Precision-Guided Therapy Selection

Respondr TNF logo

Supporting Clinical Data

Respondr® TNF is the first test to predict an inflammatory bowel disease (IBD) patient’s likelihood to respond to infliximab, adalimumab and their biosimilars prior to therapy administration. Respondr incorporates pre-therapy clearance and genetic risk to indicate a patient’s likelihood of response to these anti-TNF therapies.

Multiple studies support pre-therapy clearance and genetic risk as indicators of likely response:

  1. Aitken et al. Medicine Use and Spending in the U.S. A Review of 2017 and Outlook to 2022. IQVIA. 2018 Apr 19.
  2. Syed N et al. Proactive Drug Monitoring Is Associated with Higher Persistence to Infliximab and Adalimumab Treatment and Lower Healthcare Utilization Compared with Reactive and Clinical Monitoring. Crohns Colitis 360. 2020 Jul;2(3):otaa050.
  3. Sazonovs A et al. HLA-DQA1*05 Carriage Associated with Development of Anti-Drug Antibodies to Infliximab and Adalimumab in Patients with Crohn’s Disease. Gastroenterology. 2020 Jan;158(1):189-199.
  4. Wilson A et al. HLADQA1*05 Genotype Predicts Anti-Drug Antibody Formation and Loss of Response During Infliximab Therapy for Inflammatory Bowel Disease. Aliment Pharmacol Ther. 2020 Feb;51(3):356-363.
  5. Doherty J et al. HLA-DQA1*05 Allele Carriage and Anti-TNF Therapy Persistence in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2024 Jun 27:izae138. Epub ahead of print.
  6. Ioannou, S et al. S0735 Carriage of HLA-DQA1*05 in Hispanic IBD Patients is Common and Also Associated with Development of Antibodies to Anti-TNFs but Not Other Biologics. Am J Gastroenterol. 2020 Oct;115():S368-S369.
  7. Spencer E et al. Poor Prognostic Factors of Pharmacokinetic Origin Predict Outcomes in Inflammatory Bowel Disease Patients Treated with Anti-Tumor Necrosis Factor-α. Front Immunol. 2024 Jan 23;15:1342477.
  8. McGovern et al. Tu1767 Baseline Clearance for Anti Tumor Necrosis Factors Predicts Lack of Disease Control During Maintenance Treatment of Crohn’s Disease with Infliximab and Adalimumab. Gastroenterology. 2023 May;164:S-1117-1118.
  9. Battat R et al. Baseline Clearance of Infliximab is Associated with Requirement for Colectomy in Patients with Acute Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):511-518.e6.
  10. Dotan I et al. Patient Factors That Increase Infliximab Clearance and Shorten Half-Life in Inflammatory Bowel Disease: A Population Pharmacokinetic Study. Inflamm Bowel Dis. 2014 Dec;20(12):2247-2259.
  11. Sazonovs A et al. HLA-DQA1*05 Carriage Associated with Development of Anti-Drug Antibodies to Infliximab and Adalimumab in Patients with Crohn’s Disease. Gastroenterology. 2020 Jan;158(1):189-199.
  12. Battat R et al. Baseline Clearance of Infliximab Is Associated with Requirement for Colectomy in Patients with Acute Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):511-518.e6.
  13. Spencer E et al. Failure to Achieve Target Drug Concentrations During Induction and Not HLA-DQA1*05 Carriage Is Associated with Antidrug Antibody Formation in Patients with Inflammatory Bowel Disease. Gastroenterology. 2022 May;162(6):1746-1748.e3.
  14. Dubinsky M et al. The Combination of Predictive Factors of Pharmacokinetic Origin Associates with Enhanced Disease Control during Treatment of Pediatric Crohn’s Disease with Infliximab. Pharmaceutics. 2023 Sep 30;15(10):2408.
  15. Danese S et al. Early intervention in Crohn’s disease: towards disease modification trials. Gut. 2017; 66, 2179–2187.
  16. Solitano V et al. Early Intervention in Ulcerative Colitis: Ready for Prime Time? J Clin Med. 2020 Aug 14;9(8):2646.
  17. Colombel JC et al. Management Strategies to Improve Outcomes of Patients with Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):351-361.e5.
  18. Hanauer S et al. The Clinical Utility of Precision-Guided Dosing for Adalimumab Therapy Optimization in Inflammatory Bowel Disease: A Clinical Experience Program. Pharmaceutics. 2025;17(4): 428.

Respondr TNF is a laboratory-developed test that was developed, and analytically and clinically validated by Prometheus Laboratories Inc. under federal Clinical Laboratory Improvement Amendments (CLIA) guidelines, and is performed exclusively in our high complexity CLIA-certified (05D0917432) and College of American Pathologists-accredited (6805501) clinical laboratory. As laboratory a developed test, it has not been cleared or approved by the US FDA. This test may be covered by one or more US pending or issued patents – see prometheuslabs.com/patents. This material is provided for general information purposes only as an educational service for healthcare physicians and their patients. It is not intended as a substitute for medical advice and/or consultation with a physician.