The Pharmaceutical Journal
Vol 279 No 7466 p198
25 August 2007

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News summary

Restricted approval of rituximab and adalimumab

Arthritis treatments rituximab (Mabthera) and adalimumab (Humira) have been approved for use in England and Wales by the National Institute for Health and Clinical Excellence, with restricions, in separate technology appraisals published this week.

NICE recommends rituximab in combination with methotrexate for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to or are intolerant of other disease-modifying anti-rheumatic drugs (DMARDs), including treatment with at least one anti-tumour necrosis factor drug.

Rituximab/methotrexate treatment, NICE stipulates, should only be continued in patients who respond adequately, defined as an improvement in disease activity score of 1.2 points or greater. Furthermore, NICE limits repeat courses of rituximab to six-monthly intervals.

Adalimumab is recommended as a treatment option for adults with active and progressive psoriatic arthritis only when:

• The patient has peripheral arthritis with three or more tender joints and three or more swollen joints

• The patient has not responded to adequate treatment attempts with at least two standard DMARDs, given individually or in combination

NICE requires adalimumab treatment to be discontinued after 12 weeks if an adequate response is not achieved according to criteria set out in its guidance.