Publications by authors named "Stefano Festa"

28 Publications

  • Page 1 of 1

Primary hypogammaglobulinemia with IBD-like features: An ECCO CONFER Multicenter Case Series.

J Crohns Colitis 2021 Jul 18. Epub 2021 Jul 18.

Gastroenterology Department, Sheba Medical Center and Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.

Background: Hypogammaglobulinemia is a disorder characterized by low serum immunoglobulin levels and had high prevalence of gastrointestinal manifestations. In some cases, clinical and endoscopic features are indistinguishable from those of inflammatory bowel disease (IBD).

Methods: This was a multicenter case series performed as a part of the European Crohn's and Colitis Organisation (ECCO) Collaborative Network of Exceptionally Rare case reports (CONFER) project.

Results: This report includes 27 patients with primary hypogammaglobulinemia and IBD-like features [20 males and 7 females, median age 45.6 years (Interquartile range (IQR) 35.2-59]. Crohn's disease-like features were noted in 23 patients, four patients had ulcerative colitis-like features. The diagnosis of hypogammaglobulinemia preceded IBD-like features diagnosis in 20 patients (median of 7 years prior, IQR 2.6-20.6 years), and followed IBD-like features appearance in 7 cases (median of one year after, IQR 0.45-5.6 years).Hypogammaglobulinemia etiologies were common variable immunodeficiency (66.6%), agammaglobulinemia (7.4%), selective IgA-deficiency (11.1%), Goods syndrome (7.4%), IgG subclass deficiency with IgA deficiency (3.7%) and hyper-IgM (3.7%). In addition to antibiotics and intravenous immunoglobulin (IVIG) for hypogammaglobulinemia, 12 patients received IBD-related treatment including 5-ASA (2 patients), corticosteroids (1 patient), thiopurines (3 patients), anti-TNFs (4 patients) and vedolizumab (2 patients). By the end of the follow-up [44.5 months (IQR 18-81)], 21/27 (77%) patients were in clinical remission.

Conclusion: This case series describes IBD-like features in patients with hypogammaglobulinemia. The diagnosis of IBD-like features mainly occurred after that of hypogammaglobulinemia, with successful recovery in the majority of cases after appropriate treatment.
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http://dx.doi.org/10.1093/ecco-jcc/jjab124DOI Listing
July 2021

What are the challenges in selecting pharmacotherapy for pregnant women with inflammatory bowel disease?

Recenti Prog Med 2021 May;112(5):371-377

IBD Unit, San Filippo Neri Hospital, Rome, Italy.

The peak of incidence of inflammatory bowel disease (IBD) overlaps with the peak of reproductive age. Moreover, women affected by IBD are often concerned with the possible negative effects of their disease and medications on pregnancy and birth outcomes. From a physician point of view, managing IBD in pregnancy is challenging. Disease activity is the major cause of poor pregnancy outcomes and, therefore, achieving and maintaining IBD remission for the whole duration of pregnancy is the main therapeutic goal. The challenges in selecting therapy lie in balancing the proven efficacy of each drug with the level of safety uncertainty. Except for methotrexate and thalidomide, for which it exits an absolute contraindication in pregnancy, the evidence actually available suggest that most medications can be safely used during pregnancy if appropriately prescribed. The risks associated with drug withdrawal may be higher than the known risks of the medications themselves on pregnancy outcomes. However, all the decisions should be shared with the patient, all available information should be discussed and any therapeutic strategy must be tailored according to patient's context, including disease pattern, activity, severity and acceptance of risk.
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http://dx.doi.org/10.1701/3608.35874DOI Listing
May 2021

Long-term outcomes of acute severe ulcerative colitis in the rescue therapy era: A multicentre cohort study.

United European Gastroenterol J 2021 May 16;9(4):507-516. Epub 2021 Feb 16.

IBD Unit, San Filippo Neri Hospital, Rome, Italy.

Background: The long-term course of ulcerative colitis after a severe attack is poorly understood. Second-line rescue therapy with cyclosporine or infliximab is effective for reducing short-term colectomy but the impact in the long-term is controversial.

Objective: The purpose of this study was to evaluate the long-term course of acute severe ulcerative colitis patients who avoid early colectomy either because of response to steroids or rescue therapy.

Methods: This was a multicentre retrospective cohort study of adult patients with acute severe ulcerative colitis admitted to Italian inflammatory bowel disease referral centres from 2005 to 2017. All patients received intravenous steroids, and those who did not respond received either rescue therapy or colectomy. For patients who avoided early colectomy (within 3 months from the index attack), we recorded the date of colectomy, last follow-up visit or death. The primary end-point was long-term colectomy rate in patients avoiding early colectomy.

