Table of Contents Author Guidelines Submit a Manuscript
BioMed Research International
Volume 2014, Article ID 702701, 8 pages
http://dx.doi.org/10.1155/2014/702701
Clinical Study

Monitoring Drug and Antidrug Levels: A Rational Approach in Rheumatoid Arthritis Patients Treated with Biologic Agents Who Experience Inadequate Response While Being on a Stable Biologic Treatment

1Department of Rheumatology and Internal Medicine, “Sfanta Maria” Hospital, Bulevardul Ion Mihalache nr 37-39, 011172 Bucharest, Romania
2“Carol Davila” University of Medicine, Bucharest, Romania
3Biology Faculty, Bucharest University, Bucharest, Romania
4Biology Faculty, “Alexandru Ioan Cuza” University, Iasi, Romania

Received 28 February 2014; Revised 7 May 2014; Accepted 7 May 2014; Published 20 May 2014

Academic Editor: Frank Buttgereit

Copyright © 2014 Diana Mazilu et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. T. Sokka, H. Kautiainen, T. Möttönen, and P. Hannonen, “Work disability in rheumatoid arthritis 10 years after the diagnosis,” The Journal of Rheumatology, vol. 26, no. 8, pp. 1681–1685, 1999. View at Google Scholar · View at Scopus
  2. J. Lindhardsen, O. Ahlehoff, G. H. Gislason et al., “Risk of atrial fibrillation and stroke in rheumatoid arthritis: Danish nationwide cohort study,” British Medical Journal, vol. 344, no. 7849, Article ID e1257, 2012. View at Publisher · View at Google Scholar · View at Scopus
  3. D. H. Solomon, J. Kremer, J. R. Curtis et al., “Explaining the cardiovascular risk associated with rheumatoid arthritis: traditional risk factors versus markers of rheumatoid arthritis severity,” Annals of the Rheumatic Diseases, vol. 69, no. 11, pp. 1920–1925, 2010. View at Publisher · View at Google Scholar · View at Scopus
  4. A. Hákkinen, H. Kautiainen, P. Hannonen, J. Ylinen, M. Arkela-Kautiainen, and T. Sokka, “Pain and joint mobility explain individual subdimensions of the health assessment questionnaire (HAQ) disability index in patients with rheumatoid arthritis,” Annals of the Rheumatic Diseases, vol. 64, no. 1, pp. 59–63, 2005. View at Publisher · View at Google Scholar · View at Scopus
  5. L. Gettings, “Psychological well-being in rheumatoid arthritis: a review of the literature,” Musculoskeletal Care, vol. 8, no. 2, pp. 99–106, 2010. View at Google Scholar · View at Scopus
  6. T. Pincus, A. Kavanaugh, and T. Sokka, “Benefit/risk of therapies for rheumatoid arthritis: underestimation of the “side effects” or risks of RA leads to underestimation of the benefit/risk of therapies,” Clinical and Experimental Rheumatology, vol. 22, no. 5, supplement 35, pp. S2–S11, 2004. View at Google Scholar · View at Scopus
  7. D. J. Watson, T. Rhodes, and H. A. Guess, “All-cause mortality and vascular events among patients with rheumatoid arthritis, osteoarthritis, or no arthritis in the UK General Practice Research Database,” The Journal of Rheumatology, vol. 30, no. 6, pp. 1196–1202, 2003. View at Google Scholar · View at Scopus
  8. S. Cobb and F. B. W. Anderson, “Length of life and cause of death in rheumatoid arthritis,” The New England Journal of Medicine, vol. 249, pp. 553–556, 1953. View at Google Scholar
  9. D. P. M. Symmons, M. A. Jones, D. L. Scott, and P. Prior, “Longterm mortality outcome in patients with rheumatoid arthritis: early presenters continue to do well,” The Journal of Rheumatology, vol. 25, no. 6, pp. 1072–1077, 1998. View at Google Scholar · View at Scopus
  10. A. G. Kvalvik, M. A. Jones, and D. P. M. Symmons, “Mortality in a cohort of Norwegian patients with rheumatoid arthritis followed from 1977 to 1992,” Scandinavian Journal of Rheumatology, vol. 29, no. 1, pp. 29–37, 2000. View at Google Scholar · View at Scopus
  11. S. T. Anderson, “Mortality in rheumatoid arthritis: do age and gender make a difference?” Seminars in Arthritis and Rheumatism, vol. 25, pp. 291–296, 1996. View at Google Scholar
  12. J. M. Bathon, R. W. Martin, R. M. Fleischmann et al., “A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis,” The New England Journal of Medicine, vol. 343, no. 22, pp. 1586–1593, 2000. View at Publisher · View at Google Scholar · View at Scopus
  13. F. C. Breedveld, M. H. Weisman, A. F. Kavanaugh et al., “The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment,” Arthritis and Rheumatism, vol. 54, no. 1, pp. 26–37, 2006. View at Publisher · View at Google Scholar · View at Scopus
