The complexity of adverse side-effects to biological agents

Journal of Crohn's and Colitis

Volumn 7, Issue 4, 2013, Pages 257-262

  Aubin, François ^a   Carbonnel, Franck ^b   Wendling, Daniel ^c  

^a UNIVERSITÉ DE FRANCHE COMTÉ   (France)

^b BICÊTRE HOSPITAL   (France)

^c UNIVERSITY HOSPITAL OF BESANÇON   (France)

Author keywords

Adverse events; Biologics; Side effects

Indexed keywords

ADALIMUMAB; ALPHA4 INTEGRIN; ANTIHISTAMINIC AGENT; BIOLOGICAL PRODUCT; CERTOLIZUMAB PEGOL; CORTICOSTEROID; EFALIZUMAB; INFLIXIMAB; INTERLEUKIN 12 ANTIBODY; INTERLEUKIN 23 ANTIBODY; IPILIMUMAB; NATALIZUMAB; OMALIZUMAB; PARACETAMOL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; USTEKINUMAB; XENOBIOTIC AGENT;

ACUTE FEBRILE NEUTROPHILIC DERMATOSIS; ALOPECIA; ANAPHYLAXIS; ATOPIC DERMATITIS; AUTOIMMUNITY; AWARENESS; COLITIS; CROHN DISEASE; CYTOKINE RELEASE; DESENSITIZATION; DRUG ERUPTION; DRUG FEVER; GUILLAIN BARRE SYNDROME; HEALTH CARE PERSONNEL; HEART FAILURE; HEPATITIS; HUMAN; IMMUNE RESPONSE; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; LUPUS LIKE SYNDROME; LUPUS VULGARIS; MULTIPLE SCLEROSIS; NEPHRITIS; PRIORITY JOURNAL; PSORIASIS; REVIEW; RHEUMATIC DISEASE; RISK ASSESSMENT; SERUM SICKNESS; SYSTEMIC SCLEROSIS; THYROIDITIS; URTICARIA; VASCULITIS;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; BIOLOGICAL THERAPY; DRUG TOXICITY; HUMANS; IMMUNOLOGIC FACTORS;

EID: 84875255874     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1016/j.crohns.2012.06.024     Document Type: Review

References (49)

