EU approval for infliximab in early RA

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EU approval for infliximab in early RA

Rheumawire

Jun 22, 2004 Zosia Chustecka

London, UK - The European Agency for the Evaluation of Medicinal

Products (EMEA) has granted approval for an additional indication for

infliximab (Remicade®, Centocor/Schering-Plough), which covers use of

the TNF inhibitor together with methotrexate in early rheumatoid

arthritis (RA). This same additional indication for infliximab is

pending approval in the US; the supplemental application was accepted in

April, as reported by rheumawire.

This use of infliximab in early RA is based on the Active Controlled

Study of Patients Receiving Infliximab for Treatment of Rheumatoid

Arthritis of Early Onset (ASPIRE), in which participating RA patients

had an average duration of disease of only 7 months. The trial involved

1049 patients, lasted 54 weeks, and demonstrated the superiority of

infliximab plus methotrexate over methotrexate in improving the signs

and symptoms of RA, in preventing the progression of structural damage,

and in improving physical function.

A new subanalysis of data from ASPIRE, presented at the recent EULAR

meeting, confirms the effect of the combination on preventing

progression of structural damage. The original analysis was carried out

on the overall patient population. The new subanalysis focused on

patients who already had progressive disease and bone erosions on

enrollment into the trial (making up more than 90% of the total). In

this subgroup, more than 55% of patients treated with the infliximab and

methotrexate combination showed an improvement in bone-erosion scores,

compared with only 26.8% in the group receiving methotrexate alone. In

the small subgroup of patients who had no joint damage at the beginning

of the study, 79.7% of those treated with the combination still showed

no damage at week 54, compared with 63% of those treated with

methotrexate alone.

" The new results from the ASPIRE trial contribute to the growing body of

clinical evidence that supports earlier initiation of therapy for RA

patients, " says Prof Emery (Leeds University, UK). " Our findings

clearly demonstrate that early treatment with infliximab can prevent the

progression of this debilitating disease and can improve bone erosion

scores, suggesting that repair may be possible. "

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org