Drug monitoring of biologics in inflammatory bowel disease

Current Opinion in Gastroenterology

Volumn 29, Issue 4, 2013, Pages 391-396

  Eser, Alexander ^a   Primas, Christian ^a   Reinisch, Walter ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

anti TNF agents; antidrug antibodies; inflammatory bowel disease; pharmacokinetics; therapeutic drug monitoring

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; C REACTIVE PROTEIN; CERTOLIZUMAB PEGOL; FC RECEPTOR; IMMUNOGLOBULIN G ANTIBODY; INFLIXIMAB; METHOTREXATE; TUMOR NECROSIS FACTOR ALPHA;

ACTIVE TRANSPORT; ALGORITHM; AMINO ACID SEQUENCE; ANTIBODY DETECTION; ANTIBODY PRODUCTION; BIOLOGICAL ACTIVITY; BLOOD FLOW; BODY WEIGHT; CELL SURFACE; COHORT ANALYSIS; CONCENTRATION (PARAMETERS); CROHN DISEASE; DISTRIBUTION VOLUME; DRUG CLEARANCE; DRUG EFFICACY; DRUG MONITORING; HALF LIFE TIME; HUMAN; HUMORAL IMMUNITY; IMMUNOGENICITY; IMMUNOSUPPRESSIVE TREATMENT; MAINTENANCE THERAPY; NONHUMAN; PLASMA CLEARANCE; PREMEDICATION; PROSPECTIVE STUDY; RADIOIMMUNOASSAY; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; REVIEW; RHEUMATOID ARTHRITIS; SENSITIVITY AND SPECIFICITY; TREATMENT DURATION; ULCERATIVE COLITIS; UMBILICAL CORD BLOOD; VASCULAR ENDOTHELIUM;

ALGORITHMS; ANTIBODIES, MONOCLONAL; ANTIBODY FORMATION; BIOLOGICAL PRODUCTS; DRUG MONITORING; GASTROINTESTINAL AGENTS; HUMANS; INFLAMMATORY BOWEL DISEASES; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84879975984     PISSN: 02671379     EISSN: 15317056     Source Type: Journal    
DOI: 10.1097/MOG.0b013e328361f7f6     Document Type: Review

References (41)

