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Anti-TNFs accepted by NICE for rheumatoid arthritis

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Rheumatoid arthritis

Rheumatoid arthritis: adalimumab added to drug arsenal

Adalimumab (Humira) has been added to the anti-tumour necrosis factor (TNF) therapies that can be prescribed for rheumatoid arthritis in the latest round of guidance issued by the National Institute for Health and Clinical Excellence.

The guidance replaces a technology appraisal issued in 2002 (PJ, 30 March 2002, p419) that endorsed infliximab (Remicade) and etanercept (Enbrel) as treatments for rheumatoid arthritis.

The latest guidance additionally includes adalimumab and takes into account changes in the marketing authorisations for infliximab and etanercept.

The therapies are recommended as options for the treatment of active rheumatoid arthritis in patients in England and Wales who have already tried two disease-modifying antirheumatic drugs, including methotrexate (see Panel below).

Definitions
The technology appraisal specifies that a trial of a disease-modifying antirheumatic drug is defined as being normally of six months’ duration, with two months at standard dose, unless significant toxicity has limited the dose or duration of treatment.

Active rheumatoid arthritis is defined by a disease activity score (DAS28) greater than 5.1, confirmed on two or more occasions one month apart.

NICE recommends that the drugs should be initiated and the patients followed up only by a specialist rheumatology team and that the drugs should normally be used in combination with methotrexate. However, they may be given as monotherapy if the patient is intolerant to methotrexate or it is considered inappropriate, it adds.

The technology appraisal specifies that treatment should be continued only if there is an adequate response, defined as an improvement in disease activity score of at least 1.2 points, six months after starting therapy.

NICE advises that treatment should normally be initiated with the least expensive drug but that this may be varied because of differences in the mode of administration and treatment schedules.

An alternative TNF inhibitor can be considered for those patients whose treatment is withdrawn due to adverse effects before the first six-month assessment of efficacy.

Sequential use, defined as the use of a second TNF inhibitor where there had been no response to, or loss of response to a first TNF inhibitor, will be the subject of later guidance.

Andrew Dillon, NICE chief executive and executive lead for the appraisal, explained: “So that we could issue guidance as quickly as possible to benefit people with rheumatoid arthritis, NICE has published the recommendations relating only to the first use of the drugs. The independent appraisal committee will give further consideration to the sequential use of these drugs, and will produce separate guidance on this specific use.”

Citation: The Pharmaceutical Journal URI: 10005251

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