Remicade Possibly Linked to Tuberculosis

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Remicade Possibly Linked to Tuberculosis

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LONDON (Reuters Health) Jan 02 - Twenty-eight people throughout North America

and Europe have developed tuberculosis - and one patient died - soon after they

were given the anti-inflammatory monoclonal antibody Remicade (infliximab), the

European Agency for the Evaluation of Medicinal Products (EMEA) reported

recently.

The product, which was developed by & subsidiary Centocor Inc.,

is indicated for the treatment of moderate-to-severe Crohn's disease and for

reducing the symptoms of rheumatoid arthritis. Patients from each disease group

experienced the adverse events, although it was not immediately clear to which

disease group the one patient who died belonged.

Around 100,000 patients worldwide have taken Remicade since it was launched in

the United States in August 1998 and since it received European marketing

authorisation in August 1999.

The drug is marketed by Schering-Plough in Europe and by & in

the United States.

In a public statement dated December 20, the EMEA said: " To date, 28 cases of TB

have been reported (nine cases in North America and 19 cases in Europe) of which

one had a fatal outcome.... "

" In a significant proportion, the onset of active TB occurred after three or

less infusions of Remicade, thus supporting a possible relationship with

initiation of Remicade therapy, " the agency added.

Patients with rheumatoid arthritis are infused every eight weeks, while patients

with Crohn's disease are treated with an initial infusion followed by subsequent

infusions when symptoms reappear, according to a Centocor spokesman.

The EMEA said that in view of the seriousness of these reports, it was

recommending that Remicade treatment should be stopped if active TB was

suspected in any patient until the diagnosis was ruled out or the infection had

been treated.

The spokesman, Allman, said that prescribing information supplied by

Centocor mentions TB as a potential adverse event. " This is not out of the

blue, " Allman said, referring to the 28 cases of TB.

Remicade's prescribing information, which is approved by US and European

regulatory agencies, mentions one patient who participated in a large, ongoing

trial of Remicade who died of disseminated TB.

According to the EMEA, patients should be evaluated for active and inactive TB

before beginning Remicade therapy. Patients should also be instructed to seek

medical advice if they develop symptoms suggestive of TB. Early symptoms include

productive cough, weight loss and fever.

Dr. Quartey, medical director at Schering-Plough UK, told Reuters Health

that it was a mystery why so many more cases of TB were reported in patients in

Europe than in the United States.

Allman told Reuters Health that in Europe, " TB is much more of an epidemic

proportion than it is [in North America]. " He cited efforts by the United States

Centers for Disease Control and Prevention to combat the disease.

Dr. Quartey said a causal link between the product and TB could not be proved

because patients would previously have taken large amounts of corticosteroids

and other immunosuppressants, which by themselves tend to trigger TB.

Allman confirmed that patients with Crohn's disease and rheumatoid arthritis who

are commonly treated with multi-drug regimens comprising immunosuppressants like

steroids, methotrexate and Remicade are at greater risk for developing

infectious disease like TB.

http://rheumatology.medscape.com/reuters/prof/2001/01/01.03/20010102publ001.html