previously reported for patients with established RA treated with disease-modifying antirheumatic drug (DMARD) therapies, including methotrexate. The most common adverse effects in the ATTRACT trial included upper-respiratory-tract infections, headache, nausea, sinusitis, rash and cough. There was no increased incidence of serious adverse events during the trial (11 percent with Remicade and methotrexate compared to 16 percent with methotrexate alone). Similarly, there was no increased incidence of serious infection during the ATTRACT trial (four percent with Remicade and methotrexate compared to two percent in the control arm). This is important, as Remicade is a tumor necrosis factor (TNF)-blocking agent, and serious infections-including sepsis and fatal infections-have been reported in patients receiving TNF-blocking agents. For this reason, there remains a need for caution when considering the use of Remicade in patients with a chronic infection or a history of recurrent infection. Dr. Ravinder Maini, also co-chairman of the ATTRACT trial, concluded that "one of the most stunning aspects of the [study’s] radiographic data is that patients treated with Remicade plus methotrexate achieved positive joint-damage x-ray results, regardless of whether they experienced relief from the signs and symptoms of the disease." Dr. Maini, who is also scientific director of the Kennedy Institute of Rheumatology, in London, England, thus suggests "the need to establish new outcome measures for assessment of all therapies for RA." This satellite symposium was sponsored at the ACR meeting by the Oxford Institute for Continuing Education and was supported by an unrestricted educational grant from Centocor, Inc., of Malvern, PA.
Related Links: Centocor, Inc.
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