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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.
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