Methotrexate is a common drug with a long history; for the past 40 years, it’s been used to treat a range of diseases.
Today it is the most commonly used drug for systemic rheumatic diseases worldwide and is the first drug a physician will prescribe for a patient with rheumatoid arthritis.
But despite its use by millions of people, there is no robust data on the rates of the side effects of the drug.
Previous studies have suggested that methotrexate may elevate a person’s risk of a variety of adverse events, including liver toxicity, anemia, and difficulty in breathing, but the magnitude of risk was unknown.
In a recent study from Brigham and Women’s Hospital, researchers found the drug methotrexate could increase risks for skin cancer, gastrointestinal, infectious, lung, and blood adverse events.
The study is published in the Annals of Internal Medicine. One author is Daniel Solomon, MD, MPH, a rheumatologist in the Division of Rheumatology, Inflammation and Immunology at the Brigham.
In the study, the team took advantage of data from the Cardiovascular Inflammation Reduction Trial (CIRT) and were been able to far more accurately determine the side effects of taking methotrexate.
The study offers a detailed side-effect profile that can help doctors prescribe methotrexate in an informed way.
The team looked at data on 4,786 participants from CIRT who were randomized to receive low-dose methotrexate with folate or a placebo.
Of 2,391 people who received methotrexate, 87% experienced an adverse event of interest compared to 81.5% of those who were randomized to placebo.
The team’s most surprising finding was a doubling of the risk of skin cancer for participants taking methotrexate.
This result may be particularly important because patients with psoriatic arthritis—a form of arthritis that affects people with psoriasis—are already at increased risk of skin cancer.
Gastrointestinal, infectious, pulmonary and hematologic adverse events were also elevated, but the increased risk was mild to moderate.
As anticipated, the team also saw an increase in liver test abnormalities and five cases of cirrhosis in the methotrexate arm versus zero in the placebo group.
The team says having a clear side-effect profile allows doctors to give it with eyes wide open and better balances the risks and benefits of an age-old drug.
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