1. Carvalhoda Costa M, deCastro I, Neto AL, et al. Cyclosporin Atubular effects contribute to nephrotoxicity: role for Ca2+ and Mg2+ ions. Nephrol Dial Transplant 2003; 18:2262-2268.
2. Novick AC, Hwei HH, Steinmuller D, et al. Detrimental effect of cyclosporine on initial function of cadaver renal allografts following extended preservation. Results of a randomized prospective study. Transplantation 1986; 42:154-158.
3. (EMEA). EMA. Guidline on immunogenicity assessment of biotechnology-derived therapeutic proteins. 2008; http://www.ema.europa.eu/docs/ en-GB/document-library/Scientific-guideline/2009/09/WC500003946. pdf [Accessed 11 May 2013].
4. Klotz U, Teml A, Schwab M. Clinical pharmacokinetics and use of infliximab. Clin Pharmacokinet 2007; 46:645-660.
5. Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial. Gut 2007; 56:1232-1239.
6. Schreiber S, Rutgeerts P, Fedorak RN, et al. A randomized, placebo-con-trolled trial ofcertolizumab pegol (CDP870) for treatment of Crohn'sdisease. Gastroenterology 2005; 129:807-818.
7. EMEA. Cimzia: product information. 2013; http://www.ema.europa.eu/ema/ index.jsp?curl=pages/medicines/human/medicines/001 037/human-med-001294. jsp&mid=WC0b01ac058001d124 [Accessed 20 March 2013].
8. Ordas I, Mould DR, Feagan BG, et al. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther 2012; 91:635-646.
9. Vincent FB, Morand EF, Murphy K, et al. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflam-matory diseases: a real issue, a clinical perspective. Ann Rheum Dis 2013; 72:165-178.
10. Reinisch W, Feagan B, Rutgeerts P, et al. Infliximab concentration and clinical outcome in patients with ulcerative colitis. Gastroenterology 2012; 142:114.
11. Kevans D, Murthy S, Iacono A, et al. Accelerated clearance ofserum infliximab during induction therapy for acute ulcerative colitis is associated with treat-mentfailure. Gastroenterology 2012; 142:384-385.
12. St Clair EW, Wagner CL, Fasanmade AA, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002; 46:1451-1459.
13. Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic mono-clonal antibodies. Clin Pharmacokinet 2010; 49:633-659.
14. Fasanmade AA, Adedokun OJ, Ford J, et al. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol 2009; 65:1211-1228.
15. Fasanmade AA, Adedokun OJ, Olson A, et al. Serumalbumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol Ther 2010; 48:297-308.
16. Ternant D, Paintaud G. Pharmacokinetics and concentration-effect relation-ships oftherapeutic monoclonal antibodies and fusion proteins. Expert Opin Biol Ther 2005; 5 (Suppl 1):S37-S47.
17. Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2013; 11:286-292.
18. Roopenian DC, Christianson GJ, Sproule TJ, et al. The MHC class I-like IgG receptor controls perinatal IgG transport, IgG homeostasis, and fate of IgG-Fc-coupled drugs. J Immunol 2003; 170:3528-3533.
19. Chapman AP. PEGylated antibodies and antibody fragments for improved therapy: a review. Adv Drug Deliv Rev 2002; 54:531-545.
20. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010; 362:1383-1395.
21. Feagan BG, McDonald JW, Panaccione R, et al. S1051 methotrexate forthe prevention of antibodies to infliximab in patients with Crohn's disease. Gastroenterology 2010; 138:S167-S168.
22. Bendtzen K, Geborek P, Svenson M, et al. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum 2006; 54:3782-3789.
23. de Vries MK, Wolbink GJ, Stapel SO, et al. Decreased clinical response to infliximab in ankylosing spondylitis is correlated with antiinfliximab formation. Ann Rheum Dis 2007; 66:1252-1254.
24. Maser EA, Villela R, Silverberg MS, 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.
25. Seow CH, Newman A, Irwin SP, et al. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut 2010; 59:49-54.
26. Fasanmade A, Olson A, Bao W, et al. Relationship between infliximab pharmacokinetics and improvement in Crohn's disease. Gastroenterology 2002; 122 (4 Suppl 1):A617-A618.
27. Li J, Chiu Y, Robinson A. Evaluation of potential correlations between serum adalimumab concentration and remission in patients with Crohn's disease in CLASSIC I and II. J Crohn's Colitis 2010; 4:73.
28. Karmiris K, Paintaud G, Noman M, et al. Influence oftrough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology 2009; 137:1628-1640.
29. Ben-Horin S, Yavzori M, Katz L, et al. The immunogenic partof infliximab isthe F(ab')2, but measuring antibodies to the intact infliximab molecule is more clinically useful. Gut 2011; 60:41-48.
30. Farrell RJ, Alsahli M, Jeen YT, et al. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology 2003; 124:917-924.
31. Danese S, Fiorino G, Reinisch W. Review article: causative factors and the clinical management of patients with Crohn's disease who lose response to anti-TNF-alpha therapy. Aliment Pharmacol Ther 2011; 34:1-10.
32. Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol 2009; 104:760-767.
33. Ainsworth MA, Bendtzen K, Brynskov J. Tumor necrosis factor-alpha binding capacity and antiinfliximab antibodies measured by fluid-phase radioimmu-noassays as predictors of clinical efficacyofinfliximab in Crohn's disease. Am J Gastroenterol 2008; 103:944-948.
34. Steenholdt C, Bendtzen K, Brynskov J, et al. Cut-off levels and diagnostic accuracy of infliximab trough levels and antiinfliximab antibodies in Crohn's disease. Scand J Gastroenterol 2011; 46:310-318.
35. Hanauer SB, Wagner CL, Bala M, et al. Incidenceand importance ofantibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol 2004; 2:542-553.
36. Steenholdt C, Al-khalaf M, Brynskov J, et al. Clinical implications of variations in antiinfliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis 2012; 18:2209-2217.
37. 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; 11:444-447.
38. Feagan BG, Singh S, Lockton S, et al. 565 novel infliximab (IFX) and antibody-to-infliximab (ATI) assays are predictive of disease activity in patients with Crohn's disease (CD). Gastroenterology 2012; 142:S114.
39. Bendtzen K, Ainsworth M, Steenholdt C, et al. Individual medicine in inflam-matory bowel disease: monitoring bioavailability, pharmacokinetics and immunogenicity of antitumour necrosis factor-alpha antibodies. Scand J Gastroenterol 2009; 44:774-781.
40. Afif W, Loftus EV Jr, Faubion WA, et al. Clinical utility of measuring infliximab and human antichimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol 2010; 105:1133-1139.
41. Casteelen N, Compernolle G, Ballet V, et al. Results on the optimisation phase of the prospective controlled trough leveladapted infliximabtreatment (TAXIT) trial. Gastroenterology 2012; 142:211-212.