Results: From the included 372 patients with acute severe ulcerative colitis, 337 (90.6%) avoided early colectomy. From those, 60.5% were responsive to steroids and 39.5% to the rescue therapy. Median follow-up was 44 months (interquartile range, 21-85). Colectomy-free survival probability was 93.5%, 81.5% and 79.4% at 1, 3 and 5 years, respectively. Colectomy risk was higher among rescue therapy users than in steroid-responders (log-rank test, p = 0.02). At multivariate analysis response to steroids was independently associated with a lower risk of long-term colectomy (adjusted odds ratio = 0.5; 95% confidence interval, 0.2-0.8), while previous exposure to antitumour necrosis factor-α agents was associated with an increased risk (adjusted odds ratio = 3.0; 95% confidence interval, 1.5-5.7). Approximately 50% of patients required additional therapy or new hospitalisation within 5 years due to a recurrent flare. Death occurred in three patients (0.9%).

Conclusions: Patients with acute severe ulcerative colitis avoiding early colectomy are at risk of long-term colectomy, especially if previously exposed to antitumour necrosis factor-α agents or if rescue therapy during the acute attack was required because of steroid refractoriness.
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http://dx.doi.org/10.1177/2050640620977405DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259429PMC
May 2021

Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study.

United European Gastroenterol J 2021 02 1;9(1):102-109. Epub 2021 Mar 1.

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Background: Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response.

Objective: This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis.

Methods: Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy.

Results: A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range: 4-142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio [OR] = 3.02, 95% confidence interval [CI]: 1.44-6.29; p = 0.003) and being able to discontinue steroids at Week 8 (OR = 3.32, 95% CI: 1.34-8.30; p = 0.010) and Week 14 (OR = 2.94, 95% CI: 1.08-8.02; p = 0.036) were associated with longer persistence on therapy. At Week 54, 65/124 (52.4%) postinduction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy (p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients.

Conclusions: Biological-naïve status and not requiring steroids at Weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.
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http://dx.doi.org/10.1177/2050640620974308DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259241PMC
February 2021

Activities related to inflammatory bowel disease management during and after the coronavirus disease 2019 lockdown in Italy: How to maintain standards of care.

United European Gastroenterol J 2020 12 18;8(10):1228-1235. Epub 2020 Oct 18.

Gastroenterology Unit, Mauriziano Hospital, Turin, Italy.

Background And Aims: Restructuring activities have been necessary during the lockdown phase of the coronavirus disease 2019 (COVID-19) pandemic. Few data are available on the post-lockdown phase in terms of health-care procedures in inflammatory bowel disease (IBD) care, and no data are available specifically from IBD units. We aimed to investigate how IBD management was restructured during the lockdown phase, the impact of the restructuring on standards of care and how Italian IBD units have managed post-lockdown activities.

Methods: A web-based online survey was conducted in two phases (April and June 2020) among the Italian Group for IBD affiliated units within the entire country. We investigated preventive measures, the possibility of continuing scheduled visits/procedures/therapies because of COVID-19 and how units resumed activities in the post-lockdown phase.

Results: Forty-two referral centres participated from all over Italy. During the COVID-19 lockdown, 36% of first visits and 7% of follow-up visits were regularly done, while >70% of follow-up scheduled visits and 5% of first visits were done virtually. About 25% of scheduled endoscopies and bowel ultrasound scans were done. More than 80% of biological therapies were done as scheduled. Compared to the pre-lockdown situation, 95% of centres modified management of outpatient activity, 93% of endoscopies, 59% of gastrointestinal ultrasounds and 33% of biological therapies. Resumption of activities after the lockdown phase may take three to six months to normalize. Virtual clinics, implementation of IBD pathways and facilities seem to be the main factors to improve care in the future.

Conclusion: Italian IBD unit restructuring allowed quality standards of care during the COVID-19 pandemic to be maintained. A return to normal appears to be feasible and achievable relatively quickly. Some approaches, such as virtual clinics and identified IBD pathways, represent a valid starting point to improve IBD care in the post-COVID-19 era.
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http://dx.doi.org/10.1177/2050640620964132DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724532PMC
December 2020

The management of inflammatory bowel diseases in the era of COVID-19 pandemic: When "non-urgent" does not mean "deferrable".

Dig Liver Dis 2020 11 18;52(11):1238-1240. Epub 2020 Jun 18.

