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Background Infliximab and adalimumab are widely used for the treatment of Crohn's disease and ulcerative colitis. Aim To compare the long-term efficacy and safety of infliximab and adalimumab in a large cohort of Crohn's disease and ulcerative colitis patients reflecting real-life clinical practice. Methods Seven hundred twelve patients were retrospectively reviewed, 410 with Crohn's disease (268 treated with adalimumab and 142 with infliximab; median follow-up 60 months, range, 36-72) and 302 with ulcerative colitis (118 treated with adalimumab and 184 with infliximab; median follow-up 48 months, range, 36-84). Results In Crohn's disease, clinical remission was maintained in 75.0% of adalimumab vs. in 72.5% of infliximab patients (P = 0.699); mucosal healing and steroid-free remission were maintained in 49.5% of adalimumab vs. 63.9% of infliximab patients (P = 0.077) and in 77.7% of adalimumab vs. 77.3% in infliximab group (P = 0.957), respectively. In ulcerative colitis, clinical remission was maintained in 50.0% of adalimumab vs. 65.8% of infliximab patients (P 10 were predictors of failure in Crohn's disease; treatment with adalimumab, BMI ≥30 and Mayo score >10 were predictors of failure in ulcerative colitis. infliximab was more likely to cause adverse events than adalimumab (16.6 vs. 6.2%, P Conclusion Both adalimumab and infliximab are effective in long-term outpatients management of inflammatory bowel diseases. Adalimumab had a lower rate of adverse events.

Background Italian data currently available in managing ulcerative colitis (UC) and Crohn's disease (CD) patients with vedolizumab (VDZ) are coming just from secondary and tertiary centers. The present study aimed to assess the real-life efficacy and safety of VDZ to achieve remission in inflammatory bowel diseases (IBD) outpatients in primary gastroenterology centers. Methods Clinical activity was scored according to the Mayo score in UC and to the Harvey-Bradshaw Index (HBI) in CD. The primary endpoints were the achievement of clinical remission and safety. Secondary endpoints were clinical response to treatment, achievement of mucosal healing (MH), and steroid discontinuation. Results One hundred and thirty-six pts. were enrolled (91 UC and 45 CD pts). During an 18-month median follow-up, clinical remission was present in 63 (46.3%) pts.: in particular, it occurred in 48 (52.7%) patients in UC group and in 15 (33.3%) patients in CD group (p = 0.003). more in UC group. Fecal calprotectin ≥400 μg/g and presence of comorbidities were factors significantly related to the failure of remission in UC and CD, respectively. Ten (7.3%) cases of adverse events were recorded (2 required suspension of treatment). Clinical response was present in 105 (72.2%) pts.: 71 (78.0%) in UC and 34 (75.5%) in CD group. MH occurred in 47 (62.7%) UC and in 9 (50.0%) CD patients. Steroids discontinuation occurred in 92 (67.6%) pts.; 61 (67.0%) UC and 31 (68.9%) CD pts. Conclusion VDZ is effective and safe in IBD outpatients, especially in UC patients.

Background The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers. Methods Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety. Results One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission. Conclusion This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naive patients and those switching from IFX originator.

Background Ustekinumab (UST) is an anti-IL12/23 antibody for the treatment of Crohn’s Disease (CD). The aim of this study was to compare the efficacy and safety of UST in a large population-based cohort of CD patients who failed previous treatment with other biologics Methods 194 CD patients (108 males and 86 females, mean age 48 years (range 38–58 years) were retrospectively reviewed. 147 patients were already treated with anti-TNFα (75.8%), and 47 (24.2%) patients were already treated with anti-TNFα and vedolizumab. Concomitant treatment with steroids was present in 177 (91.2%) patients Results At week 12, clinical remission was achieved in 146 (75.2%) patients. After a mean follow-up of 6 months, clinical remission was maintained in 135 (69.6%) patients; at that time, mucosal healing was assessed in 62 (31.9%) patients, and it was achieved in 33 (53.2) patients. Three (1.5%) patients were submitted to surgery. Steroid-free remission was achieved in 115 (59.3%) patients. Both serum C-Reactive Protein and Fecal Calprotectin (FC) levels were significantly reduced with respect to baseline levels during follow-up. A logistic regression, UST therapy as thirdline therapy (after both anti-TNFα and vedolizumab), FC >200 μg/g, and HBI ≥8 were significantly associated with lack of remission. Adverse events occurred in 5 (2.6%) patients, and four of them required suspension of treatment Conclusion Ustekinumab seemed to be really effective and safe in CD patients unresponsive to other biologic treatments, especially when used as second-line treatment.

