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Expert Opinion on Drug Safety Volume 15, 2016 - Issue 1
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Reviews

Immunogenicity of infliximab and adalimumab: what is its role in hypersensitivity and modulation of therapeutic efficacy and safety?

Giuseppe MurdacaDepartment of Internal Medicine, Clinical immunology Unit, University of Genova, Viale Benedetto XV, n. 6, 16132, Genova, ItalyCorrespondence[email protected]
,
Francesca SpanòDepartment of Internal Medicine, Clinical immunology Unit, University of Genova, Viale Benedetto XV, n. 6, 16132, Genova, Italy
,
Miriam ContatoreDepartment of Internal Medicine, Clinical immunology Unit, University of Genova, Viale Benedetto XV, n. 6, 16132, Genova, Italy
,
Andrea GuastallaDepartment of Internal Medicine, Clinical immunology Unit, University of Genova, Viale Benedetto XV, n. 6, 16132, Genova, Italy
,
Elena PenzaDepartment of Internal Medicine, Clinical immunology Unit, University of Genova, Viale Benedetto XV, n. 6, 16132, Genova, Italy
,
Ottavia MagnaniDepartment of Internal Medicine, Clinical immunology Unit, University of Genova, Viale Benedetto XV, n. 6, 16132, Genova, Italy
&
Francesco PuppoDepartment of Internal Medicine, Clinical immunology Unit, University of Genova, Viale Benedetto XV, n. 6, 16132, Genova, Italy
 show all
Pages 43-52 | Published online: 11 Nov 2015

Bibliography

  • Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.
  • Murdaca G, Colombo BM, Puppo F. Anti-TNF-alpha inhibitors: a new therapeutic approach for inflammatory immune-mediated diseases: an update upon efficacy and adverse events. Int J Immunopathol Pharmacol. 2009;22(3):557–565.

•• Comprehensive review on TNF-α inhibitors.

•• Comprehensive review concerning the clinical use of TNF-α inhibitors.

•• Comprehensive article concerning current data on efficacy and safety of TNF-α inhibitors.

  • Murdaca G, Colombo BM, Puppo F. Emerging biological drugs: a new therapeutic approach for systemic lupus erythematosus. An update upon efficacy and adverse events. Autoimmun Rev. 2011;11(1):56–60.

•• Comprehensive review on the current and potential biological drugs for the treatment of SLE.

  • Murdaca G, Colombo BM, Puppo F. Adalimumab for the treatment of immune-mediated diseases: an update on old and recent indications. Drugs Today (Barc). 2011;47(4):277–288.
  • Puppo F, Murdaca G, Ghio M, et al. Emerging biologic drugs for the treatment of rheumatoid arthritis. Autoimmun Rev. 2005;4(8):537–541.
  • Murdaca G, Spanò F, Puppo F. Use of leflunomide plus TNF-α inhibitors in rheumatoid arthritis. Expert Opin Drug Saf. 2013;12(6):801–804.

•• Comprehensive paper on combination regimens.

  • Murdaca G, Spanò F, Puppo F. Long term treatment of rheumatoidarthritis with adalimumab. Open Access Rheum Res Rev. 2013;5:43–49.
  • Hochberg MC, Lebwohl MG, Plevy SE, et al. The benefit/risk profile of TNF-blocking agents: findings of a consensus panel. Semin Arthritis Rheum. 2005;34:819–836.
  • Murdaca G, Colombo BM, Barabino G, et al. Anti-tumor necrosis factor-α treatment with infliximab for disseminated granuloma annulare. Am J Clin Dermatol. 2010;11(6):437–439.
  • Murdaca G, Spanò F, Contatore M, et al. The potential use of TNF-α inhibitors in systemic sclerosis. Immunotherapy. 2014;6(3):283–289.
  • Murdaca G, Spanò F, Contatore M, et al. Efficacy and safety of etanercept in chronic immune-mediated disease. Expert Opin Drug Saf. 2014;13(5):649–661.
  • Murdaca G, Spanò F, Puppo F. Current therapies for the treatment of systemic sclerosis-related pulmonary arterial hypertension: efficacy and safety. Expert Opin Drug Saf. 2014;13(3):295–305.
  • Launois R, Avouac B, Berenbaum F, et al. Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment Bayesian metaanalysis. J Rheumatol. 2011;38(5):835–845.
  • Smith CA, Farrah T, Goodwin RG. The TNF receptor superfamily of cellular and viral proteins: activation, costimulation, and death. Cell. 1994;76:959–962.
  • Murdaca G, Colombo BM, Contini P, et al. Determination of lymphotoxin-alpha levels in patients with psoriatic arthritis undergoing etanercept treatment. J Interferon Cytokine Res. 2012;32(6):277–279.
  • Furst DE, Breedveld FC, Kalden JR, et al. Updated consensus statement on biological agents, specifically tumour necrosis factor {alpha} (TNF{alpha}) blocking agents and interleukin-1 receptor antagonist (IL-1ra), for the treatment of rheumatic diseases, 2005. Ann Rheum Dis. 2005;64(Suppl 4):iv2–14.
  • Gisondi P, Girolomoni G. Biologic therapies in psoriasis: a new therapeutic approach. Autoimmun Rev. 2007;6:515–519.

