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Monitoring Treatment Effectiveness of Inflammatory Bowel Diseases

Gastrointestinal (GI) tract disorders are often presented with non-specific symptoms and are difficult to diagnose. Inflammatory bowel disease (IBD) is one of the most common and serious gastroentestinal disorders. The two clinically-distinctive forms of IBD are ulcerative colitis and Crohn’s disease. Treatments can be complicated, involving immunosuppresant therapies, biological drugs and/or surgery.

Labcorp has developed a broad menu of test offerings to help physicians and patients with these diseases. From diagnosis to treatment with thiropurines and biologics to monitoring for efficacy and drug concentrations, Labcorp stays at the at forefront of laboratory testing to assist these patients.

The Labcorp Difference
 

  • Comprehensive laboratory services for the gastroenterology specialist

  •  Broad network of managed care health plans

  • Flexible connectivity options for test ordering and reporting

  • Patient service centers available nationwide

  • Local account representation

Diagnosis

Novel serological markers for inflammatory bowel disease (IBD) improve sensitivity and specificity to aid in differential diagnosis and provide valuable prognostic information about disease behavior.

Clinical Application

  • Five-marker IBD profile identifies and differentiates patients with ulcerative colitis (UC) and Crohn’s disease (CD)
  • Reported up to 97% specificity in differentiating UC from CD1-3
  • Reported up to 70% sensitivity in identifying patients with UC4,5
  • Reported up to 85.5% sensitivity in identifying patients with CD using multiple markers6
  • 56.4% sensitivity in identifying CD patients who are anti-Saccharomyces cerevisiae antibody (ASCA) negative6
  • Three prognostic levels for CD severity are provided, allowing for improved treatment decisions
  • Test combination formulated to be appropriate and cost effective for patients

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Thiopurines

Thiopurine-related testing may be used to assess dosing before and during treatment, as well as to identify patients who may be at risk for drug toxicity.7 Variants in the TPMT gene that lead to low-enzyme activity can lead to an increased risk of thiopurine toxicity.7-9 Because of the potentially severe bone marrow toxicity that can occur even with standard thiopurine dosages in patients with TPMT enzyme deficiency, the FDA-approved label recommends consideration for testing for the most common TPMT gene mutations (genotype) or TPMT activity (phenotype) before beginning treatment. The information can be used to adjust the drug dosage or can suggest the use of an alternative treatment.10

  • TPMT Genetic Test utilize prior to treatment to identify common mutations that cause low TPMT activity
  • TPMT Activity Test utilize prior to treatment as a screen for low TPMT activity, and directly measures red blood cell thiopurine S-methyltransferase phenotypic activity
  • Thiopurine Metabolites Test utilize during treatment to help reach and maintain therapeutic goal7

Biologics

Labcorp has developed and validated highly sensitive and specific assays for a growing number of biologics that can help: aid in titrating doses to maximize effectiveness, in a personalized, patient-specific manner11-13; help avoid a lack of response due to under-treatment11; assist in preventing and managing loss of response due to immunogenicity14-15; and minimize cost to patient by avoiding unhelpful dose escalation, esp. in the setting of immunogenicity.11,16

Labcorp Biologic Tests provide both drug concentration (TDM) & anti-drug antibody (immunogenicity). TDM for Biologics is a valuable tool to evaluate doses and to tailor dose adjustments to your individual patient.13,17 It can help differentiate under-treatment from other causes of lack of response.15 Anti-drug antibodies can adversely affect the amount of drug in the body.18 Therefore, concomitant measurement of anti-drug antibodies is an important adjunct to TDM for Biologics.

Document Downloads & Resources:
 

Resources

  1. Dotan I, Fishman S, Dgani Y, et al. Antibodies against laminariboside and chitobioside are novel serologic markers in Crohn’s disease. Gastroenterology. 2006;131:366-378.
  2. Ferrante M, Liesbet H, Joossens M, et al. New serological markers in inflammatory bowel disease are associated with complicated disease behavior. Gut. 2007;56:1394-1403.
  3. Papp M, Altorjay I, Dotan N et al. New serological markers for inflammatory bowel disease are associated with earlier age at onset, complicated disease behavior, risk for surgery, and NOD2/CARD15 genotype in a Hungarian IBD cohort. Am J Gastroenterol. 2008;103:665-681.
  4. Jaskowski TD, Litwin CM, Hill HR. Analysis of serum antibodies in patients suspected of having inflammatory bowel fisease. Clin Vaccine Immunol. 2006;13(6):655-660.
  5. Quinton J-F, Sendid B, Reumaux D, et al. Anti-saccharomyces cerevisiae mannan antibodies combined with antineutrophil cytoplasmic autoantibodies in inflammatory bowel disease: Prevalence and diagnostic role. Gut. 1998;42:788-791
  6. Malickova K, Lakatos PL, Bortlik M, Komarek V, Janatkova I, Lukas M. Anticarbohydrate antibodies as markers of inflammatory bowel disease in Central European cohort. Eur J Gastroenterol Hepatol. 2010;22(2):144-150.
  7. Chevaux JB, Peyrin-Biroulet L, Sparrow MP. Optimizing thiopurine therapy in inflammatory bowel disease. Inflamm Bowel Dis. 2011 Jun; 17(6): 1428-1435.
  8. Clunie GPR, Lennard L. Relevance of thiopurine methyltransferase status in rheumatology patients receiving azathioprine. Rheumatol. 2004 Jan; 43(1):13-18.
  9. Zhou S. Clinical pharmacogenomics of thiopurine S-methyltransferase. Curr Clin Pharmacol. 2006 Jan; 1(1):119-128.
  10. IMURAN® (azathioprine) [package insert]. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035l.... Accessed: January 27, 2016.
  11. Vande Casteele N, et al. Trough Concentrations of Infliximab Guide Dosing for Patients With Inflammatory Bowel Disease. Gastroenter 2015;148:1320-1329.
  12. Vaughn BP, et al. Proactive Therapeutic Concentration Monitoring of Infliximab May Improve Outcomes for Patients with Inflammatory Bowel Disease: Results from a Pilot Observational Study. Inflamm Bowel Dis 2014;20:1996-2003.
  13. Vaughn BP, et al. Biologic Concentration Testing in Inflammatory Bowel Disease. Inflamm Bowel Dis 2015;21:1435-4142.
  14. Ungar B, et al. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut 2014;63:1258-1264.
  15. American Gastroenterological Association. Guidelines for the Identification, Assessment and Initial Medical Treatment in Crohn’s Disease. https://www.gastro.org/IBDcarepathway
  16. Steenholdt C, et al. Individualised therapy is more cost-effective than dose intensification in patients with Crohn’s disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut 2014;63:919-927.
  17. Ordas, et al. Therapeutic Drug Monitoring of Tumor Necrosis Factor Antagonists in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol 2012;10:1079-1087.
  18. Steenholdt C, et al. Clinical Implications of Variations in Anti-infliximab Antibody Levels in Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis 2012 Vol 18(12):2209-2217.