CEMAD - IBD UNIT - Unità Operativa Complessa di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy; Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.dld.2020.05.053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7301120PMC
November 2020

Interstitial and Granulomatous Lung Disease in Inflammatory Bowel Disease Patients.

J Crohns Colitis 2020 May;14(4):480-489

Humanitas Clinical and Research Center, Gastroenterology Department, Rozzano, Milan, Italy.

Background: Interstitial lung [ILD] disease and granulomatous lung disease [GLD] are rare respiratory disorders that have been associated with inflammatory bowel disease [IBD]. Clinical presentation is polymorphic and aetiology is unclear.

Methods: This was an ECCO-CONFER project. Cases of concomitant ILD or GLD and IBD, or drug-induced ILD/GLD, were collected. The criteria for diagnosing ILD and GLD were based on definitions from the American Thoracic Society and the European Respiratory Society and on the discretion of reporting clinician.

Results: We identified 31 patients with ILD. The majority had ulcerative colitis [UC] [n = 22]. Drug-related ILD was found in 64% of these patients, 25 patients [80.6%] required hospitalisation, and one required non-invasive ventilation. The causative drug was stopped in all drug-related ILD, and 87% of patients received systemic steroids. At follow-up, 16% of patients had no respiratory symptoms, 16% had partial improvement, 55% had ongoing symptoms, and there were no data in 13%. One patient was referred for lung transplantation, and one death from lung fibrosis was reported. We also identified 22 GLD patients: most had Crohn's disease [CD] [n = 17]. Drug-related GLD was found in 36% of patients and 10 patients [45.4%] required hospitalisation. The causative drug was stopped in all drug-related GLD, and 81% of patients received systemic steroids. Remission of both conditions was achieved in almost all patients.

Conclusions: ILD and GLD, although rare, can cause significant morbidity. In our series, over half of cases were drug-related and therefore focused pharmacovigilance is needed to identify and manage these cases.
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http://dx.doi.org/10.1093/ecco-jcc/jjz165DOI Listing
May 2020

Cancer Risk in Inflammatory Bowel Disease: A 6-Year Prospective Multicenter Nested Case-Control IG-IBD Study.

Inflamm Bowel Dis 2020 02;26(3):450-459

Department of Systems Medicine, GI Unit, Università degli Studi di Roma "Tor Vergata", Rome, Italy.

Background: In a 6-year, multicenter, prospective nested case-control study, we aimed to evaluate risk factors for incident cancer in inflammatory bowel disease (IBD), when considering clinical characteristics of IBD and immunomodulator use. The secondary end point was to provide characterization of incident cancer types.

Methods: All incident cases of cancer occurring in IBD patients from December 2011-2017 were prospectively recorded in 16 Italian Group for the Study of Inflammatory Bowel Disease units. Each of the IBD patients with a new diagnosis of cancer was matched with 2 IBD patients without cancer, according to IBD phenotype (ulcerative colitis [UC] vs Crohn's disease [CD]), age (±5 years), sex. Risk factors were assessed by multivariate logistic regression analysis.

Results: Cancer occurred in 403 IBD patients: 204 CD (CD cases), 199 UC (UC cases). The study population included 1209 patients (403 IBD cases, 806 IBD controls). Cancer (n = 403) more frequently involved the digestive system (DS; 32%), followed by skin (14.9%), urinary tract (9.7%), lung (6.9%), genital tract (6.5%), breast (5.5%), thyroid (1.9%), lymphoma (2.7%, only in CD), adenocarcinoma of the small bowel (SBA; 3.9%, 15 CD, 1 pouch in UC), other cancers (15.9%). Among cancers of the DS, colorectal cancer (CRC) more frequently occurred in UC (29% vs 17%; P < 0.005), whereas SBA more frequently occurred in CD (13% vs 6.3% P = 0.039). In CD, perforating (B3) vs non-stricturing non-perforating (B1) behavior represented the only risk factor for any cancer (odds ratio [OR], 2.33; 95% confidence interval [CI], 1.33-4.11). In CD, risk factors for extracolonic cancer (ECC) were a B3 vs B1 and a stricturing (B2) vs B1 behavior (OR, 2.95; 95% CI, 1.62-5.43; OR, 1.79; 95% CI, 1.09-2.98). In UC, risk factors for ECC and for overall cancer were abdominal surgery for UC (OR, 4.63; 95% CI, 2.62-8.42; OR, 3.34; 95% CI, 1.88-5.92) and extensive vs distal UC (OR, 1.73; 95% CI, 1.10-2.75; OR, 1.99; 95% CI, 1.16-3.47). Another risk factor for ECC was left-sided vs distal UC (OR, 1.68; 95% CI, 1.00-2.86). Inflammatory bowel disease duration was a risk factor for skin and urinary tract cancers.

