Appropriateness of Testing for Anti–Tumor Necrosis Factor Agent and Antibody Concentrations, and Interpretation of Results

Clinical Gastroenterology and Hepatology

Volumn 14, Issue 9, 2016, Pages 1302-1309

  Melmed, Gil Y ^a   Irving, Peter M ^b   Jones, Jennifer ^c   Kaplan, Gilaad G ^d   Kozuch, Patricia L ^e   Velayos, Fernando S ^f   Baidoo, Leonard ^g   Sparrow, Miles P ^h   Bressler, Brian ⁱ   Cheifetz, Adam S ^j   Devlin, Shane M ^d   Raffals, Laura E ^k   Vande Casteele, Niels ^l,m   Mould, Diane R ⁿ   Colombel, Jean Fred ^o   Dubinsky, Marla ^o   Sandborn, William J ^l   Siegel, Corey A ^p  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^c DALHOUSIE UNIVERSITY   (Canada)

^d UNIVERSITY OF CALGARY   (Canada)

^e THOMAS JEFFERSON UNIVERSITY   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g UNIVERSITY OF PITTSBURGH   (United States)

^h ALFRED HOSPITAL   (Australia)

ⁱ UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^j BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^k MAYO CLINIC   (United States)

^l UNIVERSITY OF CALIFORNIA   (United States)

^m UNIVERSITY OF LEUVEN   (Belgium)

ⁿ Projections Research Inc   (United States)

^o MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^p DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

more..

Author keywords

Crohn's Disease; Patient Management; Treatment; Ulcerative Colitis

Indexed keywords

ADALIMUMAB; CERTOLIZUMAB PEGOL; DRUG ANTIBODY; IMMUNOMODULATING AGENT; INFLIXIMAB; ANTIBODY; IMMUNOLOGIC FACTOR; TUMOR NECROSIS FACTOR;

ANTIBODY BLOOD LEVEL; ARTICLE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG RESPONSE; DRUG SUBSTITUTION; EXPERIMENTAL STUDY; HUMAN; INFLAMMATORY BOWEL DISEASE; MAINTENANCE THERAPY; META ANALYSIS; OBSERVATIONAL STUDY; PATIENT CARE; PRACTICE GUIDELINE; VALIDATION STUDY; ANTAGONISTS AND INHIBITORS; BLOOD; DRUG MONITORING; IMMUNOLOGY; INFLAMMATORY BOWEL DISEASES; PROCEDURES; TIME FACTOR;

ANTIBODIES; DRUG MONITORING; HUMANS; IMMUNOLOGIC FACTORS; INFLAMMATORY BOWEL DISEASES; TIME FACTORS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84997270754     PISSN: 15423565     EISSN: 15427714     Source Type: Journal    
DOI: 10.1016/j.cgh.2016.05.010     Document Type: Article

References (25)

