Anti-TNF monoclonal antibodies in inflammatory bowel disease: Pharmacokinetics-based dosing paradigms

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 4, 2012, Pages 635-646

  Ordas I ^a,b   Mould, D R ^c   Feagan, B G ^d   Sandborn, W J ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF BARCELONA   (Spain)

^c Projections Research Inc   (United States)

^d ROBARTS RESEARCH INSTITUTE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; CERTOLIZUMAB PEGOL; INFLIXIMAB; TUMOR NECROSIS FACTOR ANTIBODY;

ANTIBODY STRUCTURE; ARTICLE; COMBINATION CHEMOTHERAPY; CROHN DISEASE; DISEASE SEVERITY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DEGRADATION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG MECHANISM; ENTERITIS; HUMAN; IMMUNOGENICITY; IMMUNOSUPPRESSIVE TREATMENT; MONOTHERAPY; NONHUMAN; PRIORITY JOURNAL; ULCERATIVE COLITIS;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; DRUG THERAPY, COMBINATION; HUMANS; INFLAMMATORY BOWEL DISEASES; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84858793037     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.328     Document Type: Article

References (75)

1. Kler, G. & Milstein, C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 256, 495-497 (1975).
2. Present, D.H. et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N. Engl. J. Med. 340, 1398-1405 (1999). (Pubitemid 29205403)
3. Edelman, G.M. Antibody structure and molecular immunology. Science 180, 830-840 (1973).
4. Knight, D.M. et al. Construction and initial characterization of a mouse-human chimeric anti-TNF antibody. Mol. Immunol. 30, 1443-1453 (1993).
5. Salfeld, J. et al. Human antibodies that bind human TNFα. US patent 6090382 (2000).
6. Athwal D. et al. Biological products. US patent 7012135 (2006).
7. Xavier, R.J. & Podolsky, D.K. Unravelling the pathogenesis of inflammatory bowel disease. Nature 448, 427-434 (2007). (Pubitemid 47123518)
8. Reinecker, H.C. et al. Enhanced secretion of tumour necrosis factor-alpha, IL-6, and IL-1 beta by isolated lamina propria mononuclear cells from patients with ulcerative colitis and Crohn's disease. Clin. Exp. Immunol. 94, 174-181 (1993).
9. Vos, A.C., Wildenberg, M.E., Duijvestein, M., Verhaar, A.P., van den Brink, G.R. & Hommes, D.W. Anti-tumor necrosis factor-a antibodies induce regulatory macrophages in an Fc region-dependent manner. Gastroenterol. 140, 221-230 (2011).
10. Nesbitt, A. et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm. Bowel Dis. 13, 1323-1332 (2007). (Pubitemid 350206841)
11. Lobo, E.D., Hansen, R.J. & Balthasar, J.P. Antibody pharmacokinetics and pharmacodynamics. J. Pharm. Sci. 93, 2645-2668 (2004). (Pubitemid 39506617)
12. Mould, D.R. & Green, B. Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs 24, 23-39 (2010).
13. Klotz, U., Teml, A. & Schwab, M. Clinical pharmacokinetics and use of infliximab. Clin. Pharmacokinet. 46, 645-660 (2007). (Pubitemid 47204851)
14. Fasanmade, A.A. et al. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur. J. Clin. Pharmacol. 65, 1211-1228 (2009).
15. Fasanmade, A.A., Adedokun, O.J., Blank, M., Zhou, H. & Davis, H.M. Pharmacokinetic properties of infliximab in children and adults with Crohn's disease: a retrospective analysis of data from 2 phase III clinical trials. Clin. Ther. 33, 946-964 (2011).
16. Nestorov, I. Clinical pharmacokinetics of TNF antagonists: how do they differ? Semin. Arthritis Rheum. 34, 12-18 (2005).
17. Wang, W., Wang, E.Q. & Balthasar, J.P. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin. Pharmacol. Ther. 84, 548-558 (2008).
18. Brambell, F.W., Hemmings, W.A. & Morris, I.G. A theoretical model of gammaglobulin catabolism. Nature 203, 1352-1354 (1964).
19. Zhu, X. et al. MHC class I-related neonatal Fc receptor for IgG is functionally expressed in monocytes, intestinal macrophages, and dendritic cells. J. Immunol. 166, 3266-3276 (2001). (Pubitemid 33117326)
20. Telleman, P. & Junghans, R.P. The role of the Brambell receptor (FcRB) in liver: protection of endocytosed immunoglobulin G (IgG) from catabolism in hepatocytes rather than transport of IgG to bile. Immunol. 100, 245-251 (2000). (Pubitemid 30348872)
21. Morell, A., Terry, W.D. & Waldmann, T.A. Metabolic properties of IgG subclasses in man. J. Clin. Invest. 49, 673-680 (1970).
22. Cohen-Solal, J.F., Cassard, L., Fridman, W.H. & Saut?-Fridman, C. Fc gamma receptors. Immunol. Lett. 92, 199-205 (2004).