  14. L. Klareskog, D. van der Heijde, J. P. de Jager et al., “Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial,” The Lancet, vol. 363, no. 9410, pp. 675–681, 2004. View at Publisher · View at Google Scholar · View at Scopus
  15. P. E. Lipsky, D. M. van der Heijde, E. W. St Clair et al., “Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group,” The New England Journal of Medicine, vol. 343, no. 22, pp. 1594–1602, 2000. View at Google Scholar
  16. R. Maini, E. W. St Clair, F. Breedveld et al., “Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial,” The Lancet, vol. 354, no. 9194, pp. 1932–1939, 1999. View at Publisher · View at Google Scholar · View at Scopus
  17. M. E. Weinblatt, J. M. Kremer, A. D. Bankhurst et al., “A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate,” The New England Journal of Medicine, vol. 340, no. 4, pp. 253–259, 1999. View at Publisher · View at Google Scholar · View at Scopus
  18. M. E. Weinblatt, E. C. Keystone, D. E. Furst et al., “Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA Trial,” Arthritis and Rheumatism, vol. 48, no. 1, pp. 35–45, 2003. View at Publisher · View at Google Scholar · View at Scopus
  19. E. C. Keystone, M. C. Genovese, L. Klareskog et al., “Golimumab, a human antibody to tumour necrosis factor α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study,” Annals of the Rheumatic Diseases, vol. 68, pp. 789–796, 2009. View at Google Scholar
  20. D. van der Heijde, M. Weinblatt, R. Landewe, N. Goel, F. Wells, and R. M. Fleischmann, “Early inhibition of progression of structural damage in certolizumab pegol-treated patients: 16-week efficacy results from RAPID,” Annals of the Rheumatic Diseases, vol. 67, supplement 2, article 51, 2008. View at Google Scholar
  21. P. Emery, R. Fleischmann, A. Filipowicz-Sosnowska et al., “The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIb randomized, double-blind, placebo-controlled, dose-ranging trial,” Arthritis and Rheumatism, vol. 54, no. 5, pp. 1390–1400, 2006. View at Publisher · View at Google Scholar · View at Scopus
  22. L. Šenolt, J. Vencovský, K. Pavelka, C. Ospelt, and S. Gay, “Prospective new biological therapies for rheumatoid arthritis,” Autoimmunity Reviews, vol. 9, no. 2, pp. 102–107, 2009. View at Publisher · View at Google Scholar · View at Scopus
  23. J. A. Singh, D. E. Furst, A. Bharat et al., “2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis,” Arthritis Care & Research, vol. 64, pp. 625–639, 2012. View at Google Scholar
  24. N. Feltelius, C. M. Fored, P. Blomqvist et al., “Results from a nationwide postmarketing cohort study of patients in Sweden treated with etanercept,” Annals of the Rheumatic Diseases, vol. 64, no. 2, pp. 246–252, 2005. View at Publisher · View at Google Scholar · View at Scopus
  25. R. F. Van Vollenhoven, C. C. Carli, and J. K. L. Bratt, “Six year report of the STURE registry for biologicals in rheumatology: satisfactory overall results but plenty of room for improvement,” Arthritis & Rheumatology, vol. 52, supplement 9, p. S135, 2005. View at Google Scholar
  26. R. Khanna, B. D. Sattin, W. Afif et al., “Review article: a clinician’s guide for therapeutic drug monitoring of infliximab in inflammatory bowel disease,” Alimentary Pharmacology & Therapeutics, vol. 38, pp. 447–459, 2013. View at Google Scholar
  27. L. Peyrin-Biroulet, P. Deltenre, N. de Suray, J. Branche, W. J. Sandborn, and J.-F. Colombel, “Efficacy and safety of tumor necrosis factor antagonists in Crohn’s disease: meta-analysis of placebo-controlled trials,” Clinical Gastroenterology and Hepatology, vol. 6, no. 6, pp. 644–653, 2008. View at Publisher · View at Google Scholar · View at Scopus
  28. W. Afif, E. V. Loftus Jr., W. A. Faubion et al., “Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease,” American Journal of Gastroenterology, vol. 105, no. 5, pp. 1133–1139, 2010. View at Publisher · View at Google Scholar · View at Scopus
  29. B. Pariente, G. Pineton de Chambrun, R. Krzysiek et al., “Trough levels and antibodies to infliximab may not predict response to intensification of infliximab therapy in patients with inflammatory bowel disease,” Inflammatory Bowel Diseases, vol. 18, no. 7, pp. 1199–1206, 2012. View at Google Scholar