1. 1 D'Haens, G.R., Panaccione, R., Higgins, P.D., et al. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organization: when to start, when to stop, which drug to choose, and how to predict response?. Am J Gastroenterol 106 (2011), 199–212 quiz 213.
2. 2 Sandborn, W.J., Crohn's disease evaluation and treatment: clinical decision tool. Gastroenterology 147 (2014), 702–705.
3. 3 Sandborn, W.J., Rutgeerts, P., Feagan, B.G., et al. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology 137 (2009), 1250–1260.
4. 4 Feagan, B.G., Panaccione, R., Sandborn, W.J., et al. Effects of adalimumab therapy on incidence of hospitalization and surgery in Crohn's disease: results from the CHARM study. Gastroenterology 135 (2008), 1493–1499.
5. 5 Feagan, B.G., Sandborn, W.J., Lazar, A., et al. Adalimumab therapy is associated with reduced risk of hospitalization in patients with ulcerative colitis. Gastroenterology 146 (2014), 110–118 e3.
6. 6 Vande Casteele, N., Khanna, R., Levesque, B.G., et al. The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn's disease. Gut 64 (2014), 1539–1545.
7. 7 Baert, F., Kondragunta, V., Lockton, S., et al. Antibodies to adalimumab are associated with future inflammation in Crohn's patients receiving maintenance adalimumab therapy: a post hoc analysis of the Karmiris trial. Gut 65 (2016), 1126–1131.
8. 8 Nanda, K.S., Cheifetz, A.S., Moss, A.C., Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol 108 (2013), 40–47 quiz 48.
9. 9 Hazlewood, G.S., Rezaie, A., Borman, M., et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis. Gastroenterology 148 (2015), 344–354 e5 quiz e14–15.
10. 10 Afif, W., Loftus, E.V. Jr., Faubion, W.A., et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol 105 (2010), 1133–1139.
11. 11 Singh, N., Rosenthal, C.J., Melmed, G.Y., et al. Early infliximab trough levels are associated with persistent remission in pediatric patients with inflammatory bowel disease. Inflamm Bowel Dis 20 (2014), 1708–1713.
12. 12 Cornillie, F., Hanauer, S.B., Diamond, R.H., et al. Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial. Gut 63 (2014), 1721–1727.
13. 13 Vaughn, B.P., Martinez-Vazquez, M., Patwardhan, V.R., 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 20 (2014), 1996–2003.
14. 14 Vande Casteele, N., Ferrante, M., Van Assche, G., et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology 148 (2015), 1320–1329 e3.
15. 15 Ainsworth, M.A., Bendtzen, K., Brynskov, J., Tumor necrosis factor-alpha binding capacity and anti-infliximab antibodies measured by fluid-phase radioimmunoassays as predictors of clinical efficacy of infliximab in Crohn's disease. Am J Gastroenterol 103 (2008), 944–948.
16. 16 Papamichael, K., Gils, A., Rutgeerts, P., et al. Role for therapeutic drug monitoring during induction therapy with TNF antagonists in IBD: evolution in the definition and management of primary nonresponse. Inflamm Bowel Dis 21 (2015), 182–197.
17. 17 Djulbegovic, B., Hozo, I., Lyman, G.H., Linking evidence-based medicine therapeutic summary measures to clinical decision analysis. MedGenMed, 2, 2000, E6.
18. 18 Brook, R.H., The RAND/UCLA Appropriateness Method. Clinical practice guideline development: methodology perspectives. 1994, Public Health Service: AHCR, Rockville, MD.
19. 19 Melmed, G.Y., Spiegel, B.M., Bressler, B., et al. The appropriateness of concomitant immunomodulators with anti-tumor necrosis factor agents for Crohn's disease: one size does not fit all. Clin Gastroenterol Hepatol 8 (2010), 655–659.
20. 20 Cheifetz, A.S., Melmed, G.Y., Spiegel, B., et al. Setting priorities for comparative effectiveness research in inflammatory bowel disease: results of an international provider survey, expert RAND panel, and patient focus groups. Inflamm Bowel Dis 18 (2012), 2294–2300.
21. 21 Mazor, Y., Almog, R., Kopylov, U., et al. Adalimumab drug and antibody levels as predictors of clinical and laboratory response in patients with Crohn's disease. Aliment Pharmacol Ther 40 (2014), 620–628.
22. 22 Roblin, X., Marotte, H., Rinaudo, M., et al. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol 12 (2014), 80–84 e2.
23. 23 Ben-Horin, S., Waterman, M., Kopylov, U., et al. Addition of an immunomodulator to infliximab therapy eliminates antidrug antibodies in serum and restores clinical response of patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 11 (2013), 444–447.
24. 24 Steenholdt, C., Brynskov, J., Thomsen, O.O., 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 63 (2014), 919–927.
25. 25 Velayos, F.S., Kahn, J.G., Sandborn, W.J., et al. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol 11 (2013), 654–666.