SAFETY OF USING METHOTREXATE SOLUTION FOR SUBCUTANEOUS INJECTIONS IN PATIENTS WITH RHEUMATOID ARTHRITIS

Abstract

Objective : to evaluate the safety of treatment with methotrexate (MT) solution for subcutaneous injections in patients with rheumatoid arthritis (RA). Subjects and methods . 237 RA patients enrolled in the study within the REMARCA protocol were given MT solution for subcutaneous injections (Metoject) to assess the standard parameters of therapy safety. Results. Overall, adverse events (AE) were noted in 49 (21%) patients. In 30 (30%) of them RA duration was less than 6 months (Group 1) and in 19 (14%) – more than 6 months (Group 2), in most cases average MT dose was 20.9±3.45 mg/week. Elevation of alanine aminotransferase and aspartate aminotransferase levels, nausea, postinjection reactions, alopecia, rash, infections, and leukopenia, were common (> 1%, but <10%); diarrhea, metallic taste in the mouth, soft tissue abscess/infiltration developing far from the injection site, were uncommon (the WHO term corresponding to 0.1–1%). AE required MT discontinuation in 4.2% of the patients. Conclusion. The results of the study allow discussing subcutaneous MT administration before treatment with biologicals, which makes it possible not only to reduce financial expenditures, but also to improve patient safety