Safety Profile of Methotrexate in Patients with Rheumatoid Arthritis

Background: Methotrexate (MTX) is recommended as first-line therapy in patients with active Rheumatoid Arthritis (RA) as monotherapy or in combination with other disease-modifying anti-rheumatic drugs (DMARDs). Despite being considered a safe drug, some toxicities of MTX are inevitable and patients discontinue further treatment with MTX for the same.

Objective: To evaluate the safety profile of Methotrexate in patients with RA.

Methodology: An observational cross sectional study was conducted at a tertiary care hospital from 1st January 2020 to 31st December 2020 at rheumatology OPD in department of medicine, KLES, Dr. Prabhakar Kore Hospital, Belagavi. 117 patients diagnosed with RA who had been undergoing methotrexate treatment for at least six months as monotherapy or in combination with other DMARDs were included. Patient demographics, disease and treatment characteristics, side effects, and blood and laboratory markers specific to RA were studied with regards to methotrexate. Continuous variables were presented as mean and standard deviation, while categorical variables were presented as frequency and percentage. Association between categorical variables was done using Fisher exact test and chi square test.

Results: The study predominantly consisted of females (85.5%), and the mean age of patients was 47.92±13.398 years. Patient-reported side effects were seen/observed in 47% of patients. Commonly reported minor side effects were fatigue (17.1%), nausea (16.2%), anorexia (11.1%), stomatitis/oral ulcers (10.3%), epigastric burning (8.5%), hair fall (3.4%), and vomiting in 0.9% of patients. Demographic and clinical factors were not associated with side effects. There was no significant association between side effects and type of treatment.

Conclusion: Use of methotrexate in combination with other DMARDs is safe and should be encouraged as first line treatment of RA on routine basis. However, periodic blood and laboratory monitoring along with patient follow-ups are essential for early detection of toxicities.