  30. K. Karmiris, G. Paintaud, M. Noman et al., “Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease,” Gastroenterology, vol. 137, no. 5, pp. 1628–1640, 2009. View at Publisher · View at Google Scholar · View at Scopus
  31. F. S. Velayos, J. G. Kahn, W. J. Sandborn, and B. G. Feagan, “A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn’s disease who lose responsiveness to infliximab,” Clinical Gastroenterology and Hepatology, vol. 11, pp. 654–666, 2013. View at Google Scholar
  32. C. Steenholdt, J. Brynskov, O. Thomsen et al., “Individualised therapy is more cost-effective than dose intensification in patients with Crohn’s disease who lose response to anti-TNF treatment: a randomised, controlled trial,” Gut, 2013. View at Publisher · View at Google Scholar
  33. N. Vande Casteele, A. Gils, S. Singh et al., “Antibody response to infliximab and its impact on pharmacokinetics can be transient,” The American Journal of Gastroenterology, vol. 108, no. 6, pp. 962–971, 2013. View at Google Scholar
  34. G. J. Wolbink, M. Vis, W. Lems et al., “Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis,” Arthritis and Rheumatism, vol. 54, no. 3, pp. 711–715, 2006. View at Publisher · View at Google Scholar · View at Scopus
  35. G. M. Bartelds, C. L. M. Krieckaert, M. T. Nurmohamed et al., “Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during longterm follow-up,” The Journal of the American Medical Association, vol. 305, no. 14, pp. 1460–1468, 2011. View at Publisher · View at Google Scholar · View at Scopus
  36. M. Svenson, P. Geborek, T. Saxne, and K. Bendtzen, “Monitoring patients treated with anti-TNF-α biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies,” Rheumatology, vol. 46, no. 12, pp. 1828–1834, 2007. View at Publisher · View at Google Scholar · View at Scopus
  37. D. Pascual-Salcedo, C. Plasencia, S. Ramiro et al., “Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis,” Rheumatology, vol. 50, no. 8, pp. 1445–1452, 2011. View at Google Scholar · View at Scopus
  38. N. Emami-shahri and T. Hagemann, “Resistance-the true face of biological defiance,” Rheumatology, vol. 51, no. 3, pp. 413–422, 2012. View at Publisher · View at Google Scholar · View at Scopus
  39. S. Garcês, J. Demengeot, and E. Benito-Garcia, “The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis,” Annals of the Rheumatic Diseases, vol. 72, pp. 1947–1955, 2013. View at Google Scholar
  40. L. A. Korswagen, G. M. Bartelds, C. L. M. Krieckaert et al., “Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: a case series and cohort study,” Arthritis and Rheumatism, vol. 63, no. 4, pp. 877–883, 2011. View at Publisher · View at Google Scholar · View at Scopus
  41. P. A. van Schouwenburg, G. M. Bartelds, M. H. Hart, L. Aarden, G. J. Wolbink, and D. Wouters, “A novel method for the detection of antibodies to adalimumab in the presence of drug reveals “hidden” immunogenicity in rheumatoid arthritis patients,” Journal of Immunological Methods, vol. 362, no. 1-2, pp. 82–88, 2010. View at Publisher · View at Google Scholar · View at Scopus
  42. M. H. Hart, H. de Vrieze, D. Wouters et al., “Differential effect of drug interference in immunogenicity assays,” Journal of Immunological Methods, vol. 372, no. 1-2, pp. 196–203, 2011. View at Publisher · View at Google Scholar · View at Scopus
  43. S. Garcês, M. Antunes, E. Benito-Garcia, J. Canas da Silva, L. Aarden, and J. Demengeot, “A preliminary algorithm introducing immunogenicity assessment in the management of patients with RA receiving tumour necrosis factor inhibitor therapies,” Annals of the Rheumatic Diseases, 2013. View at Publisher · View at Google Scholar
  44. F. C. Arnett, S. M. Edworthy, D. A. Bloch et al., “The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis,” Arthritis and Rheumatism, vol. 31, no. 3, pp. 315–324, 1988. View at Google Scholar · View at Scopus
  45. D. Aletaha, T. Neogi, A. J. Silman et al., “2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism Collaborative Initiative,” Arthritis & Rheumatism, vol. 62, no. 9, pp. 2569–2581, 2010. View at Google Scholar
  46. J. S. Smolen, D. Aletaha, J. W. Bijlsma et al., “Treating rheumatoid arthritis to target: recommendations of an international task force,” Annals of the Rheumatic Diseases, vol. 69, no. 4, pp. 631–637, 2010. View at Google Scholar
