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P448. Long-term remission among Crohn's disease patients on immunosuppressive therapy after infliximab withdrawal: a retrospective, monocentric study comparing induction alone to a 1-year maintenance therapy

A. Chauvin1, A. Amiot1, A. Le Thuault2, Y. Le Baleur1, M. Belhassan1, S. Bastuji Garin2, J.C. Delchier1, 1Henri Mondor Hospital, Paris Est Creteil University, Gastroenterology, Creteil, France, 2Henri Mondor Hospital, Paris Est Creteil University, Public Health, Creteil, France

Background

Maintenance of remission in patients with Crohn's disease (CD) on immunosuppressive therapy after infliximab (IFX) therapy was stopped is still a debated issue. Induction course alone (induction group) is associated with a high risk of relapse. The benefits of scheduled maintenance therapy every 8 weeks (maintenance group) before IFX withdrawal have not been demonstrated. The aim of this study was to compare remission and tolerance with those two regimens.

Methods

Between January 2000 and June 2012, IFX therapy was stopped 106 times in 93 patients (58 female, median age 32.4 [IQR = 24–43] yrs) in our centre, after induction therapy alone (n = 59) or followed by maintenance therapy for at least 1 year (n = 47). All patients were in clinical remission (HB scorea <4) before IFX withdrawal. Immunosuppressants were continued during follow-up. Patients' characteristics were compared using Chi2 and Wilcoxon–Mann–Whitney test. Steroid-free remission was studied with Kaplan–Meier method, log-rank test and Cox regression model.

Results

Median follow-up-time was 6.8 (IQR = 4.6–9.0) yrs. Patient's characteristics were identical in the two groups. At the end of the follow-up, 77 relapses had been observed, 44 (75%) in the induction group and 33 (70%) in the maintenance group (p = 0.62). Actuarial probabilities of steroid-free remission were 78%, 68% and 51% at 6 mo, 1 and 2 yrs, respectively. Stratification based on gender was made due to statistical differences between male and female. In the female group, relapse was associated with a CRP level >5 mg/L (HR = 4.82 [95% CI= 1.93–12.06], p = 0.001) and a leucocytes count >6000/mm3 (HR = 1.96 [95% CI= 1.03–3.72], p = 0.04) at time of IFX withdrawal. In the male group, relapse was associated with active smoking (HR = 2.81 [95% CI= 1.14–6.88], p = 0.02) at time of IFX withdrawal, immunosuppressive therapy failure stratum (HR = 3.20 [95% CI= 1.37–7.48], p = 0.01) and induction group (HR = 0.37 [95% CI=0.14–0.97], p = 0.04). After relapse, 58 (75%) patients were retreated with IFX. Seven infusion-related reactions were observed in which 6 of them occurred in the induction group (p = 0.10). After IFX retreatment, free-steroid clinical remission was observed in 44 (86%) patients at week 10.

Conclusion

One-year maintenance therapy is not superior to induction therapy alone to maintain remission in CD patients on immunosuppressive therapy after inflixmab withdrawal. Retreatment with IFX was safer in the maintenance group. Interestingly, disparities relative to gender were observed in this study.