Therapeutic Drug Monitoring

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Clinical support for PROMETHEUS® Anser® IFX and PROMETHEUS®  Anser® ADA

All tests are supported with strong clinical data and published literature.

Peer-reviewed journal articles supporting monitoring of biologics

  • Papamichael K, Cheifetz AS, Melmed GY, Irving PM, Casteele NV, Kozuch PL, Raffals LE, Baidoo L, Bressler B, Devlin SM, Jones J, Kaplan GG, Sparrow MP, Velayos FS, Ullman T, Siegel CA. Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients with Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2019;S1542-3565(19)30301-5. read
  • Melmed GY, Irving PM, Jones J, et al. Appropriateness of testing for anti-tumor necrosis factor agent and antibody concentrations, and interpretation of results. Clin Gastroenterol Hepatol. 2016;14(9):1302-1309.
  • Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose-escalation for patients with Crohn’s disease who lose responsiveness to infliximab [published online ahead of print January 25, 2013]. Clin Gastroenterol Hepatol. doi:10.1016/j.cgh.2012.12.035.
  • Ordás I, Mould DR, Feagan BG, Sandborn WJ. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther. 2012;91(4):635-646.
  • Ordás I, Feagan BG, Sandborn WJ. Therapeutic drug monitoring of tumor necrosis factor antagonists in inflammatory bowel disease.
    Clin Gastroenterol Hepatol    . 2012;10(10):1079-1087. read
  • Yanai H, Hanauer SB. Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol. 2011;106(4):685-698.
  • Guerra I, Chaparro M, Bermejo F, Gisbert JP. Utility of measuring serum concentrations of anti-TNF agents and anti-drug antibodies in inflammatory bowel disease. Curr Drug Metab. 2011;12(6):594-598.
  • Afif W, Loftus EV Jr, Faubion WA, et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010;105(5):1133-1139.
  • Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology. 2009;137(5):1628-1640. read

Publications and peer-reviewed articles using
PROMETHEUS Anser IFX and PROMETHEUS Anser ADA

  • Zitomersky N, Chi L, Liu E, et al. Low infliximab levels and anti-infliximab antibodies increase the risk of loss of response to infliximab in pediatric IBD, a prospective pediatric study. Gastroenterology. 2018;154(6 suppl 1):S-60.
  • Papamichael K, Vajravelu RK, Vaughn BP, Osterman MT, Cheifetz AS. Proactive infliximab monitoring following reactive testing is associated with better clinical outcomes than reactive testing alone in patients with inflammatory bowel disease. J Crohns Colitis. 2018;12(7):804-810.
  • Rubin DT, Naik S, Kondragunta V, Rao T, Jain A. Detection of adalimumab and antibodies to adalimumab using a homogeneous mobility shift assay. Curr Med Res Opin. 2017;33(5):837-843.
  • Yarur AJ, Jain A, Hauenstein SI, et al. Higher adalimumab levels are associated with histologic and endoscopic remission in patients with Crohn’s disease and ulcerative colitis. Inflamm Bowel Dis. 2016;22(2):409-415.
  • Zittan E, Kabakchiev B, Milgrom R, et al. Higher adalimumab drug levels are associated with mucosal healing in patients with Crohn’s disease. J Crohns Colitis. 2016;10(5):510-515.
  • Vande Casteele N, Khanna R, Levesque BG, et al. The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn’s disease. Gut. 2015;64(10):1539-1545.
  • Vaughn BP, Martinez-Vazquez M, Patwardhan VR, Moss AC, Sandborn WJ, Cheifetz AS. 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(11):1996-2003.
  • Ben-Bassat O, Hauenstein S, Iacono A, Irwin SP, Singh S,
    Greenberg GR. Serum adalimumab and immunogenicity in IBD patients after 80mg biweekly maintenance therapy. Abstract presented at: Digestive Disease Week 2013; May 18-21, 2013; Orlando, FL.
  • Velayos FS, Sheibani S, Lockton S, et al. Prevalence of antibodies to adalimumab (ATA) and significance of ATA/drug concentration on CRP and symptoms in unselected IBD patients. Abstract presented at: Digestive Disease Week 2013; May 18-21, 2013; Orlando, FL.
  • Yarur A, Hauenstein S, Lockton S, Singh S, Abreu M. Serum adalimumab levels and antibodies correlate with endoscopic intestinal inflammation and inflammatory markers in patients with inflammatory bowel disease. Abstract presented at: Digestive Disease Week 2013;
    May 18-21, 2013; Orlando, FL.
  • Wolf D, Hauenstein S, Lockton S, Singh S. Mechanisms of loss of response to adalimumab in Crohn’s disease. Abstract presented at: Digestive Disease Week 2013; May 18-21, 2013; Orlando, FL.
  • Wang S-L, Hauenstein S, Ohrmund L, et al. Monitoring of adalimumab and antibodies-to-adalimumab levels in patient serum by the homogeneous mobility shift assay. J Pharm Biomed Anal. 2013;78-79:39-44. read
  • Novel infliximab (IFX) and antibody-to-infliximab (ATI) assays are predictive of disease activity in patients with Crohn’s disease (CD). Gastroenterol Hepatol. 2012;8(7)(suppl 4):3-4.
  • Murthy S, Kevans D, Seow CH, et al. Association of serum infliximab and antibodies to infliximab to long-term clinical outcome in acute ulcerative colitis. Gastroenterology. 2012;142(5)(suppl 1):S-388.
  • Veres G, Kaplan JL, De Greef E, et al. New assay to detect infliximab levels and anti-infliximab antibodies from a single serum sample is useful in measuring efficacy of treatment with infliximab in children with IBD. Gastroenterology. 2012;142(5)(suppl 1):S-386.
  • Kevans D, Murthy S, Iacono A, Silverberg MS, Greenberg GR. Accelerated clearance of serum infliximab during induction therapy for acute ulcerative colitis is associated with treatment failure. Gastroenterology. 2012;142(5)(suppl 1):S-385.
  • Vande Casteele N, Cuypers L, Singh S, et al. Antibodies to infliximab can either be persistent or transient: a retrospective case-control study in IBD patients treated with infliximab maintenance therapy. Gastroenterology. 2012;142(5)(suppl 1):S-114.
  • Wang S-L, Ohrmund L, Hauenstein S, et al. Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum.
    J Immunol Methods. 2012;382(1-2):177-188. read