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P613 Tacrolimus as rescue therapy for steroid-dependent/steroid refractory ulcerative colitis: experience from tertiary referral centre

S. Sud*1, A. S. Puri1

1GB Pant Institute of Postgraduate Medical Education and Research, Gastroenterology, New Delhi, India

Background

Approximately 20–40% patients of severe UC are either refractory to steroids (SRUC) or become steroid dependent (SDUC). Tacrolimus is an oral and relatively cheap drug with minimal adverse events.

Methods

52 UC patients diagnosed as SDUC/SRUC were started on tacrolimus 0.05–0.1 mg/kg. Clinical Mayo Score (CMS) and UCEIS were recorded prior to starting tacrolimus and after 8 weeks. 5-ASA and immunomodulators were continued if the patients were already on these drugs. Clinical response at 8 weeks was defined as CMS decrease by at least 3 points. Clinical remission was defined as CMS ≤2 and combined remission as CMS ≤2 with UCEIS <3.

Results

The mean age of 52 patients (29 males) was 35.1 ± 12.8 years. Extent of disease was E3 in 37 (71%) patients. Thirty-one were SDUC and 21 were SRUC. 7 failed treatment within 8 weeks and 4 were subjected to surgery and 3 patients were switched to infliximab. Three patients either discontinued Tacrolimus or were lost on follow-up. Forty-two patients continued Tacrolimus for 8 weeks. Mean CMS and UCEIS prior to starting tacrolimus were 6 ± 1.1 and 4.8 ± 1.1, respectively. At 8 weeks, median CMS and UCEIS were 2.6 ± 1.7 and 2.7 ± 1.3, respectively. Twenty-nine (56%) patients responded while 25 (48%) had CMS ≤ 2 and 18 out of 35 (35%) had CMS ≤2 and UCEIS <3 suggesting that they had achieved clinical and endoscopic remission. Ten patients showed partial/no response at 8 weeks. There was a significant fall in both CMS and UCEIS at 8 weeks of Tacrolimus therapy (paired t-test p < 0.001) in both SDUC and SRUC subgroups.

Conclusion

Our results show that tacrolimus was effective in inducing a clinical response in 56% of patients with SDUC and SRUC. In view of its low cost and safety profile it may be considered as first-line therapy for SDUC/SRUC.