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Background: Infliximab [IFX] and adalimumab [ADA] are effective in Crohn's disease [CD] for induction and maintenance therapy. However, high annual rate of discontinuation for loss of response or intolerance may lead to a switch to another anti-tumor necrosis factor agent. Patients with successive failure to IFX and ADA are becoming more frequent. The aim of this study was to assess the efficacy and the tolerance of re-treatment with IFX in CD patients who successively failed IFX and ADA. Methods: A total of 61 patients with CD who received and discontinued successively IFX and ADA, and who were re-exposed to IFX, were identified in four French tertiary centers and retrospectively analyzed. Clinical data, follow-up and outcome were abstracted from medical records. Results: Median treatment duration after reintroduction was 16 months, and probability of remaining under IFX was 60% and 51%, respectively, at 12 and 24 months. In all 29 patients discontinued the second IFX treatment due to intolerance [13], primary non-response [8], loss of response [7] or patient's wish [1]. Remission was achieved in 42% at week 6-8 after IFX re-induction, and was predictive of better long-term response [p = 0.006]. In multivariate analysis, receiving co-immunosuppression in both first and second IFX treatments [p = 0.04] and shorter interval between first and second IFX treatments [p = 0.017] were independently associated with longer duration of second IFX treatment. Conclusion: For CD patients who successively failed IFX and ADA, reintroducing IFX is feasible and often clinically efficient, particularly in patients who received co-immunosuppression during both first and second IFX treatments. [ABSTRACT FROM AUTHOR]

(1) Background: Anastomotic biliary stricture (ABS) is a well-known complication of liver transplantation which can lead to secondary biliary cirrhosis and graft dysfunction. The goal of this study was to evaluate the long-term outcomes of endoscopic metal stenting of ABS in the setting of deceased donor liver transplantation (DDLT). (2) Methods: Consecutive DDLT patients with endoscopic metal stenting for ABS between 2010 and 2015 were screened. Data on diagnosis, treatment and follow-up (until June 2022) were collected. The primary outcome was endoscopic treatment failure defined as the need for surgical refection. (3) Results: Among the 465 patients who underwent LT, 41 developed ABS. It was diagnosed after a mean period of 7.4 months (+/-10.6) following LT. Endoscopic treatment was technically successful in 95.1% of cases. The mean duration of endoscopic treatment was 12.8 months (+/-9.1) and 53.7% of patients completed a 1-year treatment. After a mean follow-up of 6.9 years (+/-2.3), endoscopic treatment failed in nine patients (22%) who required surgical refection. Conclusions: Endoscopic management with metal stenting of ABS after DDLT was technically successful in most cases, and half of the patients had at least one year of indwelling stent. Endoscopic treatment long-term failure rate occurred in one fifth of the patients.

