Released 06 July 2009

Methotrexate side effects 'mild'

Adverse effects from methotrexate treatment are not serious, Dutch researchers have said.

The drug is the standard first-line treatment for people with several rheumatic diseases, including rheumatoid arthritis and psoriatic arthritis.

It works in patients by reducing levels of inflammation and is taken orally once a week - however, results are not immediate and patients may have to take the drug for several weeks before they notice a change in their condition.

In the new study, a team of researchers led by Dr JWG Jacobs of the University Medical Centre in Utrecht examined the "toxicity profiles in patients with rheumatoid arthritis treated either according to an intensive or a conventional treatment strategy approach with methotrexate".

They also looked at factors associated with toxicity caused by methotrexate intake, by analysing data from a clinical trial carried out to determine whether intensive treatment with the drug was more effective than regular treatment.

Results revealed that all side effects of the drug were mild, "although significantly more patients in the intensive treatment group experienced methotrexate-related adverse events compared to the conventional treatment group".

High body mass index (BMI) was associated with a withdrawal of the drug due to side effects and a high level of liver enzymes was related to liver toxicity, the study authors wrote in the Annals of the Rheumatic Diseases.

"Although the occurrence of adverse events in the intensive treatment group was higher than in the conventional treatment group, the previously observed clinical efficacy of an intensive treatment strategy seems to outweigh the observed toxicity profiles," they concluded.

"When starting methotrexate, attention should be given to patients with a high BMI and those with increased levels of liver enzymes and decreased renal function."

"Methotrexate is a drug that has been around for a long time and although a minority of patients can't tolerate it, the vast majority of patients with mild to moderate inflammatory arthritis find it controls their condition over a long period," said a spokesman for the Arthritis Research Campaign.



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