23. Louis, E. et al. Association between polymorphism in IgG Fc receptor IIIa coding gene and biological response to infliximab in Crohn's disease. Aliment. Pharmacol. Ther. 19, 511-519 (2004). (Pubitemid 38387177)
24. Junghans, R.P. Finally! The Brambell receptor (FcRB). Mediator of transmission of immunity and protection from catabolism for IgG. Immunol. Res. 16, 29-57 (1997).
25. Israel, E.J., Wilsker, D.F., Hayes, K.C., Schoenfeld, D. & Simister, N.E. Increased clearance of IgG in mice that lack beta 2-microglobulin: possible protective role of FcRn. Immunology 89, 573-578 (1996). (Pubitemid 26419660)
26. Ober, R.J., Radu, C.G., Ghetie, V. & Ward, E.S. Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. Int. Immunol. 13, 1551-1559 (2001). (Pubitemid 33133882)
27. Ternant, D. & Paintaud, G. Pharmacokinetics and concentration-effect relationships of therapeutic monoclonal antibodies and fusion proteins. Expert Opin. Biol. Ther. 5 (suppl. 1), S37-S47 (2005). (Pubitemid 41243344)
28. Tabrizi, M.A., Tseng, C.M. & Roskos, L.K. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov. Today 11, 81-88 (2006). (Pubitemid 43227856)
29. Travis, S.P. et al.; European Crohn's and Colitis Organisation. European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut 55 (suppl. 1), i16-i35 (2006). (Pubitemid 43268291)
30. Hanauer, S.B. et al.; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 359, 1541-1549 (2002). (Pubitemid 34621118)
31. Rutgeerts, P. et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N. Engl. J. Med. 353, 2462-2476 (2005). (Pubitemid 41770166)
32. Schreiber, S. et al.; PRECISE 2 Study Investigators. Maintenance therapy with certolizumab pegol for Crohn's disease. N. Engl. J. Med. 357, 239-250 (2007). (Pubitemid 47080388)
33. Colombel, J.F. et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterol. 132, 52-65 (2007).
34. Sandborn, W.J. et al.; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N. Engl. J. Med. 357, 228-238 (2007). (Pubitemid 47080387)
35. Reinisch, W. et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut 60, 780-787 (2011).
36. Peyrin-Biroulet, L., Deltenre, P., de Suray, N., Branche, J., Sandborn, W.J. & Colombel, J.F. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clin. Gastroenterol. Hepatol. 6, 644-653 (2008). (Pubitemid 351783447)
37. Colombel, J.F. et al.; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N. Engl. J. Med. 362, 1383-1395 (2010).
38. Bruining, D.H. & Sandborn, W.J. Do not assume symptoms indicate failure of anti-tumor necrosis factor therapy in Crohn's disease. Clin. Gastroenterol. Hepatol. 9, 395-399 (2011).
39. Modigliani, R. et al. Clinical, biological, and endoscopic picture of attacks of Crohn's disease. Evolution on prednisolone. Groupe d'Etude Thapeutique des Affections Inflammatoires Digestives. Gastroenterol. 98, 811-818 (1990). (Pubitemid 20095830)
40. Jones, J. et al. Relationships between disease activity and serum and fecal biomarkers in patients with Crohn's disease. Clin. Gastroenterol. Hepatol. 6, 1218-1224 (2008).
41. Baert, F. et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N. Engl. J. Med. 348, 601-608 (2003). (Pubitemid 36204954)
42. Karmiris, K. et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterol. 137, 1628-1640 (2009).
43. Seow, C.H., Newman, A., Irwin, S.P., Steinhart, A.H., Silverberg, M.S. & Greenberg, G.R. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut 59, 49-54 (2010).
44. Maser, E.A., Villela, R., Silverberg, M.S. & Greenberg, G.R. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin. Gastroenterol. Hepatol. 4, 1248-1254 (2006). (Pubitemid 44512213)
45. Farrell, R.J., Alsahli, M., Jeen, Y.T., Falchuk, K.R., Peppercorn, M.A. & Michetti, P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterol. 124, 917-924 (2003). (Pubitemid 36389794)
46. Vermeire, S., Noman, M., Van Assche, G., Baert, F., D'Haens, G. & Rutgeerts, P. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn's disease. Gut 56, 1226-1231 (2007). (Pubitemid 47300423)
47. Hanauer, S.B. et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin. Gastroenterol. Hepatol. 2, 542-553 (2004). (Pubitemid 38834038)
48. Feagan, B.G. et al. Methotrexate for the prevention of antibodies to infliximab in patients with Crohns disease (abstract S1051). Presented at Digestive Disease Week, New Orleans, LA, 2 May 2010.
