Time-dependent increased risk for serious infection from continuous use of tumor necrosis factor antagonists over three years in patients with rheumatoid arthritis

Arthritis Care and Research

Volumn 64, Issue 8, 2012, Pages 1125-1134

  Sakai, Ryoko ^a   Komano, Yukiko ^a   Tanaka, Michi ^a   Nanki, Toshihiro ^a   Koike, Ryuji ^a   Nagasawa, Hayato ^b   Amano, Koichi ^b   Nakajima, Atsuo ^c   Atsumi, Tatsuya ^d   Koike, Takao ^d   Ihata, Atsushi ^e   Ishigatsubo, Yoshiaki ^e   Saito, Kazuyoshi ^f   Tanaka, Yoshiya ^f   Ito, Satoshi ^g   Sumida, Takayuki ^g   Tohma, Shigeto ^h   Tamura, Naoto ⁱ   Fujii, Takao ^j   Sugihara, Takahiko ^k   Kawakami, Atsushi ^l   Hagino, Noboru ^m   Ueki, Yukitaka ⁿ   Hashiramoto, Akira ^o   Nagasaka, Kenji ^p   Miyasaka, Nobuyuki ^a   Harigai, Masayoshi ^a   more..

^a TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^b SAITAMA MEDICAL UNIVERSITY   (Japan)

^c TOKYO METROPOLITAN POLICE HOSPITAL   (Japan)

^d HOKKAIDO UNIVERSITY   (Japan)

^e YOKOHAMA CITY UNIVERSITY   (Japan)

^f UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^g UNIVERSITY OF TSUKUBA   (Japan)

^h NATIONAL HOSPITAL ORGANIZATION   (Japan)

ⁱ JUNTENDO UNIVERSITY   (Japan)

^j KYOTO UNIVERSITY   (Japan)

^k Tokyo Metropolitan Institute of Gerontology   (Japan)

^l NAGASAKI UNIVERSITY   (Japan)

^m UNIVERSITY OF TOKYO   (Japan)

ⁿ SASEBO CHUO HOSPITAL   (Japan)

^o KOBE UNIVERSITY   (Japan)

^p Ome Municipal General Hospital   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; INFLIXIMAB;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG INDUCED DISEASE; DRUG SAFETY; FEMALE; HUMAN; INFECTION; INFECTION RATE; INFECTION RISK; JAPANESE; MAJOR CLINICAL STUDY; MALE; RHEUMATOID ARTHRITIS;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ARTHRITIS, RHEUMATOID; COHORT STUDIES; COMMUNICABLE DISEASES; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOGLOBULIN G; JAPAN; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RECEPTORS, TUMOR NECROSIS FACTOR; RISK FACTORS; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84864422138     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.21666     Document Type: Article

References (38)

1. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, 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 Res (Hoboken) 2012; 64: 625-39.
2. Knevel R, Schoels M, Huizinga TW, Aletaha D, Burmester GR, Combe B, et al. Current evidence for a strategic approach to the management of rheumatoid arthritis with disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2010; 69: 987-94.
3. Nam JL, Winthrop KL, van Vollenhoven RF, Pavelka K, Valesini G, Hensor EM, et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis 2010; 69: 976-86.
4. Kievit W, Fransen J, Adang EM, den Broeder AA, Bernelot Moens HJ, Visser H, et al. Long-term effectiveness and safety of TNF-blocking agents in daily clinical practice: results from the Dutch Rheumatoid Arthritis Monitoring register. Rheumatology (Oxford) 2011; 50: 196-203.
5. Koike R, Takeuchi T, Eguchi K, Miyasaka N, and the Japan College of Rheumatology. Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis. Mod Rheumatol 2007; 17: 451-8.
6. Koike R, Harigai M, Atsumi T, Amano K, Kawai S, Saito K, et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol 2009; 19: 351-7.
7. Furst D,. The risk of infections with biologic therapies for rheumatoid arthritis. Semin Arthritis Rheum 2010; 39: 327-46.
8. Kelly C, Hamilton J,. What kills patients with rheumatoid arthritis? [editorial]. Rheumatology (Oxford) 2007; 46: 183-4.
9. Coyne P, Hamilton J, Heycock C, Saravanan V, Coulson E, Kelly CA,. Acute lower respiratory tract infections in patients with rheumatoid arthritis. J Rheumatol 2007; 34: 1832-6.
10. Riise T, Jacobsen BK, Gran JT, Haga HJ, Arnesen E,. Total mortality is increased in rheumatoid arthritis: a 17-year prospective study. Clin Rheumatol 2001; 20: 123-7.
11. Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis 2008; 67: 189-94.
12. Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol 2009; 36: 898-906.
13. Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. Mod Rheumatol 2011; 21: 343-51.
14. Komano Y, Tanaka M, Nanki T, Koike R, Sakai R, Kameda H, et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: a report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol 2011; 38: 1258-64.
15. Curtis JR, Xi J, Patkar N, Xie A, Saag KG, Martin C,. Drug-specific and time-dependent risks of bacterial infection among patients with rheumatoid arthritis who were exposed to tumor necrosis factor α antagonists. Arthritis Rheum 2007; 56: 4226-7.
16. Curtis JR, Patkar N, Xie A, Martin C, Allison JJ, Saag M, et al. Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor α antagonists. Arthritis Rheum 2007; 56: 1125-33.
17. Listing J, Strangfeld A, Kary S, Rau R, von Hinueber U, Stoyanova-Scholz M, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005; 52: 3403-12.
18. Galloway JB, Hyrich KL, Mercer LK, Dixon WG, Fu B, Ustianowski AP, et al. Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatology (Oxford) 2011; 50: 124-31.
19. Askling J, Fored C, Brandt L, Baecklund E, Bertilsson L, Feltelius N, et al. Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists. Ann Rheum Dis 2007; 66: 1339-44.
20. Dixon WG, Symmons DP, Lunt M, Watson KD, Hyrich KL, British Society for Rheumatology Biologics Register Control Centre Consortium, et al, on behalf of the British Society for Rheumatology Biologics Register. Serious infection following anti-tumor necrosis factor α therapy in patients with rheumatoid arthritis: lessons from interpreting data from observational studies. Arthritis Rheum 2007; 56: 2896-904.
21. 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: 628-34.
22. Schneeweiss S, Setoguchi S, Weinblatt ME, Katz JN, Avorn J, Sax PE, et al. Anti-tumor necrosis factor α therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis. Arthritis Rheum 2007; 56: 1754-64.
23. Favalli EG, Desiati F, Atzeni F, Sarzi-Puttini P, Caporali R, Pallavicini FB, et al. Serious infections during anti-TNFα treatment in rheumatoid arthritis patients. Autoimmun Rev 2009; 8: 266-73.
24. Dixon WG, Watson K, Lunt M, Hyrich KL, British Society for Rheumatology Biologics Register Control Centre Consortium, Silman A, et al, on behalf of the British Society for Rheumatology Biologics Register. 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: 2368-76.
25. Takeuchi T, Kameda H,. The Japanese experience with biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol 2010; 6: 644-52.
26. Sakai R, Komano Y, Tanaka M, Nanki T, Koike R, Nakajima A, et al. The REAL database reveals no significant risk of serious infection during treatment with a methotrexate dose of more than 8 mg/week in patients with rheumatoid arthritis. Mod Rheumatol 2011; 21: 444-8.
27. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315-24.
28. Steinbrocker O, Traeger C, Batterman R,. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc 1949; 140: 659-62.
29. Bruce B, Fries JF,. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes 2003; 1: 20.
30. ICH Steering Committee. ICH harmonized tripartite guideline. Clinical safety data management: definitions and standards for expedited reporting. 1994. URL:.
31. D'Agostino RB,. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 1998; 17: 2265-81.
32. Zink A, Askling J, Dixon W, Klareskog L, Silman A, Symmons D,. European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis 2009; 68: 1240-6.
33. Bongartz T, Sutton A, Sweeting M, Buchan I, Matteson E, Montori V,. 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: 2275-85.
34. Strangfeld A, Eveslage M, Schneider M, Bergerhausen HJ, Klopsch T, Zink A, et al. Treatment benefit or survival of the fittest: what drives the time-dependent decrease in serious infection rates under TNF inhibition and what does this imply for the individual patient? Ann Rheum Dis 2011; 70: 1914-20.
35. Greenberg J, Reed G, Kremer J, Tindall E, Kavanaugh A, Zheng C, et al. Association of methotrexate and tumour necrosis factor antagonists with risk of infectious outcomes including opportunistic infections in the CORRONA registry. Ann Rheum Dis 2010; 69: 380-6.
36. Au K, Reed G, Curtis JR, Kremer JM, Greenberg JD, Strand V, et al. High disease activity is associated with an increased risk of infection in patients with rheumatoid arthritis. Ann Rheum Dis 2011; 70: 785-91.
37. Harigai M, Koike R, Miyasaka N, for the Pneumocystis Pneumonia under Anti-Tumor Necrosis Factor Therapy (PAT) Study Group. Pneumocystis pneumonia associated with infliximab in Japan [letter]. N Engl J Med 2007; 357: 1874-6.
38. Singh JA, Wells GA, Christensen R, Tanjong Ghogomu E, Maxwell L, Macdonald JK, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 2011; 2:CD008794.