The Pharmaceutical Journal
Vol 272 No 7305 p796
26 June 2004

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Non-Hodgkin's lymphoma drug effective in rheumatoid arthritis

A randomised controlled trial in 161 patients with longstanding rheumatoid arthritis has shown that giving two intravenous infusions of the monoclonal antibody rituximab, leads to symptom reduction.

At 24 weeks, 43 per cent of patients given 1,000mg of rituximab on days 1 and 15 (plus methotrexate), experienced a 50 per cent improvement in symptoms assessed using American College of Rheumatology criteria (P=0.005). This compared with 41 per cent of patients given a combination of rituximab and cyclophosphamide and 13 per cent of patients in the control group, who were given methotrexate alone.

In addition, responses lasted almost up to a year with no further therapy. Analysis of responses at week 48 showed that 35, 27 and 5 per cent of patients in the rituximab-methotrexate, rituximab-cyclophosphamide and the methotrexate groups, respectively, had 50 per cent symptom improvement. “Methotrexate is doing something that is allowing the sustained response,” Paul Emery, professor of rheumatology, University of Leeds, said at a meeting during the Annual European Congress of Rheumatology.

Professor Emery said that although there seems to be many therapies for rheumatoid arthritis, in practice there is a huge need for new approaches. He explained that rheumatologists are increasingly finding patients in whom anti-tumour necrosis factor therapy is failing, usually through loss of efficacy. In his own practice, there are about 200 patients who have failed anti-TNF or have additional risks, which mean they cannot take it. Rituximab works by targeting B cells and is promising because patients who have failed with anti-TNF will respond to it, he added.

Although rituximab was given twice in the trial, how frequently it needs to be administered is unknown. “Maybe we will only need to give it once. We might be able to get away with giving half the dose, or a small dose first and a bigger dose later, but these are all things that will be sorted out in the wash,” Professor Emery said.

The study is published in The New England Journal of Medicine (2004;350:2572).


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