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P363. Retreatment with infliximab in inflammatory bowel disease: tolerability and effectiveness of different re-induction regimens

C. Felice, D. Pugliese, L. Guidi, M. Marzo, G. Andrisani, A. Papa, I. De Vitis, G.L. Rapaccini, A. Armuzzi, Catholic University, Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Rome, Italy

Background

Patients with inflammatory bowel disease (IBD) who discontinue therapy with infliximab (IFX) may require a retreatment with the same agent after a variable time from discontinuation. Few data available so far are encouraging as regard to effectiveness, but conflicting results have been reported on infusion reaction rates after IFX drug-holiday. No clear indications are described about the choice of a specific induction regimen of re-infusions.

Methods

In this single-centre retrospective study, all consecutive IBD patients who required a retreatment with IFX because clinical relapse after at least 6 months of discontinuation from the first treatment were included. Patients were classified in 3 groups depending on the prescribed induction regimen: 5 mg/kg at week 0–2–6 (group 0) or at week 0–4–8 (group 1) or at week 0–8 (group 2). Primary endpoint was the evaluation of tolerability of different induction regimens. Secondary endpoint was clinical remission at week 8 [Harvey–Bradshaw Index less than 4 in Crohn's disease (CD) or partial Mayo score less than 2 in Ulcerative Colitis (UC)].

Results

Fifty-seven IBD patients (11 CU, 46 CD) were included in the study (group 0 n = 29, group 1 n = 17, group 2 n = 11). Median time of IFX drug-holiday before retreatment was 13 months (IQR 6–37.5). No significant differences were found among baseline characteristics of groups, with the exception of extraintestinal manifestations that were more frequent in the group 0 (p = 0.032) and time of wash-out from the first IFX treatment that was shorter in the group 2 (p = 0.001). Fourteen patients (24%) presented an infusion reaction during IFX retreatment; among them 10 patients (17%) discontinued IFX due to severe re-infusion reaction. The group 1 presented significantly fewer re-infusion reactions in comparison with both groups 0 and 2 (1 VS 13, p = 0.044). Also patients who maintained immunomodulators (IM) during drug holiday between the two IFX treatments had significantly fewer re-infusion reactions in comparison with those without IM (1 VS 13, p = 0.022). At multivariate analysis, only the maintenance with IM during drug holiday was independently associated with fewer re-infusion reactions (p = 0.044). Thirty patients (53%) achieved clinical remission at week 8 with no significant differences among groups.

Conclusion

Retreatment with infliximab may be effective in IBD patients; the induction regimen with 5 mg/kg at week 0–4–8 seems to be better tolerated, although only the maintenance therapy with IM after discontinuation of the first course of IFX therapy significantly reduced infusion reactions during retreatment.