Safety Profile of Certolizumab Pegol in Patients with Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis

Drug Safety

Volumn 38, Issue 10, 2015, Pages 869-888

  Capogrosso Sansone, Alice ^a   Mantarro, Stefania ^a,d   Tuccori, Marco ^b   Ruggiero, Elisa ^c   Montagnani, Sabrina ^a   Convertino, Irma ^b   Marino, Alessandra ^a   Fornai, Matteo ^a   Antonioli, Luca ^a   Corona, Tiberio ^c   Garibaldi, Danila ^d   Blandizzi, Corrado ^a,b  

^a UNIVERSITY OF PISA   (Italy)

^b UNIVERSITY HOSPITAL OF PISA   (Italy)

^c Health District of Pisa   (Italy)

^d Pharmaceutical Unit   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CERTOLIZUMAB PEGOL; MONOCLONAL ANTIBODY;

AXIAL SPONDYLOARTHRITIS; CROHN DISEASE; DETECTION BIAS; DRUG INDUCED CANCER; DRUG SAFETY; FLU LIKE SYNDROME; GASTROENTERITIS; HUMAN; INJECTION SITE REACTION; META ANALYSIS; PERFORMANCE BIAS; PERIANAL ABSCESS; PHARYNGITIS; PRIORITY JOURNAL; PSORIASIS; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SELECTION BIAS; SINUSITIS; SPONDYLARTHRITIS; STATISTICAL BIAS; SYSTEMATIC REVIEW; TREATMENT DURATION; TUBERCULOSIS; URINARY TRACT INFECTION; INFLAMMATION;

ANTIBODIES, MONOCLONAL, HUMANIZED; CERTOLIZUMAB PEGOL; HUMANS; INFLAMMATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84942372118     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-015-0336-2     Document Type: Review

References (45)