Introduction: Rituximab is a standard treatment for gastric mucosa-associated lymphoid tissue (MALT) lymphoma (GML). We sought to compare the effectiveness and safety of subcutaneous and intravenous rituximab in a retrospective case-control study., Patients and Methods: All consecutive patients with GML treated with subcutaneous rituximab between January 2017 and December 2018 were included and compared to 3 matched control patients (based on Ann Arbor classification, presence of t(11;18) translocation, history of treatment, and type of current treatment) treated with intravenous rituximab between January 2000 and December 2018. Patients with t(11;18) translocation were treated with rituximab in combination with chlorambucil; the other patients were treated with rituximab alone. Effectiveness was assessed at week 52, and safety was assessed through weeks 0 to 52 and compared by the chi-square test., Results: Twenty-five patients were included in the subcutaneous rituximab group and 75 in the intravenous group. There was no difference between the groups in complete remission (78% vs. 76%, P = .99) or overall response rates (91% vs. 89%, P = .99) at week 52. Safety profiles were similar in both groups, with a significant decrease in postinduction grade 2 injection-related reactions and outpatient hospital length of stay in the subcutaneous rituximab group., Conclusion: In a small case-control study, we did not find any difference in the effectiveness or safety profiles between subcutaneously and intravenously delivered rituximab for the treatment of patients with GML. We found a decrease in postinduction grade 2 injection-related reactions and outpatient hospital length of stay in the subcutaneous rituximab group., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Patients' perspectives after switching from infliximab to a biosimilar have yet to be assessed., Aim: To assess patients' perspectives in a prospective manner after switching from infliximab to CT-P13., Methods: 113 consecutive patients with inflammatory bowel disease (IBD) on maintenance therapy with infliximab were switched to CT-P13. Patients' perspectives were assessed by questionnaires, including the Beliefs about Medicines Questionnaire (BMQ) and FACIT-F (questionnaire regarding fatigue), and patient-reported outcomes (IBD disability index) at the inclusion and after the fourth CT-P13 infusion., Results: After one year, the patients' perspectives did not change after the switch according to BMQ-general, BMQ-specific necessity and BMQ-specific concerns subscales. No difference was observed in the mean IBD-DI score, while a significant improvement in fatigue was observed according to the FACIT-F questionnaire. Patients' concerns were raised about the use of biosimilars and the risks of switching with a significant improvement after switching (65% vs. 42%, respectively, p = 0.01). Fourteen (12.4%) patients experienced loss of response to CT-P13, including 12 with restoration of steroid-free clinical remission after CT-P13 dose optimization., Conclusion: Although some concerns were reported, no difference was observed in patients' perspectives after switching from infliximab to CT-P13., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Cohort studies have described the short-term effectiveness and safety of vedolizumab in treating patients with Crohn's disease (CD) and ulcerative colitis (UC), but data beyond 1 year are lacking., Aim: To assess the effectiveness and safety of vedolizumab after 162 weeks in patients with UC and CD., Methods: Between June and December 2014, 294 patients including 173 patients with CD and 121 with UC were treated with vedolizumab induction therapy. Among them, 149 continued to be treated with vedolizumab beyond week 54 (78 patients with CD and 71 with UC). Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. The primary outcome was steroid-free clinical remission at week 162, computed for the whole population included at week 0., Results: Steroid-free clinical remission rates at week 162 were 19.9% and 36.1% in patients with CD and UC respectively. Vedolizumab dose optimisation to 300 mg every 4 weeks instead of 300 mg every 8 weeks was at investigator's discretion and occurred in 58.7% and 52.1% of patients with CD and UC respectively. The 1-, 2- and 3-year persistence rates of vedolizumab were 48.5%, 31.4% and 26.3% respectively, in patients with CD and 61.0%, 49.9% and 42.9% respectively, in patients with UC. No new safety signal was identified., Conclusion: Vedolizumab is able to maintain steroid-free clinical remission in patients with UC and CD up to week 162. Loss of response resulting in discontinuation of vedolizumab occurred in 10% of patients per year., (© 2019 John Wiley & Sons Ltd.)

Background and Aims: To evaluate the prevalence and the long-term course of gastric precancerous lesions in patients with GML., Patients and Methods: In this retrospective single-centre study, we included 179 patients with GML, 70 with gastric diffuse large B-cell lymphoma (GDLBCL) and 152 with Helicobacter pylori-associated gastritis (HpG), from January 1995 to January 2014. The presence of atrophic gastritis, intestinal metaplasia and neoplastic lesion has been assessed at baseline and during follow-up., Results: Atrophic gastritis was more frequent in the GML group whereas there was also a trend for intestinal metaplasia and gastric dysplasia. In patients with GML, atrophic gastritis, intestinal metaplasia and gastric dysplasia were more frequent in the GML area than in other part of the stomach. During follow-up, the prevalence of atrophic gastritis remained stable overtime whereas intestinal metaplasia and dysplasia tend to increase overtime. In multivariate analysis, the occurrence of dysplasia or carcinoma was associated with the presence of intestinal metaplasia at baseline and male gender., Conclusion: GML is associated with gastric precancerous lesion to a higher extent than GDLBCL and HpG. Those precancerous lesions do not regress despite achievement of complete remission of GML and tend to increase overtime., (Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background and Study Aims:  Urgent endoscopy is often used to diagnose and sometimes treat acute upper gastrointestinal syndromes (hemorrhage, toxic ingestion, and occlusion). However, its suitability concerning the management of lower gastrointestinal conditions in emergency circumstances is controversial., Patients and Methods:  We studied the role of emergency colonoscopy in diagnosis and treatment of all consecutive patients presenting with acute lower gastrointestinal symptoms referred to our hospital on an emergency basis. All patients were first managed by physicians from the emergency room and/or the intensive care unit (ICU); the treatments included fluid resuscitation, blood transfusion, and antibiotic or cardiotonic as needed. Bowel cleansing was performed to purge the colon of clots, stool, and blood when clinically possible; alternatively, a bowel enema was used. Patients only underwent a computed tomography (CT) scan prior to the colonoscopy in clinically relevant situations. Colonoscopy was performed within 6 - 36 hours after hospitalization or the beginning of the clinical symptoms (hemorrhage, sepsis, colon distension) or occlusion, as assessed by abdominal CT scan., Results:  From 2010 to 2015, 603 patients underwent urgent colonoscopy; among them, 214 (36 %) presented with lower GI bleeding, while 264 (44 %) had symptoms suggestive of intestinal ischemia; almost half (49 %, n = 295) of the patients were hospitalized in the ICU. Patients received therapies, such as clips (15 %), epinephrine injections (5 %), bipolar coagulation (7 %), or devolvulation (3 %) using colonoscopy or antibiotic therapy when needed. No perforation was observed after colonoscopy and only three cases of hemorrhage recurrence were documented as complications after the procedure. Overall, 192 patients died within 1 month after colonoscopy due to four independent risk situations, as follows: septic shock, heart transplantation, multiorgan failure, and ischemic colitis. Only 67 (35 %) underwent urgent intestinal surgery when ischemic colitis was identified, and this did not have a significant effect on the mortality rate., Conclusions:  Urgent bedside colonoscopy is feasible and safe for routine use. The highest advantage was observed in patients with red blood hemorrhage, diarrhea, and colon distension when symptoms were not associated with multiorgane failure, heart transplantation, or septic shock. As revealed by colonoscopy and pathological features, ischemic colitis is associated with a bad prognosis, and patients experience a higher rate of early mortality regardless of whether they undergo urgent colon surgery.

