The Impact of Infliximab Trough Level and Anti-Drug Antibody on Clinical Outcomes in Crohn's Disease Patients: A Cross-Sectional Study in Iraq
DOI:
https://doi.org/10.31351/vol35iss3pp80-88Keywords:
Crohn's Disease, Infliximab, Therapeutic Drug Monitoring, Autoantibody, Inflammatory Bowel DiseaseAbstract
Introduction:
Primary non-response and secondary loss of response, often mediated by the development of anti-drug antibodies (ADAs), limit treatment efficacy. Therapeutic drug monitoring (TDM) is gaining importance in optimizing infliximab therapy by correlating drug levels with clinical outcomes. This study aimed to investigate the relationship between infliximab levels, ADA presence, and clinical activity in Iraqi Crohn's disease patients.
Methods:
This cross-sectional study included adult Crohn's disease patients receiving infliximab treatment at a specialized hospital in Iraq. Data on demographics, clinical characteristics, and laboratory parameters were collected. Infliximab levels and ADA were measured using ELISA
Results:
Forty-three patients were included. Patients in remission had significantly higher infliximab levels (p=0.037) and lower ADA levels (p=0.049) compared to those with active disease. CDAI correlated negatively with infliximab levels (r=-0.34, p=0.025) and positively with ADA levels (r=0.36, p=0.019). Infliximab levels correlated negatively with treatment duration (r=-0.34, p=0.03) and ESR (r=-0.36, p=0.02), while positively correlating with the infliximab dose (r=0.38, p=0.011). ADA levels correlated positively with treatment duration (r=0.34, p=0.03).
Discussion :
This study, which investigated infliximab (IFX) and anti-drug antibody (ADA) levels in Crohn's disease patients during maintenance therapy, observed a patient remission rate of approximately 50% despite an initial response rate exceeding 80% during induction. The mean IFX plasma level was 3.28±5.19, with significantly higher levels in patients in remission compared to those with active disease (4.91±6.65 vs. 1.73±2.56). While some studies recommend concomitant immunosuppressants to increase IFX efficacy, this study found no significant difference in response between patients using these medications and those who weren't. Notably, active disease patients showed high ADA and low IFX levels, and a negative correlation was found between CDAI and IFX levels, and a positive correlation between CDAI and ADA. These findings, consistent with other research, underscore the critical need for therapeutic drug monitoring (TDM) to personalize IFX dosing, aiming to improve patient response rates, reduce overall treatment costs, and minimize adverse events from concomitant medications, particularly in regions like Iraq where TDM implementation is currently limited.
Conclusion:
This study demonstrated a significant association between infliximab levels and clinical activity in Crohn's disease. Patients in remission exhibited higher IFX levels and lower ADA levels, suggesting a potential role for TDM in optimizing infliximab therapy by tailoring treatment regimens to individual patient needs and improving clinical outcomes.
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