Background and aim: Limited data have been reported about Infliximab (IFX) scheduled therapy beyond 1 year and follow-up (FU) after discontinuation in Crohn's disease (CD) and ulcerative colitis (UC). Aims: to analyze the effectiveness of long-term IFX therapy in inflammatory bowel disease (IBD) and to identify predictors for sustained clinical benefit during treatment and after discontinuation. Material and methods: Medical records of patients (pts) treated with IFX scheduled therapy for more than 1 year at our Unit were reviewed and details on demographic, clinical, endoscopic characteristics and adverse events (AE) recorded. Results: 174 pts (109 CD, 65 UC) received a median of 15 infusion/patient (range:9-49) over a median of 26 months (15-91) and were observed during 42-month (18-101) median FU since first IFX infusion. CD pts: 60% (n=65) discontinued IFX for stable remission (43), AE (9), loss of response (14); 40% are in clinical benefit on IFX. Mucosal healing (MH) was observed in 55% of pts while on IFX. Cox regression identified MH (P=0.006) as predictor of clinical benefit during IFX. After 13-month (4-74) median FU since IFX discontinuation for stable remission, 51% maintain remission. Cox regression identified MH (P=0.002) and low C-reactive protein (CRP) at discontinuation (P=0.03) as predictors of sustained remission after IFX withdrawal. UC pts: 48% (31) discontinued IFX for stable remission (22), AE (4), loss of response (7); 52% are in clinical benefit on IFX. MH was observed in 56% of pts while on IFX. Cox regression identified low CRP after induction (P=0.01) as predictor of clinical benefit during IFX. After 16-month (4-30) median FU since IFX discontinuation for stable remission, 59% maintain remission. Cox regression identified MH (P=0.03) and low CRP at discontinuation (P=0.007) as predictors of sustained remission after IFX withdrawal. IBD patients: 85% discontinued steroids. AE occurred in 14% (7.5%: IFX discontinuation). MH was associated with a significant decrease in the need of abdominal surgery for CD (P=0.01) and colectomy for UC (P=0.04) during long-term FU. Conclusions: Long-term IFX treatment is effective to maintain clinical benefit in our cohort. Sustained clinical remission was observed in more than half of pts after IFX discontinuation. MH was associated with lower need of surgery. MH and CRP could help to identify IBD pts maintaining clinical benefit during IFX therapy and sustained remission after discontinuation.
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