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P396 Long-term efficacy of thiopurines as maintenance treatment in 130 patients with ulcerative colitis

Lefevre C., Fotsing G., Wangermez M., Beau P.

CHU Poitiers, Poitiers, France

Background

Thiopurines are used as maintenance therapy in ulcerative colitis (UC). However, data about long-term efficacy are limited. The aim of this study was to evaluate their long-term efficacy, and to search for predictive factors of failure.

Methods

In this retrospective monocentric study, we included UC patients responding to treatment by thiopurine alone or associated with 5-aminosalicylates (5ASA) for at least 6 months. Demographic, clinical and biological data were collected at diagnosis, 6 months after thiopurine onset (considered as T0) and at the time of treatment withdrawal, or last follow-up visit.

Clinical status at T0 was classified into two groups: response (clinical improvement but persistence of symptoms or steroids) and remission (no symptoms and no steroids). Therapeutic failure was defined by: need for anti-TNF alpha, surgery, treatment withdrawal due to side effects or flare up at the date of latest news

Results

We included 130 patients (52% males), with a median follow-up of 86 months (IQR 55–130). UC was predominantly left-sided (53%) and pancolic (35%). Major indication for thiopurine was steroid-dependence (45%), and 19 patients (15%) had severe acute colitis prior to thiopurine. Median duration of treatment was 42 months (IQR 23–80), with 119 (92%) patients having azathioprine.

Eighty-seven patients (67%) maintained clinical remission on thiopurine, and 43 (33%) underwent treatment failure. Mean duration of treatment was 25months in failure group vs 52 months in remission group. Five years after initiation, 36% (n=47) of patients were still on thiopurine. Reasons of treatment withdrawal were: secondary failure (n=31), major side effect (n=9), persistent remission (n=40) and other reason (n=3). In univariate analysis, older age at diagnosis (RR 1.02; CI95% 1.0–1.04; p=0.04) and clinical response at T0 (RR 1.98; CI95% 1.03–3.82; p=0.04) were associated to treatment failure. In multivariate analysis, only clinical response at T0 vs remission was associated with failure (RR 2.07; CI95% 1.07–3.4; p=0.03).

Relapse rate after withdrawal for persistent remission was 43%, with a median time of 29 months.

Forty patients (31%) had a significant side effect, and 9 of them (7%) stopped treatment due to it. Side effects were mainly hematologic and hepatologic. Nine neoplasic and pre-neoplasic lesions were observed during follow-up: 2 colorectal high risk adenomas, 3 basal cell carcinomas, 1 in situ cervix carcinoma and 3 other cancers (prostate, breast, lung).

Conclusion

This study shows a long term efficacy of thiopurine as a maintenance treatment in UC. Risk of relapse after thiopurine withdrawal is significant. Neoplasia rate due to thiopurine seems to be acceptable in this cohort.