Early Australian experience with infliximab, a chimeric antibody against tumour necrosis factor-α, in the treatment of Crohn’s disease: is its efficacy augmented by steroid-sparing immunosuppressive therapy?

Authors

  • M. Mortimore,

    1. Royal Brisbane Hospital,
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  • P. R. Gibson,

    1. University of Melbourne Department of Medicine, Royal Melbourne Hospital, Melbourne, Victoria,
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  • W. S. Selby,

    1. Royal Prince Alfred Hospital and
    2. Department of Medicine, University of Sydney, Sydney, New South Wales, Australia
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  • G. L. Radford-Smith,

    1. Royal Brisbane Hospital,
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  • T. H. J. Florin,

    1. University of Queensland Department of Medicine, Mater Adult Hospital, Brisbane, Queensland,
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  • THE INFLIXIMAB USER GROUP

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    • *The Infliximab User Group comprised K. Ooi and T. Florin, Mater Adult Hospital, M. Mortimore and G. Radford-Smith, Royal Brisbane Hospital, Brisbane, L. Wood, Ipswich General Hospital, Ipswich, P. Gibson, F. Macrae and S. Lachal, Royal Melbourne Hospital, W. Connell, St Vincent’s Hospital, B. Crotty, Austin Repatriation General Hospital, Melbourne, W. Selby and S. Griffin, Royal Prince Alfred Hospital, M. Grimm, St George Hospital, S. James and P. Katelaris, Concord Repatriation General Hospital, Sydney and P. Pavli, The Canberra Hospital, Canberra.


  • The results of this study were presented at the Australian Gastroenterology Week scientific conference in Hobart 18–21 October 2000: Mortimore M, Anthony S, Miller A, James S, Ooi K, Griffin S, Florin THJ. The Australian infliximab experience: a physician initiated multicentre collaboration. J Gastroenterol Hepatol 2000; 15 (Suppl.): J92.

Correspondence to: DrTimothyFlorin, Department of Medicine, Mater Adult Hospital, South Brisbane, QLD 4101, Australia. Email: t.florin@mailbox.uq.edu.au

Abstract

Abstract

Background: Tumour necrosis factor-α (TNF-α) plays an important role in the pathology of Crohn’s disease. Infliximab, a chimeric antibody against TNF-α, has been shown in controlled clinical trials to be effective in two-thirds of patients with refractory or fistulating Crohn’s disease. The factors that determine a clinical response in some patients but not others are unknown.

Aims: To document the early Australian experience with infliximab treatment for Crohn’s disease and to identify factors that may determine a beneficial clinical response.

Methods: Gastroenterologists known to have used infliximab for Crohn’s disease according to a compassionate use protocol were asked to complete a spreadsheet that included demographic information, Crohn’s disease site, severity, other medical or surgical treatments and a global clinical assessment of Crohn’s disease outcome, judged by participating physicians as complete and sustained (remission for the duration of the study), complete but unsustained (remission at 4 weeks but not for the whole study) or partial clinical improvement (sustained or unsustained).

Results: Fifty-seven patients were able to be evaluated, with a median follow-up time of 16.4 (4–70) weeks, including 23 patients with fistulae. There were 21 adverse events, including four serious events. Fifty-one patients (89%) had a positive clinical response for a median duration (range) of 11 (2–70) weeks. Thirty patients (52%) had a remission at 4 weeks, 10 of whom had remission for longer than 12 weeks. Forty-two per cent of fistulae closed. Sustained remission (P = 0.065), remission at 4 weeks (P = 0.033) and a positive clinical response of any sort (P = 0.004) were more likely in patients on immunosuppressive therapy, despite there being more smokers in this group.

Conclusion: This review of the first Australian experience with infliximab corroborates the reported speed and efficacy of this treatment for Crohn’s disease. The excellent response appears enhanced by the concomitant use of conventional steroid-sparing immunosuppressive therapy. (Intern Med J 2001; 31: 146–150)

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