A preliminary algorithm introducing immunogenicity assessment in the management of patients with RA receiving tumour necrosis factor inhibitor therapies

Annals of the Rheumatic Diseases

Volumn 73, Issue 6, 2014, Pages 1138-1143

  Garcês, Sandra ^a,b,c   Antunes, Marília ^d,e   Benito Garcia, Elizabeth ^f,g   Da Silva, José Canas ^c   Aarden, Lucien ^h   Demengeot, Jocelyne ^a  

^a INSTITUTO GULBENKIAN DE CIÊNCIA   (Portugal)

^b Gulbenkian Program for Advanced Medical Education   (Portugal)

^c HOSPITAL GARCIA DE ORTA   (Portugal)

^d UNIVERSITY OF LISBON   (Portugal)

^e Center of Statistics Applications of Lisbon University CEAUL   (Portugal)

^f BioEPI Clinical and Translational Research Center   (Portugal)

^g F HOFFMANN LA ROCHE LTD   (Switzerland)

^h SANQUIN RESEARCH   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; DRUG ANTIBODY; ETANERCEPT; INFLIXIMAB; TUMOR NECROSIS FACTOR INHIBITOR;

ADULT; ARTICLE; CLINICAL DECISION MAKING; CLINICAL PROTOCOL; CONTROLLED STUDY; DAS28; DISEASE ACTIVITY; DRUG BLOOD LEVEL; DRUG RESPONSE; DRUG SUBSTITUTION; DRUG WITHDRAWAL; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW UP; HUMAN; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS;

ANTI-TNF; DMARDS (BIOLOGIC); RHEUMATOID ARTHRITIS;

ADULT; AGED; ALGORITHMS; ANTIBODIES; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL PRODUCTS; DISEASE MANAGEMENT; FEMALE; HUMANS; IMMUNOGLOBULIN G; MALE; MIDDLE AGED; RECEPTORS, TUMOR NECROSIS FACTOR; TREATMENT FAILURE; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84899939394     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2013-203296     Document Type: Article

References (35)

1. Sokka T, Makinen H, Puolakka K, et al. Remission as the treatment goal-the FIN-RACo trial. Clin Exp Rheumatol 2006;24:S-74-6.
2. Bakker MF, Jacobs JW, Verstappen SM, et al. Tight control in the treatment of rheumatoid arthritis: efficacy and feasibility. Ann Rheum Dis 2007;66(Suppl 3): iii56-60. (Pubitemid 350032636)
3. Verstappen SM, Jacobs JW, van der Veen MJ, et al. Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial). Ann Rheum Dis 2007;66: 1443-9. (Pubitemid 350032650)
4. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010;69: 964-75.
5. Wolbink GJ, Vis M, Lems W, et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 2006;54: 711-15.
6. Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011;305: 1460-8.
7. Svenson M, Geborek P, Saxne T, et al. Monitoring patients treated with anti-TNF-alpha biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology (Oxford) 2007;46: 1828-34. (Pubitemid 350168300)
8. Pascual-Salcedo D, Plasencia C, Ramiro S, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology (Oxford) 2011;50: 1445-52.
9. Garces S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis 2013;72: 1947-55.
10. van Schouwenburg PA, van de Stadt LA, de Jong RN, et al. Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation. Ann Rheum Dis 2013;72: 104-9.
11. van der Laken CJ, Voskuyl AE, Roos JC, et al. Imaging and serum analysis of immune complex formation of radiolabelled infliximab and anti-infliximab in responders and non-responders to therapy for rheumatoid arthritis. Ann Rheum Dis 2007;66: 253-6. (Pubitemid 46226064)
12. 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: 704-7. (Pubitemid 40559296)
13. Radstake TR, Svenson M, Eijsbouts AM, et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 2009;68: 1739-45.
14. Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 2007;66: 921-6. (Pubitemid 46999794)
15. Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann Rheum Dis 2010;69: 817-21.
16. Jamnitski A, Bartelds GM, Nurmohamed MT, et al. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis 2011;70: 284-8.
17. Kremer JM, Dougados M, Emery P, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52: 2263-71. (Pubitemid 41117408)
18. Fonseca JECH, Reis P, Santos MJ, et al. Portuguese guidelines for the use of biological agents in rheumatoid arthritis-March 2010 update.Acta Reumatol Port 2010;35: 95-8.
19. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31: 315-24. (Pubitemid 18091653)
20. van Gestel AM, Anderson JJ, van Riel PL, et al. ACR and EULAR improvement criteria have comparable validity in rheumatoid arthritis trials. American College of Rheumatology European League of Associations for Rheumatology. J Rheumatol 1999;26: 705-11. (Pubitemid 29125596)
21. van Schouwenburg PA, Bartelds GM, Hart MH, et al. A novel method for the detection of antibodies to adalimumab in the presence of drug reveals "hidden" immunogenicity in rheumatoid arthritis patients. J Immunol Methods 2010;362: 82-8.
22. Hart MH, de Vrieze H, Wouters D, et al. Differential effect of drug interference in immunogenicity assays. J Immunol Methods 2011;372: 196-203.
23. Team RDC. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, 2010. ISBN 3-900051-07-0, http://www.R-project.org.
24. Karlsson JA, Kristensen LE, Kapetanovic MC, et al. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register. Rheumatology (Oxford) 2008;47: 507-13.
25. Bombardieri S, Ruiz AA, Fardellone P, et al. Effectiveness of adalimumab for rheumatoid arthritis in patients with a history of TNF-antagonist therapy in clinical practice. Rheumatology (Oxford) 2007;46: 1191-9. (Pubitemid 47053782)
26. Tak PP. A personalized medicine approach to biologic treatment of rheumatoid arthritis: a preliminary treatment algorithm. Rheumatology (Oxford) 2012;51: 600-9.
27. 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.
28. Korswagen LA, Bartelds GM, Krieckaert CL, et al. Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: a case series and cohort study. Arthritis Rheum 2011;63: 877-83.
29. 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: 3782-9. (Pubitemid 44955878)
30. Krieckaert CNS, Nurmohamed M, van Dongen C, et al. Evaluating the cost-effectiveness of personalized treatment with adalimumab using serum drug level and anti-adalimumab antibodies in rheumatoid arthritis patients. Ann Rheum Dis 2012;71(Suppl 3):104.
31. Karim Z, Wakefield RJ, Conaghan PG, et al. The impact of ultrasonography on diagnosis and management of patients with musculoskeletal conditions. Arthritis Rheum 2001;44: 2932-3. (Pubitemid 34016213)
32. Wakefield RJ, Green MJ, Marzo-Ortega H, et al. Should oligoarthritis be reclassified? Ultrasound reveals a high prevalence of subclinical disease. Ann Rheum Dis 2004;63: 382-5. (Pubitemid 38453303)
33. Colebatch AN, Edwards CJ, Ostergaard M, et al. EULAR recommendations for the use of imaging of the joints in the clinical management of rheumatoid arthritis. Ann Rheum Dis 2013;72: 804-14.
34. de Vries MK, van der Horst-Bruinsma IE, Nurmohamed MT, et al. Immunogenicity does not influence treatment with etanercept in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68: 531-5.
35. Krieckaert CL, Nurmohamed MT, Wolbink GJ. Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose dependent manner. Ann Rheum Dis 2012;71: 1914-15.