Conclusions: Perforating CD, extensive UC, and abdominal surgery for UC were identified as risk factors for overall incident cancer and for ECC. The clinical characteristics associated with severe IBD may increase cancer risk.
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http://dx.doi.org/10.1093/ibd/izz155DOI Listing
February 2020

[The advantages of patient's active involvement in the management of chronic Inflammatory Bowel Diseases.]

Recenti Prog Med 2019 05;110(5):236-243

UOS Malattie Infiammatorie Croniche dell'Intestino, UOC Gastroenterologia, Ospedale San Filippo Neri, Roma.

The patient's active involvement is an emerging hot-topic, which can be applied in to the management of chronic inflammatory bowel diseases (IBD). Since in this field most of the therapeutic strategies are not based on sturdy scientific evidences, the patient's role has become central and it is believed essential for any patients to have an active cognitive, behavioural and emotive profile. Moreover different patient's aspects should be considered, such as the patient's activation, the patient's engagement and the patient's disease knowledge. The initial evidences available on this topic within IBD context have showed how a higher patient's active profile and a deeper disease knowledge have had a positive effect on compliance, perceived health-care satisfaction, self-management and health costs. Therefore, considering the favourable outcomes so far highlighted, we hope that the evaluation of patient's involvement may become a standard procedure, allowing patients who need it to undergo active programmes which have proved to be effective in improving patient's degree of activation.
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http://dx.doi.org/10.1701/3163.31446DOI Listing
May 2019

Real-life effectiveness of ustekinumab in inflammatory bowel disease patients with concomitant psoriasis or psoriatic arthritis: An IG-IBD study.

Dig Liver Dis 2019 07 13;51(7):972-977. Epub 2019 Apr 13.

IBD Unit, Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address:

Background: Few data exist regarding the effectiveness of ustekinumab in inflammatory bowel disease (IBD) patients treated for concomitant psoriasis or psoriatic arthritis.

Aims: to describe the outcomes of IBD patients who received subcutaneous ustekinumab through a dermatological or rheumatological prescription.

Methods: This multicenter, retrospective study included all IBD patients who were started on ustekinumab for concomitant active psoriasis/ psoriatic arthritis, irrespective of IBD activity. The primary endpoint was overall ustekinumab persistence, defined as the maintenance of therapy because of sustained clinical benefit for IBD.

Results: Seventy patients (64 Crohn's disease / 6 ulcerative colitis) were enrolled. The median follow-up on ustekinumab therapy was 10.7 months (range, 1.4-67.3). Twelve patients (17.1%) withdrew the treatment after a median of 7.4 months (range, 0.9-23.8). The cumulative probability of maintaining ustekinumab treatment was 97.1% at 6 months and 77.1% at 12 months. Among the 56 patients with baseline active IBD, 34 (60.7%) were in clinical remission at the last follow-up visit. Their cumulative probability of achieving clinical remission was 84.7% and 63.9% at 6 and 12 months, respectively. Two patients stopped ustekinumab for an adverse event.

Conclusions: Subcutaneous ustekinumab had a good effectiveness profile for IBD patients treated for concomitant dermatological or rheumatological conditions.
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http://dx.doi.org/10.1016/j.dld.2019.03.007DOI Listing
July 2019

Sustained Clinical Efficacy and Mucosal Healing of Thiopurine Maintenance Treatment in Ulcerative Colitis: A Real-Life Study.

Gastroenterol Res Pract 2018 3;2018:4195968. Epub 2018 Oct 3.

IBD Unit, Presidio Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Rome 00168, Italy.

Background And Aims: Thiopurines are commonly used for treating ulcerative colitis (UC), despite the fact that controlled evidence supporting their efficacy is limited. The aim of this study was to evaluate the long-term outcome of thiopurines as maintenance therapy in a large cohort of UC patients.

Methods: All UC patients receiving thiopurine monotherapy at three tertiary IBD centers from 1995 to 2015 were identified. The primary endpoint was steroid-free clinical remission. Secondary endpoints were mucosal healing (MH), defined as Mayo endoscopic subscore 0, long-term safety, and predictors of sustained clinical remission.

