591
Views
24
CrossRef citations to date
0
Altmetric
Research Article

Rates of serious infections, opportunistic infections, inflammatory bowel disease, and malignancies in subjects receiving etanercept vs. controls from clinical trials in ankylosing spondylitis: a pooled analysis

, , , &
Pages 49-53 | Accepted 12 Aug 2013, Published online: 01 Nov 2013

References

  • Singh JA, Wells GA, Christensen R, Tanjong Ghogomu E, Maxwell L, Macdonald JK, Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 2010;2:CD008794.
  • van Luijn JC, Danz M, Bijlsma JW, Gribnau FW, Leufkens HG. Post-approval trials of new medicines: widening use or deepening knowledge? Analysis of 10 years of etanercept. Scand J Rheumatol 2011;40:183–91.
  • Strangfeld A, Listing J. Infection and musculoskeletal conditions: bacterial and opportunistic infections during anti-TNF therapy. Best Pract Res Clin Rheumatol 2006;20:1181–95.
  • Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, 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. J Am Med Assoc 2006;295:2275–85.
  • Bongartz T, Warren FC, Mines D, Matteson EL, Abrams KR, Sutton AJ. Etanercept therapy in rheumatoid arthritis and the risk of malignancies: a systematic review and individual patient data meta-analysis of randomised controlled trials. Ann Rheum Dis 2009;68:1177–83.
  • Braun J, Huang F, Burgos-Vargas R, van der Horst-Bruinsma IE, Freundlich B, Vlahos B, Assessment of clinical efficacy in a randomized, double-blind study of etanercept and sulfasalazine in patients with ankylosing spondylitis. Arthritis Rheum 2008;58(Suppl 9):S415.
  • Calin A, Dijkmans BA, Emery P, Hakala M, Kalden J, Leirisalo-Repo M, Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis 2004;63:1594–600.
  • Davis JC Jr, van der Heijde DM, Braun J, Dougados M, Clegg DO, Kivitz AJ, Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis. Ann Rheum Dis 2008;67:346–52.
  • Dijkmans B, Emery P, Hakala M, Leirisalo-Repo M, Mola EM, Paolozzi L, Etanercept in the long-term treatment of patients with ankylosing spondylitis. J Rheumatol 2009;36:1256–64.
  • Martin-Mola E, Sieper J, Leirisalo-Repo M, Dijkmans BA, Vlahos B, Pedersen R, Sustained efficacy and safety, including patient-reported outcomes, with etanercept treatment over 5 years in patients with ankylosing spondylitis. Clin Exp Rheumatol 2010;28:238–45.
  • Healey EL, Haywood KL, Jordan KP, Garratt A, Packham JC. Impact of ankylosing spondylitis on work in patients across the UK. Scand J Rheumatol 2011;40:34–40.
  • Davis JC Jr, van der Heijde D, Braun J, Dougados M, Cush J, Clegg DO, Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum 2003;48:3230–6.
  • Gorman JD, Sack KE, Davis JC Jr. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med 2002;346:1349–56.
  • van der Heijde D, Da Silva JC, Dougados M, Geher P, van der Horst-Bruinsma I, Juanola X, Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis. Ann Rheum Dis 2006;65:1572–7.
  • Sahai H, Khurshid A. Statistics in epidemiology: methods, techniques, and applications. Boca Raton, FL: CRC Press, 1996.
  • Winthrop KL. Risk and prevention of tuberculosis and other serious opportunistic infections associated with the inhibition of tumor necrosis factor. Nat Clin Pract Rheumatol 2006;2:602–10.
  • Braun J, Baraliakos X, Listing J, Davis J, van der Heijde D, Haibel H, Differences in the incidence of flares or new onset of inflammatory bowel diseases in patients with ankylosing spondylitis exposed to therapy with anti-tumor necrosis factor alpha agents. Arthritis Rheum 2007;57:639–47.
  • Gottlieb AB, Gordon K, Giannini EH, Mease P, Li J, Chon Y, Clinical trial safety and mortality analyses in patients receiving etanercept across approved indications. J Drugs Dermatol 2011;10:289–300.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.