Publications by authors named "Angela Variola"

17 Publications

  • Page 1 of 1

A Seroprevalence Study of Anti-SARS-CoV-2 Antibodies in Patients with Inflammatory Bowel Disease during the Second Wave of the COVID-19 Pandemic in Italy.

Medicina (Kaunas) 2021 Oct 1;57(10). Epub 2021 Oct 1.

IBD Unit, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella (VR), Italy.

Studies have shown a lower prevalence of anti-SARS-CoV-2 antibodies in patients with inflammatory bowel disease (IBD), including amongst those receiving biological therapy. Aims were to determine the seroprevalence of anti-SARS-CoV-2 antibodies in IBD patients and to assess any association between seropositivity and IBD characteristics. Serum from adult IBD patients was prospectively collected between December 2020 and January 2021 and analyzed for anti-SARS-CoV-2 antibodies. Information about IBD characteristics and SARS-CoV-2 exposure risk factors was collected and analyzed. Serum from non-IBD healthcare workers formed the control group. 311 IBD patients on biologics and 75 on mesalazine were enrolled. Ulcerative colitis (UC) extension ( < 0.001), Crohn's disease (CD) phenotype ( = 0.009) and use of concomitant corticosteroids ( < 0.001) were significantly different between the two IBD groups. Overall seroprevalence among IBD patients was 10.4%. The control group showed a prevalence of 13.0%, not significantly different to that of IBD patients ( = 0.145). Only a close contact with SARS-CoV-2 positive individuals and the use of non-FFP2 masks were independently associated with a higher likelihood of seropositivity amongst IBD patients. In IBD patients, the prevalence of anti-SARS-CoV-2 antibodies is not determined by their ongoing treatment. Disease-related characteristics are not associated with a greater risk of antibody seropositivity.
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http://dx.doi.org/10.3390/medicina57101048DOI Listing
October 2021

Prevalence and Real-World Management of Vedolizumab Associated Enthesitis in Successfully Treated IBD Patients.

Rheumatology (Oxford) 2021 Feb 12. Epub 2021 Feb 12.

NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust & The University of Leeds, Leeds, United Kingdom.

Background: Studies have reported the development of moderate and severe de novo spondyloarthritis (SpA) associated disease under vedolizumab (VDZ) treatment for inflammatory bowel disease (IBD). Herein, we report a case series that developed severe enthesitis under VDZ therapy from a cohort of 90 treated cases.

Methods: In a single Italian IBD Unit, where 90 cases were on VDZ therapy, we identified 11 cases that developed severe enthesitis. The onset of disease in relationship to VDZ initiation, clinical and sonographic imaging features, outcomes including therapy switches were described.

Results: 11 cases, including 8 prior anti-TNF failures, with new onset entheseal pathology were identified (Multifocal (n = 4), unifocal (n = 6), enthesitis/synovitis/dactylitis (n = 1). The mean duration to symptoms was 46 weeks (range 6-119), mean CRP was 5.1 mg/dl and the majority were HLA-B27 negative and showed good clinical response for gut disease. Clinical features and Ultrasound showed severe enthesitis including PD change in 7 patients.All patients were initially treated with NSAIDs, 5 patients underwent local steroid injections. At 12 months 5/7 cases continued VDZ and 2 were switched to Ustekinumab. At 12 months follow-up of 7 cases, 5 patients were in clinical remission and 2 patients had mild enthesitis with minimal increase of PD signal. Also 4/7 severe patients developed marked post-inflammatory entheseal calcifications.

Conclusions: A predominant isolated severe enthesitis pattern of SpA may develop under VDZ therapy with severe disease in 8% of cases. Most cases continued VDZ therapy.
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http://dx.doi.org/10.1093/rheumatology/keab135DOI Listing
February 2021

Posterior Reversible Encephalopathy Syndrome After Azathioprine Administration in Severe Ulcerative Colitis.

ACG Case Rep J 2021 Jan 29;8(1):e00521. Epub 2021 Jan 29.

Gastroenterology Unit, IRCCS Ospedale Sacro Cuore-Don Calabria, Negrar di Valpolicella, Italy.