49. Sandborn, W.J. et al. Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial. Gut 56, 1232-1239 (2007). (Pubitemid 47300424)
50. Lichtenstein, G.R. et al. Clinical trial: benefits and risks of immunomodulators and maintenance infliximab for IBD-subgroup analyses across four randomized trials. Aliment. Pharmacol. Ther. 30, 210-226 (2009).
51. Panaccione, R. et al. Infliximab, azathioprine, or infliximab + azathioprine for treatment of moderate to severe ulcerative colitis: The UC SUCCESS trial. J Crohn's and Colitis 5, S3-S12. (2011).
52. Radstake, T.R. et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann. Rheum. Dis. 68, 1739-1745 (2009).
53. Afif, W. et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am. J. Gastroenterol. 105, 1133-1139 (2010).
54. Mould, D.R. & Sweeney, K.R. The pharmacokinetics and pharmacodynamics of monoclonal antibodies-mechanistic modeling applied to drug development. Curr. Opin. Drug Discov. Devel. 10, 84-96 (2007). (Pubitemid 46438261)
55. Galluppi, G.R. et al. Integration of pharmacokinetic and pharmacodynamic studies in the discovery, development, and review of protein therapeutic agents: a conference report. Clin. Pharmacol. Ther. 69, 387-399 (2001). (Pubitemid 32564927)
56. Sheiner, L.B. Is intent-to-treat analysis always (ever) enough? Br. J. Clin. Pharmacol. 54, 203-211 (2002). (Pubitemid 35024945)
57. Schreiber, S. et al.; CDP870 Crohn's Disease Study Group. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterol. 129, 807-818 (2005). (Pubitemid 41242673)
58. Bendtzen, K., Ainsworth, M., Steenholdt, C., Thomsen, O. & Brynskov, J. Individual medicine in inflammatory bowel disease: monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factor-alpha antibodies. Scand. J. Gastroenterol. 44, 774-781 (2009).
59. Wolbink, G.J. et al. Relationship between serum trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis. Ann. Rheum. Dis. 64, 704-707 (2005). (Pubitemid 40559296)
60. Kapel, N., Meillet, D., Favennec, L., Magne, D., Raichvarg, D. & Gobert, J.G. Evaluation of intestinal clearance and faecal excretion of alpha 1-antiproteinase and immunoglobulins during Crohn's disease and ulcerative colitis. Eur. J. Clin. Chem. Clin. Biochem. 30, 197-202 (1992).
61. Dowell, J.A., Korth-Bradley, J., Liu, H., King, S.P. & Berger, M.S. Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse. J. Clin. Pharmacol. 41, 1206-1214 (2001). (Pubitemid 32983219)
62. Takeuchi, T. et al. Baseline tumour necrosis factor alpha levels predict the necessity for dose escalation of infliximab therapy in patients with rheumatoid arthritis. Ann. Rheum. Dis. 70, 1208-1215 (2011).
63. 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, 944-948 (2008). (Pubitemid 351501078)
64. Olsen, T., Goll, R., Cui, G., Christiansen, I. & Florholmen, J. TNF-alpha gene expression in colorectal mucosa as a predictor of remission after induction therapy with infliximab in ulcerative colitis. Cytokine 46, 222-227 (2009).
65. Sandborn, W.J. et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterol. 142, 257-265 (2012).
66. Ternant, D. et al. Infliximab pharmacokinetics in inflammatory bowel disease patients. Ther. Drug Monit. 30, 523-529 (2008).
67. Fasanmade, A.A., Adedokun, O.J., Olson, A., Strauss, R. & Davis, H.M. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int. J. Clin. Pharmacol. Ther. 48, 297-308 (2010).
68. Klaasen, R., Wijbrandts, C.A., Gerlag, D.M. & Tak, P.P. Body mass index and clinical response to infliximab in rheumatoid arthritis. Arthritis Rheum. 63, 359-364 (2011).
69. Peyrin-Biroulet, L. et al. Mesenteric fat in Crohn's disease: a pathogenetic hallmark or an innocent bystander? Gut 56, 577-583 (2007). (Pubitemid 46580516)
70. Adalimumab (Humira). FDA prescribing information. Revised March 2011.
71. Certolizumab (Cimzia). FDA prescribing information. Revised November 2009.
72. Infliximab (Remicade). FDA prescribing information. Revised February 2011.
73. Ghosh, S. et al.; Natalizumab Pan-European Study Group. Natalizumab for active Crohn's disease. N. Engl. J. Med. 348, 24-32 (2003). (Pubitemid 36026343)
74. Sandborn, W.J. et al.; Ustekinumab Crohn's Disease Study Group. A randomized trial of Ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterol. 135, 1130-1141 (2008).
75. ClinicalTrials.gov. A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis .