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Data support adding rituximab to methotrexate to slow joint damage in early rheumatoid arthritis

Rituximab (MabThera) in combination with methotrexate is more effectivethan methotrexate alone at slowing joint damage when taken at the earlystages of rheumatoid arthritis, data presented at the European LeagueAgainst Rheumatism conference last month (10–13 June 2009) reveal

Rituximab (MabThera) in combination with methotrexate is more effective than methotrexate alone at slowing joint damage when taken at the early stages of rheumatoid arthritis, data presented at the European League Against Rheumatism conference last month (10–13 June 2009) reveal.

The randomised phase III trial enrolled 755 patients in the Netherlands, all of whom had recently diagnosed arthritis (disease duration of less than four years).

After a year of treatment, a higher proportion of patients who received two 1,000mg doses of rituximab plus methotrexate had no joint disease progression, and a lower change in radiograph readings (read using the Genent-modified method), compared with those taking methotrexate and placebo.

In addition, by week 52, 65 per cent of patients receiving the rituximab combination achieved a 50 per cent improvement in symptoms (ACR50), while 47 per cent had achieved a 70 per cent improvement (ACR70), compared with 42 per cent and 25 per cent, respectively, on methotrexate alone.

Remission occurred in more than twice as many patients taking the rituximab combination (30.5 per cent), as those taking methotrexate and placebo (12.6 per cent).

The researchers note that two 500mg doses of rituximab did not significantly inhibit joint damage, although they did improve clinical outcomes compared with methotrexate alone.

Rituximab is not currently licensed for use in early rheumatoid arthritis. It is licensed in combination with methotrexate to treat adults with severe active rheumatoid arthritis who have failed on antitumour necrosis factor therapy.

Richard Copeland, rheumatology pharmacist practitioner at Northumbria Healthcare NHS Trust, commented that although the study “provided interesting information as to the potential benefits of rituximab”, he thought it unlikely that clinical practice would change as a result.

He told The Journal: “Patients were included in the study if they had been diagnosed with RA in the last four years; in this respect, it would be unusual not to have used methotrexate previously as a disease modifying agent, and it could be argued that an earlier use of methotrexate, or a combination use of disease-modifying antirheumatic drugs [DMARDs] — as per the National Institute for Health and Clinical Excellence clinical guideline for RA — would have resulted in less joint damage and disease progression. Nevertheless, the rituximab patients in this study did have less progression of joint erosions in comparison to those receiving methotrexate alone.”

He added: “A really interesting study would be to compare early use of intensive DMARD treatment, ie, commenced within 12 weeks of onset of symptoms, versus rituximab. … Practical studies such as [this] are perhaps more likely to answer the question of whether earlier use of biologic treatments improves outcomes for patients with RA.”

Citation: The Pharmaceutical Journal URI: 10970495

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