Posterior reversible encephalopathy syndrome is a rare syndrome characterized by brain edema and neurological symptoms, often resulting from several drugs. Treatment is based on discontinuation, and diagnosis is thus essential. Only 13 cases of posterior reversible encephalopathy syndrome have been reported in inflammatory bowel diseases, and we present the first after azathioprine in adults. A 56-year-old patient with active ulcerative colitis was found unconscious 5 days after the institution of azathioprine. Right-sided hemiplegia was found after the patient regained consciousness. Magnetic resonance imaging showed altered signal associated with diffusion restriction in the occipital lobe and cerebral vasogenic edema. Complete regression of neurological signs occurred after azathioprine discontinuation.
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http://dx.doi.org/10.14309/crj.0000000000000521DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846476PMC
January 2021

Anastomosis configuration and technique following ileocaecal resection for Crohn's disease: a multicentre study.

Updates Surg 2021 Feb 6;73(1):149-156. Epub 2021 Jan 6.

Department of Advanced Medical and Surgical Science, Universita' degli Studi della Campania Luigi Vanvitelli, Naples, Italy.

A limited ileocaecal resection is the most frequently performed procedure for ileocaecal CD and different anastomotic configurations and techniques have been described. This manuscript audited the different anastomotic techniques used in a national study and evaluated their influence on postoperative outcomes following ileocaecal resection for primary CD. This is a retrospective, multicentre, observational study promoted by the Italian Society of Colorectal Surgery (SICCR), including all adults undergoing elective ileocaecal resection for primary CD from June 2018 May 2019. Postoperative morbidity within 30 days of surgery was the primary endpoint. Postoperative length of hospital stay (LOS) and anastomotic leak rate were the secondary outcomes. 427 patients were included. The side to side anastomosis was the chosen configuration in 380 patients (89%). The stapled anastomotic (n = 286; 67%), techniques were preferred to hand-sewn (n = 141; 33%). Postoperative morbidity was 20.3% and anastomotic leak 3.7%. Anastomotic leak was independent of the type of anastomosis performed, while was associated with an ASA grade ≥ 3, presence of perianal disease and ileocolonic localization of disease. Four predictors of LOS were identified after multivariate analysis. The laparoscopic approach was the only associated with a reduced LOS (p = 0.017), while age, ASA grade ≥ 3 or administration of preoperative TPN were associated with increased LOS. The side to side was the most commonly used anastomotic configuration for ileocolic reconstruction following primary CD resection. There was no difference in postoperative morbidity according to anastomotic technique and configuration. Anastomotic leak was associated with ASA grade ≥ 3, a penetrating phenotype of disease and ileo-colonic distribution of CD.
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http://dx.doi.org/10.1007/s13304-020-00918-zDOI Listing
February 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

Role of Ulcerative Colitis Endoscopic Index of Severity (UCEIS) versus Mayo Endoscopic Subscore (MES) in Predicting Patients' Response to Biological Therapy and the Need for Colectomy.

Digestion 2021 31;102(4):534-545. Epub 2020 Jul 31.

IBD Unit, IRCCS Sacro Cuore Don Calabria, Negrar di Valpolicella, Italy.

Background: The main goal in the treatment of ulcerative colitis (UC) is to achieve mucosal healing. Despite being unvalidated, the most widely used scoring system is the Mayo endoscopic subscore (MES). However, the recently established and validated Ulcerative Colitis Endoscopic Index of Severity (UCEIS) represents an interesting alternative method in assessing endoscopic disease activity.

Objective: Due to a lack of reliable prognostic factors, the aim of this study was to investigate the diagnostic accuracy of the UCEIS and the MES, in predicting response to biological therapy and the need for colectomy.

Methods: We conducted a retrospective, uncontrolled, single-center study on UC patients with endoscopically active disease even with concomitant conventional and/or biological therapy, who had already started or had been changed a biological treatment.

Results: Sixty-one UC patients were enrolled. At baseline, 71% were naive to biological therapies and 41% had an extensive colitis. At control time (median time of 11.5 months), MES and UCEIS scores significantly decreased from those at baseline (from 2.6 to 1.8 and 5 to 3.2, respectively, p < 0.001). UCEIS, but not MES, was found to be significantly associated with unresponsiveness to therapy (p = 0.040). Moreover, when UCEIS was ≥7, all patients underwent colectomy after a median time of 5 months (p < 0.001).

Conclusion: UCEIS may be superior to MES because of its accuracy and predictive role. Therefore, UCEIS should be considered for use in daily clinical practice.
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http://dx.doi.org/10.1159/000509512DOI Listing
August 2021

A Challenging Colectomy for Acute Severe Ulcerative Colitis Complicated by COVID-19.

