Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis
DOI:
https://doi.org/10.31053/1853.0605.v64.n4.25431Abstract
Rheumatoid Arthritis (RA) is a chronic discase leacling to functional impairrncnt and early mortality. Treatment with diseasernodifying antirheumat.ic drugs have shown to achicvc disease remission and improves its evolution. The use of combined therapy should have a biological efficacy, no increased toxicity and have an acceptable dose interval. Also, it shoulcl begin its action quickly and he cost-effective. Aims: to assess the security of the combinen treatment withMethotrexate (MTX) and Leflunomide (LF) in patients with Rheurnatoid Arthritis (RA) and to evaluate whethcr the dose and route of MTX administration influence on the toxicity. Patients and Methocls: Patients with RA who fulfihlecl ACR entena and they attencled to the Rheumatology Unit at Córdoba Hospital in the Iast 2 years were assessed. All the patients that received combined treatment with MTX in doses from 7.5 mg to 25 mg weekly orally (PO) or
intramuscularly (TM) that started LF treatment in doses of 20 mg/day due to disease activity persistericc were retrospectively assessed.
Patients having at least 6 months of combined treatment were inclucled. Data on
treatment and adverse events were collected. They were evaluated at the hegirining, at 6 and 12 months of treatment. The presence of adverse events as well as the stop of combined treatment was evaluated at 6 and 12 months 01
treatment. Adverse events in patients with oral and IM MTX treatment and in different doses were compared for the analyses. P<0.05 was considered significant. Results: 62 patients with a mean age of 54 were included. 89% were female and had positive rheumatoid factor and 83% had radiological erosions. Eighty eight percent were in doses of I5mg MTX, 4.9%with lomg and 2flrngatthe
heginning of LE treatment. Twentv four percent suffered from adverse events and 33% left the medication by 6 months. Among adverse events, 6 patients had cliarrhea, 5 increased hepatic enzymes, 3 alopecia, 3 weight loss, and
2 had anemia and leucopenia. Eight patients stopped the medication in 6 months, but only 5 did because of adverse events. There was not significant statistical differcncc in adverse events hetween patients with different dose or routes of administration of MTX. Conclusions: The presence of adverse events in MTX and LF combined treatment was low and it developed dunng the first 6 months of treatment in our patients. The MTX route of administration and doses did not influence on the toxicity of the combined treatment with LF. The combined
therapy seems to be a sale treatment option in RA patients.
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