•• Comprehensive paper on the use of TNF-α inhibitors in Ps.

  • Kyle S, Chandler D, Griffiths CEM, et al. Guideline for anti-TNF-alpha therapy in psoriatic arthritis. Rheumatology. 2005;44:390–397.
  • Murdaca G, Colombo BM, Puppo F. The role of Th17 lymphocytes in the autoimmune and chronic inflammatory diseases. Intern Emerg Med. 2011;6(6):487–495.
  • Chiang EY, Kolumam GA, Yu X, et al. Targeted depletion of lymphotoxin-alpha-expressing TH1 and TH17 cells inhibits autoimmune disease. Nat Med. 2009;15(7):766–773.
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  • Filaci G, Rizzi M, Setti M, et al. Non-antigen-specific CD8(+) T suppressor lymphocytes in diseases characterized by chronic immune responses and inflammation. Ann N Y Acad Sci. 2005;1050:115–123.
  • Ceeraz S, Hall C, Choy EH, et al. Defective CD8+CD28+ regulatory T cell suppressor function in rheumatoid arthritis is restored by tumour necrosis factor inhibitor therapy. Clin Exp Immunol. 2013;174(1):18–26.
  • Booth AD, Jayne DR, Kharbanda RK, et al. Infliximab improves endothelial dysfunction in systemic vasculitis: a model of vascular inflammation. Circulation. 2004;109(14):1718–1723.
  • Murdaca G, Colombo BM, Cagnati P, et al. Endothelial dysfunction in rheumatic autoimmune diseases. Atherosclerosis. 2012;224(2):309–317.

•• Comprehensive review on the mechanisms of endothelial dysfunction.

  • Murdaca G, Spanò F, Cagnati P, et al. Free radicals and endothelial dysfunction: potential positive effects of TNF-α inhibitors. Redox Rep. 2013;18(3):95–99.
  • Colombo BM, Cacciapaglia F, Puntoni M, et al. Traditional and non traditional risk factors in accelerated atherosclerosis in systemic lupus erythematosus: role of vascular endothelial growth factor (VEGATS Study). Autoimmun Rev. 2009;8(4):309–315.
  • Colombo BM, Murdaca G, Caiti M, et al. Intima-media thickness: a marker of accelerated atherosclerosis in women with systemic lupus erythematosus. Ann N Y Acad Sci. 2007;1108:121–126.
  • Arenas IA, Armstrong SJ, Xu Y, et al. Chronic tumor necrosis factor-alpha inhibition enhances NO modulation of vascular function in estrogen-deficient rats. Hypertension. 2005;46(1):76–81.
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  • Szekanecz Z, Kerekes G, Soltész P. Vascular effects of biologic agents in RA and spondyloarthropathies. Nat Rev Rheumatol. 2009;5(12):677–684.
  • Murdaca G, Spanò F, Miglino M, et al. Effects of TNF-α inhibitors upon the mechanisms of action of VEGF. Immunotherapy. 2013;5(2):113–115.

•• A good article describing the beneficial effect of TNF-α inhibitors on endothelial dysfunction.

  • Ciprandi G, Murdaca G, Colombo BM, et al. Serum vascular endothelial growth factor in allergic rhinitis and systemic lupus erythematosus. Hum Immunol. 2008;69(8):510–512.
  • Ciprandi G, Colombo BM, Murdaca G, et al. Serum vascular endothelial growth factor and sublingual immunotherapy. Allergy. 2008;63(7):945–946.
  • Murdaca G, Spanò F, Puppo F. Selective TNF-α inhibitor-induced injection site reactions. Expert Opin Drug Saf. 2013;12(2):187–193.
  • Murdaca G, Spanò F, Contatore M, et al. Infection risk associated with anti-TNF-α agents: a review. Expert Opin Drug Saf. 2015;14(4):571–582.
  • Bender NK, Heilig CE, Dröll B, et al. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatol Int. 2007;27:269–274.
  • Steenholdt C, Svenson M, Bendtzen K, et al. Acute and delayed hypersensitivity reactions to infliximab and adalimumab in a patient with Crohn’s disease. J Crohns Colitis. 2012;6(1):108–111.

