Year: 2025 | Month: October-December | Volume: 10 | Issue: 4 | Pages: 55-62
DOI: https://doi.org/10.52403/ijshr.20250409
Comparative Study of Efficacy and Safety of Iguratimod Plus Methotrexate versus Methotrexate Monotherapy in Patients with Rheumatoid Arthritis
Priyanka Kumari1, Santosh Kumar1, Kumar Gaurav1, Arun Kumar1, Asha Singh2
1Tutor/Senior Resident, 2Professor & Head
Department of Pharmacology, Nalanda Medical College, Patna, Bihar, India
Corresponding Author: Arun Kumar
ABSTRACT
Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease associated with progressive joint destruction, disability, and comorbidities. Methotrexate (MTX) is the cornerstone of RA therapy, but many patients exhibit inadequate response or intolerance. Iguratimod (IGU), a novel disease-modifying antirheumatic drug (DMARD), inhibits NF-κB signaling and complements MTX’s mechanisms. Evidence from East Asia suggests that IGU combined with MTX improves disease control, but data from Indian populations remain limited.
Methods: This was a prospective, randomized, open-label, parallel-group clinical trial conducted over 18 months. A total of 120 RA patients fulfilling the 2010 ACR/EULAR criteria with active disease despite stable MTX therapy were randomized into two groups: MTX monotherapy (n=60) and MTX + IGU (n=60). Patients were followed for 24 weeks. The primary endpoint was the proportion achieving ACR20 at week 24. Secondary outcomes included ACR50/70, DAS28-ESR/CRP, HAQ-DI, ESR, CRP, and safety assessments. Statistical analysis was performed using intention-to-treat principles.
Results: Baseline characteristics were comparable between groups. At 24 weeks, the MTX + IGU group demonstrated significantly greater improvements in tender/swollen joint counts, ESR, CRP, DAS28, and HAQ-DI compared to MTX alone (all p < 0.0001). ACR20, ACR50, and ACR70 response rates were higher in the combination group (90%, 70%, and 26.7%) versus MTX monotherapy (83.3%, 33.3%, and 16.7%). Adverse events, including nausea, leukopenia, and elevated liver enzymes, were mild and comparable between groups, with no significant differences.
Conclusion: The combination of iguratimod and methotrexate was significantly more effective than methotrexate monotherapy in reducing disease activity and improving functional outcomes in Indian RA patients, without increasing adverse events. These findings support IGU + MTX as a safe, potent, and cost-effective therapeutic strategy for RA in resource-limited settings.
Keywords: Rheumatoid arthritis; Methotrexate; Iguratimod; Combination therapy; Disease Activity