Background and Aims: Subcutaneous vedolizumab formulation has been shown to be as effective and safe as the intravenous one in randomized control trials. Real-life data are limited especially for patients receiving long-term intravenous therapy. This study aimed to evaluate the safety and effectiveness of switching from intravenous to subcutaneous vedolizumab in a large cohort of patients with stable clinical remission. Methods: In this prospective cohort study, we enrolled consecutive patients attending our center between September 2021 and April 2022. The baseline demographic characteristics, 12- and 24-weeks follow-up clinical activity, C-reactive protein levels, and adverse events were recorded. The primary endpoint was to assess combined steroid-free clinical remission plus biochemical remission 24-week after the switch. Results: 93 patients (43 Crohn’s disease, 50 ulcerative colitis), switched to subcutaneous vedolizumab after a median duration of intravenous treatment of 36 months [IQR 16-52]. At baseline, 80 patients (86%) had a combined remission. At 24-week, 89.2% (n=74) maintained combined steroid-free clinical remission plus biochemical remission. 25 adverse events were reported, mostly SARS-CoV-2 infections and injection site reactions, with a further four recurrence episodes. Twelve patients (12.9%) discontinued subcutaneous administration and restarted intravenous vedolizumab. Conclusions: Switching from intravenous to subcutaneous vedolizumab can be considered effective and safe for maintaining remission in patients with inflammatory bowel disease. In addition, this might reduce healthcare costs. However, large-scale real-life studies with long-term follow-up are necessary.

Background and aims: Intravenous corticosteroids (IVCS) and rescue therapy with infliximab (IFX) are useful for managing patients with acute severe ulcerative colitis (ASUC). However, nearly one fifth of responders undergo colectomy. Predictive factors of colectomy in this subset of patients are not fully known. We retrospectively examined the long-term risk and the predictors of colectomy in ASUC patients achieving clinical remission following treatment with IVCS or IFX. Patients and methods: Clinical and demographic characteristics were evaluated in consecutive ASUC patients who were admitted to the “Tor Vergata University” hospital between 2010 and 2020 and responded to IVCS or IFX. A multivariate logistic regression model was constructed to identify independent predictors of colectomy. Results: A total of 116 ASUC patients responding to IVCS (98 patients) or IFX (18 patients) were followed up for a median of 46 months. After discharge, 29 patients (25%) underwent colectomy. Multivariate analysis showed that a serum albumin level <3 g/dL and colonic dilation >5.5 cm on admission were independent predictors of colectomy (OR: 6.9, 95% CI: 2.08–22.8, and OR 8.5, 95% CI: 1.23–58.3, respectively). Patients with both these factors had a risk of colectomy 13 times greater than those with no risk factor. Conclusions: A low serum albumin level and colonic dilation are risk factors of long-term colectomy in ASUC patients responding to IVCS or IFX.

Ulcerative colitis (UC) and colonic diverticulosis can co-exist in some patients. However, the natural history of UC associated with colonic diverticulosis is not well known. We here compared the disease characteristics and outcome of UC patients with and without concomitant colonic diverticulosis. Medical records of 347 UC patients were included in an observational, retrospective, nested-matched case-control study. Cases were 92 patients with UC and concomitant colonic diverticulosis, while controls were 255 UC patients without concomitant colonic diverticulosis. A propensity score matching (PSM) was used to homogenate cases (n = 92) and controls (n = 153) for age. UC patients with concomitant colonic diverticulosis were less likely to have an extensive disease (25/92, 27.1%) and to experience steroid dependence (8/92, 8.6%) compared to patients without concomitant colonic diverticulosis (70/153, 45.7% and 48/153, 31.3%, respectively; p < 0.001). The use of immunosuppressants (9/92, 9.7% vs. 37/153, 24.1%; p = 0.007) or biologics (3/92, 3.2% vs. 26/153, 16.9%, p < 0.001) was significantly lower in UC patients with concomitant diverticulosis compared to the control group. On multivariate analysis, steroid dependence and extensive colitis were significantly less frequent in UC patients with concomitant colonic diverticulosis compared to UC patients without diverticula. UC patients with coexisting colonic diverticulosis are less likely to have an extensive disease and to be steroid-dependent.

