Remicade as first-line therapy in early RA

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Rheumawire

Apr 21, 2004

Infliximab as first-line therapy in early RA?

Malvern, PA - The US FDA has accepted a supplemental filing for the TNF

antagonist infliximab (Remicade®, Centocor), which would allow its use

as a first-line therapy (in combination with methotrexate) in patients

with early rheumatoid arthritis (RA). If approved, infliximab will

become the only drug in its class with such a claim.

Infliximab is currently indicated for use in RA (in combination with

methotrexate) in patients with moderately to severely active disease who

have an inadequate response to methotrexate alone. The new supplemental

submission expands this indication to first-line therapy for early RA in

patients with moderately to severely active disease.

The submission is based on the results of the Active Controlled Study of

Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis

of Early Onset (ASPIRE), which were announced at last year's EULAR

meeting, as reported then by rheumawire. This 54-week study was

conducted in 1049 patients with early RA (<3 years) who had not

previously taken methotrexate and compared treatment with the

combination of infliximab and methotrexate with that with methotrexate

alone. The combination was superior on all primary and secondary end

points, including inhibition of the progression of structural damage,

prevention of bone erosions, and improvement in both physical function

and clinical symptoms.

The manufacturer has also filed a supplemental application for the use

of infliximab for the treatment of ankylosing spondylitis. This

indication is already approved for infliximab in Europe and is also

approved in the US for the rival TNF antagonist etanercept (Enbrel®,

Immunex/Wyeth).

Zosia Chustecka

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org