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European Commission Approves Label Extension for Infliximab Allowing for Shortened Infusion Time in Patients With Rheumatoid Arthritis

HORSHAM, Pennsylvania and KENILWORTH, New Jersey, December 14/PRNewswire/ -- Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission (EC) has approved a label extension for REMICADE(R) (infliximab) allowing for a shortened infusion time in patients with rheumatoid arthritis (RA). The EC approval follows a positive opinion by the Committee for Medicinal Products for Human Health (CHMP) of the European Medicines Agency (EMEA) received in September.

The shortened infusion time label extension will allow carefully selected patients with RA who have tolerated three initial two-hour infusions of REMICADE to be administered subsequent infusions over a one hour period. This is half the time of the current recommended infusion time. Shortened infusions at doses greater than 6 mg/kg have not been studied.

"This is welcome news for European rheumatologists who regularly manage rheumatoid arthritis patients," said Paul Emery, MD, Arthritis Research Campaign Professor and Head of Academic Medicine, University of Leeds. "This label change will provide physicians and their patients with a new option in the treatment of this debilitating disease."

"This latest regulatory action further validates the safety and efficacy profile of REMICADE for the treatment of patients with rheumatoid arthritis," said Robert Spiegel, MD, chief medical officer and senior vice president, Schering-Plough Research Institute. "The European Commission approval represents greater convenience for rheumatoid arthritis patients, physicians and their staffs with a new option to shorten the infusion time for REMICADE."

The EC approval of the shortened infusion time is based on data from the ASPIRE (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) trial, a 54-week, randomized, double blind, placebo control study involving 1,040 patients with RA. The study found that of the infliximab-treated patients who received at least one shortened infusion of 90 minutes or less, infusion-related reactions occurred in 15 percent of patients and serious infusion reactions occurred in 0.4 percent of patients.

About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, debilitating inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. Symptoms of RA include inflammation of the joints, swelling, difficulty moving, and pain. The most commonly affected joints are the hands and feet. The joint pain of RA can impact a patient's ability to perform normal daily activities, limit job opportunities, and make family and household responsibilities a challenge. RA afflicts more than 9.7 million people worldwide; according to the World Health Organization, the incidence of RA in Europe is expected to increase over the next decade as the population ages.

About ASPIRE
ASPIRE evaluated the efficacy and safety of REMICADE in combination with methotrexate compared with placebo plus methotrexate. Patients in the ASPIRE study had an average of only seven months of disease duration and more than 90 percent already had evidence of erosive joint destruction. At randomization, all patients received methotrexate and either placebo, REMICADE 3mg/kg or REMICADE 6mg/kg at weeks 0, 2 and 6 and then every eight weeks thereafter. The ASPIRE trial had three co-primary endpoints at week 54: reduction of signs and symptoms, reduction in the rate of the progression of joint damage and improvement in physical function. All three primary endpoints were met, with the REMICADE and methotrexate regimen being superior to placebo and methotrexate alone on all primary and major secondary endpoints.

Sixty-six percent of patients with rheumatoid arthritis who tolerated the initial three infusions (686 out of 1040) received at least one shortened infusion of 90 minutes or less and forty four percent of patients with rheumatoid arthritis who tolerated the initial three infusions (454 out of 1040) received at least one shortened infusion of 60 minutes or less. Of the REMICADE-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15 percent of patients and serious infusion reactions occurred in 0.4 percent of patients.

Source: Centocor, Inc. and Schering-Plough Corporation

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