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Adding etanercept to MTX improves early remission

Patients with early severe rheumatoid arthritis (RA) have a greater chance of remission in the first year of therapy if treated with combined methotrexate and tumour necrosis factor (TNF) inhibitor, a trial published online on 16 July 2008 in The Lancet suggests.

The combination of methotrexate and etanercept in early rheumatoid arthritis (COMET) trial showed that remission and radiographic non–progression rates were improved within one year by the combination treatment, compared with methotrexate monotherapy.

The trial involved 542 adults diagnosed with adult-onset RA, with a disease duration of at least three months but no longer than two years. Patients had received no previous treatment with methotrexate, etanercept or other TNF inhibitors, and had not received other disease-modifying antirheumatic drugs or corticosteroid injections in the four weeks preceding baseline visits.

The proportion of participants who achieved Disease Activity Score 28 (a 28-joint count assessment) remission from weeks 2–52 of treatment was greater in the combined treatment group than in the monotherapy group (50 per cent compared with 28 per cent; P<0.0001).

A significant difference was also seen in DAS44 (a 44-joint count assessment) remission between the two treatment groups. One fifth more subjects in the combined-treatment group had radiographic non-progression of joint damage than in the methotrexate group (P<0.0001).

An accompanying comment on the COMET study (ibid) questions whether or not the difference between the response to the combination versus methotrexate alone is worth the additional cost, inconvenience and potential toxic effects.

Joel Kremer, of the centre for rheumatology, Albany Medical College, Albany, points out that the kinds of patient typically included in randomised trials “have a great deal more disease than might be typically seen in the clinic. With low disease activity at the time of drug initiation, so-called floor effects make the achievements in standard outcome measures more problematic”.

He proposes the collection of real-world data by national registries over 10 years to investigate whether the improved outcome resulting from combination treatment persists over longer periods and, if so, whether “the overall incidence of serious adverse events, serious infections and societal expense warrant the difference in outcomes between the two interventions”.

Citation: The Pharmaceutical Journal URI: 10022814

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