  47. R. Ionescu, Ghiduri de Diagnostic si Tratament in Reumatolgie, 2013.
  48. C. O. Bingham III, C. Pohl, T. G. Woodworth et al., “Developing a standardized definition for disease “flare” in rheumatoid arthritis (OMERACT 9 special interest group),” The Journal of Rheumatology, vol. 36, no. 10, pp. 2335–2341, 2009. View at Publisher · View at Google Scholar · View at Scopus
  49. A. Van der Maas and A. A. den Broeder, “Measuring flares in rheumatoid arthritis. (Why) do we need validated criteria?” The Journal of Rheumatology, vol. 41, pp. 189–191, 2014. View at Google Scholar
  50. B. Gorovits, “Antidrug antibody assay validation: industry survey results,” AAPS Journal, vol. 11, no. 1, pp. 133–138, 2009. View at Publisher · View at Google Scholar · View at Scopus
  51. C. Plasencia, D. Pascual-Salcedo, L. Nuño et al., “Influence of immunogenicity on the efficacy of longterm treatment of spondyloarthritis with infliximab,” Annals of the Rheumatic Diseases, vol. 71, no. 12, pp. 1955–1960, 2012. View at Google Scholar
  52. F. Llinares-Tello, J. R. de Salazar, J. M. Gallego et al., “Analytical and clinical evaluation of a new immunoassay for therapeutic drug monitoring of infliximab and adalimumab,” Clinical Chemistry and Laboratory Medicine, vol. 50, no. 10, pp. 1845–1847, 2012. View at Google Scholar
  53. P. A. van Schouwenburg, L. A. van de Stadt, R. N. de Jong et al., “Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation,” Annals of the Rheumatic Diseases, vol. 72, no. 1, pp. 104–109, 2013. View at Publisher · View at Google Scholar
  54. C. Plasencia, D. Pascual-Salcedo, S. García-Carazo et al., “The immunogenicity to the first anti-TNF therapy determines the outcome of switching to a second anti-TNF therapy in spondyloarthritis patients,” Arthritis Research & Therapy, vol. 15, no. 4, article R79, 2013. View at Google Scholar
  55. C. Plasencia, D. Pascual-Salcedo, P. Alcocer et al., “The timing of serum infliximab loss, or the appearance of antibodies to infliximab (ATI), is related with the clinical activity in ATI-positive patients with rheumatoid arthritis treated with infliximab,” Annals of the Rheumatic Diseases, vol. 72, pp. 1888–1890, 2013. View at Google Scholar
  56. B. Ruiz-Argüello, A. R. del Agua, N. Torres, A. Monasterio, A. Marti'nez, and D. Nagore, “Comparison study of two commercially available methods for the determination of infliximab, adalimumab, etanercept and anti-drug antibody levels,” Clinical Chemistry and Laboratory Medicine, vol. 51, no. 12, pp. e287–e289, 2013. View at Google Scholar
  57. C. L. Krieckaert, S. C. Nair, M. T. Nurmohamed et al., “Personalised treatment using serum drug levels of adalimumab in patients wih rheumatoid arthritis: an evaluation of costs and effects,” Annals of the Rheumatic Diseases, 2013. View at Publisher · View at Google Scholar
  58. R. M. Thurlings, K. Vos, C. A. Wijbrandts, A. H. Zwinderman, D. M. Gerlag, and P. P. Tak, “Synovial tissue response to rituximab: mechanism of action and identification of biomarkers of response,” Annals of the Rheumatic Diseases, vol. 67, no. 7, pp. 917–925, 2008. View at Publisher · View at Google Scholar · View at Scopus
  59. Y. K. O. Teng, E. W. N. Levarht, M. Hashemi et al., “Immunohistochemical analysis as a means to predict responsiveness to rituximab treatment,” Arthritis and Rheumatism, vol. 56, no. 12, pp. 3909–3918, 2007. View at Publisher · View at Google Scholar · View at Scopus
  60. G. Ferraccioli, B. Tolusso, F. Bobbio-Pallavicini et al., “Biomarkers of good EULAR response to the B cell depletion therapy in all seropositive rheumatoid arthritis patients: clues for the pathogenesis,” PLoS One, vol. 7, Article ID e40362, 2012. View at Publisher · View at Google Scholar
  61. K. Chatzidionysiou, E. Lie, E. Nasonov et al., “Highest clinical effectiveness of rituximab in autoantibody-positive patients with rheumatoid arthritis and in those for whom no more than one previous TNF antagonist has failed: pooled data from 10 European registries,” Annals of the Rheumatic Diseases, vol. 70, no. 9, pp. 1575–1580, 2011. View at Publisher · View at Google Scholar · View at Scopus
  62. M. Hoshino, T. Yoshio, S. Onishi, and S. Minota, “Influence of antibodies against infliximab and etanercept on the treatment effectiveness of these agents in Japanese patients with rheumatoid arthritis,” Modern Rheumatology, vol. 22, no. 4, pp. 532–540, 2012. View at Google Scholar