Antibodies to adalimumab are associated with future inflammation in Crohnis patients receivingmaintenance adalimumab therapy: a post hoc analysis of the Karmiris trial

Gut

Volumn 65, Issue 7, 2016, Pages 1126-1131

  Baert, Filip ^a   Kondragunta, Venkateswarlu ^b   Lockton, Steven ^b   Casteele, Niels Vande ^c   Hauenstein, Scott ^b   Singh, Sharat ^b   Karmiris, Konstantinos ^d   Ferrante, Marc ^a   Gils, Ann ^c   Vermeire, Séverine ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b Prometheus Laboratories   (United States)

^c UNIVERSITY OF LEUVEN   (Belgium)

^d Venizelion General Hospital   (Greece)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; DRUG ANTIBODY; ANTIBODY; ANTIINFLAMMATORY AGENT;

ADULT; ANTIBODY DETECTION; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL (TOPIC); CROHN DISEASE; DRUG BLOOD LEVEL; DRUG RESPONSE; DRUG WITHDRAWAL; FEMALE; HUMAN; INFLAMMATION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; POST HOC ANALYSIS; PRIORITY JOURNAL; RISK FACTOR; ANTIBODY PRODUCTION; BLOOD; IMMUNOLOGY; MAINTENANCE CHEMOTHERAPY; METABOLISM; RETROSPECTIVE STUDY; YOUNG ADULT;

ADALIMUMAB; ADULT; ANTI-INFLAMMATORY AGENTS; ANTIBODIES; ANTIBODY FORMATION; C-REACTIVE PROTEIN; CLINICAL TRIALS AS TOPIC; CROHN DISEASE; FEMALE; HUMANS; MAINTENANCE CHEMOTHERAPY; MALE; RETROSPECTIVE STUDIES; RISK FACTORS; YOUNG ADULT;

EID: 84973911417     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2014-307882     Document Type: Article

References (24)

1. 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;137:1628-40.
2. Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol 2009;104:760-7.
3. Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn's disease: a systematic review. Am J Gastroenterol 2011;106:674-84.
4. Baert F, Glorieus E, Reenaers C, et al. Adalimumab dose escalation and dose de-escalation success rate and predictors in a large national cohort of Crohn's patients. J Crohns Colitis 2013;7:154-60.
5. Colombel JF, Sandborn WJ, 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.
6. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 2007;146:829-38.
7. Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial. Gut 2007;56:1232-9.
8. Wang SL, 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.
9. Baert F, Drobne D, Gils A, et al. Early trough levels and antibodies to infliximab predict safety and success of re-initiation of infliximab therapy. Clin Gastroenterol Hepatol 2014;12:1474-81.e1472; quiz e1491.
10. Andres J, Yarur A, Deshpande A. Serum adalimumab levels and antibodies correlate with endoscopic intestinal inflammation and inflammatory markers in patients with inflammatory bowel disease. Gastroenterology 2013;114(Suppl 1):S774-5.
11. Velayos FS, Sheibani S, Lockton S, et al. 490 Prevalence of antibodies to adalimumab (ATA) and correlation between ATA and low serum drug concentration on CRP and clinical symptoms in a prospective sample of IBD patients. Gastroenterology 2013;144:S-91.
12. Baert F, Drobne D, Gils A, et al. Early trough levels and antibodies to infliximab predict safety and success of reinitiation of infliximab therapy. Clin Gastroenterol Hepatol 2014;12:1474-81.e1472; quiz e1491.
13. 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 2013;11:444-7.
14. Colombel JF, Feagan BG, Sandborn WJ, et al. Therapeutic drug monitoring of biologics for inflammatory bowel disease. Inflamm Bowel Dis 2012;18:349-58.
15. Adedokun O, Xu Z, Marano C, et al. Pharmacokinetics and exposure-response relationship of golimumab in patients with moderately to severely active ulcerative colitis: results from phase2/3 induction and maintenance studies. Gastroenterology 2013:114.
16. Krieckaert CL, Lems WF. Are we ready for therapeutic drug monitoring of biologic therapeutics? Arthritis Res Ther 2011;13:120.
17. Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011;305:1460-8.
18. Sandborn WJ, Colombel JF, D'Haens G, et al. One-year maintenance outcomes among patients with moderately-to-severely active ulcerative colitis who responded to induction therapy with adalimumab: subgroup analyses from ULTRA 2. Aliment Pharmacol Ther 2013;37:204-13.
19. Frederiksen MT, Ainsworth MA, Brynskov J, et al. Antibodies against infliximab are associated with de novo development of antibodies to adalimumab and therapeutic failure in infliximab-to-adalimumab switchers with IBD. Inflamm Bowel Dis 2014;20:1714-21.
20. Steenholdt C, Bendtzen K, Brynskov J, et al. Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn's disease: post hoc analysis of a randomized controlled trial. Am J Gastroenterol 2014;109:1055-64.
21. Clark M. Antibody humanization: a case of the 'Emperor's new clothes'? Immunol Today 2000;21:397-402.
22. Mould DR, Green B. Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs 2010;24:23-39.
23. vande Casteele N, Peeters M, Ferrante M. Functional cellular based assay reveals neutralising anti drug antibodies in IBD patients treated with maintenance adalimumab. J Crohns Colitis 2013;8:S268-9.
24. Ordas I, Feagan BG, Sandborn WJ. Therapeutic drug monitoring of tumor necrosis factor antagonists in inflammatory bowel disease. Clin Gastroenterol Hepatol 2012;10:1079-87.