Background & Aims: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres.Methods: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score ≤2, at 6-month follow-up.Results: Ninety-three patients were enrolled. At 6-month follow-up, remission was obtained in 34 (36.5%) patients. Shorter duration of disease was the only significant predictive factor of remission. Clinical response was achieved in 60 (64.5%) patients, while mucosal healing (MH) was obtained in 18 (19.3%) patients. Sixteen (47.0%) patients under remission were still under therapy with steroids. C-reactive protein and fecal calprotectin significantly dropped during the follow-up (p

Background: Use of herbal remedies (HR) has increased in the general population, particularly among patients with chronic diseases. Marketing of HR is usually regulated by imperfect standards, and the reporting of HR-related adverse reactions has increased. Studies assessing prevalence of HR use among patients with liver/biliary tract disorders are limited and no data are available in Italy. Aims of this study were to assess the prevalence of HR use, the clinical and demographic variables of HR users, and to evaluate their safety perception about HR. Study: From October 1, 2007 to April 30, 2008, 231 consecutive patients attending the Liver Disease Unit clinic at Sant'Andrea Hospital, II Faculty of Medicine "La Sapienza" Rome, were interviewed using an ad hoc developed questionnaire. The questionnaire addressed the following items: demographic and clinical characteristics, use of conventional therapy, use of HR and safety perception. Data were expressed as mean (± SD) or number/ total, and evaluated by student t and χ 2 tests; univariate analysis and multivariate logistic regression (MLR) were conducted. Results: Prevalence of HR use was 35.5%. HR use was more common among women (P=0.01), and in patients attending sports activity (P = 0.03). 72% of patients using HR had never considered potentially harmful HR-side effects or interactions. Sixty-seven percent used HR in addition to conventional therapy. Conclusions: More than a third of patients attending Liver/Biliary Disorders Clinic uses HR. Misconceptions about HR safety is common.

Adalimumab (ADA) was approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments in 2014, but no data from real life are currently available. The aim of the present study was to assess the real-life efficacy and safety of ADA in managing UC outpatients in some Italian primary inflammatory bowel disease (IBD) centers after approval of ADA reimbursement.Consecutive UC outpatients with at least 3-month follow-up were retrospectively evaluated. The primary end point was the induction and maintenance of remission in UC, defined as Mayo score ≤2.One hundred seven patients were included. At 3-month follow-up, obtained in 102 (95.3%) patients, 56 (54.9%) patients achieved a clinical remission. At univariate analysis, both Mayo partial score >7 and Mayo subscore for endoscopy = 3 at entry showed to be significantly associated with the lack of remission induction.During a median (95% confidence interval [CI]) follow-up of 18 (12-24) months, 56.6% of patients were under clinical remission; clinical response was achieved in 89.2% of cases. Mucosal healing was achieved in 66 (76.7%) patients, and colectomy occurred in 3 (2.8%) patients. Both C-reactive protein and fecal calprotectin values significantly decreased during follow-up. Steroids discontinuation occurred in 67 (66.7%) patients, and ADA dose escalation was adopted in 9 (16.1%) patients under remission. No factor was significantly related to the maintenance of clinical remission.This first Italian experience found ADA safe and effective to induce and maintain remission in real-life UC outpatients.

Hepatitis B virus (HBV) infection affects a large part of the world population. Within the different virological HBV categories that have been identified, patients with occult HBV infection represent a peculiar group. These individuals harbor a replication competent virus, inhibited in its replicative function. Accordingly, cases of reactivations have been observed in immunosuppressed individuals who lose immunological control over the infection. Patients with hematological malignancies (HM) are treated with intense myelo- and immunosuppressive chemotherapy regimens which favor HBV reactivation. This event can have severe consequences, such as hepatitis flare, hepatic failure and even death. In addition, it can lead to delays or interruptions of curative treatments, resulting in a decreased disease free and overall survival. In this review, we will examine the event of HBV reactivation in patients with signs of resolved HBV infection undergoing treatment for HM and propose possible management strategies.