To assess the risk of second primary malignancy (SPM) in patients with gastric mucosa-associated lymphoid tissue (MALT) Lymphoma (GML), we included 175 patients with GML in the present study. The incidence of SPM in the general population, used for reference, was determined from the French network of cancer registries. During the 1442.9 patient-years of follow-up, 29 patients were diagnosed with incident SPM, including five patients diagnosed with gastric cancer (20.1/1000 patient-years). An increased incidence of SPM was observed in patients with GML (standardized incidence ratios [SIR]: 1.71 [1.14-2.45]) compared to the general French population especially for gastric cancer (SIR: 16.1 [5.19-37.56]). This elevated risk of SPM was significantly increased only in patients treated with immuno/chemotherapy but not in patients treated with Helicobacter pylori eradication alone. Long-term follow-up of patients with GML is mandatory even in patients who have achieved complete remission.

Background: We recently showed that vedolizumab is effective in patients with Crohn's disease (CD) and ulcerative colitis (UC) with prior anti-TNF failure in a multicentre compassionate early-access programme before marketing authorisation was granted to vedolizumab., Aims: To assess effectiveness and safety of vedolizumab at week 54 in patients UC and CD., Methods: Between June and December 2014, 173 patients with Crohn's disease (CD) and 121 with ulcerative colitis (UC) were treated with vedolizumab induction therapy. Among those 294 patients, 272 completed the induction period and were evaluated at the week 14 visit (161 patients with CD and 111 with UC). Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. The primary outcome was steroid-free clinical remission at week 54., Results: At week 54, steroid-free clinical remission rates at week 54 were 27.2% and 40.5% in patients with CD and UC respectively. In addition, the sustained steroid-free clinical remission (from week 14 to week 54) rates were 8.1% and 19.0% respectively. No deaths were observed. Severe adverse events occurred in 17 (7.2%) patients, including six (2.5%) leading to vedolizumab discontinuation., Conclusion: Vedolizumab is able to maintain steroid-free clinical remission in up to one-third of patients with UC and CD at week 54 with a reasonable safety profile. A significant number of patients experienced loss of response during the first year of treatment, particularly in patients with CD., (© 2017 John Wiley & Sons Ltd.)

