Hypersensitivity Reactions to Biologic Drugs in Children with Rheumatologic Disease

cocukromatolojisi-5-1-2024

Cansu ÖZDEMİRALa , Özge SOYERa

aHacettepe University Faculty of Medicine, Department of Paediatric Immunology and Allergy Diseases, Ankara, Türkiye

ABSTRACT
In recent years, a growing number of biologic drugs (BD) targeting disease mechanisms directly have become available for the treatment of rheumatologic diseases. Numerous patients who are introduced to the BD exhibit significant clinical improvements. However, BD are structurally immunogenic and could provoke a comprehensive cellular and humoral immune response. A variety of adverse effects in particular hypersensitivity reactions to these medicines take part in treatment challenges. BD can cause on-target immune-mediated toxicities and both immediate and delayed type hypersensitivity reactions. There is a lack of data regarding hypersensitivity reactions to BD and evaluation with skin tests in pediatric population. Continuation of treatment with desensitization is considered an option when culprit drug is a mainstay therapy in certain cases. Recognizing the variety of reactions that BD could elicit, as well as the underlying mechanisms, might help clinicians to use medications more effectively.
Keywords: Biologic drug; hypersensitivity reactions; rheumatology

Referanslar

  1. CFR - Code of Federal Regulations Title 21. Accessed September 3, 2023. [Link]
  2. Biotherapeutic products. Accessed September 3, 2023. [Link]
  3. Köhler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature. 1975;256(5517):495-7. [Crossref]  [PubMed]
  4. Purcell RT, Lockey RF. Immunologic responses to therapeutic biologic agents. J Investig Allergol Clin Immunol. 2008;18(5):335-42.
  5. Soyer O, Demir S, Bilginer Y, Batu ED, Sonmez HE, Arıcı ZS, et al. Severe hypersensitivity reactions to biological drugs in children with rheumatic diseases. Pediatr Allergy Immunol. 2019;30(8):833-40. [Crossref]  [PubMed]
  6. Quercia O, Emiliani F, Foschi FG, Stefanini GF. Adalimumab desensitization after anaphylactic reaction. Annals of Allergy, Asthma & Immunology. 2011;106(6):547-8. [Crossref]  [PubMed]
  7. Shepard HM, Phillips GL, Thanos CD, Feldmann M. Developments in therapy with monoclonal antibodies and related proteins. Clin Med (Lond). 2017;17(3):220-32. [Crossref]  [PubMed]  [PMC]
  8. Galvão VR, Castells MC. Hypersensitivity to biological agents-updated diagnosis, management, and treatment. J Allergy Clin Immunol Pract. 2015;3(2):175-85; quiz 186. [Crossref]  [PubMed]
  9. Pichler WJ. Adverse side-effects to biological agents. Allergy. 2006;61(8):912-20. [Crossref]  [PubMed]
  10. Bonamichi-Santos R, Castells M. Diagnoses and Management of Drug Hypersensitivity and Anaphylaxis in Cancer and Chronic Inflammatory Diseases: Reactions to Taxanes and Monoclonal Antibodies. Clin Rev Allergy Immunol. 2018;54(3):375-85. [Crossref]  [PubMed]
  11. Bavbek S, Pagani M, Alvarez-Cuesta E, et al. Hypersensitivity reactions to biologicals: An EAACI position paper. Allergy. 2022;77(1):39-54. [Crossref]  [PubMed]
  12. Monaco C, Nanchahal J, Taylor P, Feldmann M. Anti-TNF therapy: past, present and future. Int Immunol. 2015;27(1):55-62. [Crossref]  [PubMed]  [PMC]
  13. Brown SGA. Clinical features and severity grading of anaphylaxis. Journal of Allergy and Clinical Immunology. 2004;114(2):371-6. [Crossref]  [PubMed]
