Search

Background and Aims: Subcutaneous (SC) formulations of infliximab (IFX) and vedolizumab (VDZ) are approved for the treatment of inflammatory bowel diseases (IBDs). Our aim was to evaluate the effectiveness of switching from intravenous (IV) to SC formulations of IFX and VDZ in IBDs. Methods: This multicentre, retrospective study collected data of adult patients with Crohn's disease (CD) or ulcerative colitis (UC) switched to SC IFX or VDZ. The primary endpoint was clinical remission at 12 months stratified based on timing of switch. A composite endpoint consisting of therapy discontinuation, reverse‐switch, need for steroids, and drug optimization was evaluated. A multivariate analysis investigated the association between patients' characteristics and outcomes. Results: Two hundred and thirty‐one patients (59% UC, 53% male, mean age 44 ± 15 years, 68% IFX) from 13 centres were included. The switch occurred at Week 6 in a third of cases (36%). Median time to switch was 13 months. Most patients switched to SC IFX and VDZ were in clinical remission at 3 (87% and 77%), 6 (86% and 83%) and 12 (63% and 60%) months. In the multivariate analysis, there was no difference in clinical remission rate at 12 months; however, patients switched at Week 6 had a higher rate of experiencing any therapeutic changes at 3 (false discovery rate (FDR) =.002), 6 (FDR <1 × 10−10) or 12 months (FDR =.08). Clinical disease activity at baseline (only in UC) (FDR =.07) and previous exposure to biologics (FDR =.001) were risk factors for composite endpoint at 6 and 12 months. Conclusion: SC IFX and VDZ are effective in daily clinical practice in IBD patients. Switching patients in remission reduces the risk of negative outcomes. [ABSTRACT FROM AUTHOR]

Background: Rectal cancer is a major mortality cause in the United States (US), and its treatment is based on individual risk factors for recurrence in each patient. In patients with rectal cancer, accurate assessment of response to chemoradiotherapy has increased in importance as the variety of treatment options has grown. In this scenario, a controversial non-operative approach may be considered in some patients for whom complete tumor regression is believed to have occurred. The recommended treatment for locally advanced rectal cancer (LARC, T3-4 ± N+) is total mesorectal excision (TME) after neoadjuvant chemoradiotherapy (nCRT). Magnetic resonance imaging (MRI) has become a standard technique for local staging of rectal cancer (tumor, lymph node, and circumferential resection margin [CRM] staging), in both the US and Europe, and it is getting widely used for restaging purposes. Aim: In our study, we aimed to use an MRI radiomic model to identify features linked to the different responses of chemoradiotherapy of rectal cancer before surgery, and whether these features are helpful to understand the effectiveness of the treatments. Methods: We retrospectively evaluated adult patients diagnosed with LARC who were subjected to at least 2 MRI examinations in 10–12 weeks at our hospital, before and after nCRT. The MRI acquisition protocol for the 2 exams included T2 sequence and apparent diffusion coefficient (ADC) map. The patients were divided into 2 groups according to the treatment response: complete or good responders (Group 1) and incomplete or poor responders (Group 2). MRI images were segmented, and quantitative features were extracted and compared between the two groups. Features that showed significant differences (SF) were then included in a LASSO regression method to build a radiomic-based predictive model. Results: We included 38 patients (26 males and 12 females), who are classified from T2 and T4 stages in the rectal cancer TNM. After the nCRT, the patients were divided into Group 1 (13 patients), complete or good responders, and Group 2 (25 patients), incomplete or poor responders. Analysis at baseline generated the following significant features for the Mann–Whitney test (out of a total of 107) for each sequence. Also, the analysis at the end of the follow-up yielded a high number of significant features for the Mann–Whitney test (out of a total of 107) for each image. Features selected by the LASSO regression method for each image analyzed; ROC curves relative to each model are represented. Conclusion: We developed an MRI-based radiomic model that is able to differentiate and predict between responders and non-responders who went through nCRT for rectal cancer. This approach might identify early lesions with high surgical potential from lesions potentially resolving after medical treatment. [ABSTRACT FROM AUTHOR]