Results: We identified 192 patients, contributing a total of 747 person-years of follow-up (median follow-up 36 months, range 1-210 months). Steroid dependency was the most common indication for thiopurine treatment (58%). Steroid-free remission occurred in 45.3% of patients; 36.3% stopped thiopurines because of treatment failure and 18.2% for adverse events or intolerance. The cumulative probability of maintaining steroid-free remission while on thiopurine treatment was 87%, 76%, 67.6%, and 53.4% at 12, 24, 36, and 60 months, respectively. MH occurred in 57.9% of patients after a median of 18 months (range 5-96). No independent predictors of sustained clinical remission could be identified.

Conclusions: Thiopurines represent an effective and safe long-term maintenance therapy for UC patients.
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http://dx.doi.org/10.1155/2018/4195968DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192086PMC
October 2018

A safety evaluation of budesonide MMX for the treatment of ulcerative colitis.

Expert Opin Drug Saf 2018 Apr 23;17(4):437-444. Epub 2018 Feb 23.

a Gastroenterology Unit , Rho Hospital, ASST Rhodense , Garbagnate Milanese , Italy.

Introduction: Budesonide belongs to low-bioavailability steroids class. A novel oral formulation of budesonide, which uses the Multi-Matrix System (MMX) for delivering drugs to the colon, is now available as a possible treatment of ulcerative colitis patients intolerant or not-responding to first-line therapy with 5-ASA. Areas covered: in this review we present information about the development and the use of budesonide MMX and we provide data about its mechanism of action as well as, pharmacodynamics and pharmacokynetics. Moreover, we present the available literature data about the efficacy and, mainly, the safety of budesonide-MMX. Expert opinion: budesonide-MMX is a new therapeutic option in mild-to-moderate UC patients. Its good safety profile in clinical trials undoubtedly represents a strength for a possible wide use in clinical practice, mainly if it will be confirmed by post-marketing data. Other indications, such as treatment of colonic Crohn's disease, could theoretically be considered, if sustained by reliable scientific data.
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http://dx.doi.org/10.1080/14740338.2018.1442432DOI Listing
April 2018

[Towards new therapeutic paradigms beyond symptom control in the management of inflammatory bowel diseases.]

Recenti Prog Med 2018 Jan;109(1):50-58

UOC Gastroenterologia, UOS Malattie Infiammatorie Croniche dell'Intestino, Ospedale San Filippo Neri, Roma.

Inflammatory bowel diseases, Crohn's disease and ulcerative colitis are chronic relapsing conditions that may result in progressive bowel damage, high risk of complications, surgery and permanent disability. The conventional therapeutic approach for inflammatory bowel diseases is based mainly on symptom control. Unfortunately, a symptom-based therapeutic approach has little impact on major long-term disease outcomes. In other chronic disabling conditions such as diabetes, hypertension and rheumatoid arthritis, the development of new therapeutic approaches has led to better outcomes. In this context a "treat to target" strategy has been developed. This strategy is based on identification of high-risk patients, regular assessment of disease activity by means of objective measures, adjustment of treatment to reach the pre-defined target. A treat to target approach has recently been proposed for inflammatory bowel disease with the aim at modifying the natural history of the disease. In this review, the evidence and the limitations of the treat to target paradigm in inflammatory bowel disease are analyzed and discussed.
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http://dx.doi.org/10.1701/2848.28755DOI Listing
January 2018

Chemoprevention of colorectal cancer in ulcerative colitis: digging deep in current evidence.

Expert Rev Gastroenterol Hepatol 2017 Apr 16;11(4):339-347. Epub 2017 Feb 16.

b IBD Unit , San Filippo Neri Hospital , Rome , Italy.

Introduction: Patients with ulcerative colitis (UC) have an increased risk of developing colorectal cancer (CRC). Surveillance colonoscopy is currently recommended for patients with long-standing extensive colitis for reducing CRC risk. Chemoprevention is an attractive complementary strategy. Areas covered: Inflammation is a major determinant of CRC risk and is potentially modifiable. Reducing inflammation is supposed to reduce CRC risk. Several medications have been evaluated in this setting: 5-ASA, thiopurines, anti-TNFα agents and ursodeoxycholic acid (UCDA) in patients with associated primary sclerosing cholangitis (PSC). This review offers a critical evaluation of current evidence of the potential chemopreventive effect of such medications. Expert commentary: No randomized controlled trials have been performed and the available evidence come from observational studies. Although biological plausibility supports a chemopreventive role of the aforementioned agents, the overall evidence of efficacy is weak because of several methodological limitations of the studies. Indirect epidemiological evidence, biologic plausibility and results of meta-analyses reasonably support a potential chemopreventive effect of 5-ASA. Available evidence does not support a specific chemopreventive effect of purine analogues and anti-TNFα medications, despite their efficacy in the management of inflammatory bowel disease. Data addressing UDCA and folate supplementation are inconclusive. Limited data are available for statins.
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http://dx.doi.org/10.1080/17474124.2017.1292129DOI Listing
April 2017

Methotrexate in Crohn's disease: a new face for an old drug?