  14. Corominas M, Gastaminza G, Lobera T. Hypersensitivity reactions to biological drugs. J Investig Allergol Clin Immunol. 2014;24(4):212-25; quiz 1p following 225.
  15. Scherer K, Spoerl D, Bircher AJ. Adverse drug reactions to biologics. J Dtsch Dermatol Ges. 2010;8(6):411-26. [Crossref]  [PubMed]
  16. Bendele A, Colloton M, Vrkljan M, Morris J, Sabados K. Cutaneous mast cell degranulation in rats receiving injections of recombinant human interleukin-1 receptor antagonist (rhIL-1ra) and/or its vehicle: possible clinical implications. J Lab Clin Med. 1995;125(4):493-500.
  17. Vultaggio A, Matucci A, Nencini F, Pratesi S, Parronchi P, Rossi O, et al. Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy. 2010;65(5):657-61. [Crossref]  [PubMed]
  18. Bavbek S, Ataman Ş, Bankova L, Castells M. Injection site reaction to adalimumab: Positive skin test and successful rapid desensitisation. Allergol Immunopathol (Madr). 2013;41(3):204-6. [Crossref]  [PubMed]
  19. Hausmann OV, Seitz M, Villiger PM, Pichler WJ. The complex clinical picture of side effects to biologicals. Med Clin North Am. 2010;94(4):791-804, xi-ii. [Crossref]  [PubMed]
  20. 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(7):601-8. [Crossref]  [PubMed]
  21. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002;359(9317):1541-9. [Crossref]  [PubMed]
  22. Han PD, Cohen RD. Managing immunogenic responses to infliximab: treatment implications for patients with Crohn's disease. Drugs. 2004;64(16):1767-77. [Crossref]  [PubMed]
  23. Brennan PJ, Bouza TR, Hsu FI, Sloane DE, Castells MC. Hypersensitivity reactions to mAbs: 105 desensitizations in 23 patients, from evaluation to treatment. Journal of Allergy and Clinical Immunology. 2009;124(6):1259-66. [Crossref]  [PubMed]
  24. Łyszkiewicz M, Ziętara N, Frey L, Pannicke U, Stern M, Liu Y, et al. Human FCHO1 deficiency reveals role for clathrin-mediated endocytosis in development and function of T cells. Nat Commun. 2020;11(1):1031. [Crossref]
  25. Isabwe GAC, Garcia Neuer M, de Las Vecillas Sanchez L, Lynch DM, Marquis K, Castells M. Hypersensitivity reactions to therapeutic monoclonal antibodies: Phenotypes and endotypes. J Allergy Clin Immunol. 2018;142(1):159-70.e2. [Crossref]  [PubMed]
  26. Cheifetz A, Smedley M, Martin S, Reiter M, Leone G, Mayer L, Plevy S. The incidence and management of infusion reactions to infliximab: a large center experience. Am J Gastroenterol. 2003;98(6):1315-24. [Crossref]  [PubMed]
  27. Shimabukuro-Vornhagen A, Gödel P, Subklewe M, Stemmler HJ, Schlößer HA, Schlaak M, et al. Cytokine release syndrome. J Immunother Cancer. 2018;6(1):56. [Crossref]  [PubMed]  [PMC]
  28. Vasquez EM, Fabrega AJ, Pollak R. OKT3-induced cytokine-release syndrome: occurrence beyond the second dose and association with rejection severity. Transplant Proc. 1995;27(1):873-4.
  29. Picard M, Galvão VR. Current Knowledge and Management of Hypersensitivity Reactions to Monoclonal Antibodies. J Allergy Clin Immunol Pract. 2017;5(3):600-9. [Crossref]  [PubMed]
  30. Puxeddu I, Giori L, Rocchi V, Bazzichi L, Bombardieri S, Tavoni A, et al. Hypersensitivity reactions during treatment with infliximab, etanercept, and adalimumab. Ann Allergy Asthma Immunol. 2012;108(2):123-4. [Crossref]  [PubMed]
  31. Soyak Aytekin E, Keskin A, Tan C, Yalçın E, Dogru D, Ozcelik U, et al. Differential diagnosis of primary immunodeficiency in patients with BCGitis and BCGosis: A single-centre study. Scand J Immunol. 2021;94(4):e13084. [Crossref]  [PubMed]
