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P337 Efficacy of intravenous cyclosporine in fulminant steroid-refractory ulcerative colitis with massive bleeding: a retrospective, observational study

Ogashiwa T., Nishio M., Otake H., Inoue E., Kimura H., Kunisaki R.

Yokohama City University Medical centre, Inflammatory Bowel Disease Centre, Yokohama, Japan

Background

Intravenous cyclosporine (ivCys) is used for rescue therapy for steroid-refractory ulcerative colitis (UC), as well as anti-TNF-α antibodies. For fulminant steroid-refractory UC with massive bleeding, colectomy is usually recommended. However, the efficacy and limitation of ivCys for these patients remains unclear. This study aimed to clarify the short- and long-term outcomes, limitations, and safety of ivCys for fulminant steroid-refractory UC with massive bleeding.

Methods

We retrospectively reviewed the outcome of patients with steroid-refractory fulminant UC with massive bleeding treated with ivCys between 2009 and 2015 in a single tertiary centre. At the starting of ivCys, the patients did not consent to colectomy, their vital signs were maintained, and they could not take medicine orally for severe abdominal pain. IBD surgeons waited for 24 hours for an emergency operation. Administration of ivCys was performed for 2 weeks (blood concentrations, 400–600 ng/ml), and was discontinued when symptoms were exacerbated or vital signs of shock that did not recover with transfusion were observed. In patients who were determined to be responsive on the 14th day, ivCys was discontinued at that time. The short-term outcome was evaluated by clinical efficacy (partial-Mayo score) and the long-term outcome was calculated using Kaplan–Meier method. Cox regression analysis was performed to identify predictors of colectomy.

Results

The study population comprised 51 patients with fulminant steroid-refractory ulcerative colitis with massive bleeding treated with ivCys. The median baseline partial-Mayo score was 8.6. Within 2 weeks of ivCys treatment, 11 (22%) patients achieved remission, and nine (18%) partial response. Thirty-two (62%) patients underwent colectomy. Among 17 patients who responded to ivCys, the non-relapse rate was 45% at 1 year and 36% at 3 years. The non-hospitalisation rate was 67% at 1 year and 50% at 3 years, and the remaining free of colectomy rate was 79% at 1 year and 64% at 3 years. Adverse reactions, including hypomagnesemia (n=38, 72%), hyperkalaemia, (n=13, 25%), catheter infection (n=2, 4%), and renal dysfunction (n=1, 2%) occurred. No major reaction nor mortality occurred.

Conclusion

The short-term efficacy of ivCys for fulminant steroid-refractory UC with massive bleeding was limited in our patients because 60% underwent colectomy within 2 weeks. However, patients who improved with ivCys had a good long-term prognosis and remained colectomy-free. No serious adverse effects were observed with ivCys.