Inflamm Bowel Dis 2020 Sep;26(10):e120-e122

Department of Surgery, Istituto di Ricovero e Cura a Carattere Scientifico Sacro Cuore Don Calabria, Negrar di Valpolicella (Verona), Italy.

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http://dx.doi.org/10.1093/ibd/izaa186DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529110PMC
September 2020

The IBIS-Q (IBd Identification of Spondyloarthrytis Questionnaire): a novel tool to detect both Axial and Peripheral Arthritis in Inflammatory Bowel Disease patients.

J Crohns Colitis 2020 May 15. Epub 2020 May 15.

Rheumatology Unit, IRCCS Sacro Cuore Don Calabria, Negrar, Italy.

Background And Aimes: Both peripheral and axial spondyloarthritis (SpA) occurs in inflammatory bowel disease (IBD) and represents the commonest extra-intestinal manifestation. We aimed to develop an easy and quick questionnaire through psycometric analysis to identify peripheral and axial SpA in IBD patients within an integrated combined multidisciplinary rheumatological-gastroenterology clinic.

Methods: Initially, SpA-IBD experts generated a 42-item list covering SpA manifestations including spinal, articular and entheseal involvement. The new questionnaire was administered before routine clinical IBD assessment. In the same day Rheumatologic assessment blinded to both history and questionnaire results was performed to explore the presence of the Assessment of SpondyloArthritis international Society (ASAS) criteria for SpA, diagnostic criteria for fibromyalgia (FM) and non-specific low back pain (NSLB). Factorial analysis of questionnaire items to identify the main factors; ROC curves for sensitivity/specificity and Youden index for cut-off were performed.

Results: Of the 181 consecutive patients, 56 met the ASAS SpA criteria (prevalence of 30%) with 10 new cases detected (5.5%: 7 peripheral and 3 axial). Through the psychometric and factorial analysis, we selected 14-items for the final questionnaire (named IBIS-Q). The IBIS-Q was quick and performed well for detection of axial SpA and peripheral SpA (AUC 0.88 with CI 95% 0.83- 0.93). A cut-off of 3 positive questions had a sensitivity 93% and specificity 77%) for SpA patient identification.

Conclusions: The IBIS-Q is a useful and simple tool to use in IBD clinics for SpA detection, with a good statistical performance. Further studies are needed to validate it.
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http://dx.doi.org/10.1093/ecco-jcc/jjaa096DOI Listing
May 2020

Outcomes of COVID-19 in 79 patients with IBD in Italy: an IG-IBD study.

Gut 2020 07 30;69(7):1213-1217. Epub 2020 Apr 30.

IBD Center, Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy.

Objectives: COVID-19 has rapidly become a major health emergency worldwide. Patients with IBD are at increased risk of infection, especially when they have active disease and are taking immunosuppressive therapy. The characteristics and outcomes of COVID-19 in patients with IBD remain unclear.

Design: This Italian prospective observational cohort study enrolled consecutive patients with an established IBD diagnosis and confirmed COVID-19. Data regarding age, sex, IBD (type, treatments and clinical activity), other comorbidities (Charlson Comorbidity Index (CCI)), signs and symptoms of COVID-19 and therapies were compared with COVID-19 outcomes (pneumonia, hospitalisation, respiratory therapy and death).

Results: Between 11 and 29 March 2020, 79 patients with IBD with COVID-19 were enrolled at 24 IBD referral units. Thirty-six patients had COVID-19-related pneumonia (46%), 22 (28%) were hospitalised, 7 (9%) required non-mechanical ventilation, 9 (11%) required continuous positive airway pressure therapy, 2 (3%) had endotracheal intubation and 6 (8%) died. Four patients (6%) were diagnosed with COVID-19 while they were being hospitalised for a severe flare of IBD. Age over 65 years (p=0.03), UC diagnosis (p=0.03), IBD activity (p=0.003) and a CCI score >1 (p=0.04) were significantly associated with COVID-19 pneumonia, whereas concomitant IBD treatments were not. Age over 65 years (p=0.002), active IBD (p=0.02) and higher CCI score were significantly associated with COVID-19-related death.

Conclusions: Active IBD, old age and comorbidities were associated with a negative COVID-19 outcome, whereas IBD treatments were not. Preventing acute IBD flares may avoid fatal COVID-19 in patients with IBD. Further research is needed.
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http://dx.doi.org/10.1136/gutjnl-2020-321411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242872PMC
July 2020

Clinical and sonographic discrimination between fibromyalgia and spondyloarthopathy in inflammatory bowel disease with musculoskeletal pain.

