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Title: BSR: Study Looks At Incidence Of Adverse Events With Infliximab In Rheumatoid Arthritis
URL: http://www.pslgroup.com/dg/1F8FF6.htm
Doctor's Guide
April 25, 2001


By David Jack, M. D.
Special to DG News


EDINBURGH, SCOTLAND -- April 25, 2001 -- Infliximab, the anti TNF-alpha monoclonal antibody, is a major advance in the treatment of rheumatoid arthritis (RA). In combination with methotrexate, it is the most effective method available for inhibiting the structural damage caused by RA. However, no guidelines have yet been established for the administration of infliximab based on timing and the impact of adverse events. At present, infusions are given over a two hour period followed by monitoring two hours after the end of the infusion.

The results of a study by Dr. M. H. Buch and colleagues from the Rheumatology and Rehabilitation Research Unit, Leeds, England, were presented at the annual meeting of the British Society of Rheumatology in Edinburgh in which they intended to determine the time of reactions with respect to the infusion, the consequences of these reactions and the evidence of adverse events two hours post-infusion.

A total of 340 infusions were given to 31 patients, the range being two to 37 infusions per patient. The group consisted of 25 females and six males with an age range of 21 - 83 years. The methotrexate dose was 7.5 - 20 mg weekly.

No patient dropped out and all reactions were found to occur within the first four infusions. The most commonly observed event was pyrexia (ranging from 37.2 - 38.2 o C) while about 15 percent of patients had a drop in systolic blood pressure below 90 mmHg. However, this only needed conservative measures such as bed-tilting and temporarily stopping the infusion. One patient stopped treatment because of mouth ulcers, another patient developed a macular-papular rash one week after the first infusion and a further four patients developed non-specific rashes, all of which resolved on their own. One patient exhibited an acute flare of arthritis 12 hours after the sixth infusion with no toxicity following the next infusion. Common mild adverse events included nausea, headache and upper respiratory tract infection.

Since, apart from the patient with mouth ulcers, no one needed to stop treatment, no patient developed a new reaction after the fourth infusion, and no one developed any adverse events in the two hour post-infusion period, Dr. Buch and his group recommend that: 1) greatest care should be taken during the first 4 infusions, and 2) the rate of infusion can be increased after the fourth infusion because many of the patients studied had received doses of 10 mg/kg at four weekly intervals.

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