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Postmarketing observational studies reporting incidence of mycobacterial infections in patients receiving biologic therapies in Europe, North America, and Asia

Postmarketing observational studies reporting incidence of mycobacterial infections in patients receiving biologic therapies in Europe, North America, and Asia
  • TB incidence (patient-years) in biologic-treated patients (incidence reflects combined outcome for anti-TNF therapy unless otherwise indicated): Arkema 2015 21.6/100,000 (anti-TNF, abatacept, anakinra, rituximab, tocilizumab); Abreu 2013 405/100,000 for etanercept (not pictured 792/100,000 for adalimumab and 1337/100,000 for infliximab); Baddley 2014 40/100,000; Sanchez-Moya 2013 146/100,000 (anti-TNF, ustekinumab, efalizumab); Winthrop 2013 49/100,000; Dixon 2010 95/100,000; Favalli 2009 212/100,000; Tubach 2009 116.7/100,000; Rybar 2008 237/100,000; Gomez-Reino 2007 172/100,000; Brassard 2006 257/100,000; Dixon 2006 150/100,000 for infliximab (not pictured 50/100,000 for etanercept and 90/100,000 for adalimumab); Sichletidis 2006 449/100,000; Askling 2005 118/100,000; Carmona 2005 117/100,000; Listing 2005 310/100,000 for infliximab; Wolfe 2004 52.5/100,000 for infliximab; Gomez-Reino 2003 1113/100,000 for infliximab; Yoo 2014 1700/100,000; Ke 2013 954.5/100,000; Lee 2013 519/100,000; Mok 2014 930/100,000 (anti-TNF, rituximab, tocilizumab); Kim 2011 561/100,000; Seong 2007 2558/100,000 for infliximab (not pictured 0/100,000 for etanercept).[1-24]
  • NTM incidence (patient-years) in biologic-treated patients: Baddley 2014 40/100,000; Winthrop 2013 74/100,000; Lee 2013 230.7/100,000.[3,5,21]
TB: tuberculosis; NTM: non-tuberculous mycobacteria; TNF: tumor necrosis factor.
References:
  1. Arkema EV, Jonsson J, Baecklund E, et al. Are patients with rheumatoid arthritis still at an increased risk of tuberculosis and what is the role of biological treatments? Ann Rheum Dis 2015; 74:1212.
  2. Abreu C, Magro F, Santos-Antunes J, et al. Tuberculosis in anti-TNF-alpha treated patients remains a problem in countries with an intermediate incidence: analysis of 25 patients matched with a control population. J Crohns Colitis 2013; 7:e486.
  3. Baddley JW, Winthrop KL, Chen L, et al. Non-viral opportunistic infections in newusers of tumour necrosis factor inhibitor therapy: Results of the SAfety Assessment of Biologic ThERapy (SABER) Study. Ann Rheum Dis 2014; 73:1942.
  4. Sanchez-Moya AI, Garcia-Doval I, Carretero G, et al. Latent tuberculosis infection and active tuberculosis in patients with psoriasis: a study on the incidence of tuberculosis and the prevalence of latent tuberculosis disease in patients with moderate-severe psoriasis in Spain. BIOBADADERM registry. J Eur Acad Dermatol Venereol 2013; 27:1366.
  5. Winthrop KL, Baxter R, Liu L, et al. Mycobacterial diseases and antitumour necrosis factor therapy in USA. Ann Rheum Dis 2013; 72:37.
  6. Dixon WG, Hyrich KL, Watson KD, et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR). Ann Rheum Dis 2010; 69:522.
  7. Favalli EG, Desiati F, Atzeni F, et al. Serious infections during anti-TNF alpha treatment in rheumatoid arthritis patients. Autoimmun Rev 2009; 8:266.
  8. Tubach F, Salmon D, Ravaud P, et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: the three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum 2009; 60:1884.
  9. Rybar I, Rozborilova E, Zanova E, et al. The effectiveness for prevention of tuberculosis in patients with inflammatory rheumatic diseases treated with TNF inhibitors. Bratisl Lek Listy 2008; 109:164.
  10. Gomez-Reino JJ, Carmona L, Angel Descalzo M, et al. Risk of tuberculosis inpatients treated with tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection. Arthritis Rheum 2007; 57:756.
  11. Brassard P, Kezouh A, Suissa S. Antirheumatic drugs and the risk of tuberculosis. Clin Infect Dis 2006; 43:717.
  12. 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.
  13. Sichletidis L, Settas L, Spyratos D, et al. Tuberculosis in patients receiving anti-TNF agents despite chemoprophylaxis. Int J Tuberc Lung Dis 2006; 10:1127.
  14. Askling J, Fored CM, Brandt L, et al. Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden. Arthritis Rheum 2005; 52:1986.
  15. Carmona L, Gomez-Reino JJ, Rodriguez-Valverde V, et al. Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists. Arthritis Rheum 2005; 52:1766.
  16. Listing J, Strangfeld A, Kary S, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005; 52:3403.
  17. Wolfe F, Michaud K, Anderson J, et al. Tuberculosis infection in patients with rheumatoid arthritis and the effect of infliximab therapy. Arthritis Rheum 2004; 50:372.
  18. Gomez-Reino JJ, Carmona L, Valverde VR, et al. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum 2003; 48:2122.
  19. Yoo IK, Choung RS, Hyun JJ, et al. Incidences of serious infections and tuberculosis among patients receiving anti-tumor necrosis factor-alpha therapy. Yonsei Med J 2014; 55:442.
  20. Ke WM, Chen LS, Parng IM, et al. Risk of tuberculosis in rheumatoid arthritis patients on tumour necrosis factor-alpha inhibitor treatment in Taiwan. Int J Tuberc Lung Dis 2013; 17:1590.
  21. Lee SK, Kim SY, Kim EY, et al. Mycobacterial infections in patients treated with tumor necrosis factor antagonists in South Korea. Lung 2013; 191:565.
  22. Mok CC, Chan KY, Lee KL, et al. Factors associated with withdrawal of the anti-TNF alpha biologics in the treatment of rheumatic diseases: data from the Hong Kong Biologics Registry. Int J Rheum Dis 2014; 17:1.
  23. Kim EM, Uhm WS, Bae SC, et al. Incidence of tuberculosis among korean patients with ankylosing spondylitis who are taking tumor necrosis factor blockers. J Rheumatol 2011; 38:2218.
  24. Seong SS, Choi CB, Woo JH, et al. Incidence of tuberculosis in Korean patients with rheumatoid arthritis (RA): effects of RA itself and of tumor necrosis factor blockers. J Rheumatol 2007; 34:706.
Winthrop KL, Novosad SA, Baddley JW, et al. Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance. Ann Rheum Dis 2015; 74:2107. Reproduced with permission from BMJ Publishing Group, Ltd. Copyright © 2015.
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