1. Feldmann M. Pathogenesis of arthritis: recent research progress. Nature Immunol. 2001;2(9):771–3.
2. Redlich K, Schett G, Steiner G, Hayer S, Wagner EF, Smolen JS. Rheumatoid arthritis therapy after tumor necrosis factor and interleukin-1 blockade. Arthritis Rheum. 2003;48(12):3308–19.
3. Bruner V, Atteno M, Spano A, Scarpa R, Peluso R. Biological therapies for spondyloarthritis. Ther Adv Musculoskelet Dis. 2014;6(3):92–101.
4. Goel N. Stephens S. Certolizumab Pegol mAbs. 2010;2(2):137–47.
5. Vavricka SR, Schoepfer AM, Bansky G, Binek J, Felley C, Geyer M, et al. Efficacy and safety of certolizumab pegol in an unselected Crohn’s disease population: 26-week data of the FACTS II survey. Inflamm Bowel Dis. 2011;17(7):1530–9.
6. 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.
7. Nesbitt A, Fossati G, Bergin M, Stephens P, Stephens S, Foulkes R, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis. 2007;13(11):1323–32.
8. Ruiz Garcia V, Jobanputra P, Burls A, Cabello JB, Galvez Munoz JG, Saiz Cuenca ES, et al. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults. Cochrane Database Syst Rev. 2011;2:CD007649.
9. Nikfar S, Ehteshami-Afshar S, Abdollahi M. 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. Iran Red Crescent Med J. 2013;15(8):668–75.
10. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.
11. Choy EH, Hazleman B, Smith M, Moss K, Lisi L, Scott DG, et al. Efficacy of a novel PEGylated humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: a phase II double-blinded, randomized, dose-escalating trial. Rheumatology (Oxford). 2002;41(10):1133–7.
12. World Health Organization. International drug monitoring: the role of national centres. Report of a WHO meeting. World Health Organ Tech Rep Ser. 1972;498:1–25.
13. Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
14. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177–88.
15. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions (version 5.1.0). The Cochrane Collaboration (2011). http://www.cochrane-handbook.org.
16. Rucker G, Schwarzer G, Carpenter JR, Schumacher M. Undue reliance on I(2) in assessing heterogeneity may mislead. BMC Med Res Methodol. 2008;8:79.
17. Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, et al. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012;51(7):1226–34.
18. Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009;68(6):805–11.
19. Furst DE, Shaikh SA, Greenwald M, Bennett B, Staelens F, Koetse W, et al. Evaluation of two dosing regimens of certolizumab pegol for maintenance of clinical response in patients with active rheumatoid arthritis: primary results from doseflex, a phase IIIB study [abstract]. Ann Rheum Dis. 2013;71(Suppl. 3):513.
20. Keystone E, Heijde D, Mason D Jr, Landewe R, Vollenhoven RV, Combe B, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008;58(11):3319–29.
21. Kivitz AJ, Schechtman J, Texter M, Fichtner A, de Longueville M, Chartash EK. Vaccine responses in patients with rheumatoid arthritis treated with certolizumab pegol: results from a single-blind randomized phase IV trial. J Rheumatol. 2014;41(4):648–57.
22. Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009;68(6):797–804.
23. Smolen JS, Emery P, Ferraccioli GF, Samborski W, Berenbaum F, Davies OR, et al. Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial. Ann Rheum Dis. 2015;74(5):843–50.
24. Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012;51(12):2204–14.
25. Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: the HIKARI randomized, placebo-controlled trial. Mod Rheumatol. 2014;24(4):552–60.
26. Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Mod Rheumatol. 2014;24(5):715–24.
27. Kang YM, Park W, Park YE, Choe JY, Bae SC, Cho CS, et al. Efficacy and safety of certolizumab pegol (CZP) with concomitant methotrexate (MTX) in Korean rheumatoid arthritis (RA) patients (PTS) with an inadequate response to MTX [abstract]. Ann Rheum Dis. 2013;71(Suppl. 3):666.
28. 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.
29. 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):670–8, e3.
30. 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.
31. Landewé R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled phase 3 study. Ann Rheum Dis. 2014;73(1):39–47.
32. Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73(1):48–55.
33. Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, et al. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab’ certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012;167(1):180–90.
34. Galloway JB, Hyrich KL, Mercer LK, Dixon WG, Fu B, Ustianowski AP, et al. Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatology (Oxford). 2011;50(1):124–31.
35. Singh JA, Wells GA, Christensen R, Tanjong Ghogomu E, Maxwell L, Macdonald JK, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011;2:CD008794.
36. Lopez-Olivo MA, Tayar JH, Martinez-Lopez JA, Pollono EN, Cueto JP, Gonzales-Crespo MR, et al. Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis. JAMA. 2012;308(9):898–908.
37. Williams CJ, Peyrin-Biroulet L, Ford AC. Systematic review with meta-analysis: malignancies with anti-tumour necrosis factor-alpha therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2014;39(5):447–58.
38. Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008;117(2):244–79.
39. Horiuchi T, Mitoma H, Harashima S, Tsukamoto H, Shimoda T. Transmembrane TNF-alpha: structure, function and interaction with anti-TNF agents. Rheumatology (Oxford). 2010;49(7):1215–28.
40. Askling J, Fored CM, Brandt L, Baecklund E, Bertilsson L, Coster L, et al. Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden. Arthritis Rheum. 2005;52(7):1986–92.
41. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295(19):2275–85.
42. Cantini F, Niccoli L, Goletti D. Adalimumab, etanercept, infliximab, and the risk of tuberculosis: data from clinical trials, national registries, and postmarketing surveillance. J Rheumatol Suppl. 2014;91:47–55.
43. Fallahi-Sichani M, Flynn JL, Linderman JJ, Kirschner DE. Differential risk of tuberculosis reactivation among anti-TNF therapies is due to drug binding kinetics and permeability. J Immunol. 2012;188(7):3169–78.
44. Bykerk VP, Cush J, Winthrop K, Calabrese L, Lortholary O, de Longueville M, et al. Update on the safety profile of certolizumab pegol in rheumatoid arthritis: an integrated analysis from clinical trials. Ann Rheum Dis. 2015;74(1):96–103.
45. Andersen NN, Jess T. Risk of infections associated with biological treatment in inflammatory bowel disease. World J Gastroenterol. 2014;20(43):16014–9.