Background and Aims: Treatment with intravenous corticosteroids (IVCS) is a mainstay in the management of acute severe ulcerative colitis (UC). Although most patients respond to IVCS, little is known about the long-term outcomes. In this study, we assessed the long-term outcomes of IVCS in a real-life cohort. Methods: Disease activity, clinical relapse (partial Mayo score >4), the need for steroids or other maintenance therapies and the rates of colectomy and re-hospitalization were evaluated in consecutive patients admitted to the Tor Vergata University hospital between 2010 and 2020 for acute severe UC who responded to IVCS. Results: Eighty-eight patients were followed up with for a median period of 46 (range 6–133) months. Of these, 56 (64%) patients were treated with 5-aminosalycilic acid and 32 (36%) with immunomodulators or biologics after discharge. A total of 60 out of 88 patients (68%) relapsed, 28 (32%) were re-hospitalized, and 15 (17%) underwent a colectomy with no difference between the two maintenance therapy groups. The multivariate analysis showed that patients in clinical remission 6 months after discharge had a lower risk of relapse during the follow-up. Conclusions: Nearly two-thirds of patients with acute UC responding to IVCS experienced relapse after a median follow-up of 4 years, and this was not influenced by the maintenance therapy.

Golimumab is a fully human monoclonal antibody against tumor necrosis factor (TNF) approved for the treatment of ulcerative colitis and not for Crohn disease (CD). Many CD patients experience primary, secondary failure, or intolerance to other TNF inhibitors (TNFi) approved in Italy for CD (adalimumab and infliximab). Spondyloarthritis (SpA) may be associated with CD (enteropathic, ESpA) in up to 50% of patients requiring a multidisciplinary and tailored approach. However, only few data from literature and no formal trials determined the efficacy and safety of golimumab in ESpA patients. We performed a case series on 12 patients affected by active CD and active ESpA were failure or intolerant to previous TNFi approved in Italy for both SpA and CD, infliximab and adalimumab. Golimumab was administered following rheumatologic dosage (subcutaneous 50 mg monthly; 100 mg monthly for patients >= 100 kg). Gastrointestinal and rheumatologic disease activity was evaluated with a follow-up of 2 years. A total of 9 patients were followed for 2 years of golimumab treatment. CD clinical activity ameliorated as shown by the reduction of Harvey-Bradshaw index and Crohn disease activity index (CDAI) at 12 and 24 months of treatment (P = .03 and P = .04, respectively) associated with reduction of C-reactive protein at 12 and 24 months (P = .04 for both comparisons) of treatment. SpA assessment revealed a significant reduction in tender joint count at 6 (P = .03), 12 (P = .03), and 24 months (P = .007) of treatment. Swollen joint count, pain, SpA disease activity, and disability reduced in several patients during the follow-up. No adverse events were registered in the follow-up. We demonstrate good clinical efficacy and safety profile of both gastrointestinal and rheumatologic involvement. This may indicate promising therapeutic option for ESpA patients affected by CD, and non-responsive to other TNFi.

