Long Term Safety of Infliximab
Infliximab is a chimeric anti-tumour necrosis factor-alpha monoclonal antibody that has been studied for the treatment of Crohn’s disease and rheumatoid arthritis. In several placebo controlled, randomized clinical trials and open trials, 771 patients have been given infliximab (a further 192 receiv...
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| Main Author: | |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2000-01-01
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| Series: | Canadian Journal of Gastroenterology |
| Online Access: | http://dx.doi.org/10.1155/2000/698523 |
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| Summary: | Infliximab is a chimeric
anti-tumour necrosis factor-alpha monoclonal antibody that has
been studied for the treatment of Crohn’s disease and rheumatoid
arthritis. In several placebo controlled, randomized clinical trials
and open trials, 771 patients have been given infliximab (a further
192 received placebo). Follow-up for safety has included the time
of study (12 weeks after the last infusion), plus three additional
years. Acute infusion reactions (headache, fever, chills, urticaria,
chest pain) were seen in17% of patients receiving infliximab compared
with 7% of those receiving placebo. While infections were
reported more frequently overall in the patients given infliximab
(26% over 27 weeks of follow-up versus 16% of placebo-treated
patients over 20 weeks of follow-up), there was no increased risk of
serious infections. There was no difference in the overall mortality
rate between the groups. While low titres of autoantibodies developed
in less than 10% of patients, drug-induced lupus was seen in
less than 1%, with these cases resolving upon discontinuation of
the drug. Overall, infliximab showed an acceptable safety profile. |
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| ISSN: | 0835-7900 |