Background & Aims: Phase 3 trials have shown the efficacy of vedolizumab, which binds to integrin α4β7, in patients with Crohn's disease (CD) or ulcerative colitis (UC). We investigated the effectiveness and safety of vedolizumab in patients who failed anti-tumor necrosis factor therapy., Methods: From June through December 2014, there were 173 patients with CD and 121 patients with UC who were included in a multicenter nominative compassionate early access program granted by French regulatory agencies. This program provided patients with access to vedolizumab before it was authorized for marketing. Vedolizumab (300 mg) was administered intravenously at weeks 0, 2, and 6, and then every 8 weeks. Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. We report results obtained after the 14-week induction phase., Results: Among the 294 patients treated with vedolizumab (mean age, 39.5 ± 14.0 y; mean disease duration, 10.8 ± 7.6 y; concomitant steroids, 44% of cases), 276 completed the induction period, however, 18 discontinued vedolizumab because of a lack of response (n = 14), infusion-related reaction (n = 2), or infections (n = 2). At week 14, 31% of patients with CD were in steroid-free clinical remission and 51% had a response; among patients with UC, 36% were in steroid-free clinical remission and 50% had a response. No deaths were reported. Severe adverse events occurred in 24 patients (8.2%), including 15 (5.1%) that led to vedolizumab discontinuation (1 case of pulmonary tuberculosis and 1 rectal adenocarcinoma)., Conclusions: In a cohort of patients with CD or UC who failed previous anti-tumor necrosis factor therapy, approximately one third of patients achieved steroid-free clinical remission after 14 weeks of induction therapy with vedolizumab. This agent had an acceptable safety profile in these patients., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Purpose: The study aimed to compare, using propensity score matching (PSM) analyses, the short- and long-term results of laparoscopic colectomy (LC) versus open colectomy (OC) in a bicentric cohort of patients with T4 colon cancer., Methods: This is a retrospective PSM analysis of consecutive patients undergoing elective LC or OC for pT4 colon cancer (TNM stage II/III) between 2005 and 2014., Results: Overall, 237 patients were selected. After PSM, 106 LC-and 106 OC-matched patients were compared. LC was associated with longer operative time and lower blood loss than OC (220 vs. 190 min, p < 0.0001; 116 vs. 150 mL, p = 0.002, respectively). LC patients showed a faster recovery, which translated into a shorter hospital stay compared to OC (10.5 vs. 15.3 days, p < 0.0001). Conversion was required in 13 (12.2 %) LC patients. No group difference was observed for 30- and 90-day mortality. R0 resection was achieved in the majority of LC and OC patients (93.9 %). The 1-, 3-, and 5-year overall survival was 99, 76.8, and 58.6 %, respectively, for the LC group and 98, 70.1, and 59.9 %, respectively, for the OC group (p = 0.864). The 1-, 3-, and 5-year disease-free survival was 86.3, 66, 57.6 %, respectively, for the LC group and 79.1, 55.1, and 50.2 % for the OC group (p = 0.261)., Conclusion: With an acceptable conversion rate, laparoscopy can achieve complete oncologic resections of T4 colon cancer similar to open surgery and can be considered a safe and feasible alternative approach that confers the advantage of a faster recovery.

Background: There is no evidence that therapeutic drug monitoring is helpful in patients with inflammatory bowel disease patients in clinical remission with infliximab therapy., Methods: Eighty consecutive inflammatory bowel disease patients in clinical remission on infliximab maintenance therapy were included and followed-up for at least one year. Infliximab trough level and antibody to infliximab concentration were measured prior to enrollment. At the time of enrollment, physicians in charge were free to alleviate infliximab therapy. Discrepancies between blind and therapeutic drug monitoring-based adjustments were assessed at the end of the follow-up period. Relapse-free survival was analyzed using univariate and multivariate analyses., Results: The mean infliximab trough level was 3.1 μg/mL. Antibody to infliximab was found in 15 (19%) patients. At the end of the follow-up period, 18 (22.5%) patients experienced a relapse. The 3, 6, 9 and 12-month relapse-free rates were 98%, 87%, 86% and 80%, respectively. In our multivariate analysis, relapse-free survival was negatively associated with discrepancies between therapeutic drug monitoring-based and blind adjustments of infliximab therapy, absence of concomitant immunomodulator, the absence of mucosal healing, prior use of infliximab, infliximab therapy duration>2 years and C-reactive protein levels>5mg/L at the time of enrollment., Conclusion: In patients with inflammatory bowel disease in clinical remission on infliximab therapy, de-escalation of infliximab therapy should be considered based on therapeutic drug monitoring rather than according to symptoms and CRP., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)