Profile of use of anti tumor necrosis factor in Colombian patients
Keywords:
Antirheumatic agents, tumor necrosis factor-alpha, arthritis, rheumatoid, juvenile rheumatoid, spondylitis, ankylosing, psoriatic, Colombia
Abstract
Introduction. Tumor necrosis factor-alpha antagonists (anti-TNFa) have shown an increasing consumption and generate a significant economic burden on health systems.
Objectives. The prescribing patterns of tumor necrosis factor-alpha antagonists were determined in a patient population associated with the Sistema General de Seguridad Social en Salud in Colombia.
Materials and methods. A descriptive observational study was conducted in 316 patients with respect to use of tumor necrosis factor-alpha antagonists during a treatment period from January 2008 to June 2009. The database examined contained indications of use, inclusion criteria to medication, duration of illness, co-morbidities and adverse reactions. The data were retrieved from the clinical histories. Student´s t test was used for the comparison of quantitative variables, and the chi-square test was used to establish associations between categorical variables and multivariate analysis were used.
Results. Mean age was 44.6±13.9 years; 63.9% of participants were female. Of the 316 patients, 17.1% received monotherapy. The order of prescription drugs was as follows: adalimumab (37.3%), infliximab (37.3%) and etanercept (25.4%), all were prescribed in appropriately defined daily doses. Co-medication drugs most frequently prescribed were: disease-modifying anti-rheumatic (82.9%), NSAIDs (29.1%), omeprazole (22.5%), antihypertensives (21.2%), folic acid (19.9%) calcium plus vitamin D (9.8%), calcitriol (6.0%). 10.4% of patients had a record of some adverse drug reaction. The average cost of therapy per patient per year was US$23,464.
Conclusions. Anti-TNFa are being used at recommended doses, particularly in rheumatoid arthritis and in combination with other anti-rheumatic drugs. The direct cost of therapy was high for the country's health system.
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References
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14. Ministerio de la Protección Social. Comisión de Regulación en Salud. Acuerdo 08 de 2009. Fecha de consulta: 1° de agosto de 2010. Disponible en: http://www.pos.gov.co/Documents/Acuerdo%20008%20Dic%2029-09.pdf.
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16. Kavanaugh A, Cohen S, Cush J. The evolving use of TNF inhibitors in rheumatoid arthritis. J Rheumatol. 2004;31:1881-4.
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18. Lambert CM. Medical therapy for rheumatoid arthritis-value for money? Rheumatology. 2001;40:961-4.
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20. Rat AC, Boissier MC. Rheumatoid arthritis: Direct and indirect costs. Joint Bone Spine. 2004;71:518-24.
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22. McLeod C, Bagust A, Boland A, Dagenais P, Dickson R, Dundar Y, et al. Adalimumab, etanercept and infliximab for the treatment of ankylosing spondylitis: A systematic review and economic evaluation. Health Technol Assess. 2007;11:1-158.
23. Bravo Y, Hawkins NS, Claxton K, Asseburg C, Palmer S, Woolacott N, et al. The cost-effectiveness of etanercept and infliximab for the treatment of patients with psoriatic arthritis. Rheumatology (Oxford). 2007;46:1729-35.
24. Sarzi-Puttini P, Antivalle M, Marchesoni A, Favalli EG, Gorla R, Filippini M, et al. Efficacy and safety of anti-TNF agents in the Lombardy rheumatoid arthritis network (LORHEN). Reumatismo. 2008;60:290-5.
25. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340:253-9.
26. Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: A randomized phase III trial. ATTRACT Study Group. Lancet. 1999;354:1932-9.
27. Warris A, Bjørneklett A, Gaustad P. Invasive pulmonary aspergillosis associated with infliximab therapy. N Engl J Med. 2001;344:1099-100.
28. Kamath BM, Mamula P, Baldassano RN, Markowitz JE. Listeria meningitis after treatment with infliximab. J Pediatr Gastroenterol Nutr. 2002;34:410-2.
29. Nakelchik M, Mangino JE. Reactivation of histoplasmosis after treatment with infliximab. Am J Med. 2002;112:78.
30. Brown SL, Greene MH, Gershon SK, Edwards ET, Braun MM. Tumor necrosis factor antagonist therapy and lymphoma development: Twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum. 2002;46:3151-8.
31. Shakoor N, Michalska M, Harris CA, Block JA. Drug-induced systemic lupus erythematosus associated with etanercept therapy. Lancet. 2002;359:579-80.
32. Machado JE, Alzate JA. Patterns of antiretroviral drug prescription in 997 Colombian patients. Biomédica. 2008;28:78-86.
2. Nawroth PP, Bank I, Handley D, Cassimeris J, Chess L, Stern D. Tumor necrosis factor/cachectin interacts with endothelial cell receptors to induce release of interleukin 1. J Exp Med. 1986;163:1363-75.
3. Butler DM, Maini RN, Feldmann M, Brennan FM. Modulation of proinflammatory cytokine release in rheumatoid synovial membrane cell cultures. Comparison of monoclonal anti TNF-alpha antibody with the interleukin-1 receptor antagonist. Eur Cytokine Netw. 1995;6:225-30.
4. Haworth C, Brennan FM, Chantry D, Turner M, Maini RN, Feldmann M. Expression of granulocyte-macrophage colony-stimulating factor in rheumatoid arthritis: Regulation by tumor necrosis factor-alpha. Eur J Immunol. 1991;21:2575-9.
5. Chin JE, Winterrowd GE, Krzesicki RF, Sanders ME. Role of cytokines in inflammatory synovitis: The coordinate regulation of intercellular adhesion molecule 1 and HLA class I and class II antigens in rheumatoid synovial fibroblasts. Arthritis Rheum. 1990;33:1776-8.
