(B-305) Methotrexate Safety Monitoring in Patients with Rheumatoid Arthritis

Background: Methotrexate (MTX) is the first-line disease-modifying antirheumatic drug for Rheumatoid Arthritis (RA) treatment. While effective, MTX can induce hepatotoxicity, nephrotoxicity, and bone marrow suppression. The South African Standard Treatment Guidelines (STG) mandate monitoring of aminotransferase (ALT) and full blood count (FBC) levels before MTX initiation and at 12-week intervals during treatment to mitigate these adverse effects. The Western Cape Department of Health has modified these guidelines for stable patients (those on MTX ≥6 months), recommending FBC and ALT monitoring at minimum six-month intervals. Additionally, concurrent folic acid supplementation (5 mg) is required.

Objectives: This study evaluated adherence to STG safety monitoring recommendations for RA patients receiving MTX in the Western Cape public sector.

Methods: A retrospective review of medical records for RA patients who received MTX was conducted between January and December 2022. Inclusion criteria comprised: age ≥18 years, oral MTX treatment duration ≥6 months, and documented arthritis diagnosis. Data extraction from the Western Cape Government Health and Wellness Central database included demographic information, disease characteristics, MTX treatment parameters, laboratory monitoring results (FBC, platelets, ALT), and folic acid prescription status. Statistical analysis employed descriptive methods, presenting results as counts, frequencies, and means with standard deviations.

Results: Analysis of 820 patient records revealed a mean age of 55.3±13.3 years, with female predominance (82.0%). Mean MTX treatment duration was 77.3±46.4 months. Laboratory monitoring at MTX initiation showed 72% compliance for both FBC and ALT testing. Recent monitoring revealed high compliance rates, with 91% and 89% of patients receiving FBC and ALT tests within six months of their latest MTX prescription, respectively. Folic acid co-prescription was documented in 96% of cases. Final laboratory results demonstrated normal ranges for white blood cell count (86%), platelet count (74%), and ALT concentration (90%).

Conclusions: The findings demonstrate substantial adherence to monitoring protocols, with most patients receiving recommended laboratory testing at both the initiation and maintenance phases of MTX therapy. While laboratory parameters were predominantly within normal ranges, study limitations include the exclusion of RA patients lacking electronic diagnostic records and the analysis of only the most recent monitoring data. A more comprehensive study is in progress to evaluate guideline adherence patterns, which will inform policy development and resource allocation strategies.