OBJECTIVE:The clinical significance of increased serum pancreatic enzymes (PEs) in coronavirus disease 2019 (COVID-19) patients has not yet been fully understood. We aimed to investigate the frequency and the impact on clinical outcome of PE elevation and acute pancreatitis in such patients.METHODS:Clinical data, laboratory tests, and cross-sectional images were analyzed from COVID-19 patients admitted to the Tor Vergata Hospital in Rome. Variables associated with PE abnormalities, intensive care unit (ICU) admission, or death were investigated through univariate and multivariate analyses and Cox proportional hazard model.RESULTS:Pancreatic enzymes were available in 254 of 282 COVID-19 patients. Among these, 66 patients (26%) showed mild elevation of PE, and 11 patients (4.3%) had severe elevation (>3 times of the upper limit of normal). Overall, 2 patients met the diagnostic criteria for acute pancreatitis. Hepatic and renal involvements were associated with PE elevation. Multivariate analysis showed that mild and severe PE elevations were significantly associated with ICU admission (odds ratios, 5.51 [95% confidence interval, 2.36-12.89; P < 0.0001] and 26.2 [95% confidence interval, 4.82-142.39; P < 0.0001]).CONCLUSIONS:Increase in serum PE, but not acute pancreatitis, is frequent in hospitalized COVID-19 patients and associates with ICU admission.

After its first description in December 2019, Covid-19, an infectious respiratory disease caused by the novel coronavirus SARS-CoV-2 ([1]Zhu N. Zhang D. Wang W. Li X. Yang B. Song J. Zhao X. Huang B. Shi W. Lu R. Niu P. Zhan F. Ma X. Wang D. Xu W. Wu G. Gao G.F. Tan W. China novel coronavirus investigating and research team. a novel Coronavirus from patients with Pneumonia in China, 2019.N Engl J Med. 2020; 382: 727-733Crossref PubMed Scopus (18371) Google Scholar), has spread throughout the world and on March 11, 2020 the World Health Organization declared it a pandemic. The SARS‐CoV‐2 infection is more frequent in elderly and in subjects with co-existing pathologies and weakened immune system. The risk of infection or death due to Covid-19 in patients with inflammatory bowel diseases (IBD) is unknown at this stage. However, it has been presumed that IBD patients who are on steroids, immunosuppressive drugs or biologics could be more susceptible to SARS-CoV-2 infection, as these therapies are associated with increased risk of viral infections ([2]Dulai P.S. Thompson K.D. Blunt H.B. Dubinsky M.C. Siegel C.A Risks of serious infection or lymphoma with anti-tumor necrosis factor therapy for pediatric inflammatory bowel disease: a systematic review.Clin Gastroenterol Hepatol. 2014; 12: 1443-1451Abstract Full Text Full Text PDF PubMed Scopus (129) Google Scholar). To gain entry into the cells SARS‐CoV‐2 uses angiotensin-converting enzyme 2, a protein that is highly expressed in the human gut ([3]Hoffmann M. Kleine-Weber H. Schroeder S. Krüger N. Herrler T. Erichsen S. Schiergens T.S. Herrler G. Wu N.H. Nitsche A. Müller M.A. Drosten C. Pöhlmann S SARS-CoV-2 Cell entry depends on ACE2 and TMPRSS2 and is blocked by a clinically proven protease inhibitor.Cell. 2020; (Mar 4. pii: S0092-8674(20)30229-4)https://doi.org/10.1016/j.cell.2020.02.052Abstract Full Text Full Text PDF PubMed Scopus (13243) Google Scholar,[4]Harmer D. Gilbert M. Borman R Quantitative mRNA expression profiling of ACE 2, a novel homologue of angiotensin converting enzyme.FEBS Lett. 2002; 532: 107-110Crossref PubMed Scopus (651) Google Scholar). An analysis of patients with SARS-CoV-2 infection showed that some patients experienced gastrointestinal symptoms/signs and the virus was identified in stool samples of infected patients. Viral RNA was present in the stool of over 50% of patients and, even after testing negative for SARS-CoV-2 in respiratory samples, nearly one fifth of the patients remained positive for the virus in stool samples ([5]Wang W. Xu Y. Gao R. Lu R. Han K. Wu G. Tan W Detection of SARS-CoV-2 in Different Types of Clinical Specimens.JAMA. 2020; (Mar 11)https://doi.org/10.1001/jama.2020.3786Crossref Scopus (3745) Google Scholar,[6]Xiao F. Tang M. Zheng X. Liu Y. Li X. Shan H Evidence for gastrointestinal infection of SARS-CoV-2.Gastroenterology. 