•• A good article describing the influence of delayed hypersensitivity reaction to infliximab and adalimumab.

  • Atzeni F, Benucci M, Sallì S, et al. Different effects of biological drugs in rheumatoid arthritis. Autoimmun Rev. 2013;12(5):575–579.
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  • Chaparro M, Guerra I, Muñoz-Linares P, et al. Systematic review: antibodies and anti-TNF-α levels in inflammatory bowel disease. Aliment Pharmacol Ther. 2012;35(9):971–986.

•• A good article describing the beneficial effect of TNF-α inhibitors on inflammatory bowel disease.

  • Van der Laken CJ, Voskuyl AE, Roos JC, et al. The formation of infliximab and anti-infliximab immune complexes as an explanation for non-responding to infliximab treatment of rheumatoid arthritis: observational study in 4 patients. Ned Tijdschr Geneeskd. 2008;152(30):1672–1677.
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  • Bendtzen K, Geborek P, Svenson M, et al. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum. 2006;54(12):3782–3789.
  • Pascual-salcedo D, Plasencia C, Ramiro S, et al. Influence of immunogenicity on the efficacy of longterm treatment of spondyloarthritis with infliximab. Ann Rheum Dis. 2012;71:1955–1960.
  • Miele E, Markowitz JE, Mamula P, et al. Human antichimeric antibody in children and young adults with inflammatory bowel disease receiving infliximab. J Pediatr Gastroenterol Nutr. 2004;38(5):502–508.
  • de Vries MK, Wolbink GJ, Stapel SO, et al. Decreased clinical response to infliximab in ankylosing spondylitis is correlated with anti-infliximab formation. Ann Rheum Dis. 2007;66(9):1252–1254.

•• A good article describing the influence of anti-IFX Abs on TNF-α inhibitors’ efficacy.

  • Vultaggio A, Matucci A, Nencini F, et al. Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy. 2010;65(5):657–661.
  • Finkelman FD. Anaphylaxis: lessons from mouse models. J Allergy Clin Immunol. 2007;120:506–515.
  • Oettgen HC, Martin TR, Wynshaw-Boris A, et al. Active anaphylaxis in IgE-deficient mice. Nature. 1994;370:367–370.
  • Vultaggio A, Matucci A, Parronchi P, et al. Safety and tolerability of infliximab therapy: suggestions and criticisms based on wide clinical experience. Int J Immunopathol Pharmacol. 2008;21:367–374.
  • Matucci A, Pratesi S, Petroni G, et al. Allergological in vitro and in vivo evaluation of patients with hypersensitivity reactions to infliximab. Clin Exp Allergy. 2013;43:659–664.
  • Steenholdt C, Svenson M, Bendtzen K, et al. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011;34(1):51–58.
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  • Wolbink GJ, Voskuyl AE, Lems WF, et al. Relationship between serum trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis. Ann Rheum Dis. 2005;64(5):704–707.
  • 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(5):297–308.
  • Magira E, Lind C, Baldassano R, et al. The HLA DRß13 residue is associated with the development of human anti-chimeric antibody in some Crohn’s patients treated with infliximab. Human Immunol. 2009;70(S1):131.
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  • Moss AC, Brinks V, Carpenter JF. Review article: immunogenicity of anti-TNF biologics in IBD - the role of patient, product and prescriber factors. Aliment Pharmacol Ther. 2013;38(10):1188–1197.
  • Pallagi-Kunstár É, Farkas K, Szepes Z, et al. Utility of serum TNF-α, infliximab trough level, and antibody titers in inflammatory bowel disease. World J Gastroenterol. 2014;20(17):5031–5035.
  • Bender NK, Heilig CE, Dröll B, et al. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatol Int. 2007;27(3):269–274.
  • Jani M, Chinoy H, Warren RB, et al. Clinical utility of random anti-tumour necrosis factor drug testing and measurement of anti-drug antibodies on long-term treatment response in rheumatoid arthritis. Lancet. 2015;385(Suppl 1):S48.
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•• A good article describing the influence of anti-ADA Abs on TNF-α inhibitors’ efficacy.

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•• A good article describing the influence of anti-ADA Abs on TNF-α inhibitors’ efficacy.

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