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PJ Online: Tumour necrosis factor antibody effective over two years

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The Pharmaceutical Journal Vol 266 No 7154 p873-877
June 30, 2001

Clinical Pharmacy News summary

Tumour necrosis factor antibody effective over two years

Adalimumab, a tumour necrosis factor (TNF) antibody currently in development, is effective and well tolerated in patients using the drug over a two-year period, according to the results of two studies.

In the first, 54 patients, who were partial responders to methotrexate, were randomised to receive adalimumab 1mg/kg either intravenously or subcutaneously, or placebo, in addition to methotrexate therapy. After the first two injections of adalimumab or placebo, all patients received open-label subcutaneous injections of adalimumab. The frequency of administration (every other week up to every other month) depended on the individual response to treatment.

The results of this study were presented by Professor Ferdinand Breedveld, Leiden University medical centre, the Netherlands, at the EULAR meeting. They showed that, overall, 50 per cent of patients achieved at least 20 per cent improvement in the signs and symptoms of their rheumatoid arthritis (defined using American College of Rheumatology criteria).

A total of 44 patients (81 per cent) completed the study, the reasons for withdrawal being the occurrence of adverse events (six patients), a lack of efficacy (two patients), death from a myocardial infarction (one patient), and protocol violation (one patient).

In the second study, presented by Professor Manfred Schattenkirchner, Munich University, Germany, 24 patients, who had failed to respond to at least one disease-modifying antirheumatic drug, were treated with adalimumab for up to two years. Initially, the patients received either adalimumab 0.5mg/kg weekly or placebo in a double-blind, controlled, 12-week trial.

Patients who achieved a good response at this dose continued to receive adalimumab 0.5mg/kg each week on an open-label basis. Patients on placebo, and those on adalimumab 0.5mg/kg weekly who had not achieved a clinically relevant response, went on to receive adalimumab 1mg/kg weekly.

The results of the open-label two-year follow-up study showed that 61 per cent of patients had achieved a 20 per cent improvement in the signs and symptoms of their arthritis. This represented a “good response in this group of DMARD-refactory patients” said Professor Schattenkirchner.

The trials reported on this page were presented at the European League Against Rheumatism (EULAR) meeting in Prague, Czech Republic, earlier this month. The Journal attended the meeting courtesy of Abbott Laboratories

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