6. Saxne T, Palladino MA Jr, Heinegard D, Talal N, Wollheim FA. Detection of tumor necrosis factor alpha but not tumor necrosis factor beta in rheumatoid arthritis synovial fluid and serum. Arthritis Rheum. 1988;31:1041-5.
7. Chu CQ, Field M, Feldmann M, Maini RN. Localization of tumor necrosis factor alpha in synovial tissues and at the cartilage pannus junction in patients with rheumatoid arthritis. Arthritis Rheum. 1991;34:1125-32.
8. Neidel J, Schulze M, Lindschau J. Association between degree of bone-erosion and synovial fluid-levels of tumor necrosis factor alpha in the knee-joints of patients with rheumatoid arthritis. Inflamm Res. 1995;44:217-21.
9. van Dullemen HM, van Deventer SJ, Hommes DW, Bijl HA, Jansen J, Tytgat GN, et al. Treatment of Crohn's disease with anti-tumor necrosis factor chimeric monoclonal antibody (cA2). Gastroenterology. 1995;109:129-35.
10. Chen Y, Jobanputra P, Barton P, Jowet S, Bryan S, Clark W, et al. A systematic review of the effectiveness of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis in adults and an economic evaluation of their cost-effectiveness. Health Technol Assess. 2006;10:1-248.
11. Jacobsson LT, Turesson C, Nilsson JA, Petersson IF, Lindqvist E, Saxne T, et al. Treatment with TNF blockers and mortality risk in patients with rheumatoid arthritis. Ann Rheum Dis. 2007;66:670-5.
12. Lee TW, Fedorak RN. Tumor necrosis factor-α monoclonal antibodies in the treatment of inflammatory bowel disease: Clinical practice pharmacology. Gastroenterol Clin North Am. 2010;39:543-57.
13. Sandborn WJ. State-of-the-art: Immunosuppression and biologic therapy. Dig Dis. 2010;28:536-42.
14. Ministerio de la Protección Social. Comisión de Regulación en Salud. Acuerdo 08 de 2009. Fecha de consulta: 1° de agosto de 2010. Disponible en: http://www.pos.gov.co/Documents/Acuerdo%20008%20Dic%2029-09.pdf.
15. Doan QV, Chiou CF, Dubois RW. Review of eight pharmacoeconomic studies of the value of biologic DMARDs (adalimumab, etanercept, and infliximab) in the management of rheumatoid arthritis. J Manag Care Pharm. 2006;12:555-69.
16. Kavanaugh A, Cohen S, Cush J. The evolving use of TNF inhibitors in rheumatoid arthritis. J Rheumatol. 2004;31:1881-4.
17. Wong J. Cost-effectiveness of anti-tumor necrosis factor agents. Clin Exp Rheumatol. 2005;22:S65-70.
18. Lambert CM. Medical therapy for rheumatoid arthritis-value for money? Rheumatology. 2001;40:961-4.
19. Hurst NP, Forbes J. Does economic evaluation have anything to offer the rheumatologist? Rheumatology. 1999;38:2-5.
20. Rat AC, Boissier MC. Rheumatoid arthritis: Direct and indirect costs. Joint Bone Spine. 2004;71:518-24.
21. Bertele V, Assisi A, Di Muzio V, Renzo D, Garattini S. New antirheumatic drugs: Any real added value? A critical overview of regulatory criteria for their marketing approval. Eur J Clin Pharmacol. 2007;63:879-89.
22. McLeod C, Bagust A, Boland A, Dagenais P, Dickson R, Dundar Y, et al. Adalimumab, etanercept and infliximab for the treatment of ankylosing spondylitis: A systematic review and economic evaluation. Health Technol Assess. 2007;11:1-158.
23. Bravo Y, Hawkins NS, Claxton K, Asseburg C, Palmer S, Woolacott N, et al. The cost-effectiveness of etanercept and infliximab for the treatment of patients with psoriatic arthritis. Rheumatology (Oxford). 2007;46:1729-35.
24. Sarzi-Puttini P, Antivalle M, Marchesoni A, Favalli EG, Gorla R, Filippini M, et al. Efficacy and safety of anti-TNF agents in the Lombardy rheumatoid arthritis network (LORHEN). Reumatismo. 2008;60:290-5.
25. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340:253-9.
26. Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: A randomized phase III trial. ATTRACT Study Group. Lancet. 1999;354:1932-9.
27. Warris A, Bjørneklett A, Gaustad P. Invasive pulmonary aspergillosis associated with infliximab therapy. N Engl J Med. 2001;344:1099-100.
28. Kamath BM, Mamula P, Baldassano RN, Markowitz JE. Listeria meningitis after treatment with infliximab. J Pediatr Gastroenterol Nutr. 2002;34:410-2.
29. Nakelchik M, Mangino JE. Reactivation of histoplasmosis after treatment with infliximab. Am J Med. 2002;112:78.
30. Brown SL, Greene MH, Gershon SK, Edwards ET, Braun MM. Tumor necrosis factor antagonist therapy and lymphoma development: Twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum. 2002;46:3151-8.
31. Shakoor N, Michalska M, Harris CA, Block JA. Drug-induced systemic lupus erythematosus associated with etanercept therapy. Lancet. 2002;359:579-80.
32. Machado JE, Alzate JA. Patterns of antiretroviral drug prescription in 997 Colombian patients. Biomédica. 2008;28:78-86.
How to Cite
1.
Machado J, Moncada JC, Pineda R. Profile of use of anti tumor necrosis factor in Colombian patients. biomedica [Internet]. 2011 Mar. 7 [cited 2024 May 17];31(2):250-7. Available from: https://revistabiomedica.org/index.php/biomedica/article/view/319
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