Have any questions? info@mediranos.com

INFLAMMATORY BOWEL DISEASE TESTING SERVICES

Inflammatory Bowel Disease (IBD) is a chronic disease impacting nearly 1.2 million Americans.1 Developments in treatment, such as biologics, have greatly improved quality of life for patients and advancements in laboratory testing are helping to support diagnosis and optimize therapy. Med lab offers leading expertise and comprehensive testing services to support physicians in the management of IBD patients.

For a detailed look at how Med lab’s IBD test offerings support complete care decisions, see our IBD Test Offerings Matrix in the Related Documents section below.

IBD Treatment Monitoring

Patient response to IBD treatments may be highly variable but new Therapeutic Drug Monitoring (TDM) assays can help optimize therapy using a personalized, patient-specific approach.

Monitoring Biologics

Biologics monitoring assays measure both drug concentration and anti-drug antibodies to support improved clinical outcomes and characterize those patients who may have diminished response to therapy.2, 3, 4, 5

  • All biologics have variable pharmacokinetics and the potential to induce an antibody-mediated immune response 6,7
  • TDM helps optimize dosing and frequency of treatment 2,7,8
  • TDM assists in preventing and managing loss of response due to immunogenicity9,10
  • TDM has been shown to be cost-effective and may direct more appropriate care.7
Biologic Drug Name Med lab Test LabCorp Test No

Infliximab

Remicade®
Inflectra®

Infliximab Concentration and Anti-Infliximab Antibody 503870

Adalimumab

Humira®

Adalimumab Concentration and Anti-Adalimumab Antibody 503890

Vedolizumab

Entyvio®

Vedolizumab Concentration and Anti-Vedolizumab Antibody 504567

Golimumab

Simponi®

Golimumab and Anti-Golimumab Antibody 504563

 

Patient-specific clinical context must be taken into account when evaluating drug and anti-drug antibody. Serial measurements over time may be helpful. NOTE: These target ranges were those used in landmark studies and do not necessarily transplant into general recommendations for individual patients. Trough collections are recommended in most cases.

Monitoring Immunomodulators

Monitoring drug levels for Immunomodulators supports dosing decisions, assessing patient compliance, and determining effectiveness of treatment.

  • Utilize during treatment to help reach and maintain therapeutic goal11
  • Assists with evaluating unresponsive patients11
  • Thiopurine drugs monitoring helps avoid potential toxicity in responsive patients11
  • Approximately 30% ñ 40% of RA patients do not adequately respond to methotrexate treatment12
Drug Name Med lab Test Med lab Test No
Purinethol®
Azasan®
Imuran®
Tabloid®
Thiopurine Metabolites 503800
Rasuvo®
Rheumatrex®
DosePack®
Otrexup®
Trexall®
Methotrexate Polyglutamates 504104

TPMT genetic and TPMT activity testing is additionally available to assess dosing prior to Thiopurine treatment, as well as to identify patients who may be at risk for drug toxicity.

IBD Diagnosis

A combination of clinical findings, endoscopic, histopathologic, radiologic, and laboratory testing is used to establish the diagnosis of IBD.

Diagnostic challenges arise when clinical presentation is indolent, invasive procedures are not obtainable, or results are inconclusive. Novel serological markers for IBD offer improved sensitivity and specificity to aid in differential diagnosis and provide valuable prognostic information about disease behavior.

  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.