2020; (Mar 3. pii: S0016-5085(20)30282-1. doi. 1053/j.gastro.2020.02.055)Abstract Full Text Full Text PDF Scopus (1990) Google Scholar). These findings suggest that the course of SARS-CoV-2 infection may involve cells of the gastrointestinal tract, a finding of importance for patients with IBD. We here examined the frequency of symptoms/signs suggestive of Covid-19 in IBD patients and assessed the risk of SARS-CoV-2 infection in IBD. This was an observational study including IBD patients regularly followed in our tertiary referral center at the "Tor Vergata University Hospital", Rome, Italy. Like many countries worldwide, Italy has been placed under lockdown as Covid-19 cases surge in our country since February 2020. Consequently, the scheduled follow-up visits in the IBD centres were canceled or postponed and the patients have had the possibility to communicate with the IBD team through a dedicated phone number. During the calls, we recorded any symptom/sign suggestive of Covid-19 as well as information about direct contacts with subjects known to be affected by SARS-CoV-2 and data relative to the admission of the patients to the hospital for undergoing a nasopharyngeal swab to identify carriers of SARS-CoV-2. Clinical activity and management of the IBD patients were also monitored. All patients had provided their informed consent for the use of personal and clinical data for scientific purposes, and no patient refused to participate. The study variables were summarized descriptively using numbers and percentages for discrete variables, while median and range were used for continuous variables. Cumulative incidence of SARS-CoV-2 infection in IBD was calculated dividing the positive cases by the overall population of IBD patients enrolled for the study. Cumulative incidence of laboratory-confirmed SARS-CoV-2 infection in the Italian population was extracted from data of the Italian Health Minister (www.salute.gov). Incidence rate of SARS-CoV-2 in the IBD population was obtained with the direct method using the general Italian population as standard. Results were presented as odds ratios (OR) and their 95% confidence intervals (CI). From March 24 to April 30, 2020, we collected information regarding 672 IBD patients who were scheduled to receive a visit at the Tor Vergata Hospital in the same period. Baseline demographic and clinical characteristics, as well as concomitant treatments for IBD are shown in the table. The median age of the patients was 46 years (range: 16–83), 46% of the patients were female, and 59% had a diagnosis of CD. No patient refused to provide information regarding his/her symptoms/signs. Most patients remain on stable therapy with conventional drugs or biologics, and 20 patients (3%) discontinued treatment during the Covid-19 outbreak (table 1). A flare-up occurred in 90 (13%) patients; adjustment of therapy led to disappearance of the symptoms in all the patients.Table 1Demographic and clinical characteristics of IBD patients.Number of patients672Gender female n (%)311 (46)Median Age (range) years46 (16–83)Patients working during quarantine n (%)125 (20)Median co-habiting persons (range)3 (1–8)IBD diagnosis n (%)Crohn's disease397 (59)ulcerative colitis269 (40)IBD unclassified6 (1)Patients experiencing IBD flare n (%)90 (13)Current treatments n (%)No therapy56 (9)Mesalamine367 (54)Steroids29 (4)Immune suppressant43 (6)Anti-TNFa183 (27)Vedolizumab27 (4)Ustekinumab31 (5)Antibiotics38 (6)Experimental drug6 (1)Therapy discontinuation n (%)20 (3)Causes for therapy discontinuation n (%)Fear for covid-194 (0.6)Adverse events6 (0.9)Physician's indication1 (0.1)Others9 (1.3) Open table in a new tab Ten out of 672 patients (1.5%) underwent rhino-pharyngeal swab: 3 patients because experienced respiratory symptoms, which were highly suggestive of Covid-19, and 7 patients because had a direct contact with SARS-CoV-2-infected individuals. Three out of these 10 patients resulted positive and two of them were hospitalized: one patient had a lung cancer and eventually died. Of the 672 patients, 38 (5.6%) had been travelling to high risk