Expert Rev Gastroenterol Hepatol 2016 Oct 13;10(10):1135-1144. Epub 2016 May 13.

b IBD Unit , San Filippo Neri Hospital , Rome , Italy.

Introduction: Methotrexate is commonly used in rheumatoid arthritis but randomised controlled trials demonstrated its efficacy also in Crohn's disease. Methotrexate, although marginally used in clinical practice, is considered an appropriate immunomodulator particularly in patients refractory or intolerant to thiopurines. Areas covered: A literature search using 'methotrexate', 'Crohn's disease' and 'Inflammatory Bowel Disease' as key words, identified randomised controlled trials, meta-analyses and observational studies. The aim of this review is to summarise and critically discuss the available evidence concerning the efficacy and safety of methotrexate in the treatment of Crohn's disease. Expert commentary: Methotrexate is effective in inducing and maintaining remission in steroid-dependent CD at a dose of 25 mg/week and 15 mg/week, respectively. Data from observational studies suggest that methotrexate may be as efficacious as thiopurines with a similar safety profile. In specific clinical settings, (patients with a history of malignancy or young Epstein-Barr Virus-seronegative patients), methotrexate compete favourably with thiopurines.
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http://dx.doi.org/10.1080/17474124.2016.1185363DOI Listing
October 2016

A Case of Pancreatic Small Cell Neuroendocrine Carcinoma Associated With SIADH.

Pancreas 2016 May-Jun;45(5):e20-2

Digestive and Liver Disease Unit Sant' Andrea Hospital University Sapienza Rome, Italy Department of Clinical and Molecular Medicine Sant' Andrea Hospital University Sapienza Rome, Italy Nuclear Medicine Unit Sant' Andrea Hospital University Sapienza Rome, Italy Digestive and Liver Disease Unit Sant' Andrea Hospital University Sapienza Rome, Italy Nuclear Medicine Unit Sant' Andrea Hospital University Sapienza Rome, Italy Gastroenterology Unit Moscati Hospital Avellino, Italy Radiology Unit Sant' Andrea Hospital University Sapienza Rome, Italy Nephrology Unit Sant' Andrea Hospital University Sapienza Rome, Italy Digestive and Liver Disease Unit Sant' Andrea Hospital University Sapienza Rome, Italy

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http://dx.doi.org/10.1097/MPA.0000000000000558DOI Listing
January 2017

Diffuse intestinal pneumatosis after an Endoscopic Retrograde Cholangiopancreatography: A paradigmatic case for an old pathogenetic dilemma.

Dig Liver Dis 2016 Jun 27;48(6):693. Epub 2016 Feb 27.

Digestive Endoscopy Unit, Fondazione di Ricerca e Cura Giovanni Paolo II, Università Cattolica del Sacro Cuore, Campobasso, Italy.

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http://dx.doi.org/10.1016/j.dld.2016.02.010DOI Listing
June 2016

Acute fulminant hepatitis E virus genotype 3e infection: description of the first case in Europe.

Infect Dis (Lond) 2015 Feb 12;47(2):113. Epub 2014 Nov 12.

Ospedale Sant'Andrea, School of Medicine and Psychology, Sapienza University of Rome , Rome , Italy.

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http://dx.doi.org/10.3109/00365548.2014.968613DOI Listing
February 2015

Acute fulminant hepatitis E virus genotype 3e infection: description of the first case in Europe.

Scand J Infect Dis 2014 Oct 19;46(10):727-31. Epub 2014 Aug 19.

From the Digestive and Liver Disease Unit, School of Medicine and Psychology, Sapienza University of Rome , Sant'Andrea Hospital.

