Optimizing Anti-TNF-α Therapy: Serum Levels of Infliximab and Adalimumab Are Associated With Mucosal Healing in Patients With Inflammatory Bowel Diseases

Clinical Gastroenterology and Hepatology

Volumn 14, Issue 4, 2016, Pages 550-557.e2

  Ungar, Bella ^a   Levy, Idan ^a   Yavne, Yarden ^a   Yavzori, Miri ^a   Picard, Orit ^a   Fudim, Ella ^a   Loebstein, Ronen ^a   Chowers, Yehuda ^b   Eliakim, Rami ^a   Kopylov, Uri ^a   Ben Horin, Shomron ^a  

^a TEL AVIV UNIVERSITY   (Israel)

^b TECHNION ISRAEL INSTITUTE OF TECHNOLOGY   (Israel)

Author keywords

Crohn's Disease; Pharmacokinetics; Response to Therapy; Ulcerative Colitis

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; INFLIXIMAB; IMMUNOSUPPRESSIVE AGENT; TUMOR NECROSIS FACTOR;

ADULT; AREA UNDER THE CURVE; ARTICLE; COHORT ANALYSIS; COLONOSCOPY; CONTROLLED STUDY; CROHN DISEASE; CROSS-SECTIONAL STUDY; DRUG BLOOD LEVEL; ENDOSCOPY; FEMALE; HUMAN; ISRAEL; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; RETROSPECTIVE STUDY; TREATMENT OUTCOME; ULCERATIVE COLITIS; ANTAGONISTS AND INHIBITORS; BLOOD; CHEMISTRY; IMMUNOMODULATION; INFLAMMATORY BOWEL DISEASES; INTESTINE MUCOSA; MIDDLE AGED; PATHOLOGY; SERUM; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

ADALIMUMAB; ADULT; C-REACTIVE PROTEIN; COLONOSCOPY; CROSS-SECTIONAL STUDIES; FEMALE; HUMANS; IMMUNOMODULATION; IMMUNOSUPPRESSIVE AGENTS; INFLAMMATORY BOWEL DISEASES; INFLIXIMAB; INTESTINAL MUCOSA; ISRAEL; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; SERUM; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA; YOUNG ADULT;

EID: 84960799161     PISSN: 15423565     EISSN: 15427714     Source Type: Journal    
DOI: 10.1016/j.cgh.2015.10.025     Document Type: Article

References (30)

1. Armuzzi A., Van Assche G., Reinisch W., et al. Results of the 2nd scientific workshop of the ECCO (IV): therapeutic strategies to enhance intestinal healing in inflammatory bowel disease. J Crohns Colitis 2012, 6:492-502.
2. Schnitzler F., Fidder H., Ferrante M., et al. Mucosal healing predicts long-term outcome of maintenance therapy with infliximab in Crohn's disease. Inflamm Bowel Dis 2009, 15:1295-1301.
3. Beigel F., Deml M., Schnitzler F., et al. Rate and predictors of mucosal healing in patients with inflammatory bowel disease treated with anti-TNF-alpha antibodies. PloS One 2014, 9:e99293.
4. Colombel J.F., Rutgeerts P., Reinisch W., et al. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology 2011, 141:1194-1201.
5. Rutgeerts P., Sandborn W.J., Feagan B.G., et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Eng J Med 2005, 353:2462-2476.
6. Colombel J.F., Sandborn W.J., Rutgeerts P., et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007, 132:52-65.
7. Vande Casteele N., Ferrante M., Van Assche G., et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology 2015, 148:1320-1329.
8. 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 2014, 64:1539-1545.
9. Khanna R., Bouguen G., Feagan B.G., et al. A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design. Inflamm Bowel Dis 2014, 20:1850-1861.
10. Samaan M.A., Mosli M.H., Sandborn W.J., et al. A systematic review of the measurement of endoscopic healing in ulcerative colitis clinical trials: recommendations and implications for future research. Inflamm Bowel Dis 2014, 20:1465-1471.
11. Ben-Horin S., Yavzori M., Katz L., et al. The immunogenic part of infliximab is the F(ab')2, but measuring antibodies to the intact infliximab molecule is more clinically useful. Gut 2011, 60:41-48.
12. Kopylov U., Mazor Y., Yavzori M., et al. Clinical utility of antihuman lambda chain-based enzyme-linked immunosorbent assay (ELISA) versus double antigen ELISA for the detection of anti-infliximab antibodies. Inflamm Bowel Dis 2012, 18:1628-1633.
13. Higgins P.D., Schwartz M., Mapili J., et al. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut 2005, 54:782-788.
14. Harvey R.F., Bradshaw J.M. A simple index of Crohn's-disease activity. Lancet 1980, 1:514.
15. Vermeire S., Schreiber S., Sandborn W.J., et al. Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity. Clin Gastroenterol Hepatol 2010, 8:357-363.
16. Reinisch W., Colombel J.F., Sandborn W.J., et al. Factors associated with short- and long-term outcomes of therapy for Crohn's disease. Clin Gastroenterol Hepatol 2015, 13:539-547 e2.
17. Yanai H., Lichtenstein L., Assa A., et al. Levels of drug and antidrug antibodies are associated with outcome of interventions after loss of response to infliximab or adalimumab. Clin Gastroenterol Hepatol 2015, 13:522-530 e2.
18. 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 2014, 12:80-84 e2.
19. Schnitzler F., Fidder H., Ferrante M., et al. Long-term outcome of treatment with infliximab in 614 patients with Crohn's disease: results from a single-centre cohort. Gut 2009, 58:492-500.
20. Colombel J.F., Feagan B.G., Sandborn W.J., et al. Therapeutic drug monitoring of biologics for inflammatory bowel disease. Inflamm Bowel Dis 2012, 18:349-358.
21. Ordas I., Feagan B.G., Sandborn W.J. Therapeutic drug monitoring of tumor necrosis factor antagonists in inflammatory bowel disease. Clin Gastroenterol Hepatol 2012, 10:1079-1087. quiz e85-6.
22. Yarur A.J., Kubiliun M.J., Czul F., et al. Concentrations of 6-thioguanine nucleotide correlate with trough levels of infliximab in patients with inflammatory bowel disease on combination therapy. Clin Gastroenterol Hepatol 2015, 13:1118-1124.
23. Brandse J.F., Vos L.M., Jansen J., et al. Serum concentration of anti-TNF antibodies, adverse effects and quality of life in patients with inflammatory bowel disease in remission on maintenance treatment. J Crohns Colitis 2015, 9:973-981.
24. af Bjorkesten C.G., Nieminen U., Turunen U., et al. Surrogate markers and clinical indices, alone or combined, as indicators for endoscopic remission in anti-TNF-treated luminal Crohn's disease. Scand J Gastroenterol 2012, 47:528-537.
25. Falvey J.D., Hoskin T., Meijer B., et al. Disease activity assessment in IBD: clinical indices and biomarkers fail to predict endoscopic remission. Inflamm Bowel Dis 2015, 21:824-831.
26. Maser E.A., Villela R., Silverberg M.S., et al. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol 2006, 4:1248-1254.
27. 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 2014, 63:1721-1727.
28. 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 2014, 40:620-628.
29. 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, 137:1628-1640.
30. Ungar B., Chowers Y., Yavzori M., et al. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut 2014, 63:1258-1264.