Occupational health and safety of anti-tumour necrosis factor alpha monoclonal antibodies with casual exposure

Expert Opinion on Biological Therapy

Volumn 14, Issue 1, 2014, Pages 27-36

  Chang, Jeff ^a,b   Leong, Rupert W L ^a,b  

^a Department of Geriatric Medicine   (Australia)

^b UNIVERSITY OF NEW SOUTH WALES   (Australia)

Author keywords

Colitis; Crohn; Inflammatory bowel disease; Monoclonal antibody; Occupational health safety; Tumour necrosis factor; Ulcerative

Indexed keywords

ADALIMUMAB; CERTOLIZUMAB PEGOL; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; TUMOR NECROSIS FACTOR INHIBITOR;

DANGEROUS GOODS; FETUS RISK; HUMAN; INHALATION; NEEDLESTICK INJURY; OCCUPATIONAL EXPOSURE; OCCUPATIONAL HEALTH; OCCUPATIONAL SAFETY; OPPORTUNISTIC INFECTION; PHYSICAL CHEMISTRY; PREGNANCY; REVIEW; RISK ASSESSMENT; SKIN; TUBERCULOSIS;

ACCIDENTS, OCCUPATIONAL; ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; HEALTH PERSONNEL; HUMANS; OCCUPATIONAL EXPOSURE; OCCUPATIONAL HEALTH; RISK ASSESSMENT; RISK FACTORS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84890251448     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2014.853738     Document Type: Review

References (66)