1. Park B.K., Pirmohamed M., Kitteringham N.R. Role of drug disposition in drug hypersensitivity: a chemical, molecular, and clinical perspective. Chem Res Toxicol 1998, 11:969-988.
2. Naisbitt D.J., Gordon S.F., Pirmohamed M., Park B.K. Immunological principles of adverse drug reactions: the initiation and propagation of immune responses elicited by drug treatment. Drug Saf 2000, 23:483-507.
3. Steenholdt C., Svenson M., Bendtzen K., Thomsen O.Ø., Brynskov J., Ainsworth M.A. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2011, 34:51-58.
4. Baert F., Noman M., Vermeire S., Van Assche G., D' Haens G., Carbonez A., et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003, 348:601-608.
5. Lee S.J., Kavanaugh A. Adverse reactions to biologic agents: focus on autoimmune disease therapies. J Allergy Clin Immunol 2005, 116:900-905.
6. Pichler W.J. Adverse side-effects to biological agents. Allergy 2006, 61:912-920.
7. Descotes J., Gouraud A. Clinical immunotoxicity of therapeutic proteins. Expert Opin Drug Metab Toxicol 2008, 4:1537-1549.
8. Scherer K., Spoerl D., Bircher A.J. Adverse drug reactions to biologics. J Dtsch Dermatol Ges 2010, 8:411-426.
9. Kumar G., Bernstein J.M., Waibel J.S., Baumann M.A. Sweet's syndrome associated with sargramostim (granulocyte-macrophage colony stimulating factor) treatment. Am J Hematol 2004, 76:283-285.
10. Wang H., Ma S. The cytokine storm and factors determining the sequence and severity of organ dysfunction in multiple organ dysfunction syndrome. Am J Emerg Med 2008, 26:711-715.
11. Atzeni F., Sarzi-Puttini P. Autoantibody production in patients treated with anti-TNF-alpha. Expert Rev Clin Immunol 2008, 4:275-280.
12. Vermeire S., Noman M., Van Assche G., Baert F., D'Haens G., Rutgeerts P. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn's disease. Gut 2007, 56:1226-1231.
13. Cassinotti A., Travis S. Incidence and clinical significance of immunogenicity to infliximab in Crohn's disease: a critical systematic review. Inflamm Bowel Dis 2009, 15:1264-1275.
14. Barbaud A., Granel F., Waton J., Poreaux C. How to manage hypersensitivity reactions to biological agents?. Eur J Dermatol 2011, 21:667-674.
15. Benucci M., Manfredi M., Saviola G., Baiardi P., Campi P. Correlation between atopy and hypersensitivity reactions during therapy with three different TNF-alpha blocking agents in rheumatoid arthritis. Clin Exp Rheumatol 2009, 27:333-336.
16. Lecluse L.L., Piskin G., Mekkes J.R., Bos J.D., de Rie M.A. Review and expert opinion on prevention and treatment of infliximab-related infusion reactions. Br J Dermatol 2008, 159:527-536.
17. Hong D.I., Bankova L., Cahill K.N., Kyin T., Castells M.C. Allergy to monoclonal antibodies: cutting-edge desensitization methods for cutting-edge therapies. Expert Rev Clin Immunol 2012, 8:43-52.
18. Farrell R.J., Alsahli M., Jeen Y.T., Falchuk K.R., Peppercorn M.A., Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology 2003, 124:917-924.
19. Lipsky P.E., van der Heijde D.M., St Clair E.W., Furst D.E., Breedveld F.C., Kalden J.R., et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 2000, 343:1594-1602.
20. Wolbink G.J., Vis M., Lems W., Voskuyl A.E., de Groot E., Nurmohamed M.T., et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 2006, 54:711-715.
21. Ramos-Casals M., Brito-Zerón P., Muñoz S., Soria N., Galiana D., Bertolaccini L., et al. Autoimmune diseases induced by TNF-targeted therapies: analysis of 233 cases. Medicine (Baltimore) 2007, 86:242-251.
22. Strangfeld A., Listing J., Herzer P., Liebhaber A., Rockwitz K., Richter C., et al. Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents. JAMA 2009, 301:737-744.
23. Tan C.S., Koralnik I.J. Progressive multifocal leukoencephalopathy and other disorders caused by JC virus: clinical features and pathogenesis. Lancet Neurol 2010, 9:425-437.
24. Bongartz T., Sutton A.J., Sweeting M.J., Buchan I., Matteson E.L., 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, 295:2275-2285.
25. Shale M., Kanfer E., Panaccione R., Ghosh S. Hepatosplenic T cell lymphoma in inflammatory bowel disease. Gut 2008, 57:1639-1641.
26. Askling J., van Vollenhoven R.F., Granath F., Raaschou P., Fored C.M., Baecklund E., et al. Cancer risk in patients with rheumatoid arthritis treated with anti-tumor necrosis factor alpha therapies: does the risk change with the time since start of treatment?. Arthritis Rheum 2009, 60:3180-3189.