Rituximab has provided a revolutionary contribution to the treatment of B-cell non-Hodgkin’s lymphomas (NHL). A high prevalence of hepatitis C virus (HCV) infection has been described in B-cell NHL patients. Cases of liver dysfunction in HCV-positive patients have been reported with Rituximab-containing regimens. In this paper we review the recent data regarding the effects of Rituximab in NHL patients with HCV infection. We also added a section devoted to improving communication between oncohaematologists and hepatologists. Furthermore, we propose a common methodological ground to study hepatic toxicity emerging during chemotherapy.

Background: Rituximab has been associated with hepatitis B virus reactivation (HBV-R). However, the characteristics and scope of this association remain largely undefined.

s / Digestive and Liver Disease 47S (2015) e43–e66 e63 driving the synthesis of abnormal peptides, possibly leading to virion assembly defects and to the intracytoplasmatic accumulation of HBsAg. Conclusions Selective pressure by the immune system selects variants in theprecore region that arenotproportionally detectable in the periphery, possibly due to the abnormal release of defective virions. This may also have clinical implications for hepatic pathology (steatosis) andmay lead to the underestimation of viral load. A better comprehensionof the relationshipbetween intrahepatic and peripheral (virological and clinical) markers may confer to these a higher diagnostic power. http://dx.doi.org/10.1016/j.dld.2015.01.136

Dear Editor, We read with interest the article by Yi-Fu H. et al. [1] about the effectiveness of Lamivudine (LAM) prophylaxis in preventing hepatitis B viral (HBV) reactivation in Rituximab containing regimens (so called immunochemotheraphy, ICT) for lymphoma and would like to make a contribution to this emerging topic. All patients diagnosed with Non-Hodgkin Lymphoma (NHL) from January 2005 to March 2008, at our Institution, were screened for HBV serology: HBsAg, anti-HBs, anti-HBc, HBeAg, anti-HBe. Patients were also tested for HCV antibodies (HIV-positive patients were not included): 18 out of 159 patients (11.3%) had serological signs of HBV exposure. 12 out of 159 (8.1%) patients were HCV-infected. Seven out of 18 HBV carriers were coinfected with HCV (38.8%). In 11 out of 18 patients (61%), HBsAg were negative [2], anti-HBc (nine patients), anti-HBs (one patient, no history of previous vaccination), anti-HBc/anti-HBe/anti-HBs (one patient) being the only positive markers of previous HBV exposure. Three patients were known to be affected by mild HBV chronic active hepatitis at the time of lymphoma diagnosis and were treated with LAM to contain the disease process before and after ICT. The remaining four inactive HBsAg carriers and the 11 HBsAg-negative/antiHBc-positive patients were started on LAM as a preemptive treatment to prevent possible disease reactivation [3]. Patients began treatment with LAM 100 mg/day po on average 3–4 weeks before embarking on chemotherapy, after signing informed consent. All 159 patients were given R-CHOP or R-CHOP-like regimens [4]. LAM treatment was extended to 18 months after that the new indications from the dedicated commission of the Italian Study of the Liver became widely available in 2007 [3]. During and after ICT discontinuation, patients were tested every 2 months for HBsAg, quantitative-HBV-DNA, ALT, and AST. Median follow-up time was 7 months (range 3–43). Five of the seven HBsAg-positive patients (71.4%) became HBV-DNA positive during follow-up at 25, 18, 18, 10, and 7 months after commencing LAM. In two patients, emergence of HBV-DNA positivity was associated with an increase of serum transaminases (up to five times the upper normal limit). In these five patients, AdefovirDipivoxyl, 10 mg/day po, was combined with LAM, resulting in a disappearance of HBV-DNA and regression of the biochemical signs of hepatitis. None of these patients had to discontinue ICT because of HBV reactivation. No liver-related deaths occurred. None of the HBcAbpositive, anti-HBs-positive/HBsAg-negative patients (potential silent carriers) developed HBV reactivation during the period of observation. No side effect related either to LAM or ADV was registered. Four out of seven of these patients are now undergoing new treatments because of lymphoma progression. The prevalence of HBV infection is high among patients diagnosed with NHL as compared to less than 2% of the Italian adult population [5]. Reactivation of HBV infection can present a serious threat to these patients and to the Ann Hematol (2009) 88:283–284 DOI 10.1007/s00277-008-0609-2