Abstract
Background: The role of azathioprine (AZA) and 6-mercaptopurine (6-MP) in the induction of remission in patients with ulcerative colitis (UC) remains unclear. Aims: To compare the efficacy and safety of low-dose thiopurine (AZA/6-MP) and cytapheresis (CAP) for the induction of remission in patients with steroid- dependent UC. Patients and Methods: We reviewed the clinical course of 65 patients with steroid-dependent UC with moderate activity, who were treated with either low-dose AZA/6-MP (T-group, n = 38) or with CAP (C-group, n = 27). The efficacy and safety for the first 10 weeks after the start of the therapies were compared between the two groups. The cumulative probability curves of treatment failure were estimated by the Kaplan-Meier method. Clinical remission was defined as an ulcerative colitis activity index value of less than 150 without any other treatments. Results: Neither clinical characteristics, concomitant therapies, nor laboratory data (except for serum albumin levels) were different between the two groups. The remission rate at 10 weeks was not different between the two groups (55.3% in the T-group and 70.4% in the C-group, p = 0.22 in the intention-to-treat analysis). The frequencies of adverse events did not differ be- tween the two groups (p = 0.12). The cumulative pro- bability of treatment failure at 10 weeks was 44.7% for the T-group and 29.6% for the C-group (p = 0.23). Conclusions: Low-dose thiopurine therapy is an alter- native candidate for the induction of remission in pa- tients with steroid-dependent, moderate UC.
Highlights
For patients with steroid-dependent or steroid-refractory ulcerative colitis (UC), immunomodulatory agents, such as azathioprine (AZA), 6-mercaptopurine (6-MP), cyclosporine, or methotrexate, have been used for the induction and maintenance of clinical remission of the disease [1,2,3,4,5,6,7,8,9,10]
No significant differences were observed in gender, age, duration of the disease, site of involvement, UCAI, frequency and dose of PSL, adjusted dose of 5-ASA, or laboratory parameters between the groups
Previous studies have reported that AZA at a dose of 2 2.5 mg/kg/day [3,4,5,6] and 6-MP at a dose of 50 - 150 mg/day [7] or 1.5 mg/kg/day [8] were effective in inducing clinical remission in active [4,5,6] or steroid-dependent [3,7,8] UC, while others have failed to demonstrate such an efficacy [21,22]
Summary
For patients with steroid-dependent or steroid-refractory ulcerative colitis (UC), immunomodulatory agents, such as azathioprine (AZA), 6-mercaptopurine (6-MP), cyclosporine, or methotrexate, have been used for the induction and maintenance of clinical remission of the disease [1,2,3,4,5,6,7,8,9,10]. The efficacy of such a low-dose of AZA/6-MP therapy for inducing remission in patients with UC has not been fully examined. Cytapheresis (CAP) has been reported to be a useful therapy for inducing clinical remission in patients with active UC, and is an alternative to systemic corticosteroid therapy [11,12,13,14,15,16,17,18]. Aims: To compare the efficacy and safety of low-dose thiopurine (AZA/6-MP) and cytapheresis (CAP) for the induction of remission in patients with steroiddependent UC. Patients and Methods: We reviewed the clinical course of 65 patients with steroid-dependent UC with moderate activity, who were treated with either low-dose AZA/6-MP (T-group, n = 38) or with CAP (C-group, n = 27). Conclusions: Low-dose thiopurine therapy is an alternative candidate for the induction of remission in patients with steroid-dependent, moderate UC
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