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FDA Approves Drug for Rheumatoid Arthritis Combination Treatment

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By News Release • • January 27, 2000

SUMMARY: Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate (alone), the current standard of treatment.

MALVERN, PA -- The Food and Drug Administration (FDA) approved the use of Remicadeā„¢ (infliximab) with methotrexate for the treatment of patients with rheumatoid arthritis who have had inadequate response to methotrexate alone. Remicade is the first monoclonal antibody to reduce signs and symptoms of this crippling disease. Centocor, Inc. and Ortho-McNeil Pharmaceutical, Inc., both Johnson & Johnson affiliates, will co-promote Remicade for this indication in the United States.

"Remicade is a breakthrough in the treatment of rheumatoid arthritis and signals an exciting new era in our understanding and management of rheumatoid arthritis," said Dr. Peter E. Lipsky, who was co-chairman of the ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy) trial while director of the Harold C. Simmons Arthritis Research Center at the University of Texas Southwestern Medical Center at Dallas(1).

Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate, the current standard of treatment. Remicade is administered intravenously in 3 mg/kg doses at zero, two and six weeks and then every eight weeks thereafter. In the first year of treatment, patients will generally receive eight infusions and in subsequent years, patients receive six infusions.

Infused drugs such as Remicade meet current criteria for Medicare reimbursement, which is an important consideration because as many as 50 percent of patients with rheumatoid arthritis are eligible to receive Medicare benefits.

Today's approval is based on findings from Attract, which is a double- blind, placebo-controlled, randomized clinical trial involving 428 patients at 34 clinical sites. Attract is one of the largest clinical studies ever conducted in patients with advanced rheumatoid arthritis.

At week 30, the primary endpoint for this study, 50 percent of all patients treated with Remicade and methotrexate, compared to 20 percent of patients receiving methotrexate alone, experienced a reduction in signs and symptoms of rheumatoid arthritis as measured by ACR 20, a standard assessment of disease activity and a primary endpoint of the study. All treated patients had active disease despite methotrexate treatment.

ACR 20 represents a 20 percent reduction in the number of tender and swollen joints, as well as other criteria including physician and patient global assessments and a laboratory marker of inflammation and pain. Two other key assessments were ACR 50 and ACR 70. These represent 50 and 70 percent reductions, respectively, in these same parameters.

Patients enrolled in the Attract trial were characterized as having disease that was particularly difficult to manage. The median duration of disease in trial patients was 8.4 years, and all patients were receiving methotrexate therapy. Approximately half of trial patients had been on methotrexate for three or more years. More than a third of all patients had previous joint surgery and nearly half were classified as functional class three or four, which indicates progressive and advanced disease.

The first dose of Remicade delivered significant relief. After two weeks, the median percent improvement in the number of tender joints was 25 percent for Remicade plus methotrexate-treated patients compared to four percent for patients receiving methotrexate alone. The median percent improvement in the number of swollen joints two weeks after infusion was 27 percent for Remicade plus methotrexate-treated patients compared to 11 percent of those receiving
methotrexate only.

Additional ATTRACT clinical trial data at 30 weeks demonstrated:

-- Twenty-seven percent of all patients treated with Remicade and methotrexate achieved an ACR 50 response compared to five percent of those on methotrexate alone;
-- Eight percent of patients treated with Remicade and methrotrexate achieved an ACR 70 response compared to zero percent of patients receiving methotrexate alone.
These data were first presented in November 1998 at the American College of Rheumatology meeting in San Diego. "This rapid onset of action and durable response will be welcome news to patients suffering the pain of rheumatoid arthritis," said Dr. Ravinder Maini, scientific director, Kennedy Institute of Rheumatology, London, and co- chairman of Attract with Dr. Lipsky. "Remicade targets a key mediator of disease called tumor necrosis factor alpha with high specificity and avidity."

The most common adverse events in the Attract trial included upper respiratory tract infections, headache, nausea, sinusitis, rash and cough. There was no increased incidence of serious adverse events (11 percent with Remicade and methotrexate vs. 16 percent with methotrexate alone) or serious infections (four percent with Remicade plus methotrexate vs. six percent with methotrexate alone). The incidence of infusion reactions was also low in Remicade plus methotrexate patients (five percent) compared to those receiving methotrexate alone (two percent).

Tumor necrosis factor-alpha (TNF-alpha) mediates inflammation and cellular immune response including response to infection. Serious infections, including sepsis and fatal infections, have been reported in patients receiving TNF-blocking agents. Many of the serious infections in patients treated with Remicade have occurred in patients on concomitant immunosuppressive therapy that, in addition to their Crohn's disease or rheumatoid arthritis could predispose them to infections. Patients treated with Remicade may have an increased risk of infection. Caution should be exercised when considering the use of Remicade in patients with chronic infection or a history of recurrent infection. Remicade should not be given to patients with a clinically important, active infection. Patients who develop a new infection while undergoing treatment with Remicade should be monitored closely. If a patient develops a serious infection or sepsis, Remicade therapy should be discontinued. Please see Remicade full prescribing information for additional information regarding warnings, precautions and adverse events.

Remicade is currently available in the United States for use in patients with Crohn's disease, a serious gastrointestinal disorder, and now rheumatoid arthritis. It was cleared for marketing by the FDA for Crohn's disease in August 1998.

Remicade reduces inflammation in patients with Crohn's disease and rheumatoid arthritis by binding to and neutralizing TNF-alpha on the cell membrane and in the blood. TNF-alpha is a key inflammatory mediator, or cytokine, in rheumatoid arthritis, Crohn's disease and other autoimmune disorders. Overproduction of TNF-alpha leads to inflammation in these chronic conditions. A pioneer of TNF-alpha inhibitor technology, Centocor is among the world's leading producers of monoclonal antibodies for therapeutic use.

Centocor currently markets Remicade in the United States. Schering-Plough Corporation has rights to market Remicade in all other countries throughout the world, except in Japan and parts of the Far East where Remicade will be marketed by Tanabe Seiyaku, Ltd. In August 1999, a centralized Type II variation was submitted to the European Agency for the Evaluation of Medicinal Products seeking clearance to market Remicade for the treatment of rheumatoid arthritis.

(1) Dr. Lipsky is senior director of the Intramural Research Program at the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the National Institutes of Health in Bethesda, Md. The views expressed by Dr. Lipsky in this release do not necessarily represent those of the National Institutes of Health or the Department of Health and Human Services.

Sources: Centocor, Inc.

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