Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease

Alimentary Pharmacology and Therapeutics

Volumn 42, Issue 2, 2015, Pages 188-202

  Rosario, M ^a   Dirks, N L ^b   Gastonguay, M R ^b   Fasanmade, A A ^a   Wyant, T ^a   Parikh, A ^c   Sandborn, W J ^d   Feagan, B G ^e   Reinisch, W ^f,g   Fox, I ^a  

^a TAKEDA PHARMACEUTICAL COMPANY LIMITED   (Japan)

^b Metrum Research Group LLC   (United States)

^c Takeda Pharmaceuticals International Inc   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e ROBARTS RESEARCH INSTITUTE   (Canada)

^f MEDICAL UNIVERSITY OF VIENNA   (Austria)

^g MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; PLACEBO; VEDOLIZUMAB; ALBUMINOID; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ALBUMIN BLOOD LEVEL; ARTICLE; BODY WEIGHT; CROHN DISEASE; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); ULCERATIVE COLITIS; ADOLESCENT; CLINICAL TRIAL; COLITIS, ULCERATIVE; CONTROLLED STUDY; HALF LIFE TIME; INFLAMMATORY BOWEL DISEASES; METABOLIC CLEARANCE RATE; MIDDLE AGED; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ALBUMINS; ANTIBODIES, MONOCLONAL, HUMANIZED; BODY WEIGHT; COLITIS, ULCERATIVE; CROHN DISEASE; FEMALE; GASTROINTESTINAL AGENTS; HALF-LIFE; HEALTHY VOLUNTEERS; HUMANS; INFLAMMATORY BOWEL DISEASES; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; YOUNG ADULT;

EID: 84931563838     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.13243     Document Type: Article

References (34)