Hepatitis E virus (HEV) is the most important causative agent of acute hepatitis in developing countries. The disease is usually characterized by a self-limiting, benign course. However, when particular conditions coexist (pregnancy, old age, pre-existing liver disease) it may run an unfavourable course. To date, 4 HEV genotypes have been described. Historically, in the Western world, HEV infection was considered a travel-related disease, however in the last 2 decades a great number of non-travel-related autochthonous cases have been described, more often related to genotype 3 or 4 and in the context of zoonosis. We report the case of an elderly Italian man with an acute fulminant HEV infection genotype 3e that developed in the context of pre-existing liver disease; this is the first case of an unfavourable outcome associated with subgenotype 3e. The potential pathogenicity of this subgenotype together with the influence of host-related risk factors are discussed.
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http://dx.doi.org/10.3109/00365548.2014.928417DOI Listing
October 2014

"Mucosal healing" in ulcerative colitis: Between clinical evidence and market suggestion.

World J Gastrointest Pathophysiol 2014 May;5(2):54-62

Cristiano Pagnini, Francesca Menasci, Stefano Festa, Gianenrico Rizzatti, Gianfranco Delle Fave, "Sapienza" University of Rome, Faculty of Medicine and Psychology, S. Andrea Hospital, 00189 Rome, Italy.

In recent decades, the prominent role of endoscopy in the management of ulcerative colitis (UC) has been translated into the concept of mucosal healing (MH) as a fundamental therapeutic end-point. This is partially the consequence of growing evidence of a positive prognostic role of MH on the disease course and partially due to market cues indicating a higher rate of MH in patients treated by novel potent biologic agents. The aim of the present review is to clarify the current knowledge of MH in UC, analyzing the definition, the putative prognostic role and the association of MH with the current drugs used to treat UC patients. Because solid data about the management of UC patients based solely on the healing of the mucosa are not yet available, a tailored approach for individual patients thatconsiders the natural history of UC and the presence of prognostic indicators of aggressive disease is desirable. Consequently, unnecessary examinations and treatment would be avoided and restricted to UC patients who require the maximum amount of effort to affect the disease course in the short and long term.
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http://dx.doi.org/10.4291/wjgp.v5.i2.54DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4025073PMC
May 2014

Proton pump inhibitor therapy and potential long-term harm.

Curr Opin Endocrinol Diabetes Obes 2014 Feb;21(1):3-8

aDepartment of Gastroenterology and Digestive Endoscopy, School of Medicine and Psychology, Sapienza University of Rome, Sant'Andrea Hospital bCentro Ricerche S. Pietro, Ospedale S. Pietro, Rome, Italy.

Purpose Of Review: This review summarizes the recent literature on the potential side-effects of proton pump inhibitors (PPIs) and known interactions with the metabolism/absorption of other drugs.

Recent Findings: Data confirm that PPIs are a very well tolerated drug class. Their high safety, efficacy and wide distribution lead to overuse, inappropriate dosage or excessive duration of treatment. Despite the absorption of micronutrients or other plausible effects on the development of bacterial infections linked to PPI-induced hypochlorhydria, it is difficult to demonstrate an association between PPI and specific symptoms. A possible negative effect of PPIs on bone integrity appears weak, but hypomagnesemia is likely a PPI drug class effect. A higher risk of Clostridium difficile infection and other infectious diseases such as small intestinal bacterial overgrowth and spontaneous bacterial peritonitis remain controversial in PPI users. However, the careful use of PPIs in cirrhotic or otherwise fragile patients is mandatory. Short-term or long-term PPI use may trigger microscopic colitis, and the management of this condition may include PPI withdrawal. The effect of PPIs on stimulating exocrine or endocrine gastric cell proliferation is poorly understood. A diagnostic delay or masking of diseases such as gastrinoma is difficult to evaluate.

Summary: Short-term standard dose PPI treatment is low risk. Long-term PPI use may complicate health conditions by various mechanisms linked to PPIs and/or to hypochlorhydria.
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http://dx.doi.org/10.1097/MED.0000000000000031DOI Listing
February 2014

Critical review of the evidence on 5-aminosalicilate for chemoprevention of colorectal cancer in ulcerative colitis: a methodological question.

Curr Clin Pharmacol 2014 Feb;9(1):84-90

Department of Medical and Surgical Sciences and Translational Medicine, Faculty of Medicine and Psychology, Sant'Andrea Hospital, "Sapienza" University, Rome, Italy.

