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

Bibliography

• 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
   Google Scholar
• American Society of Health System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm 2006;63:1172-93
   Web of Science ®Google Scholar
• Burger D, Travis S. Conventional medical management of inflammatory bowel disease. Gastroenterology 2011;140:1827-37; e2
   PubMed Web of Science ®Google Scholar
• Cheifetz AS. Management of active Crohn disease. JAMA 2013;309:2150-8
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Langford S, Fradgley S, Evans M, et al. Assessing the risk of handling monoclonal antibodies. Hospital Pharmacist 2008;15:60-3
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Rivkin A. Certolizumab pegol for the management of Crohn's disease in adults. Clin Ther 2009;31:1158-76
   PubMed Web of Science ®Google Scholar
• Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975;256:495-7
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Chematch. Janssen Remicade Independent Material Safety Data Sheet. 2013
   Google Scholar
• Drug Bank. Open data drug and drug target database. 2012. Available from: http://www.drugbank.ca/ [Last accessed 4 August 2013]
   Google Scholar
• 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]
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Hoentjen F, van Bodegraven AA. Safety of anti-tumor necrosis factor therapy in inflammatory bowel disease. World J Gastroenterol 2009;15:2067-73
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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]
   Google Scholar
• Balkwill F, Coussens LM. Cancer: an inflammatory link. Nature 2004;431:405-6
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Moulis G, Sommet As, Be´´. neJ, 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Simister NE. Placental transport of immunoglobulin G. Vaccine 2003;21:3365-9
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Marchioni RM, Lichtenstein GR. Tumor necrosis factor-alpha inhibitor therapy and fetal risk: a systematic literature review. World J Gastroenterol 2013;19:2591-602
   PubMed Web of Science ®Google Scholar
• 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
   Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMedGoogle Scholar
• Bos JD, Meinardi MM. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol 2000;9:165-9
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Powles AV, Baker BS, McFadden J, et al. Intralesional injection of cyclosporin in psoriasis. Lancet 1988;1:537
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMedGoogle Scholar
• Patton JS. Mechanisms of macromolecule absorption by the lungs. Adv Drug Deliv Rev 1996;19:3-36
   Web of Science ®Google Scholar
• 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
   PubMedGoogle Scholar
• National Institute for Occupational Safety and Health. Transcript of the NIOSH Public Meeting on Hazardous Drug List Update (NIOSH Docket 105). 2007
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMedGoogle Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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-safety-topics/medication-safety/?entryid45=59812&p=2 [Last accessed 4 August 2013]
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Summerhayes M, Cole J. Assessing the risk of handling monoclonal antibodies. Hosp Pharm 2008;15:138
   Google Scholar
• Work Safe Australia. Guidance on the Classification of Hazardous Chemicals under the Work Health and Safety (WHS) Regulations. 2012. 26/04/2012.
   Google Scholar
• REMICADE Infliximab Janssen-Cilag Pty Ltd. Data on file (JC121220): REMICADE (Infliximab) company safety information - cumulative exposure estimates. 2012
   Google Scholar
• Crul M, Franki A -S, Simmons K. Preparation of monoclonal antibodies: practice across Europe. Eur J Oncol Pharm 2011;5:6-8
   Google Scholar