1. Centers for Disease Control and Prevention. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings. 2012. Available from: www.cdc.gov/niosh/eNews
2. American Society of Health System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm 2006;63:1172-93
3. Burger D, Travis S. Conventional medical management of inflammatory bowel disease. Gastroenterology 2011;140:1827-37; e2
4. Cheifetz AS. Management of active Crohn disease. JAMA 2013;309:2150-8
5. Ford AC, Sandborn WJ, Khan KJ, et al. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol 2011;106:644-59
6. Halpin SJ, Hamlin PJ, Greer DP, et al. Efficacy of infliximab in acute severe ulcerative colitis: a single-centre experience. World J Gastroenterol 2013;19:1091-7
7. Magro F, Portela F. Management of inflammatory bowel disease with infliximab and other anti-tumor necrosis factor alpha therapies. BioDrugs 2010;24(Suppl 1):3-14
8. Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med 1999;340:1398-405
9. Langford S, Fradgley S, Evans M, et al. Assessing the risk of handling monoclonal antibodies. Hospital Pharmacist 2008;15:60-3
10. St Clair EW, van der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004;50:3432-43
11. van der Heijde D, Dijkmans B, Geusens P, et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005;52:582-91
12. Burmester GR, Panaccione R, Gordon KB, et al. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease. Ann Rheum Dis 2013;72:517-24
13. Kouklakis G, Efremidou EI, Pitiakoudis M, et al. Development of primary malignant melanoma during treatment with a TNF-alpha antagonist for severe Crohn's disease: a case report and review of the hypothetical association between TNF-alpha blockers and cancer. Drug Des Devel Ther 2013;7:195-9
14. Rivkin A. Certolizumab pegol for the management of Crohn's disease in adults. Clin Ther 2009;31:1158-76
15. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975;256:495-7
16. Ordas I, Mould DR, Feagan BG, et al. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther 2012;91:635-46
17. Knight DM, Trinh H, Le J, et al. Construction and initial characterization of a mouse-human chimeric anti-TNF antibody. Mol Immunol 1993;30:1443-53
18. Chematch. Janssen Remicade Independent Material Safety Data Sheet. 2013
19. Drug Bank.Open data drug and drug target database. 2012. Available from: http://www.drugbank.ca/ [Last accessed 4 August 2013]
20. Abbott Laboratories Pharmaceutical Products Group. Humira adalumimab material safety data sheet. 2011. Available from: http://abbott-msds. complyplus.com/frame.asp [Last accessed 4 August 2013]
21. Colombel JF, Sandborn WJ, Panaccione R, et al. Adalimumab safety in global clinical trials of patients with Crohn's disease. Inflamm Bowel Dis 2009;15:1308-19
22. Hoentjen F, van Bodegraven AA. Safety of anti-tumor necrosis factor therapy in inflammatory bowel disease. World J Gastroenterol 2009;15:2067-73
23. Lichtenstein GR, Feagan BG, Cohen RD, et al. Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT registry. Am J Gastroenterol 2012;107:1409-22
24. Poddubnyy D, Rudwaleit M. Efficacy and safety of adalimumab treatment in patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. Expert Opin Drug Saf 2011;10:655-73
25. Rahier JF, Ben-Horin S, Chowers Y, et al. European evidence-based Consensus on the prevention, diagnosis and management of opportunistic infections in inflammatory bowel disease. J Crohns Colitis 2009;3:47-91
26. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001;345:1098-104
27. Ford AC, Peyrin-Biroulet L. Opportunistic infections with anti-tumor necrosis factor-alpha therapy in inflammatory bowel disease: meta-analysis of randomized controlled trials. Am J Gastroenterol 2013;108:1268-76
28. NSW Government Health. Communicable diseases protocol: tuberculosis. 2012. Available from: http://www.health. nsw.gov.au/Infectious/controlguideline/ Pages/tuberculosis.aspx [Last accessed 4 August 2013]
29. Balkwill F, Coussens LM. Cancer: an inflammatory link. Nature 2004;431:405-6
30. van Horssen R, Ten Hagen TL, Eggermont AM. TNF-alpha in cancer treatment: molecular insights, antitumor effects, and clinical utility. Oncologist 2006;11:397-408
31. Subramaniam K, D'Rozario J, Pavli P. Lymphoma and other lymphoproliferative disorders in inflammatory bowel disease: a review. J Gastroenterol Hepatol 2013;28:24-30
32. Siegel CA, Marden SM, Persing SM, et al. Risk of lymphoma associated with combination anti-tumor necrosis factor and immunomodulator therapy for the treatment of Crohn's disease: a meta-analysis. Clin Gastroenterol Hepatol 2009;7:874-81
33. Colombel JF, Loftus EV Jr, Tremaine WJ, et al. The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients. Gastroenterology 2004;126:19-31
34. Peyrin-Biroulet L, Deltenre P, de Suray N, et al. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol 2008;6:644-53
35. Wolfe F, Michaud K. Biologic treatment of rheumatoid arthritis and the risk of malignancy: analyses from a large US observational study. Arthritis Rheum 2007;56:2886-95
