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

BioMed Research International

Volumn 2014, Issue , 2014, Pages

  Mazilu, Diana ^a,b   Opriş, Daniela ^a,b   Gainaru, Cecilia ^b   Iliuta, Mihaela ^b   Apetrei, Natalia ^c   Luca, Giorgiana ^d   Borangiu, Andreea ^a,b   Gudu, Tania ^a   Peltea, Alexandra ^a   Groseanu, Laura ^a,b   Constantinescu, Cosmin ^a,b   Saulescu, Ioana ^a,b   Bojinca, Violeta ^a,b   Balanescu, Andra ^a,b   Predeteanu, Denisa ^a,b   Ionescu, Ruxandra ^a,b  

^a Sfanta Maria Hospital Bucharest   (Romania)

^b CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^c UNIVERSITY OF BUCHAREST   (Romania)

^d ALEXANDRU IOAN CUZA UNIVERSITY OF IASI   (Romania)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; DISEASE MODIFYING ANTIRHEUMATIC DRUG; DRUG ANTIBODY; ETANERCEPT; INFLIXIMAB; LEFLUNOMIDE; METHOTREXATE; RITUXIMAB; SALAZOSULFAPYRIDINE; ANTIBODY; ANTIRHEUMATIC AGENT; BIOLOGICAL PRODUCT;

ANTIBODY BLOOD LEVEL; ANTIGEN BINDING; ARTICLE; BIOLOGICAL THERAPY; CLINICAL EVALUATION; COMPARATIVE STUDY; CONTROLLED STUDY; DAS28; DISEASE ACTIVITY; DISEASE ACTIVITY SCORE; DISEASE EXACERBATION; DRUG BLOOD LEVEL; DRUG MONITORING; ENZYME LINKED IMMUNOSORBENT ASSAY; EUROPEAN LEAGUE AGAINST RHEUMATISM; FOLLOW UP; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; MAJOR CLINICAL STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PATIENT MONITORING; RHEUMATOID ARTHRITIS; SIMPLIFIED DISEASE ACTIVITY INDEX; TREATMENT DURATION; TREATMENT RESPONSE; ARTHRITIS, RHEUMATOID; BLOOD; DISEASE COURSE; DOSE RESPONSE; IMMUNOLOGY; TREATMENT OUTCOME;

ANTIBODIES; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL PRODUCTS; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; HUMANS; TREATMENT OUTCOME;

EID: 84902256305     PISSN: 23146133     EISSN: 23146141     Source Type: Journal    
DOI: 10.1155/2014/702701     Document Type: Article

References (62)