1. Soler D, Chapman T, Yang LL, Wyant T, Egan R, Fedyk ER,. The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther 2009; 330: 864-75.
2. Paul S, Moreau AC, Del Tedesco E, et al,. Pharmacokinetics of adalimumab in inflammatory bowel diseases: a systematic review and meta-analysis. Inflamm Bowel Dis 2014; 20: 1288-95.
3. Ordas I, Mould DR, Feagan BG, Sandborn WJ,. Anti-TNF Monoclonal Antibodies in Inflammatory Bowel Disease: Pharmacokinetics-Based Dosing Paradigms. Clin Pharmacol Ther 2012; 91: 635-46.
4. Colombel JF, Feagan BG, Sandborn WJ, Van Assche G, Robinson AM,. Therapeutic drug monitoring of biologics for inflammatory bowel disease. Inflamm Bowel Dis 2012a; 18: 349-58.
5. Feagan BG, Greenberg GR, Wild G, et al,. Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin. Clin Gastroenterol Hepatol 2008; 6: 1370-7.
6. Feagan BG, Greenberg GR, Wild G, et al,. Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin. N Engl J Med 2005; 352: 2499-507.
7. Parikh A, Leach T, Wyant T, et al,. Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis 2012; 18: 1470-9.
8. Feagan BG, Rutgeerts P, Sands BE, et al,. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013; 369: 699-710.
9. Sandborn WJ, Feagan BG, Rutgeerts P, et al,. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013; 369: 711-21.
10. Sands BE, Feagan BG, Rutgeerts P, et al,. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology 2014; 147: 618-27.
11. Rosario M, French J, Dirks N, Milton A, Fox I, Gastonguay M, eds. Exposure-response relationship during vedolizumab induction therapy in adults with ulcerative colitis. 9th Congress of the European Crohn's and Colitis Organisation; 20-22 February 2014; Copenhagen, Denmark: J Crohns Colitis, 2014a.
12. Rosario M, French J, Dirks N, Milton A, Fox I, Gastonguay M, eds. Exposure-response relationship of vedolizumab after 6 weeks of treatment in adults with Crohn's disease. 9th Congress of the European Crohn's and Colitis Organisation; 20-22 February 2014; Copenhagen, Denmark: J Crohns Colitis, 2014b.
13. Beal SL, Sheiner LB, Boeckmann AJ, Bauer RJ, eds. NONMEM Users Guide Part I-VIII. Hanover, MD: ICON Development Solutions, 1989-2012.
14. Gastonguay M, ed. A full model estimation approach for covariate effects: Inference based on clinical importance and estimation precision. American Association of Pharmaceutical Scientists Annual Meeting and Exposition; 7-11 November 2004; Baltimore, MD: AAPS Journal, 2004.
15. Gibiansky L, Gibiansky E,. Target-mediated drug disposition model: relationships with indirect response models and application to population PK-PD analysis. J Pharmacokinet Pharmacodyn 2009; 36: 341-51.
16. Tabrizi MA, Tseng CM, Roskos LK,. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today 2006; 11: 81-8.
17. Dirks NL, Nolting A, Kovar A, Meibohm B,. Population pharmacokinetics of cetuximab in patients with squamous cell carcinoma of the head and neck. J Clin Pharmacol 2008; 48: 267-78.
18. Frey N, Grange S, Woodworth T,. Population pharmacokinetic analysis of tocilizumab in patients with rheumatoid arthritis. J Clin Pharmacol 2010; 50: 754-66.
19. Ng CM, Joshi A, Dedrick RL, Garovoy MR, Bauer RJ,. Pharmacokinetic-pharmacodynamic-efficacy analysis of efalizumab in patients with moderate to severe psoriasis. Pharm Res 2005; 22: 1088-100.
20. Xu Z, Seitz K, Fasanmade A, et al,. Population pharmacokinetics of infliximab in patients with ankylosing spondylitis. J Clin Pharmacol 2008; 48: 681-95.
21. Fasanmade AA, Adedokun OJ, Ford J, et al,. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol 2009; 65: 1211-28.
22. Zhou H, Jang H, Fleischmann RM, et al,. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol 2007; 47: 383-96.
23. Colombel JF, Feagan B, Sandborn W, Assche Gv, Robinson A,. Therapeutic drug monitoring of biologics for inflammatory bowel disease. Inflamm Bowel Dis 2012; 18: 349-58.
24. Nestorov I,. Clinical pharmacokinetics of TNF antagonists: how do they differ? Semin Arthritis Rheum 2005; 5 (Suppl. 1): 12-8.
25. Dirks NL, Meibohm B,. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 2010; 49: 633-59.
26. Fasanmade AA, Adedokun OJ, Olson A, Strauss R, Davis HM,. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol Ther 2010; 48: 297-308.
27. Brandse JF, van der Kleij D, Wolbink GJ, et al,. The pharmacokinetics of infliximab induction therapy in patients with moderate to severe ulcerative colitis. Gastroenterology 2014; 146 (5 Suppl. 1): S134.
28. Van Moerkercke W, Ackaert C, Compernolle G, et al,. High infliximab levels are associated with mucosal healing in Crohn's disease. Gastroenterology 2010; 138 (Suppl. 1): S60.
29. 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: 80-4.
30. Colombel JF, Sandborn WJ, Allez M, et al,. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol 2014; 12: 423-31.
31. Wade JR, Parker G, Kosutic G, et al,. Population pharmacokinetic analysis of certolizumab pegol in patients with Crohn's disease. J Clin Pharmacol 2015 [Epub ahead of print].
32. Velagapudi RB, Noertersheuser P, Awni W, et al,., eds. Effect of methotrexate (MTX) coadministration on the pharmacokinetics (PK) of adalimumab (HUMIRA (TM), Abbott) following a single intravenous (iv) injection. American College of Rheumatology 67th Annual Meeting; 23-28 October 2003; Orlando, FL: Arthritis Rheum, 2003.
33. Chow A, Earp J, Gupta M, et al,. Utility of population pharmacokinetic modeling in the assessment of therapeutic protein-drug interactions. J Clin Pharmacol 2014; 54: 593-601.
34. Earp J, Fang L, Ma L, et al,. Assessing labeling claims for drug interactions using a population PK approach: Vedolizumab. J Pharmacokinet Pharmacodyn 2014; 41: S39.