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79 Percent of Patient Subset Show No Joint Erosion in Infliximab Trial

SAN ANTONIO, Oct. 18 /PRNewswire/ -- New data from the ASPIRE trial (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) show that 79 percent of rheumatoid arthritis patients treated with REMICADE (infliximab) plus methotrexate (REMICADE regimen) who began the study with no joint erosions, maintained an erosion-free state by developing no new joint erosions at one year compared with 58 percent of patients treated with methotrexate alone.

Additionally, in all patients, 64 percent of patients in the REMICADE treated groups experienced no worsening in joint erosion scores compared with 49 percent of patients receiving methotrexate alone. These new findings emerged from the ASPIRE trial and were presented today at the American College of Rheumatology (ACR) 68th Annual Scientific Meeting.

"Any joint damage caused by RA can often lead to loss of function and disability, indicating the need for early intervention to prevent new joint damage," said David E. Yocum, MD, director, Arizona Arthritis Center, the University of Arizona College of Medicine, and ASPIRE investigator. "The fact that more than three-fourths of patients in this subset of patients developed no new joint erosions through one year constitutes a new approach in the treatment of RA. These data should encourage rheumatologists to reset treatment expectations in treating patients with RA from clinical improvement to prevention of new structural damage."

Based on the ASPIRE study results, on September 29th, the Food and Drug Administration (FDA) granted approval of the REMICADE regimen as first line therapy to treat patients with moderate to severe active rheumatoid arthritis. REMICADE, in combination with methotrexate, is now indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. This new approval eliminates the requirement that patients must first fail to respond to methotrexate, the current standard of treatment for RA, before starting on REMICADE combination therapy.

About the ASPIRE
Sub-Analysis In the ASPIRE study, a total of 1004 patients with early RA (3 years disease duration) were evaluable for efficacy. Of these, 138 patients had no erosions at baseline. Patients were randomly assigned to receive infusions of placebo or REMICADE (3 or 6 mg/kg) at weeks 0, 2, and 6, and then every 8 weeks thereafter, through week 46 in a 4:5:5 ratio. All patients received concomitant methotrexate. Of the patients with an erosion score of zero at baseline, in the REMICADE regimen groups, 79 percent (77/98) had no new erosions at one year, while in the methotrexate only group, 58 percent (23/40) had no new erosions (p=0.012). Additionally, 64 percent of all patients (390/612) in the REMICADE regimen groups experienced no worsening in joint erosion scores at one year compared with 49 percent of patients (110/226) who received methotrexate only. Furthermore, 53 percent of patients (323/612) in the REMICADE regimen groups had no new erosions in previously uninvolved joints at one year compared with 41 percent of patients (93/227) receiving methotrexate only. Overall, the mean number of erosions that developed in previously uninvolved joints per patient was significantly less in the REMICADE regimen groups compared with patients treated with methotrexate only. Patients in the REMICADE regimen groups experienced a mean of 0.66 joints with new erosions, compared with 1.43 in the methotrexate only group (p0.001).

ASPIRE, the largest controlled trial ever conducted exclusively in RA patients with early disease found REMICADE plus methotrexate to be superior to methotrexate alone in patients with moderately to severely active disease. ASPIRE was a 54-week, randomized, double blind, active control study involving 1,004 patients with early disease enrolled in 125 centers in North America and Europe. In the ASPIRE trial, more than 80 percent of patients had evidence of erosive joint damage despite the fact that the median disease duration was only seven months. At randomization, all patients received methotrexate and either placebo, 3mg/kg of REMICADE or 6mg/kg of REMICADE at weeks 0, 2 and 6 and then every eight weeks thereafter. The ASPIRE trial demonstrated superiority of the REMICADE regimen over methotrexate alone on all three primary endpoints, including reduction of signs and symptoms, inhibition of the progression of structural damage and improvement in physical function.

The most commonly reported adverse events were upper respiratory infection, nausea and headache. Serious infections included pneumonia, TB and sepsis. Please see "Important Information" below.

About Rheumatoid Arthritis
RA is a chronic, progressive disease and research suggests that a critical therapeutic window may exist within the first two years of disease onset when the rate of radiographic progression of the disease can be "reset."(1),(2),(3) Radiographic changes occur within two years of disease onset in 50-70 percent of RA patients.(4) The American College of Rheumatology (ACR) suggests control of disease progression should start early to limit joint damage in RA.(3) RA is associated with substantial disability and economic losses, and one study showed that one-third of patients in the UK who were employed became work-disabled within two years of disease onset.(5) Rheumatologic disorders also account for 25 percent of Social Security disability payments.(6)

(1) Landewe RB, Boers M, Verhoeven AC, et al. COBRA combination therapy in patients with early rheumatoid arthritis: long-term structural benefits of a brief intervention. Arthritis Rheum. 2002;46:347-356.
(2) Egsmose C, Lund B, Borg G, et al. Patients with rheumatoid arthritis benefit from early 2nd line therapy: 5 year follow up of a prospective double blind placebo controlled study. J. Rheumatol. 1995;22:2208-2213.
(3) American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines, 2002 Update.
(4) van der Heijde DM. Joint erosions and patients with early rheumatoid arthritis. Br J Rheumatol. 1995;34(suppl 2):74-78.
(5) Barrett EM, Scott DGI, Wiles NJ, Symmons DPM. The impact of rheumatoid arthritis on employment status in the early years of disease: a UK community-based study. Rheumatology. 2000;39:1403-1409.
(6) Social Security Disability Insurance Program.

Source: Centocor

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