Laboratory Monitoring of Biological Therapies in Rheumatology: The Role of Immunogenicity

키워드

참고문헌 (94)

1. "International nonproprietary names (INN) for biological and biotechnological substances"[URL]
2. Scott DL, "Biologics-based therapy for the treatment of rheumatoid arthritis", Clin Pharmacol Ther, 91, pp.30~43 (2012)
3. "Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product–draft guidance"[URL]
4. Isaacs J, "The biosimilar approval process : how different is it", Considerations Med, 1, pp.3~6 (2017)
5. Takeuchi T, "Impact of trough serum level on radiographic and clinical response to infliximab plus methotrexate in patients with rheumatoid arthritis : results from the RISING study", Mod Rheumatol, 19, pp.478~487 (2009)
6. Svenson M, "Monitoring patients treated with anti-TNF-α biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies", Rheumatology(Oxford), 46, pp.1828~1834 (2007)
7. St. Clair E, "The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlled trial", Arthritis Rheum, 46, pp.1451~1459 (2002)
8. Garcês S, "The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis", Ann Rheum Dis, 72, pp.1947~1955 (2013)
9. Maneiro JR, "Immunogenicity of monoclonal antibodies against tumor necrosis factor used in chronic immune-mediated inflammatory conditions: systematic review and meta-analysis", JAMA Intern Med, 173, pp.1416~1428 (2013)
10. Smolen JS, "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs : 2013 update", Ann Rheum Dis, 73, pp.492~509 (2014)
11. Hart MH, "Differential effect of drug interference in immunogenicity assays", J Immunol Methods, 372, pp.196~203 (2011)
12. Jani M, "Clinical utility of random anti-tumor necrosis factor drug-level testing and measurement of antidrug antibodies on the long-term treatment response in rheumatoid arthritis", Arthritis Rheum, 67, pp.2011~2019 (2015)
13. Vincent FB, "Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective", Ann Rheum Dis, 72, pp.165~178 (2013)
14. Smith HW, "Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation(SPEAD)sample treatment prior to ELISA", Regul Toxicol Pharmacol, 49, pp.230~237 (2007)
15. Llinares-Tello, "Practical application of acid dissociation in monitoring patients treated with adalimumab", Rheumatol Int, 34, pp.1701~1708 (2014)
16. Radstake TR, "Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis", Ann Rheum Dis, 68, pp.1739~1745 (2009)
17. Bendtzen K, "Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab", Arthritis Rheum, 54, pp.3782~3789 (2006)
18. Bartelds GM, "Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up", JAMA, 305, pp.1460~1468 (2011)
19. Dore RK, "The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly inpatients with rheumatoid arthritis", Clin Exp Rheumatol, 25, pp.40~46 (2007)
20. de Vries MK, "Immunogenicity does not influence treatment with etanercept in patients with ankylosing spondylitis", Ann Rheum Dis, 68, pp.531~535 (2009)
21. Moots RJ, "The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: results from a multinational, real-world clinical practice, non-interventional study", PLoS One, 12, pp.e0175207~ (2017)
22. Conti F, "Biological therapies in rheumatic diseases", Clin Ter, 164, pp.e413~428 (2013)
23. Schaeverbeke T, "Immunogenicity of biologic agents in rheumatoid arthritis patients: lessons for clinical practice", Rheumatology(Oxford), 55, pp.210~220 (2016)
24. Tracey D, "Tumor necrosis factor antagonist mechanisms of action : a comprehensive review", Pharmacol Ther, 117, pp.244~279 (2008)
25. Matucci A, "Influence of anti-TNF immunogenicity on safety in rheumatic disease: a narrative review", Expert Opin Drug Saf, 15, pp.3~10 (2016)
26. Strand V, "Immunogenicity of biologics in chronic inflammatory diseases : a systematic review", BioDrugs, 31, pp.299~316 (2017)
27. Quistrebert J, "Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis : a European retrospective multicohort analysis", Semin Arthritis Rheum, 48, pp.967~975 (2019)
28. Magill L, "Low percentage of signal regulatory protein α", β+ memory B cells in blood predicts development of anti-drug antibodies (ADA) in adalimumab-treated rheumatoid arthritis patients, 2018, pp.9, 2865~
29. Bartelds S, "Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumor necrosis factor naive patients: a cohort study", Ann Rheum Dis, 69, pp.817~821 (2010)
30. Chen DY, "Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis", Ann Rheum Dis, 74, pp.e16~ (2015)
31. Jani M, "SAT0052 Influence of immunogencity and drug levels on the efficacy of long-term treatment of rheumatoid arthritis with adalimumab and etanercept: a UK-based prospective study", Ann Rheum Dis, 73, pp.608~ (2014)
32. Eng G, "Presence of antibodies to adalimumab and infliximab in patients with rheumatoid arthritis in clinical remission", Ann Rheum Dis, 72, pp.230~ (2013)
33. Docourau E, "Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatoid disease", Arthitis Res Ther, 13, pp.R105~ (2011)