1. Sokka T., Kautiainen H., Möttönen T., Hannonen P., Work disability in rheumatoid arthritis 10 years after the diagnosis. The Journal of Rheumatology 1999 26 8 1681 1685 2-s2.0-0032770474
2. Lindhardsen J., Ahlehoff O., Gislason G. H., Madsen O. R., Olesen J. B., Svendsen J. H., Torp-Pedersen C., Hansen P. R., Risk of atrial fibrillation and stroke in rheumatoid arthritis: Danish nationwide cohort study. British Medical Journal 2012 344 7849 2-s2.0-84858826903 10.1136/bmj.e1257 e1257
3. Solomon D. H., Kremer J., Curtis J. R., Hochberg M. C., Reed G., Tsao P., Farkouh M. E., Setoguchi S., Greenberg J. D., Explaining the cardiovascular risk associated with rheumatoid arthritis: traditional risk factors versus markers of rheumatoid arthritis severity. Annals of the Rheumatic Diseases 2010 69 11 1920 1925 2-s2.0-77956503955 10.1136/ard.2009.122226
4. Hákkinen A., Kautiainen H., Hannonen P., Ylinen J., Arkela-Kautiainen M., Sokka T., 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 2005 64 1 59 63 2-s2.0-11344294877 10.1136/ard.2003.019935
5. Gettings L., Psychological well-being in rheumatoid arthritis: a review of the literature. Musculoskeletal Care 2010 8 2 99 106 2-s2.0-77955458252
6. Pincus T., Kavanaugh A., Sokka T., 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 2004 22 5, supplement 35 S2 S11 2-s2.0-4944258175
7. Watson D. J., Rhodes T., Guess H. A., 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 2003 30 6 1196 1202 2-s2.0-0037643388
8. Cobb S., Anderson F. B. W., Length of life and cause of death in rheumatoid arthritis. The New England Journal of Medicine 1953 249 553 556
9. Symmons D. P. M., Jones M. A., Scott D. L., Prior P., Longterm mortality outcome in patients with rheumatoid arthritis: early presenters continue to do well. The Journal of Rheumatology 1998 25 6 1072 1077 2-s2.0-0031853541
10. Kvalvik A. G., Jones M. A., Symmons D. P. M., Mortality in a cohort of Norwegian patients with rheumatoid arthritis followed from 1977 to 1992. Scandinavian Journal of Rheumatology 2000 29 1 29 37 2-s2.0-0033974592
11. Anderson S. T., Mortality in rheumatoid arthritis: do age and gender make a difference? Seminars in Arthritis and Rheumatism 1996 25 291 296
12. Bathon J. M., Martin R. W., Fleischmann R. M., Tesser J. R., Schiff M. H., Keystone E. C., Genovese M. C., Wasko M. C., Moreland L. W., Weaver A. L., Markenson J., Finck B. K., A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. The New England Journal of Medicine 2000 343 22 1586 1593 2-s2.0-0034735827 10.1056/NEJM200011303432201
13. Breedveld F. C., Weisman M. H., Kavanaugh A. F., Cohen S. B., Pavelka K., Van Vollenhoven R., Sharp J., Perez J. L., Spencer-Green G. T., 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 2006 54 1 26 37 2-s2.0-31044442965 10.1002/art.21519
14. Klareskog L., van der Heijde D., de Jager J. P., Gough A., Kalden J., Malaise M., Martín Mola E., Pavelka K., Sany J., Settas L., Wajdula J., Pedersen R., Fatenejad S., Sanda M., 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 2004 363 9410 675 681 2-s2.0-10744223002 10.1016/S0140-6736(04)15640-7
15. Lipsky P. E., van der Heijde D. M., St Clair E. W., 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 2000 343 22 1594 1602
16. Maini R., St Clair E. W., Breedveld F., Furst D., Kalden J., Weisman M., Smolen J., Emery P., Harriman G., Feldmann M., Lipsky P., 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 1999 354 9194 1932 1939 2-s2.0-0033524159 10.1016/S0140-6736(99)05246-0
17. Weinblatt M. E., Kremer J. M., Bankhurst A. D., Bulpitt K. J., Fleischmann R. M., Fox R. I., Jackson C. G., Lange M., Burge D. J., 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 1999 340 4 253 259 2-s2.0-0033611472 10.1056/ NEJM199901283400401
18. Weinblatt M. E., Keystone E. C., Furst D. E., Moreland L. W., Weisman M. H., Birbara C. A., Teoh L. A., Fischkoff S. A., Chartash E. K., 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 2003 48 1 35 45 2-s2.0-0037231533 10.1002/art.10697
19. Keystone E. C., Genovese M. C., Klareskog L., 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 2009 68 789 796
20. van der Heijde D., Weinblatt M., Landewe R., Goel N., Wells F., Fleischmann R. M., Early inhibition of progression of structural damage in certolizumab pegol-treated patients: 16-week efficacy results from RAPID. Annals of the Rheumatic Diseases 2008 67, supplement 2, article 51
21. Emery P., Fleischmann R., Filipowicz-Sosnowska A., Schechtman J., Szczepanski L., Kavanaugh A., Racewicz A. J., Van Vollenhoven R. F., Li N. F., Agarwal S., Hessey E. W., Shaw T. M., 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 2006 54 5 1390 1400 2-s2.0-33646483031 10.1002/art.21778
