Pharmacokinetics of infliximab in children with moderate-to-severe ulcerative colitis: Results from a randomized, multicenter, open-label, phase 3 study

Inflammatory Bowel Diseases

Volumn 19, Issue 13, 2013, Pages 2753-2762

  Adedokun, Omoniyi J ^a   Xu, Zhenhua ^a   Padgett, Lakshmi ^b   Blank, Marion ^c   Johanns, Jewel ^b   Griffiths, Anne ^d   Ford, Joyce ^e   Zhou, Honghui ^a   Guzzo, Cynthia ^c   Davis, Hugh M ^e   Hyams, Jeffrey ^f  

^a Janssen R and D US   (United States)

^b Biologics Clinical Biostatistics   (United States)

^c Biologics Clinical Medical Affairs   (United States)

^d HOSPITAL FOR SICK CHILDREN   (Canada)

^e Clin Pharmacol   (United States)

^f Farmington   (United States)

Author keywords

Inflammatory bowel disease; Pediatric; Serum concentration; Tumor necrosis factor

Indexed keywords

IMMUNOMODULATING AGENT; INFLIXIMAB;

ADOLESCENT; ARTICLE; BLOOD SAMPLING; CHILD; CLINICAL ASSESSMENT; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG EFFICACY; FEMALE; HUMAN; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; SCHOOL CHILD; TREATMENT DURATION; TREATMENT RESPONSE; ULCERATIVE COLITIS; WOUND HEALING;

ADOLESCENT; ADULT; ANTIBODIES, MONOCLONAL; CHILD; COLITIS, ULCERATIVE; FEMALE; FOLLOW-UP STUDIES; GASTROINTESTINAL AGENTS; HUMANS; MALE; TISSUE DISTRIBUTION; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84890180643     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1097/01.MIB.0000435438.84365.f7     Document Type: Article

References (22)

1. Kelsen J, Baldassano RN. Inflammatory bowel disease: the difference between children and adults. Inflamm Bowel Dis. 2008;14(suppl 2):S9-S11.
2. Sauer CG, Kugathasan S. Pediatric inflammatory bowel disease: highlighting pediatric differences in IBD. Gastroenterol Clin North Am. 2009;38:611-628.
3. Bradley GM, Oliva-Hemker M. Pediatric ulcerative colitis: current treatment approaches including role of infliximab. Biologics. 2012;6:125-134.
4. Mehrotra N, Garnett C, Zhang L, et al. Role of exposure-response relationship to guide dose selection in pediatric drug development when extrapolating efficacy from adults. Inflamm Bowel Dis. 2011;17:S5-S6. Abstract O-11.
5. Hyams J, Damaraju L, Blank M, et al. Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis. Clin Gastroenterol Hepatol. 2012;10:391-399.e1.
6. Hyams J, Crandall W, Kugathasan S, et al. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children. Gastroenterology. 2007;132:863-873.
7. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353: 2462-2476.
8. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987;317:1625-1629.
9. Turner D, Otley AR, Mack D, et al. Development, validation and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007;133:423-432.
10. Hanauer SB, Wagner CL, Bala M, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol. 2004;2:542-553.
11. Adedokun OJ, Xu Z, Damaraju L, et al. Pharmacokinetics of infliximab in pediatric patients with moderate-to-severe ulcerative colitis: results from a randomized, multicenter, open-label phase 3 study. Paper presented at: Poster presentation at Digestive Disease Week (DDW); May 19-22, 2012; San Diego, California.
12. Institute of Medicine (US) Committee on Clinical Research Involving Children. The necessity and challenges of clinical research involving children. In: Field MJ, Behrman RE, eds. Ethical Conduct of Clinical Research Involving Children. Washington, DC: National Academies Press (US); 2004, 2. Available at: http://www.ncbi.nlm.nih.gov/books/NBK25553/. Accessed January 22, 2013.
13. Smyth RL. Research with children. Paediatric practice needs better evidence -gained in collaboration with parents and children. BMJ. 2001;322:1377-1378.
14. Edwards SD, McNamee MJ. Ethical concerns regarding guidelines for the conduct of clinical research on children. J Med Ethics. 2005;31:351-354.
15. Food and Drug Administration. Specific requirements on content and format of labeling for human prescription drugs: revision of "pediatric use" subsection in the labeling: final rule. Fed Regist. 1994;59:FR Doc No: 94-30238.
16. Dunne J, Rodriguez WJ, Murphy MD, et al. Extrapolation of adult data and other data in pediatric drug-development programs. Pediatrics. 2011; 128:e1242-e1249.
17. Fasanmade AA, Adedokun OJ, Blank M, et al. 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. 2011;33: 946-964.
18. Xu Z, Mould DR, Hu C, et al. Population pharmacokinetic analysis of infliximab in pediatrics using integrated data from six clinical trials. Clin Pharmacol Drug Dev. 2012;1:203. Abstract 1393750.
19. Kelsen J, Gupta K, Grossman A, et al. Infliximab therapy in pediatric patients 7 years of age and younger. Inflamm Bowel Dis. 2011;17(suppl): S5. Abstract O-10.
20. Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. 1998;41:1552-1563.
21. Fasanmade AA, Adedokun OJ, Olson A, et al. 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.
22. Hyams JS, Lerer T, Griffiths A, et al. Outcome following infliximab therapy in children with ulcerative colitis. Am J Gastroenterol. 2010; 105:1430-1436.