34. Siljehult F, "Concentration of infliximab and anti-drug antibodies in relation to clinical response in patients with rheumatoid arthritis", Scand J Rheumatol, 47, pp.345~350 (2018)
35. Chen DY, "Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis and ankyloses spondyloarthritis after 24-week golimumab treatment", Ann Rheum Dis, 74, pp.2261~2264 (2015)
36. Krieckaert CL, "Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose dependent manner", Ann Rheum Dis, 71, pp.1914~1915 (2012)
37. Thomas SS, "Comparative immunogenicity of TNF Inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases. A systematic review and meta-analysis", BioDrugs, 29, pp.241~258 (2015)
38. Wu C, "Effect of anti-TNF antibodies on clinical response in rheumatoid arthritis patients : a meta-analysis", BioMed Res Int, 2016, pp.7185708~ (2016)
39. Krintel SB, "The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the association with adverse drug reaction and treatment failure", Rheumatology (Oxford), 52, pp.1245~1253 (2013)
40. Hoxha A, "The clinical relevance of early anti-adalimumab antibodies detection in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis: a prospective multicentre study", Joint Bone Spine Rev Rheum, 83, pp.167~171 (2016)
41. Pascual-Salcedo D, "Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis", Rheumatology, 50, pp.1445~1452 (2011)
42. Genovese MC, "Longterm safety and efficacy of subcutaneous abatacept in patients with rheumatoid arthritis : 5-year results from a phase IIIb trial", J Rheumatol, 45, pp.1085~1092 (2018)
43. Brunner HI, "Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous abatacept in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study", Arthritis Rheumatol, 70, pp.1144~1154 (2018)
44. Burmester GR, "Low immunogenicity of tocilizumab in patients with rheumatoid arthritis", Ann Rheum Dis, 76, pp.1078085~ (2017)
45. Benucci M, "Correlations between immunogenicity, drug levels, and disease activity in an Italian cohort of rheumatoid arthritis patients treated with tocilizumab", Biologics, 10, pp.53~58 (2016)
46. Sigaux J, "Immunogenicity of tocilizumab in patients with rheumatoid arthritis", Joint Bone Spine, 84, pp.39~45 (2017)
47. Mok CC, "Rituximab for the treatment of rheumatoid arthritis : an update", Drug Des Devel Ther, 8, pp.87~100 (2013)
48. Karle A, "Secukinumab, a novel anti-IL-17A antibody, shows low immunogenicity potential in human in vitro assays comparable to other marketed biotherapeutics with low clinical immunogenicity", MAbs, 8, pp.536~550 (2016)
49. Verstockt B, "A safety assessment of biological therapies targeting the IL-23", IL-17 axis in inflammatory bowel diseases, 2017, pp.16, 809~821
50. European Medicines Agency, "Guideline on similar biological medicinal products (Revision)", CHMP, 04 Rev 1, pp.2014, 1~7
51. Park W, "A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study", Ann Rheum Dis, 72, pp.1605~1612 (2013)
52. Yoo DH, "A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study", Ann Rheum Dis, 72, pp.1613~1620 (2013)
53. Reinisch W, "Evaluation of the cross-reactivity of antidrug antibodies to CT-P13 and infliximab reference product (Remicade): an analysis using immunoassays tagged with both agents", BioDrugs, 31, pp.223~237 (2017)
54. Lamb YN, "SB2 : an infliximab biosimilar", BioDrugs, 31, pp.461~464 (2017)
55. Emery P, "A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy", Ann Rheum Dis, 76, pp.51~57 (2017)
56. Emery P, "Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4", Ann Rheum Dis, pp.211591~ (2017)
57. "European public assessment report (EPAR): Benepali (etanercept) 2016"[URL]
58. Emery P, "52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis", Rheumatology(Oxford), 56, pp.2093~2101 (2017)
59. Poetzl J, "State-of-the-art immunogenicity evaluation in phase 3 confirmatory study (EGALITY) with etanercept biosimilar GP2015", J Eur Acad Dermatol Venereol, 32, pp.e130~e132 (2018)
60. Yoo DH, "A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis", Ann Rheum Dis, 76, pp.566~570 (2017)
61. Coiffier B, "Pharmacokinetic and safety of CT-P10, a biosimilar candidate to the rituximab reference product, in patients with newly diagnosed advanced stage follicular lymphoma (AFL)", Blood, 128, pp.1807~ (2016)
62. Smolen JS, "A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis", Ann Rheum Dis, 76, pp.1598~1602 (2017)
63. Garcês S, "A preliminary algorithm introducing immunogenicity assessment in the management of patients with RA receiving tumour necrosis factor inhibitor therapies", Ann Rheum Dis, 73, pp.1138~1143 (2014)
64. Park W, "Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CTP13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study", Arthritis Res Ther, 18, pp.25~ (2016)
65. Yoo DH, "A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study", Arthritis Res Ther, 18, pp.82~ (2016)