geographical areas and 64 (9.5%) had direct contacts with individuals living in high risk areas. All these patients experienced no suggestive symptoms of Covid-19. On April 30, 2020 205,463 subjects were positive among an overall Italian population of 6031,7000. Cumulative incidence of laboratory-confirmed SARS-CoV-2 in Italy was 3.41 cases per 1000 habitants. In our IBD population, the crude incidence rate of SARS-CoV-2 infection was 4.46 cases per 1000 patients. Patients with IBD had a numerically, but non statistically higher standardized risk of SARS-CoV-2 infection compared with the general population (OR 1.31; 95% CI 0.26–3.85; p 0.50). Up to April 30, 2020, more than 205,463 cases of SARS-CoV-2 infection have been diagnosed in Italy, accounting for 0,3% of the total population. Although, we need more robust epidemiological data to draw a conclusion regarding the incidence rate of Covid-19 in IBD, our findings suggest that IBD patients are not at increased risk of Covid-19 as compared with the general population. Indeed, after more than 2 months from the first Covid-19 patient diagnosed in Italy, only 3 out of our 672 patients (0,44%) were infected by SARS-CoV-2. Approximately one sixth of our patients, who had direct contacts with either infected patients or individuals living in high risk geographical areas or were themselves travelling to such regions, were negative for SARS-CoV-2 and/or remain asymptomatic. We are aware that the present study has some limitations. It is likely that the incidence of SARS-CoV-2 infection in our IBD population is underestimated as the majority of the patients did not underwent rhino-pharyngeal swab. However, in this context, it is noteworthy that such a diagnostic test was not provided to the general Italian population unless there were reasons to suspect SARS-CoV-2 infection. Thus, it is unlikely this limitation have had a major impact on the comparison of incidences. We restricted our analysis to the IBD patients scheduled to receive a visit during the study period and, therefore, this cohort could be not representative of our IBD population, which comprises more than 3000 patients. However, our data are in line with those published recently by Norsa and colleagues, who reported no case of SARS-CoV-2 infection in a cohort of IBD patients living in a high-risk area of Northern Italy ([7]Norsa L. Indriolo A. Sansotta N. Cosimo P. Greco S. D'Antiga L Uneventful course in IBD patients during SARS-CoV-2 outbreak in northern Italy.Gastroenterology. 2020; (Apr 2pii: S0016-5085(20)30445-5)https://doi.org/10.1053/j.gastro.2020.03.062Abstract Full Text Full Text PDF PubMed Scopus (116) Google Scholar). We did not attempt to assess risk factors for SARS-CoV-2 infection in IBD, as the only 3 cases documented in our study prevented the use of logistic regression models. Notably, more than one third of our patients were receiving biologics and all of them experienced no Covid-19-related symptoms thus supporting the hypothesis that such drugs do not increase the risk of Covid-19 ([8]Monteleone G. Ardizzone S. Are patients with inflammatory bowel disease at increased risk for Covid-19 infection?.J Crohns Colitis. 2020; (Mar 26:jjaa061)https://doi.org/10.1093/ecco-jcc/jjaa061Crossref Scopus (155) Google Scholar,[9]Monteleone G. Sarzi-Puttini P.C. Ardizzone S Preventing COVID-19-induced pneumonia with anticytokine therapy.Lancet Rheumatol. 2020; 2 (May): e255-e256https://doi.org/10.1016/S2665-9913(20)30092-8Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar). Based upon these data, we feel IBD patients should be encouraged to continue their treatment even during Covid-19 outbreak in order to prevent disease flares and IBD-associated complications. At the same time, IBD patients, particularly those with co-existing comorbidities (e.g. hypertension, diabetes, cardiovascular diseases) should strictly adhere to healthcare infection prevention and control measures. Giovanni Monteleone served as an advisory board member for AbbVie. Emma Calabrese has received fees from ABBVIE, TAKEDA and JANSSEN. The other authors have no conflict of interest. No specific funding has been received for this work.