Background: Branch duct-intraductal papillary mucinous neoplasms (BD-IPMNs) are the most common pancreatic cystic tumors and have a low risk of malignant transformation. Features able to early identify high-risk BD-IPMNs are lacking, and guidelines currently rely on the occurrence of worrisome features (WF) and high-risk stigmata (HRS). Aim: In our study, we aimed to use a magnetic resonance imaging (MRI) radiomic model to identify features linked to a higher risk of malignant degeneration, and whether these appear before the occurrence of WF and HRS. Methods: We retrospectively evaluated adult patients with a known BD-IPMN who had had at least two contrast-enhanced MRI studies at our center and a 24-month minimum follow-up time. MRI acquisition protocol for the two examinations included pre- and post-contrast phases and diffusion-weighted imaging (DWI)/apparent diffusion coefficient (ADC) map. Patients were divided into two groups according to the development of WF or HRS at the end of the follow-up (Group 0 = no WF or HRS; Group 1 = WF or HRS). We segmented the MRI images and quantitative features were extracted and compared between the two groups. Features that showed significant differences (SF) were then included in a LASSO regression method to build a radiomic-based predictive model. Results: We included 50 patients: 31 in Group 0 and 19 in Group 1. No patients in this cohort developed HRS. At baseline, 47, 67, 38, and 68 SF were identified for pre-contrast T1-weighted (T1-W) sequence, post-contrast T1-W sequence, T2-weighted (T2- W) sequence, and ADC map, respectively. At the end of follow-up, we found 69, 78, 53, and 91 SF, respectively. The radiomic-based predictive model identified 16 SF: more particularly, 5 SF for pre-contrast T1-W sequence, 6 for post-contrast T1-W sequence, 3 for T2-W sequence, and 2 for ADC. Conclusion: We identified radiomic features that correlate significantly with WF in patients with BD-IPMNs undergoing contrast-enhanced MRI. Our MRI-based radiomic model can predict the occurrence of WF. [ABSTRACT FROM AUTHOR]

Objectives: Inflammatory bowel disease (IBD) can affect young and reproductively active patients. Our aim was to analyze pregnancy outcomes in a large cohort of women with IBD. Methods: All women with at least one pregnancy were given a questionnaire regarding the outcome of their pregnancy. They were divided into IBD pregnancies and controls depending on whether pregnancy occurred within or over 10 years prior to the diagnosis of IBD. Results: Three hundred questionnaires were analyzed for a total of 478 pregnancies that led to live‐born babies. Age at conception was older in IBD women than in the controls. Active smoking was more frequent in the control group. The risk of intrauterine growth restriction (IUGR) was higher in IBD pregnancies (odds ratio [OR] 3.028, 95% confidence interval [CI] 1.245–7.370, P = 0.013). The week of gestation at delivery was lower in the IBD population. And the risk of cesarean section was higher in IBD pregnancies (OR 1.963, 95% CI 1.274–3.028, P = 0.002). Among women with IBD pregnancy, the risk of preterm birth was higher in patients with active disease at the time of conception (OR 4.088, 95% CI 1.112–15.025, P = 0.030), but lower in patients who continued regular therapy during pregnancy. Similarly, the risk of urgent cesarean section was reduced in the case of disease remission, while the risk of a planned cesarean delivery was higher in patients with perianal disease (OR 11.314, 95% CI 3.550–36.058, P < 0.01). Conclusions: Our study shows a higher risk of IUGR, cesarean section, and poor blood pressure control in IBD pregnancies. We emphasize the importance of achieving disease remission before considering pregnancy. [ABSTRACT FROM AUTHOR]

Background: Inflammatory bowel disease (IBD) is a chronically relapsing disease with a continuous need for proactive monitoring to decide appropriate treatments and follow-up strategies. To date, gastrointestinal endoscopy with histologic examination of biopsies and contrast-enhanced imaging are mandatory techniques for the diagnosis and the activity assessment of IBD. Summary: In recent decades, many research efforts in the IBD field have been placed on finding non-invasive and reliable biomarkers of disease burden that can be easily tested in body fluids without impacting the quality of life of patients. Unfortunately, the ideal biomarker is yet to be discovered and recent studies have investigated the possibility to increase the accuracy of such measurements by combining different markers. In this review, we provide an update about the current knowledge on biomarkers of intestinal inflammation in IBD, focussing on disease diagnosis, correlation with endoscopic findings, and prediction of relapse. We also summarize composite scores of clinical and laboratory markers that have been recently proposed in various scenarios of disease activity. Key Messages: To date, only C-reactive protein and faecal calprotectin can be considered reliable markers of disease activity with demonstrated utility in IBD management. The combination of different parameters has recently shown higher accuracy and might substitute single-marker approaches in the future of research and clinical practice. [ABSTRACT FROM AUTHOR]