22. Šenolt L., Vencovský J., Pavelka K., Ospelt C., Gay S., Prospective new biological therapies for rheumatoid arthritis. Autoimmunity Reviews 2009 9 2 102 107 2-s2.0-70350531479 10.1016/j.autrev.2009.03.010
23. Singh J. A., Furst D. E., Bharat A., 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 2012 64 625 639
24. Feltelius N., Fored C. M., Blomqvist P., Bertilsson L., Geborek P., Jacobsson L. T., Lindblad S., Lysholm J., Rantapää-Dahlqvist S., Saxne T., Klareskog L., Results from a nationwide postmarketing cohort study of patients in Sweden treated with etanercept. Annals of the Rheumatic Diseases 2005 64 2 246 252 2-s2.0-19944433874 10.1136/ard.2004.023473
25. Van Vollenhoven R. F., Carli C. C., Bratt J. K. L., Six year report of the STURE registry for biologicals in rheumatology: satisfactory overall results but plenty of room for improvement. Arthritis & Rheumatology 2005 52, supplement 9 S135
26. Khanna R., Sattin B. D., Afif W., Review article: a clinician's guide for therapeutic drug monitoring of infliximab in inflammatory bowel disease. Alimentary Pharmacology & Therapeutics 2013 38 447 459
27. 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. Clinical Gastroenterology and Hepatology 2008 6 6 644 653 2-s2.0-44649187924 10.1016/j.cgh.2008.03.014
28. Afif W., Loftus E. V. Jr., Faubion W. A., Kane S. V., Bruining D. H., Hanson K. A., Sandborn W. J., Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. American Journal of Gastroenterology 2010 105 5 1133 1139 2-s2.0-77951974444 10.1038/ajg.2010.9
29. Pariente B., Pineton de Chambrun G., Krzysiek R., Trough levels and antibodies to infliximab may not predict response to intensification of infliximab therapy in patients with inflammatory bowel disease. Inflammatory Bowel Diseases 2012 18 7 1199 1206
30. Karmiris K., Paintaud G., Noman M., Magdelaine-Beuzelin C., Ferrante M., Degenne D., Claes K., Coopman T., Van Schuerbeek N., Van Assche G., Vermeire S., Rutgeerts P., Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology 2009 137 5 1628 1640 2-s2.0-70350130547 10.1053/j.gastro.2009.07.062
31. Velayos F. S., Kahn J. G., Sandborn W. J., Feagan B. G., 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 2013 11 654 666
32. Steenholdt C., Brynskov J., Thomsen O., 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 10.1136/gutjnl-2013-305279
33. Vande Casteele N., Gils A., Singh S., Antibody response to infliximab and its impact on pharmacokinetics can be transient. The American Journal of Gastroenterology 2013 108 6 962 971
34. Wolbink G. J., Vis M., Lems W., Voskuyl A. E., De Groot E., Nurmohamed M. T., Stapel S., Tak P. P., Aarden L., Dijkmans B., Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis and Rheumatism 2006 54 3 711 715 2-s2.0-33644931095 10.1002/art.21671
35. Bartelds G. M., Krieckaert C. L. M., Nurmohamed M. T., Van Schouwenburg P. A., Lems W. F., Twisk J. W. R., Dijkmans B. A. C., Aarden L., Wolbink G. J., 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 2011 305 14 1460 1468 2-s2.0-79953906254 10.1001/jama.2011.406
36. Svenson M., Geborek P., Saxne T., Bendtzen K., Monitoring patients treated with anti-TNF- α biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology 2007 46 12 1828 1834 2-s2.0-36448985258 10.1093/rheumatology/kem261
37. Pascual-Salcedo D., Plasencia C., Ramiro S., Nuño L., Bonilla G., Nagore D., Ruiz Del Agua A., Martínez A., Aarden L., Martín-Mola E., Balsa A., Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology 2011 50 8 1445 1452 2-s2.0-79960935860
38. Emami-shahri N., Hagemann T., Resistance-the true face of biological defiance. Rheumatology 2012 51 3 413 422 2-s2.0-84857562149 10.1093/ rheumatology/ker326
39. Garcês 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. Annals of the Rheumatic Diseases 2013 72 1947 1955
40. Korswagen L. A., Bartelds G. M., Krieckaert C. L. M., Turkstra F., Nurmohamed M. T., Van Schaardenburg D., Wijbrandts C. A., Tak P. P., Lems W. F., Dijkmans B. A. C., Van Vugt R. M., Wolbink G. J., Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: a case series and cohort study. Arthritis and Rheumatism 2011 63 4 877 883 2-s2.0-79953685909 10.1002/art.30209
41. van Schouwenburg P. A., Bartelds G. M., Hart M. H., Aarden L., Wolbink G. J., Wouters D., 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 2010 362 1-2 82 88 2-s2.0-77958507060 10.1016/j.jim.2010.09.005
