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

Background: Tumour necrosis factor-alpha (TNF-alpha) plays an important rol e in the pathology of Crohn's disease. Infliximab, a chimeric antibody agai nst TNF-alpha, 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 oth ers are unknown. Aims: To document the early Australian experience with infliximab treatment for Crohn's disease and to identify factors that may determine a beneficia l clinical response. Methods: Gastroenterologists known to have used infliximab for Crohn's dise ase according to a compassionate use protocol were asked to complete a spre adsheet that included demographic information, Crohn's disease site, severi ty, other medical or surgical treatments and a global clinical assessment o f Crohn's disease outcome, judged by participating physicians as complete a nd sustained (remission for the duration of the study), complete but unsust ained (remission at 4 weeks but not for the whole study) or partial clinica l improvement (sustained or unsustained). Results: Fifty-seven patients were able to be evaluated, with a median foll ow-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 clos ed. 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 pat ients on immunosuppressive therapy, despite there being more smelters in th is 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.