Even though the exact amount of the increased risk is not known, patients with Ulcerative Colitis (UC) are more likely to develop colonic malignancy compared with the general population. 5-aminosalicilic acid (5-ASA) compounds are the mainstay therapy for mild-moderate UC, and their use for chemoprevention of colorectal cancer has been proposed, but the evidences are not univocal. Aim of the present work is to critically revise the available data on 5- ASA utilization for cancer chemoprevention, as well as the possible impact in the management of UC patients. In clinical practice, in fact, the best means to measure the dimension of a therapeutic effect is the number needed to treat (NNT). In our study, we show how different basal risk of colorectal cancer reported in studies coming from Europe and USA can affect the NNT, making the strategy "cost-effective" or not. Since prospective randomized controlled trials to address the chemopreventive effect of 5-ASA are not feasible, evidence relays upon observational studies that may imply several biases. Therefore, the heterogeneity of the data is mainly consequent to the different methodological approach of the published studies, in terms of study design, data collection, definitions of regular use of medication and measures of therapeutic efficacy. In addition, two meta-analyses are available with apparently conflicting results. Nonetheless, 5-ASA represents an ideal chemopreventive agent for its anti-inflammatory property, safety, acceptability and inexpensiveness, and even ECCO guidelines recommend 5-ASA long term use, as these compounds may decrease the incidence of CRC.
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http://dx.doi.org/10.2174/1574884708666131111202337DOI Listing
February 2014

Molecular pathology and genetics of pancreatic endocrine tumours.

J Mol Endocrinol 2012 Aug 26;49(1):R37-50. Epub 2012 Jun 26.

Digestive and Liver Disease Unit, Faculty of Medicine and Psychology, S. Andrea Hospital, Sapienza University of Rome, Via di Grottarossa 1035, 00189 Rome, Italy.

Pancreatic neuroendocrine tumours (PETs) are the second most frequent pancreatic neoplasms. Their poor chemosensitivity, high rate of metastatic disease and relatively long survival make PETs an ideal field to be explored for novel therapies based on specific molecular changes. PETs are generally sporadic but can also arise within hereditary syndromes, such as multiple endocrine neoplasia type 1, von Hippel-Lindau, neurofibromatosis type 1 and tuberous sclerosis complex, which represent a model for sporadic cases too. Among allelic imbalances, main genomic changes involve gain of 17q, 7q and 20q and loss of 11q, 6q and 11p, which identify regions of putative candidate oncogenes or tumour suppressor genes (TSGs), respectively, sometime with potential prognostic significance. Overexpression of Src-like kinases and cyclin D1 (CCND1) oncogene has been described. As for TSGs, P53 (TP53), DPC4/SMAD4 and RB (RB1) are not implicated in PET tumorigenesis, while for p16INK4a (CDKN2A), TIMP3, RASSF1A and hMLH1, more data are available, suggesting a role for methylation as a silencing mechanism. In the last decade, gene expression profile studies, analysis of microRNAs and, more recently, large-scale mutational analysis have highlighted commonly altered molecular pathways in the pathology of PETs. The roles of the mammalian target of rapamycin pathway, and its connection with Src kinases, and the activity of a number of tyrosine kinase receptors seem to be pivotal, as confirmed by the results of recent clinical trials with targeted agents. Mutations of DAXX and ATRX are common and related to altered telomeres but not to prognosis.
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http://dx.doi.org/10.1530/JME-12-0069DOI Listing
August 2012

Molecular target therapy for gastroenteropancreatic endocrine tumours: biological rationale and clinical perspectives.

Crit Rev Oncol Hematol 2009 Nov 26;72(2):110-24. Epub 2009 Feb 26.

Digestive and Liver Disease Unit, S. Andrea Hospital, II Medical School, University "La Sapienza", Via Di Grottarossa 1035-1039, 00189, Rome, Italy.

Gastroenteropancreatic endocrine tumours (GEP ETs) represent a relatively rare and heterogeneous group of neoplasms whose therapy can be challenging. The poorly differentiated, fast-growing cases are treated with chemotherapy. In the slow-growing ones, biotherapy is usually performed. Several categories of targeted therapies have been studied for their treatment in vitro and in vivo. A critical review of molecular alterations suggests a rationale for targeting angiogenesis, and the phosphatidylinositol 3 kinase (PI(3)K)/AKT/mammalian target of rapamycin (mTOR) pathway. Accordingly, antiangiogenic agents and mTOR inhibitors are presently the most tested agents in phase II and III studies. Bevacizumab, some multitarget inhibitors, and mTOR inhibitors showed promising results in patients with advanced GEP ETs. A limited activity has been reported for imatinib and epidermal growth factor receptor (EGFR) inhibitors. Combinations of molecular targeted therapies with different sites of action, and somatostatin analogues may be relevant to avoid molecular escape pathways. Future trials should include more homogeneous groups of patients and pay more attention to the subgroup with progressive disease.
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http://dx.doi.org/10.1016/j.critrevonc.2009.01.008DOI Listing
November 2009
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