  32. Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008;358(11):1109-17. [Crossref]  [PubMed]  [PMC]
  33. ESID - European Society for Immunodeficiencies. Accessed March 12, 2023. [Link]
  34. Mirakian R, Ewan PW, Durham SR, Youlten LJ, Dugué P, Friedmann PS, et al. BSACI. BSACI guidelines for the management of drug allergy. Clin Exp Allergy. 2009;39(1):43-61. [Crossref]  [PubMed]
  35. Muraro A, Worm M, Alviani C, Cardona V, DunnGalvin A, Garvey LH, et al. European Academy of Allergy and Clinical Immunology, Food Allergy, Anaphylaxis Guidelines Group. EAACI guidelines: Anaphylaxis (2021 update). Allergy. 2022;77(2):357-77. [Crossref]  [PubMed]
  36. Khan DA. Hypersensitivity and immunologic reactions to biologics: opportunities for the allergist. Ann Allergy Asthma Immunol. 2016;117(2):115-20. [Crossref]  [PubMed]
  37. Brockow K, Garvey LH, Aberer W, Atanaskovic-Markovic M, Barbaud A, Bilo MB, et al. ENDA/EAACI Drug Allergy Interest Group. Skin test concentrations for systemically administered drugs -- an ENDA/EAACI Drug Allergy Interest Group position paper. Allergy. 2013;68(6):702-12. [Crossref]  [PubMed]
  38. Akarsu A, Soyer O, Sekerel BE. Hypersensitivity Reactions to Biologicals: from Bench to Bedside. Curr Treat Options Allergy. 2020;7(1):71-83. [Crossref]  [PubMed]  [PMC]
  39. Matucci A, Nencini F, Maggi E, Vultaggio A. Hypersensitivity reactions to biologics used in rheumatology. Expert Review of Clinical Immunology. 2019;15(12):1263-71. [Crossref]  [PubMed]
  40. Gorovits B, Baltrukonis DJ, Bhattacharya I, Birchler MA, Finco D, Sikkema D, et al. Immunoassay methods used in clinical studies for the detection of anti-drug antibodies to adalimumab and infliximab. Clin Exp Immunol. 2018;192(3):348-65. [Crossref]  [PubMed]  [PMC]
  41. Cernadas JR, Brockow K, Romano A, Aberer W, Torres MJ, Bircher A, et al. European Network of Drug Allergy and the EAACI interest group on drug hypersensitivity. General considerations on rapid desensitization for drug hypersensitivity - a consensus statement. Allergy. 2010;65(11):1357-66. [Crossref]  [PubMed]
  42. Simnani FZ, Singh D, Kaur R. COVID-19 phase 4 vaccine candidates, effectiveness on SARS-CoV-2 variants, neutralizing antibody, rare side effects, traditional and nano-based vaccine platforms: a review. 3 Biotech. 2022;12(1):15. [Crossref]  [PubMed]  [PMC]
  43. Chu MT, Chang WC, Pao SC, Hung SI. Delayed Drug Hypersensitivity Reactions: Molecular Recognition, Genetic Susceptibility, and Immune Mediators. Biomedicines. 2023;11(1):177. [Crossref]  [PubMed]  [PMC]
  44. Clark RA, Chong B, Mirchandani N, Brinster NK, Yamanaka K, Dowgiert RK, et al. The vast majority of CLA+ T cells are resident in normal skin. J Immunol. 2006;176(7):4431-9. [Crossref]  [PubMed]
  45. Chiriac AM, Demoly P. Drug allergy diagnosis. Immunol Allergy Clin North Am. 2014;34(3):461-471, vii. [Crossref]  [PubMed]
  46. Copaescu A, Gibson A, Li Y, Trubiano JA, Phillips EJ. An Updated Review of the Diagnostic Methods in Delayed Drug Hypersensitivity. Frontiers in Pharmacology. 2021;11. Accessed September 19, 2023. [Crossref]  [PubMed]  [PMC]
  47. Lichtenstein L, Ron Y, Kivity S, Ben-Horin S, Israeli E, Fraser GM, Dotan I, Chowers Y, Confino-Cohen R, Weiss B. Infliximab-Related Infusion Reactions: Systematic Review. J Crohns Colitis. 2015;9(9):806-15. [Crossref]  [PubMed]  [PMC]