Rheumatology (Oxford) 2020 Oct;59(10):2857-2863

Rheumatology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena.

Objectives: Joint pain is common in subjects with IBD and is linked to several factors including SpA, drug therapy, concomitant OA or FM. The primary aim of this study was to estimate the prevalence of primary FM and concomitant FM and SpA in a cohort of patients with IBD utilizing clinical and US assessment.

Methods: A total of 301 consecutive cases with IBD attending two IBD Units were assessed by a rheumatologist for Assessment of SpondyloArthritis International Society criteria fulfilment for SpA or the 2010 ACR criteria for FM. Some 158 cases also had US entheseal examination on large insertions in the upper and lower limbs.

Results: Thirty-seven IBD patients (12%) met the ACR criteria for primary FM with 9% presenting with primary FM and 3.3% presenting with concomitant FM and SpA. Meeting FM criteria was not related to smoking, sedentary job, BMI or the presence of psoriasis. FM patients presented higher Leeds Enthesitis Index, BASDAI and BASFI scores than SpA patients. At US examination, patients who satisfied the Assessment of SpondyloArthritis International Society criteria for SpA had significantly higher mean enthesis or patient power Doppler positive as compared with the IBD and FM group (P < 0.001).

Conclusion: We found that FM occurred in 12% of SpA patients and in this setting SpA disease activity indices performed poorly. US examination in a large patient subgroup showed a promising discriminating capacity between FM and SpA in IBD patients.
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http://dx.doi.org/10.1093/rheumatology/keaa036DOI Listing
October 2020

The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy.

Inflamm Bowel Dis 2019 02;25(3):568-579

Luigi Sacco University Hospital, Gastroenterology and IBD Unit, Milan, Italy.

Background: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.

Methods: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.

Results: Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naïve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19%), leading to cessation of the biosimilar in 103 subjects (12.7%). Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5%), being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4%), and 188 (25.6%) lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71%, 64%. and 82% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P < 0.0001) compared with baseline.

Conclusions: In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.
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http://dx.doi.org/10.1093/ibd/izy264DOI Listing
February 2019

Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real-life experience from two Italian IBD centers.

J Dig Dis 2018 Aug 31;19(8):468-474. Epub 2018 Aug 31.

IBD Unit, Gastroenterology Department, University of Florence, Careggi Hospital, Florence, Italy.

Objective: To evaluate the efficacy and safety of golimumab in biological naive and experienced patients with moderately to severely active ulcerative colitis (UC) treated at two Italian IBD centers.

Methods: We retrospectively reviewed our prospectively maintained UC database from March 2015 to March 2017. Patients received golimumab 200 mg at week 0, 100 mg at week 2, then 50 mg or 100 mg every 4 weeks. Follow-up was recorded at 12 and 24 weeks and in March 2017, with a median follow-up of 64 weeks. The main outcomes evaluated were clinical remission (CR) and adverse event rates.

Results: Of the 59 patients (44% naive and 56% experienced), CR rate was 47% at 12-week follow-up, 55% (among the 49 patients on treatment) at 24-week follow-up and 49% (among 35 patients on treatment) at the last follow-up visit. Median treatment duration was 52 weeks (interquartile range 30-64 weeks) among patients treated for >6 months. Overall, 10 (17%) patients experienced adverse events, of whom 50% discontinued treatment. The most frequent adverse events were infections. Biological naive and experienced patients did not differ in terms of CR and adverse event rates.

Conclusions: Our real-life experience showed that CR decreased over time and was achieved by almost one-third of the cohort at the last follow-up visit. Golimumab showed an overall favorable safety profile and the results were not different between biological naive and experienced patients. Future research is needed to confirm our results and to identify criteria to select patients most likely to respond.
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http://dx.doi.org/10.1111/1751-2980.12648DOI Listing
August 2018

The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar.

