COMPARATIVE STUDY ON PHARMACOVIGILANCE AND PHARMACOECONOMIC EVALUATION OF CONVENTIONAL AND BIOLOGICAL DMARD THERAPY IN RHEUMATOID ARTHRITIS

Abstract

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease requiring long-term treatment. Conventional disease-modifying antirheumatic drugs remain the foundation of therapy, whereas biological DMARDs are important for patients requiring treatment escalation. Their safety monitoring and economic burden are important in clinical practice. Objective: To evaluate the pharmacovigilance profile, treatment pattern and drug-cost burden associated with conventional and biological DMARD therapy in patients with RA. Methods: A comparative observational evaluation was performed using data from 30 patients with RA. Demographic characteristics, symptoms, laboratory investigations, treatment patterns, documented adverse drug reactions (ADRs), ADR management, WHO–UMC causality and drug costs were analyzed descriptively. Results: The study population included 21 females (70.0%) and 9 males (30.0%), with most patients aged 40–59 years. Methotrexate monotherapy was the most common treatment (46.7%), while adalimumab monotherapy was recorded in 6.7%. Three valid documented ADRs were identified (10.0%): an adalimumab-related injection-site reaction, methotrexate-associated nausea and leflunomide-associated skin rash. Two ADRs were mild, one was moderate, all recovered, and all were classified as probable by WHO–UMC assessment. Total recorded drug expenditure was ₹88,570, with a mean of ₹2,952.33 and median of ₹835 per patient; costs ranged from ₹195 to ₹18,800. Conclusion: Conventional DMARDs, particularly methotrexate, predominated and appeared economically accessible in this cohort, whereas higher-cost therapy contributed to substantial expenditure variability. The low number of documented ADRs does not permit a definitive comparative safety conclusion between DMARD categories. Larger studies with standardized direct group-wise cost and safety comparisons are required.