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P529. Compassionate access use of anti-TNF therapy in ulcerative colitis in six Australian IBD centres has been beneficial to patient outcomes

S. Costello1, S. Ghaly2, S. O'Connor3, A. Agarwal1, L. Beswick4, B. Headon4, A. Pudipeddi2, A. Sechi5, R. Prosser6, S. Connor5, M. Sparrow4, P. Bampton6, A. Walsh2, J. Andrews1, 1Royal Adelaide Hospital, Gastroenterology and Hepatology, Adelaide, Australia, 2St Vincent's Hospital, Department of Gastroenterology, Sydney, Australia, 3Princess Alexandra Hospital, Gastroenterology, Brisbane, Australia, 4The Alfred Hospital, Department of Gastroenterology, Melbourne, Australia, 5Liverpool Hospital, Department of Gastroenterology, Sydney, Australia, 6Flinders Medical Centre, Department of Gastroenterology, Adelaide, Australia

Background

Many patients with ulcerative colitis (UC) have disease that is refractory to thiopurines or are admitted to hospital with acute severe colitis (ASC) and fail IV steroids with insufficient time to wait for a response to thiopurines. In Australia, these patients cannot access anti-TNF therapy under the pharmaceutical benefits scheme (PBS). We therefore sought to examine the local experience of using anti-TNF therapy in UC.

Methods

The IBD patient data-bases of 6 Australian adult teaching hospitals were interrogated for patients who had received compassionate access (CA) anti-TNF therapy for UC. The case notes were reviewed to determine demographic and disease characteristics, previous and current medication use, indication and duration of CA anti-TNF therapy as well as each clinician's impression of patients' response to treatment.

Results

Sixty-five patients, 33 female, received CA drug. Mean UC duration pre CA therapy was 5 years and 6 months. 59 patients received CA infliximab and 6 received CA adalimumab.

Twenty-nine patients received CA anti-TNF therapy for ASC and 36 patients for disease refractory to an immunomodulator and/or steroid therapy. 7/29 (24%) of the ASC patients underwent colectomy, as compared to the expected rate of colectomy of at least 40% (Travis et al, Gut 1996; 38: 905–910) in those with ASC receiving rescue on day 3 after IV steroids (p = 0.059). In 20/29 (69%) ASC patients anti-TNF therapy was discontinued as clinical remission was achieved and in 7/29 (24%) there was treatment failure and all underwent colectomy. The treating physician felt that CA anti-TNF therapy was successful in 19/29 (66%) of ASC patients.

Of the 36 patients with steroid and/or immunomodulator refractory disease, only 8 (22%) went on to have a colectomy. Given the refractory nature of this cohort's disease, surgery or ongoing active disease would have been otherwise inevitable in the majority. 29/36 (81%) patients with medically refractory disease had received steroids continuously for a period of 6 months or more at some stage prior to CA anti-TNF therapy. The majority of the patients with medically refractory disease (20/36 or 56%) had CA for 4 months or more. By contrast 27/29 (93%) of ASC patients had CA for 3 months or less.

Conclusion

These data show an excellent overall benefit for anti-TNF therapy in UC, particularly for ASC failing steroids, but also in those with truly refractory UC. In the majority of ASC patients only a short duration of anti-TNF therapy was required. These data thus support the desirability of expanding Australia's PBS criteria for anti-TNF therapy to include patients with refractory or acute severe UC. The short duration of anti-TNF required to achieve remission in ASC patients is likely to be cost effective.