Background Acute severe ulcerative colitis (ASUC) is a potentially life-threatening disease, and the best option in cases of steroid-refractory disease is still debated. We compared the early- and long-term efficacy and safety of the 2 available "rescue therapies", infliximab (IFX) and cyclosporine (CYS), in this setting. Methods We retrospectively evaluated patients admitted for ASUC and treated with "rescue therapy". The primary endpoint was early colectomy-free survival (30 days) and colectomy-free survival until the end of follow up. The secondary endpoints were predictors of colectomy and long-term maintenance of the treatment strategy over time. Results Of 129 patients admitted, 68 received rescue therapy (47 with IFX), whereas 7 underwent early colectomy (10.3%). At 30 days, fewer patients treated with IFX showed a need for colectomy (8.5% vs. 14.3%) compared to those in the CYS group, though the difference was non-significant (odds ratio [OR] 0.69, 95% confidence interval [CI] 0.10-4.69; P=0.47). No severe side effects due to IFX and CYS were observed. During a mean follow up of 40 months, 23 additional patients (37.7%) underwent colectomy, and the rate was significantly lower in the IFX group (25.6%) than in the CYS group (66.7%) (hazard ratio 0.25, 95%CI 0.10-0.61; P=0.003). Colectomy-free survival was significantly higher in the IFX group than in the CYS group (P=0.018) at 12 months. Conclusions In our setting, the early outcomes of IFX and CYS for ASUC were comparable. IFX was associated with significantly lower colectomy rates during the observation period and had a similar safety profile to CYS. [ABSTRACT FROM AUTHOR]

Jejunoileal neuroendocrine tumours (NETs) are frequently multifocal and represent a consistent source of obscure gastrointestinal bleeding (OGIB). We report the real-life case of a female presenting to our attention for severe episodes of haematochezia caused by multiple localisation of jejunoileal NETs. A discrepancy between pre-operative total body contrast-enhancement computed tomography scan and capsule endoscopy (CE) emerged, in terms of numbers of lesions, so that, as completeness, an intraoperative balloon-assisted enteroscopy (BAE) was carried out, leading to the detection of the multiple lesions missed during CE. In case of obscure gastrointestinal bleeding sources missed by capsule endoscopy, laparoscopicassisted balloon enteroscopy plays an essential role, allowing both to assess a precise diagnosis and to resect the intestinal bleeding tract. [ABSTRACT FROM AUTHOR]

Moreover, a recent meta-analysis pooled all data derived from clinical trials assessing therapies for luminal CD, providing important information about indirect comparative efficacy of the available treatment options [[3]]. The "biologic revolution" began with the approval of infliximab for the treatment of inflammatory bowel disease (IBD) about 20 years ago. In this evolving circumstance, in which more and more agents will be available for patients with CD, the outcome of a given treatment is certainly influenced by disease severity, but also by previous therapeutic failures [[4]]. [Extracted from the article]

Stevens–Johnson syndrome (SJS) is a severe mucocutaneous adverse drug reaction with a relatively high mortality rate. SJS is described during herpes simplex virus type 1 (HSV1) infection and, rarely, even during adalimumab therapy. We report the case of a patient with Crohn's disease who developed SJS during an HSV1 infection and a contemporaneous anti-TNFα therapy with adalimumab. Remission was achieved with suspension of adalimumab and high doses of intravenous steroids and antivirals. Patients with HSV1 infection and on adalimumab therapy have a combined risk of SJS and should be monitored closely. [ABSTRACT FROM AUTHOR]

Azathioprine is a cornerstone of the therapy of Crohn's disease. Unfortunately, infections and malignancies are relatively common adverse effects related to this drug; however, cirrhosis is exceptionally reported as a side effect. We report the case of a 49-year-old male patient with ileocolonic steno-penetrating Crohn's disease who developed hepatic cirrhosis while treated with azathioprine. After taking azathioprine for 3 years with regular follow-up, he developed pancytopenia, and liver cirrhosis was diagnosed with ultrasound, abdomen computed tomography scan, transient elastography, and liver biopsy. As all other causes of liver damage were excluded, azathioprine was believed to be the cause of liver injury and therefore was interrupted. [ABSTRACT FROM AUTHOR]