36. Moulis G, Sommet As, Bene J, et al. Cancer risk of anti-TNF-a at recommended doses in adult rheumatoid arthritis: a meta-analysis with intention to treat and per protocol analyses. PLoS ONE 2012;7:e48991
37. Simard JF, Neovius M, Askling J, Group AS. Mortality rates in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: drug-specific comparisons in the Swedish biologics register. Arthritis Rheum 2012;64:3502-10
38. El Mourabet M, El-Hachem S, Harrison JR, et al. Anti-TNF antibody therapy for inflammatory bowel disease during pregnancy: a clinical review. Curr Drug Targets 2010;11:234-41
39. Simister NE. Placental transport of immunoglobulin G. Vaccine 2003;21:3365-9
40. Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2013;11:286-92
41. Zelinkova Z, de Haar C, de Ridder L, et al. High intra-uterine exposure to infliximab following maternal anti-TNF treatment during pregnancy. Aliment Pharmacol Ther 2011;33:1053-8
42. Cheent K, Nolan J, Shariq S, et al. Case report: fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's disease. J Crohns Colitis 2010;4:603-5
43. Marchioni RM, Lichtenstein GR. Tumor necrosis factor-alpha inhibitor therapy and fetal risk: a systematic literature review. World J Gastroenterol 2013;19:2591-602
44. Mahadevan U, Martin CF, Sandler RS, et al. PIANO: a 1000 patient prospective registry of pregnancy outcomes in women with IBD exposed to immunomodulators and biologic therapy [abstract]. Gastroenterology 2012;142:S-149
45. Kane S, Ford J, Cohen R, et al. Absence of infliximab in infants and breast milk from nursing mothers receiving therapy for Crohn's disease before and after delivery. J Clin Gastroenterol 2009;43:613-16
46. Vasiliauskas EA, Church JA, Silverman N, et al. Case report: evidence for transplacental transfer of maternally administered infliximab to the newborn. Clin Gastroenterol Hepatol 2006;4:1255-8
47. Ben-Horin S, Yavzori M, Kopylov U, et al. Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis 2011;5:555-8
48. Halsen G, Kramer I. Assessing the risk to health care staff from long-term exposure to anticancer drugs - the case of monoclonal antibodies. J Oncol Pharm Pract 2011;17:68-80
49. Bos JD, Meinardi MM. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol 2000;9:165-9
50. De Rie MA, Meinardi MM, Bos JD. Lack of efficacy of topical cyclosporin A in atopic dermatitis and allergic contact dermatitis. Acta derm Venereol 1991;71:452-4
51. Powles AV, Baker BS, McFadden J, et al. Intralesional injection of cyclosporin in psoriasis. Lancet 1988;1:537
52. Charles CA, Romanelli P, Martinez ZB, et al. Tumor necrosis factor-alfa in nonhealing venous leg ulcers. J Am Acad Dermatol 2009;60:951-5
53. Streit M, Beleznay Z, Braathen LR. Topical application of the tumour necrosis factor-alpha antibody infliximab improves healing of chronic wounds. Int Wound J 2006;3:171-9
54. Patton JS. Mechanisms of macromolecule absorption by the lungs. Adv Drug Deliv Rev 1996;19:3-36
55. Patton JS, Fishburn CS, Weers JG. The lungs as a portal of entry for systemic drug delivery. Proc Am Thorac Soc 2004;1:338-44
56. National Institute for Occupational Safety and Health. Transcript of the NIOSH Public Meeting on Hazardous Drug List Update (NIOSH Docket 105). 2007
57. Perry DG, Wisniowski P, Daugherty GL, et al. Nonimmune phagocytosis of liposomes by rat alveolar macrophages is enhanced by vitronectin and is vitronectin-receptor mediated. Am J Respir Cell Mol Biol 1997;17:462-70
58. Rohde KA, Dupler AE, Postma J, et al. Minimizing nurses' risks for needlestick injuries in the hospital setting. Workplace health Saf 2013;61:197-202
59. den Broeder A, van de Putte L, Rau R, et al. A single dose, placebo controlled study of the fully human anti-tumor necrosis factor-alpha antibody adalimumab (D2E7) in patients with rheumatoid arthritis. J Rheumatol 2002;29:2288-98
60. National Patient Safety Agency National Health Service United Kingdom. Promoting safer use of injectable medicines. 2007.Available from: http://www.nrls. npsa.nhs.uk/resources/patient-safetytopics/ medication-safety/? entryid45=59812&p=2 [Last accessed 4 August 2013]
61. Vincent FB, Morand EF, Murphy K, et al. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis 2013;72:165-78
62. Chaparro M, Guerra I, Munoz-Linares P, et al. Systematic review: antibodies and anti-TNF-alpha levels in inflammatory bowel disease. Aliment Pharmacol Ther 2012;35:971-86
63. Summerhayes M, Cole J. Assessing the risk of handling monoclonal antibodies. Hosp Pharm 2008;15:138
64. Work Safe Australia. Guidance on the Classification of Hazardous Chemicals under the Work Health and Safety (WHS) Regulations. 2012. 26/04/2012.
65. REMICADE Infliximab Janssen-Cilag Pty Ltd. Data on file (JC121220): REMICADE (Infliximab) company safety information - cumulative exposure estimates. 2012
66. Crul M, Franki A -S, Simmons K. Preparation of monoclonal antibodies: practice across Europe. Eur J Oncol Pharm 2011;5:6-8