Is certolizumab pegol safe and effective in the treatment of patients with moderate to severe crohn's disease? A meta-analysis of controlled clinical trials

Iranian Red Crescent Medical Journal

Volumn 15, Issue 8, 2013, Pages 668-675

  Nikfar, Shekoufeh ^a,b   Ehteshami Afshar, Solmaz ^a,c   Abdollahi, Mohammad ^a  

^a TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^b MINISTRY OF HEALTH AND MEDICAL EDUCATION   (Iran)

^c SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCES   (Iran)

Author keywords

Certolizumab pegol; Crohn's disease; Meta analysis

Indexed keywords

C REACTIVE PROTEIN; CERTOLIZUMAB PEGOL; PLACEBO; TUMOR NECROSIS FACTOR ALPHA;

ARTICLE; CROHN DISEASE; CROHN DISEASE ACTIVITY INDEX; DRUG EFFICACY; DRUG SAFETY; HUMAN; META ANALYSIS; MULTICENTER STUDY (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; RISK FACTOR; UNSPECIFIED SIDE EFFECT;

EID: 84885713015     PISSN: 20741804     EISSN: None     Source Type: Journal    
DOI: 10.5812/ircmj.11258     Document Type: Article

References (17)

1. Rahimi R, Nikfar S, Abdollahi M. Do anti-tumor necrosis factors induce response and remission in patients with acute refractory Crohn's disease? A systematic meta-analysis of controlled clinical trials. Biomed Pharmacother. 2007;61(1):75-80.
2. Ehteshami-Afshar S, Nikfar S, Rezaie A, Abdollahi M. A systematic review and meta-analysis of the effects of infliximab on the rate of colectomy and post-operative complications in patients with inflammatory bowel disease. Arch Med Sci. 2011;7(6):1000-12.
3. Peyrin-Biroulet L, Deltenre P, de Suray N, Branche J, Sandborn WJ, Colombel JF. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol. 2008;6(6):644-53.
4. Shao LM, Chen MY, Cai JT. Meta-analysis: the efficacy and safety of certolizumab pegol in Crohn's disease. Aliment Pharmacol Ther. 2009;29(6):605-14.
5. Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007;357(3):228-38.
6. Schreiber S, Khaliq-Kareemi M, Lawrance IC, Thomsen OO, Hanauer SB, McColm J, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007;357(3):239-50.
7. Schreiber S, Rutgeerts P, Fedorak RN, Khaliq-Kareemi M, Kamm MA, Boivin M, et al. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology. 2005;129(3):807-18.
8. Winter TA, Wright J, Ghosh S, Jahnsen J, Innes A, Round P. Intravenous CDP870, a PEGylated Fab' fragment of a humanized antitumour necrosis factor antibody, in patients with moderate-tosevere Crohn's disease: an exploratory study. Aliment Pharmacol Ther. 2004;20(11-12):1337-46.
9. Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, et al. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011;9(8):670-678 e3.
10. HERCEPTIN. Genentech. U.S. BLA Supplement:; 2002 [updated 2002; cited]; Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm092753.pdf
11. Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev. 2008;(1):CD006893.
12. Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):644-59.
13. Jadad AR, Enkin MW. Randomised controlled trials. 2 ed. London, United Kingdom: BMJ Books 2007.
14. Hanauer SB, Panes J, Colombel JF, Bloomfield R, Schreiber S, Sandborn WJ. Clinical trial: impact of prior infliximab therapy on the clinical response to certolizumab pegol maintenance therapy for Crohn's disease. Aliment Pharmacol Ther. 2010;32(3):384-93.
15. Sandborn WJ, Schreiber S, Hanauer SB, Colombel JF, Bloomfield R, Lichtenstein GR. Reinduction with certolizumab pegol in patients with relapsed Crohn's disease: results from the PRECiSE 4 Study. Clin Gastroenterol Hepatol. 2010;8(8):696-702 e1.
16. Rutgeerts P, Schreiber S, Feagan B, Keininger DL, O'Neil L, Fedorak RN. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn's disease. Int J Colorectal Dis. 2008;23(3):289-96.
17. Schreiber S, Lawrance IC, Thomsen OO, Hanauer SB, Bloomfield R, Sandborn WJ. Randomised clinical trial: certolizumab pegol for fistulas in Crohn's disease-subgroup results from a placebocontrolled study. Aliment Pharmacol Ther. 2011;33(2):185-93.