Suboptimal methotrexate use in rheumatoid arthritis patients in Italy: the MARI study.

Objective Methotrexate (MTX) is the first choice in the treatment of rheumatoid arthritis (RA), but the doses and regimens vary significantly. For this purpose, we conducted an observational study on the use of MTX for RA in Italy (MARI study). Methods The MARI study included 1,327 RA patients on MIX treatment for at least 12 months, at 60 Italian rheumatology units. Concomitant medications with corticosteroids, other DMARDs or biological therapies were recorded. The clinical assessment included the Disease Activity Score 28 (DAS28) and the serological positivity for the rheumatoid factor or for the anti-citrullinated protein antibodies. Results The included patients were treated with either oral (n=288) or parenteral (n=1039) MIX. Only 15.5% of the total number of the patients was on adequate MTX dose (i.e. >= 15 mg for the oral route of administration and > 12 mg for the parenteral one). The initially established MIX dose was modified in 37.1% of the patients, for intolerance or clinical criteria. A DAS28 remission (DAS28 < 2.6) was observed only in 58.5% of the cases, while 52.9% of the patients still presenting an active form of the disease were on suboptimal doses of MTX. Conclusion The weekly dose of MTX prescribed for the treatment of RA is often suboptimal, even in conditions of inadequate control of the disease activity. The recommendations for the use of MTX in RA patients should take into account the efficacy and tolerability data derived from its use in real clinical practice.