Investigating the Link between Serum Folate and Homocysteine Levels and Methotrexate Treatment Response in Juvenile Idiopathic Arthritis: A Prospective Observational Study (Code-T0067)

Background: Juvenile Idiopathic Arthritis (JIA) is a chronic inflammatory condition in children, often treated with methotrexate (MTX). However, the response to MTX therapy can vary among individuals, with some patients experiencing suboptimal outcomes. Previous studies suggest that serum folate and homocysteine levels may influence the therapeutic response to MTX. This study aims to evaluate the relationship between serum folate and homocysteine levels and the clinical response to MTX in patients with JIA.

Aim and Objectives:

Primary Objective:

1. To evaluate the association between baseline serum folate levels and change in disease activity score after 3 months of methotrexate therapy in children with JIA
2. To evaluate the association between serum homocysteine levels and change in disease activity score after 3 months of  methotrexate therapy in children with JIA

Secondary Objective:

1. To evaluate correlation between serum folate and serum homocysteine levels in children with JIA .
2. Change in serum folate level after supplementation with folic acid during treatment with Methotrexate at baseline and after 3 months.
3. Change in homocysteine level after supplementation with folic acid during treatment with Methotrexate at baseline and after 3 months.

Methods: This prospective observational study was conducted on 80 children diagnosed with JIA who were undergoing MTX therapy. Serum folate and homocysteine levels were measured at baseline and after 12 weeks of treatment. The clinical response to MTX was assessed using the American College of Rheumatology Pediatric 30 (ACR Pedi 30) criteria. Data were analyzed to determine if baseline serum folate and homocysteine levels were predictive of the response to MTX therapy.

Results: The study found a significant association between lower baseline serum folate levels and a poor response to MTX therapy (p < 0.05). Additionally, elevated serum homocysteine levels were correlated with a decreased response to MTX (p < 0.05). Patients with optimal folate levels and lower homocysteine levels showed a significantly better clinical response to MTX, with higher rates of achieving ACR Pedi 30 improvement.

Conclusion: Serum folate and homocysteine levels are potential biomarkers for predicting the response to methotrexate therapy in children with Juvenile Idiopathic Arthritis. Monitoring these levels could help tailor MTX treatment for better clinical outcomes.

Keywords: Juvenile Idiopathic Arthritis, Methotrexate, Folate, Homocysteine, Biomarkers, ACR Pedi 30.