66. Aarden L, "Immunogenicity of anti-tumor necrosis factor antibodies toward improved methods of anti-antibody measurement", Curr Opin Immunol, 20, pp.431~435 (2008)
67. Wolbink GJ, "Dealing with immunogenicity of biologicals : assessment and clinical relevance", Curr Opin Rheumatol, 21, pp.211~215 (2009)
68. Hart MH, "Differential effect of drug interference in immunogenicity assays", J Immunol Methods, 372, pp.196~203 (2011)
69. Salimi-Moosavi H, "Rapid affinity measurement of protein–protein interactions in a microfluidic platform", Anal Biochem, 426, pp.134~141 (2012)
70. "Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins", EMEA, BMWP, pp.14327, 2006[DOI]
71. "Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use", EMA, BMWP, pp.86289, 2010[DOI]
72. Guidi L, "Therapeutic drug monitoring is more cost-effective than a clinically-based approach in the management of loss of response to infliximab in inflammatory bowel disease: an observational multicentre study", J Crohns Colitis, 9, pp.1079~1088 (2018)
73. Bader L, "Assays for infliximab drug levels and antibodies : a matter of scales and categories", Scand J Immunol, 86, pp.165~170 (2017)
74. Steenholdt C, "Comparison of techniques for monitoring infliximab and antibodies against infliximab in Crohn’s disease", Ther Drug Monit, 35, pp.530~538 (2013)
75. Steenholdt C, "Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn’s disease: post hoc analysis of a randomized controlled trial", Am J Gastroenterol, 109, pp.1055~1064 (2014)
76. Vande Casteele N, "Detection of infliximab levels and anti-infliximab antibodies : a comparison of three different assays", Aliment Pharmacol Ther, 36, pp.765~771 (2012)
77. Ananthakrishnan AN, "Epidemiology and risk factors for IBD", Nat Rev Gastroenterol Hepatol, 12, pp.205~217 (2015)
78. Enciso IP, "Comparison of four assay kits for measuring infliximab trough levels and antibodies to infliximab in patients with inflammatory bowel disease", Gastroenterology, 4, pp.S415~ (2016)
79. Guiotto C, "Clinical relevance and inter-test reliability of anti-infliximab antibodies and infliximab trough levels in patients with inflammatory bowel disease", Dig Liver Dis, 48, pp.138~143 (2016)
80. Lee MW, "Comparison of infliximab drug measurement across three commercially available ELISA kits", Pathology, 48, pp.608~612 (2016)
81. Malickova K, "Serum trough infliximab levels: a comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease", Biologicals, 44, pp.33~36 (2016)
82. Schmitz EM, "Therapeutic drug monitoring of infliximab : performance evaluation of three commercial ELISA kits", Clin Chem Lab Med, 54, pp.1211~1219 (2016)
83. Van Bezooijen JS, "A comparison of three assays to quantify infliximab, adalimumab and etanercept serum concentrations", Ther Drug Monit, 38, pp.432~438 (2016)
84. Freeman K, "Test accuracy of drug and antibody assays for predicting response to antitumor necrosis factor treatment in Crohn’s disease: a systematic review and meta-analysis", BMJ Open, 7, pp.e014581~ (2017)
85. Pérez I, "Reliability evaluation of four different assays for therapeutic drug monitoring of infliximab levels", Ther Adv Gastroenterol, 11, pp.1~10 (2018)
86. Afonso J, "Therapeutic drug monitoring of CT-P13 : a comparison of four different immunoassays", Therap Adv Gastroenterol, 10, pp.661~671 (2017)
87. Schmitz EMH, "Therapeutic drug monitoring (TDM) as a tool in the switch from infliximab innovator to biosimilar in rheumatic patients: results of a 12-month observational prospective cohort study", Clin Rheumatol, 36, pp.2129~2134 (2017)
88. Afonso J, "Proactive therapeutic drug monitoring of infliximab: a comparative study of a new point-of-care quantitative test with two established ELISA assays", Aliment Pharmacol Ther, 44, pp.684~692 (2016)
89. Magro F, "Clinical performance of an infliximab rapid quantification assay", Ther Adv Gastroenterol, 10, pp.651~660 (2017)
90. Nasser Y, "Comparison of point of care and classical immunoassay for the monitoring Infliximab and antibodies against Infliximab in IBD", Dig Dis Sci, 63, pp.2714~2721 (2018)
91. Meacci F, "Anti Etanercept and anti SB4 antibodies detection : impact of the assay method", Ann Rheum Dis, 75, pp.e39~ (2016)
92. Meacci F, "Infliximab and CT-P13 immunogenicity assessment in PLANETAS and PLANETRAS main and extension studies : utility of laboratory methods description", Ann Rheum Dis, 75, pp.e62~ (2016)
93. Xuzhen Qin, "Multi-center Performance Evaluations of Tacrolimus and Cyclosporine Electrochemiluminescence Immunoassays in the Asia-Pacific Region", Annals of Laboratory Medicine, 38(2), pp.85~94 (2018), 대한진단검사의학회[DOI]
94. 최리화, "Recommendations for Optimizing Tuberculosis Treatment: Therapeutic Drug Monitoring, Pharmacogenetics, and Nutritional Status Considerations", Annals of Laboratory Medicine, 37(2), pp.97~107 (2017), 대한진단검사의학회

관련 논문AI추천