42. Hart M. H., de Vrieze H., Wouters D., Wolbink G.-J., Killestein J., de Groot E. R., Aarden L. A., Rispens T., Differential effect of drug interference in immunogenicity assays. Journal of Immunological Methods 2011 372 1-2 196 203 2-s2.0-80052505451 10.1016/j.jim.2011.07.019
43. Garcês S., Antunes M., Benito-Garcia E., Canas da Silva J., Aarden L., Demengeot J., 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 10.1136/annrheumdis-2013- 203296
44. Arnett F. C., Edworthy S. M., Bloch D. A., McShane D. J., Fries J. F., Cooper N. S., Healey L. A., Kaplan S. R., Liang M. H., Luthra H. S., Medsger T. A. Jr., Mitchell D. M., Neustadt D. H., Pinals R. S., Schaller J. G., Sharp J. T., Wilder R. L., Hunder G. G., The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis and Rheumatism 1988 31 3 315 324 2-s2.0-0023945481
45. Aletaha D., Neogi T., Silman A. J., 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Arthritis & Rheumatism 2010 62 9 2569 2581
46. Smolen J. S., Aletaha D., Bijlsma J. W., Treating rheumatoid arthritis to target: recommendations of an international task force. Annals of the Rheumatic Diseases 2010 69 4 631 637
47. Ionescu R., Ghiduri de Diagnostic si Tratament in Reumatolgie 2013
48. Bingham C. O. III, Pohl C., Woodworth T. G., Hewlett S. E., May J. E., Rahman M. U., Witter J. P., Furst D. E., Strand C. V., Boers M., Alten R. E., Developing a standardized definition for disease "flare" in rheumatoid arthritis (OMERACT 9 special interest group). The Journal of Rheumatology 2009 36 10 2335 2341 2-s2.0-70450179790 10.3899/jrheum.090369
49. Van der Maas A., den Broeder A. A., Measuring flares in rheumatoid arthritis. (Why) do we need validated criteria? The Journal of Rheumatology 2014 41 189 191
50. Gorovits B., Antidrug antibody assay validation: industry survey results. AAPS Journal 2009 11 1 133 138 2-s2.0-65549156596 10.1208/s12248-009-9091-6
51. Plasencia C., Pascual-Salcedo D., Nuño L., Influence of immunogenicity on the efficacy of longterm treatment of spondyloarthritis with infliximab. Annals of the Rheumatic Diseases 2012 71 12 1955 1960
52. Llinares-Tello F., de Salazar J. R., Gallego J. M., Analytical and clinical evaluation of a new immunoassay for therapeutic drug monitoring of infliximab and adalimumab. Clinical Chemistry and Laboratory Medicine 2012 50 10 1845 1847
53. van Schouwenburg P. A., van de Stadt L. A., de Jong R. N., Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation. Annals of the Rheumatic Diseases 2013 72 1 104 109 10.1136/annrheumdis-2012-201445
54. Plasencia C., Pascual-Salcedo D., García-Carazo S., 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 2013 15 4, article R79
55. Plasencia C., Pascual-Salcedo D., Alcocer P., 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 2013 72 1888 1890
56. Ruiz-Argüello B., del Agua A. R., Torres N., Monasterio A., Marti'nez A., Nagore D., Comparison study of two commercially available methods for the determination of infliximab, adalimumab, etanercept and anti-drug antibody levels. Clinical Chemistry and Laboratory Medicine 2013 51 12 e287 e289
57. Krieckaert C. L., Nair S. C., Nurmohamed M. T., 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 10.1136/annrheumdis-2013-204101
58. Thurlings R. M., Vos K., Wijbrandts C. A., Zwinderman A. H., Gerlag D. M., Tak P. P., Synovial tissue response to rituximab: mechanism of action and identification of biomarkers of response. Annals of the Rheumatic Diseases 2008 67 7 917 925 2-s2.0-38149044612 10.1136/ard.2007.080960
59. Teng Y. K. O., Levarht E. W. N., Hashemi M., Bajema I. M., Toes R. E. M., Huizinga T. W. J., Van Laar J. M., Immunohistochemical analysis as a means to predict responsiveness to rituximab treatment. Arthritis and Rheumatism 2007 56 12 3909 3918 2-s2.0-37149010203 10.1002/art.22967
60. Ferraccioli G., Tolusso B., Bobbio-Pallavicini F., Biomarkers of good EULAR response to the B cell depletion therapy in all seropositive rheumatoid arthritis patients: clues for the pathogenesis. PLoS One 2012 7 e40362 10.1371/journal.pone.0040362
61. Chatzidionysiou K., Lie E., Nasonov E., Lukina G., Hetland M. L., Tarp U., Gabay C., Van Riel P. L. C. M., Nordström D. C., Gomez-Reino J., Pavelka K., Tomsic M., Kvien T. K., Van Vollenhoven R. F., 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 2011 70 9 1575 1580 2-s2.0-80051473134 10.1136/ard.2010.148759
62. Hoshino M., Yoshio T., Onishi S., Minota S., Influence of antibodies against infliximab and etanercept on the treatment effectiveness of these agents in Japanese patients with rheumatoid arthritis. Modern Rheumatology 2012 22 4 532 540.