July 22, 2009 — Intensive treatment with methotrexate may be helpful in early rheumatoid arthritis despite greater adverse events vs conventional treatment, according to the results of a study reported online in the July 5 issue of the Annals of the Rheumatic Diseases.
"In the two year Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA) study, more patients in the intensive MTX [methotrexate] strategy group (I-group) compared to the conventional MTX strategy group (C-group) achieved at least one period of remission during follow-up," write S.M.M. Verstappen, PhD, from University Medical Center in Utrecht, the Netherlands, and colleagues from the Utrecht Rheumatoid Arthritis Cohort study group.
"However, to compare the value of the two strategies, both beneficial effects and adverse effects are important to weigh. The aim of the present study was to compare toxicity profiles between both MTX treatment strategies and to study possible associations between baseline characteristics with MTX withdrawal and liver toxicity during follow-up."
The investigators used logistic regression analyses to identify possible associations between baseline factors and study withdrawal because of methotrexate-related adverse events or liver toxicity at follow-up.
Patients in the conventional treatment group attended outpatient clinic once every 3 months vs once per 4 weeks in the intensive treatment group. Both groups were permitted an increase in methotrexate dose to 30 mg/week when the patient had not responded, and after subcutaneous administration of methotrexate, cyclosporin was added to the methotrexate therapy.
All recorded adverse events were relatively mild and often reversible, but significantly more patients in the intensive treatment group vs those in the conventional treatment group went on to have methotrexate-related adverse events.
Multiple regression analyses showed that higher body mass index (BMI) was significantly associated with study withdrawal for methotrexate-related adverse events. There was also a trend towards decreased creatinine clearance being associated with methotrexate withdrawal. Liver toxicity during follow-up was predicted by higher serum liver enzyme levels at baseline.
Limitations of this study include missing baseline data in 42% of patients.
"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," the study authors write. "When starting MTX, attention should be given to patients with a high BMI and those with increased levels of liver enzymes and decreased renal function."
Ann Rheum Dis. Published online July 5, 2009.
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