Comparative safety of infliximab and etanercept on the risk of serious infections: Does the association vary by patient characteristics?

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue 5, 2012, Pages 524-534

  Toh, Sengwee ^a   Li, Lingling ^a   Harrold, Leslie R ^b   Bayliss, Elizabeth A ^c,d   Curtis, Jeffrey R ^e   Liu, Liyan ^f   Chen, Lang ^e   Grijalva, Carlos G ^g   Herrinton, Lisa J ^f  

^a HARVARD MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^c KAISER PERMANENTE   (United States)

^d UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^e The University of Alabama at Birmingham   (United States)

^f DIVISION OF RESEARCH   (United States)

^g VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Anti TNF agents; Database; Pharmacoepidemiology; Propensity score; Serious infections

Indexed keywords

ETANERCEPT; INFLIXIMAB;

ADULT; AGED; ANKYLOSING SPONDYLITIS; ARTICLE; BODY MASS; DISEASE ASSOCIATION; DRUG SAFETY; ETHNICITY; FEMALE; HOSPITALIZATION; HUMAN; INFECTION; INFECTION RATE; INFECTION RISK; INFECTION SENSITIVITY; MAJOR CLINICAL STUDY; MALE; MEDICAID; MEDICARE; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; PRIVATE HEALTH INSURANCE; PSORIASIS; PSORIATIC ARTHRITIS; RHEUMATOID ARTHRITIS; SIDE EFFECT; SMOKING;

ADOLESCENT; ADULT; AGE FACTORS; AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; AUTOIMMUNE DISEASES; CALIFORNIA; COHORT STUDIES; DATABASES, FACTUAL; FEMALE; FOLLOW-UP STUDIES; HOSPITALIZATION; HUMANS; IMMUNOGLOBULIN G; IMMUNOLOGIC FACTORS; INFECTION; MALE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; RECEPTORS, TUMOR NECROSIS FACTOR; RISK; TIME FACTORS; TUMOR NECROSIS FACTOR-ALPHA; YOUNG ADULT;

EID: 84862792046     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3238     Document Type: Article

References (41)

