• Internal medicine journal · Jun 2015

    Multicenter Study Observational Study

    Compassionate access anti-tumour necrosis factor-α therapy for ulcerative colitis in Australia: the benefits to patients.

    • S P Costello, S Ghaly, L Beswick, A Pudipeddi, A Agarwal, A Sechi, S O'Connor, S J Connor, M P Sparrow, P Bampton, A J Walsh, J M Andrews, and Australian Inflammatory Bowel Disease Association (AIBDA).
    • Inflammatory Bowel Disease Service, Department of Gastroenterology and School of Medicine, University of Adelaide at Royal Adelaide Hospital, Adelaide, South Australia, Australia.
    • Intern Med J. 2015 Jun 1; 45 (6): 659-66.

    BackgroundThe efficacy of infliximab has been demonstrated in patients with both acute severe and moderate-severe ulcerative colitis (UC). However, there is a need for 'real-life data' to ensure that conclusions from trial settings are applicable in usual care. We therefore examined the national experience of anti-tumour necrosis factor-α (TNF-α) therapy in UC.MethodsCase notes review of patients with UC who had received compassionate access (CA) anti-TNF-α therapy from prospectively maintained inflammatory bowel disease databases of six Australian adult teaching hospitals.ResultsPatients either received drug for acute severe UC (ASUC) failing steroids (n = 29) or for medically refractory UC (MRUC) (n = 35). In ASUC, the treating physicians judged that anti-TNF-α therapy was successful in 20/29 patients (69%); in these cases, anti-TNF-α was able to be discontinued (after 1-3 infusions in 19/20 responders) as clinical remission was achieved. Consistent with this perceived benefit, only 7/29 (24%) subsequently underwent colectomy during a median follow up of 12 months (interquartile range (IQR) 5-16). Eight of the 35 patients with MRUC (23%) required colectomy during a median follow up of 28 months (IQR 11-43). The majority of these patients (20/35 or 57%) had anti-TNF-α therapy for ≥4 months, whereas, 27/29 (93%) of ASUC patients had CA for ≤3 months.ConclusionsThese data show an excellent overall benefit for anti-TNF-α therapy in both ASUC and MRUC. In particular, only short-duration anti-TNF-α was required in ASUC. These real-life data thus support the clinical trial data and should lead to broader use of this therapy in UC.© 2015 Royal Australasian College of Physicians.

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