The PROMPT-study (Probable rheumatoid arthritis: Methotrexate versus Placebo Treatment-study) is a double-blind placebo controlled randomized multicenter trial in 110 patients with undifferentiated arthritis, which means they have arthritis but the exact diagnosis is undetermined. The aim of the study was to determine whether the patients would benefit from treatment with methotrexate (MTX). At the end of the study, patients were tested with a special antibody blood test (anti-cyclic citrullinated peptide antibody, anti-CCP) to confirm a diagnosis of RA, one of the most aggressive and debilitating forms of rheumatism.
The study concluded that, in the MTX group, fewer patients developed RA during the observed time and more patients reached remission than in the group receiving placebo. “This data is excellent news as it shows that methotrexate appears to delay or even prevent progression to rheumatoid arthritis amongst patients”, said study investigator Professor Tom Huizinga, Rheumatology, Leiden University Medical Center, Leiden.
Methotrexate is an antimetabolite drug, which means it is capable of blocking the metabolism of cells, and is well established in the treatment of cancer and autoimmune diseases such as RA. It acts specifically by inhibiting the metabolism of folic acid. In rheumatoid arthritis, MTX seems to work, in part, by altering aspects of immune function which may play a role in causing the disease.
“One of the most interesting findings from the study was that the patients who benefited the most were the ones showing a positive anti-CCP test, which would in general terms show that a patient has a very high likelihood to develop full-blown RA. However, this study indicates that the progression to a full-blown disease amongst these patients could be influenced”, noted Mrs. Dongen.
Henrike Van Dongen was one of only 12 scientists to be awarded Clinical Science Winner at this year’s Annual European Congress of Rheumatology as a result of this research. This work was also supported by The Dutch Arthritis Association.
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