1. Maini R, St Clair EW, Breedveld F, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999; 354: 1932-1939.
2. Lipsky PE, van der Heijde DM, St Clair EW, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 2000; 343: 1594-1602.
3. Moreland LW, Schiff MH, Baumgartner SW, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 1999; 130: 478-486.
4. Genovese MC, Bathon JM, Martin RW, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum 2002; 46: 1443-1450.
5. Keystone EC, Kavanaugh AF, Sharp JT, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004; 50: 1400-1411.
6. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of ombination 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 Rheum 2006; 54: 26-37.
7. Listing J, Strangfeld A, Kary S, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005; 52: 3403-3412.
8. Bongartz T, Sutton AJ, Sweeting MJ, et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006; 295: 2275-2285.
9. Bernatsky S, Hudson M, Suissa S. Anti-rheumatic drug use and risk of serious infections in rheumatoid arthritis. Rheumatology (Oxford) 2007; 46: 1157-1160.
10. Askling J, Fored CM, Brandt L, et al. Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists. Ann Rheum Dis 2007; 66: 1339-1344.
11. Askling J, Dixon W. The safety of anti-tumour necrosis factor therapy in rheumatoid arthritis. Curr Opin Rheumatol 2008; 20: 138-144.
12. Curtis JR, Patkar N, Xie A, et al. Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists. Arthritis Rheum 2007; 56: 1125-1133.
13. Curtis JR, Xi J, Patkar N, et al. Drug-specific and time-dependent risks of bacterial infection among patients with rheumatoid arthritis who were exposed to tumor necrosis factor alpha antagonists. Arthritis Rheum 2007; 56: 4226-4227.
14. Strangfeld A, Listing J, Herzer P, et al. Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents. JAMA 2009; 301: 737-744.
15. Wallis RS, Ehlers S. Tumor necrosis factor and granuloma biology: explaining the differential infection risk of etanercept and infliximab. Semin Arthritis Rheum 2005; 34: 34-38.
16. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001; 345: 1098-1104.
17. Wallis RS, Broder MS, Wong JY, et al. Granulomatous infectious diseases associated with tumor necrosis factor antagonists. Clin Infect Dis 2004; 38: 1261-1265.
18. Dixon WG, Symmons DP, Lunt M, et al. Serious infection following anti-tumor necrosis factor alpha therapy in patients with rheumatoid arthritis: lessons from interpreting data from observational studies. Arthritis Rheum 2007; 56: 2896-2904.
19. Salliot C, Gossec L, Ruyssen-Witrand A, et al. Infections during tumour necrosis factor-alpha blocker therapy for rheumatic diseases in daily practice: a systematic retrospective study of 709 patients. Rheumatology (Oxford) 2007; 46: 327-334.
20. Favalli EG, Desiati F, Atzeni F, et al. Serious infections during anti-TNFalpha treatment in rheumatoid arthritis patients. Autoimmun Rev 2009; 8: 266-273.
21. Curtis JR, Xie F, Chen L, et al. The comparative risk of serious infections among rheumatoid arthritis patients starting or switching biological agents. Ann Rheum Dis 2011; 70: 1401-1406.
22. Grijalva CG, Chen L, Delzell E, et al. Initiation of tumor necrosis factor-alpha antagonists and the risk of hospitalization for infection in patients with autoimmune diseases. JAMA 2011; 306: 2331-2339.
23. Herrinton LJ, Curtis JR, Chen L, et al. Study design for a comprehensive assessment of biologic safety using multiple healthcare data systems. Pharmacoepidemiol Drug Saf 2011; 20: 1199-1209.
24. Patkar NM, Curtis JR, Teng GG, et al. Administrative codes combined with medical records based criteria accurately identified bacterial infections among rheumatoid arthritis patients. J Clin Epidemiol 2009; 62: 321-327, 327 e321-327.
25. Schneeweiss S, Robicsek A, Scranton R, et al. Veteran's affairs hospital discharge databases coded serious bacterial infections accurately. J Clin Epidemiol 2007; 60: 397-409.
26. Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol 1992; 45: 613-619.
27. Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika 1983; 70: 41-55.
28. Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. J Am Stat Assoc 1984; 79: 516-524.
29. Prentice R. Use of the logistic model in retrospective studies. Biometrics 1976; 32: 599-606.
30. Hernán MA, Hernandez-Diaz S, Robins JM. A structural approach to selection bias. Epidemiology 2004; 15: 615-625.
31. Toh S, Hernán MA. Causal inference from longitudinal studies with baseline randomization. Int J Biostat 2008; 4: Article22.
32. Marino S, Sud D, Plessner H, et al. Differences in reactivation of tuberculosis induced from anti-TNF treatments are based on bioavailability in granulomatous tissue. PLoS Comput Biol 2007; 3: 1909-1924.
33. Gardner ID. The effect of aging on susceptibility to infection. Rev Infect Dis 1980; 2: 801-810.
34. Gavazzi G, Krause KH. Ageing and infection. Lancet Infect Dis 2002; 2: 659-666.
35. Dixon WG, Watson K, Lunt M, et al. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum 2006; 54: 2368-2376.
36. Doran MF, Crowson CS, Pond GR, et al. Predictors of infection in rheumatoid arthritis. Arthritis Rheum 2002; 46: 2294-2300.
37. Wolfe F, Caplan L, Michaud K. Treatment for rheumatoid arthritis and the risk of hospitalization for pneumonia: associations with prednisone, disease-modifying antirheumatic drugs, and anti-tumor necrosis factor therapy. Arthritis Rheum 2006; 54: 628-634.
38. Wolfe F, Michaud K, Chakravarty EF. Rates and predictors of herpes zoster in patients with rheumatoid arthritis and non-inflammatory musculoskeletal disorders. Rheumatology (Oxford) 2006; 45: 1370-1375.
39. Doshi JA, Li P, Puig A. Impact of the Medicare Modernization Act of 2003 on utilization and spending for medicare part B-covered biologics in rheumatoid arthritis. Arthritis Care Res (Hoboken) 2010; 62: 354-361.
40. Sherman CB. The health consequences of cigarette smoking. Pulmonary diseases. Med Clin North Am 1992; 76: 355-375.
41. Almirall J, Gonzalez CA, Balanzo X, et al. Proportion of community-acquired pneumonia cases attributable to tobacco smoking. Chest 1999; 116: 375-379.