Proactive therapeutic concentration monitoring of infliximab may improve outcomes for patients with inflammatory bowel disease: results from a pilot observational study.

Abstract

BACKGROUND:

Infliximab (IFX) is effective in the treatment of inflammatory bowel disease; however, the effect is often not durable. It is unknown if proactive therapeutic concentration monitoring (TCM) of IFX improves outcomes.

METHODS:

This is a retrospective observational study examining the use of proactive TCM and titration of IFX to a target concentration for patients with inflammatory bowel disease in clinical remission at a tertiary care center. The primary aim was to describe the clinical course of patients who had proactive TCM. A secondary analysis was done to assess if this strategy was superior to the standard of care.

RESULTS:

Forty-eight patients were identified as having proactive TCM. Fifteen percent had an initial undetectable trough concentration. Twenty-five percent (12 of 48) of patients escalated IFX after the first proactive TCM while 15% (7 of 48) of patients de-escalated IFX therapy over the study period. A control group of 78 patients was identified. Patients who had proactive TCM had a greater probability of remaining on IFX than controls (hazard ratio, 0.3; 95% confidence interval, 0.1-0.6; log rank test; P = 0.0006). The probability of remaining on IFX was greatest for patients who achieved a trough concentration >5 μg/mL (hazard ratio, 0.03; 95% confidence interval, 0.01-0.1; P < 0.0001 versus trough <5 μg/mL). Fewer patients in the proactive TCM group stopped IFX (10% versus 31%, P = 0.009).

CONCLUSIONS:

In this pilot observational study, proactive TCM of IFX frequently identified patients with low or undetectable trough concentrations and resulted in a greater probability of remaining on IFX.

• Authors: Byron P Vaughn, Manuel Martinez-Vazquez, Vilas R Patwardhan, Alan C Moss, William J Sandborn, Adam S Cheifetz
• Journal: Inflammatory bowel diseases (Inflamm Bowel Dis) Vol. 20 Issue 11 Pg. 1996-2003 (Nov 2014) ISSN: 1536-4844 [Electronic] England
• PMID: 25192499 (Publication Type: Comparative Study, Journal Article, Observational Study, Research Support, N.I.H., Extramural)

Chemical References

• Antibodies, Monoclonal
• Gastrointestinal Agents
• Infliximab

Topics

• Adult
• Antibodies, Monoclonal (pharmacokinetics, therapeutic use)
• Case-Control Studies
• Drug Monitoring
• Female
• Follow-Up Studies
• Gastrointestinal Agents (pharmacokinetics, therapeutic use)
• Humans
• Inflammatory Bowel Diseases (blood, drug therapy, immunology)
• Infliximab
• Male
• Middle Aged
• Pilot Projects
• Prognosis
• Retrospective Studies
• Tissue Distribution