27. Wolfe F., Michaud K. The effect of methotrexate and anti-tumor necrosis factor therapy on the risk of lymphoma in rheumatoid arthritis in 19,562 patients during 89,710 person-years of observation. Arthritis Rheum 2007, 56:1433-1439.
28. Dommasch E.D., Abuabara K., Shin D.B., Nguyen J., Troxel A.B., Gelfand J.M. The risk of infection and malignancy with tumor necrosis factor antagonists in adults with psoriatic disease: a systematic review and meta-analysis of randomized controlled trials. J Am Acad Dermatol 2011, 64:1035-1050.
29. Kerbleski F.K., Gottlieb A.B. Dermatological complications and safety of anti-TNF treatment. Gut 2009, 58:1033-1039.
30. Siegel C.A., Marden S.M., Persing S.M., Larson R.J., Sands B.E. 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, 7:874-881.
31. Peyrin-Biroulet L., Deltenre P., de Suray N., Branche J., Sandborn W.J., Colombel J.F. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol 2008, 6:644-653.
32. Burmester GR, Panaccione R, Gordon KB, McIlraith MJ, Lacerda AP. 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 Jul 6. [Epub ahead of print].
33. Prinz J.C. Autoimmune-like syndromes during TNF blockade: does infection have a role?. Nat Rev Rheumatol 2011, 7:429-434.
34. Viguier M., Richette P., Bachelez H., Wendling D., Aubin F. Paradoxical adverse effects of anti-TNF-alpha treatment: onset or exacerbation of cutaneous disorders. Expert Rev Clin Immunol 2009, 5:421-431.
35. Freeman H.J. Colitis associated with biological agents. World J Gastroenterol 2012, 18:1871-1874.
36. Seneschal J., Milpied B., Vergier B., Lepreux S., Schaeverbeke T., Taïeb A. Cytokine imbalance with increased production of interferon-alpha in psoriasiform eruptions associated with antitumour necrosis factor-alpha treatments. Br J Dermatol 2009, 161:1081-1088.
37. Notley C.A., Inglis J.J., Alzabin S., McCann F.E., McNamee K.E., Williams R.O. Blockade of tumor necrosis factor in collagen-induced arthritis reveals a novel immunoregulatory pathway for Th1 and Th17 cells. J Exp Med 2008, 205:2491-2497.
38. Ma H.L., Napierata L., Stedman N., Benoit S., Collins M., Nickerson-Nutter C., et al. Tumor necrosis factor alpha blockade exacerbates murine psoriasis-like disease by enhancing Th17 function and decreasing expansion of Treg cells. Arthritis Rheum 2010, 62:430-440.
39. Mangge H., Gindl S., Kenzian H., Schauenstein K. Atopic dermatitis as a side effect of anti-tumor necrosis factor-alpha therapy. J Rheumatol 2003, 30:2506-2507.
40. Chan J.L., Davis-Reed L., Kimball A.B. Counter-regulatory balance: atopic dermatitis in patients undergoing infliximab infusion therapy. J Drugs Dermatol 2004, 3:315-318.
41. Aerts N.E., De Knop K.J., Leysen J., Ebo D.G., Bridts C.H., Weyler J.J., et al. Increased IL-17 production by peripheral T helper cells after tumour necrosis factor blockade in rheumatoid arthritis is accompanied by inhibition of migration-associated chemokine receptor expression. Rheumatology (Oxford) 2010, 49:2264-2272.
42. Berman D., Parker S.M., Siegel J., Chasalow S.D., Weber J., Galbraith S., et al. Blockade of cytotoxic T-lymphocyte antigen-4 by ipilimumab results in dysregulation of gastrointestinal immunity in patients with advanced melanoma. Cancer Immun 2010, 10:11.
43. Peuvrel L., Bachmeyer C., Reguiai Z., Bachet J.B., André T., Bensadoun R.J., et al. Semiology of skin toxicity associated with epidermal growth factor receptor (EGFR) inhibitors. Support Care Cancer 2012, 20:909-921.
44. Kenis G., Prickaerts J., van Os J., Koek G.H., Robaeys G., Steinbusch H.W., et al. Depressive symptoms following interferon-α therapy: mediated by immune-induced reductions in brain-derived neurotrophic factor?. Int J Neuropsychopharmacol 2011, 14:247-253.
45. Mavrogiorgou P., Juckel G. Interferon-Induced Obsessive-Compulsive Symptoms in Malignant Melanoma. Pharmacopsychiatry 2012, 45:28-30.
46. Khanna D., McMahon M., Furst D.E. Anti-tumor necrosis factor alpha therapy and heart failure: what have we learned and where do we go from here?. Arthritis Rheum 2004, 50:1040-1050.
47. Hausmann O.V., Seitz M., Villiger P.M., Pichler W.J. The complex clinical picture of side effects to biologicals. Med Clin North Am 2010, 94:791-804. (xi-ii).
48. Lacaná E., Amur S., Mummanneni P., Zhao H., Frueh F.W. The emerging role of pharmacogenomics in biologics. Clin Pharmacol Ther 2007, 82:466-471.
49. Giezen T.J., Mantel-Teeuwisse A.K., Straus S.M., Schellekens H., Leufkens H.G., Egberts A.C. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 2008, 300:1887-1896.