Inflamm Bowel Dis 2017 02;23(2):233-243

1IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Humanitas University, Rozzano, Italy; 2Department of Gastroenterology, AOU Careggi, Florence, Italy; 3IBD Unit, Complesso Integrato Columbus-Gemelli Hospital Catholic University Foundation, Rome, Italy; 4Department of Internal Medicine 2, IBD Unit, Riuniti Villa Sofia-Cervello Hospital, Palermo, Italy; 5Unit of Gastroenterology, Centro Malattie Retto-Intestinali, Sacro Cuore Don Calabria Hospital, Negrar, Italy; 6Gastroenterology Unit, IRCCS-CSS Hospital, San Giovanni Rotondo, Italy; 7Gastroenterology and IBD Unit, Luigi Sacco University Hospital, Milan, Italy; 8Unit of Gastroenterology, University of Padova, Padova, Italy; 9Department of Gastroenterology and Nutrition, Meyer Children's Hospital, Florence, Italy; 10Unit of Gastroenterology, S. Camillo-Forlanini Hospital, Rome, Italy; 11Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy; 12Department of Gastroenterology, IRCCS Policlinico, San Donato Milanese-Milano, Italy; 13Unit of Gastroenterology, AOUP, Pisa, Italy; 14Department of Gastroenterology and Endoscopy, AO Hospital, Legnano, Italy; 15Department of Systems Medicine, Gastroenterology, University of Rome Tor Vergata, Roma, Italy; 16Unit of Gastroenterology, AOU di Circolo Fondazione Macchi, Varese, Italy; 17Department of Gastroenterology, Ospedale Valduce, Como, Italy; and 18Department of Gastroenterology, Fatebenefratelli-Oftalmico Hospital, Milano, Italy.

Background: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease.

Methods: A prospective, multicenter, cohort study using a structured database.

Results: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64).

Conclusions: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.
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http://dx.doi.org/10.1097/MIB.0000000000000995DOI Listing
February 2017

A 35-year follow-up of a large cohort of patients with primary biliary cirrhosis seen at a single centre.

Liver Int 2011 Mar 8;31(3):361-8. Epub 2010 Nov 8.

Department of Surgical and Gastroenterological Sciences, University of Padova, Padova, Italy.

Background: The natural history of primary biliary cirrhosis (PBC) is still debated.

Aims: To evaluate: (i) long-term survival in a large cohort of PBC patients observed prospectively at a single centre and (ii) mortality in relation to baseline characteristics and ursodeoxycholic acid (UDCA) treatment.

Methods: We considered all consecutive patients between 1973 and 2007 (327 subjects; 310 females, 17 males).

Results: The mean follow-up was 9.1±7.7 years. The patients' age at diagnosis for representative periods (1973-1980, 1981-1990, 1991-2000, 2001-2007) increased progressively from 47.7±1.5 to 53.2±1.2, to 65.2±2.1 and then 63.6±2.9 years. The proportion of asymptomatic patients at diagnosis increased from 30 to 48% in the last decade, while associated symptoms of extrahepatic autoimmunity remained unchanged. Eighty patients (24.4%) died, 74 of them because of liver failure (12 patients developed hepatocellular carcinoma); nine patients underwent liver transplantation. From 1988 onwards, all patients were treated with UDCA (n=288). The mean age at death for the sample as a whole was 67.2±1.3 years. The survival probability at 20 years was 82% for patients with histological stages I-II at entry, 64% for those with stage III and 42% for those with stage IV (P=0.0007). Mortality was significantly reduced in patients treated with UDCA (P=0.012), whereas it was independently associated with oesophageal varices (P=0.015). Patients treated with UDCA had a better prognosis than those untreated, irrespective of the histological stage. Early treated subjects with a good response to UDCA have an 85% chance of survival at 20 years.

Conclusions: The clinical presentation of PBC has been changing over the years. Its early detection and early treatment improve the related survival rates.
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http://dx.doi.org/10.1111/j.1478-3231.2010.02366.xDOI Listing
March 2011

Hepatic expression of endocannabinoid receptors and their novel polymorphisms in primary biliary cirrhosis.

J Gastroenterol 2010 ;45(1):68-76

Department of Surgical and Gastroenterological Sciences, University of Padua, Via Giustiniani, 2, 35128 Padua, Italy.

Background: The endocannabinoid system (EC) has emerged as a crucial mediator in a variety of pathophysiological conditions.

Aims: To evaluate: (1) whether the EC system is activated in the livers of patients with primary biliary cirrhosis (PBC); (2) if genetic variations in human EC receptor genes (CB1 and CB2) may be associated with a different phenotypic expression of the disease and response to therapy.

Methods: The expression of CB1 and CB2 receptors was studied by immunohistochemistry in liver biopsy specimens from 13 patients with PBC, and CB1 and CB2 mRNA expression was studied by real-time polymerase chain reaction testing (RT-PCR) in liver samples. In addition, genetic polymorphisms in the EC receptor gene were sought in 68 patients with PBC from Italy, 84 patients who were residents of the United States (US), and 70 controls matched for sex, age, and for geographical area with the Italian PBC patients. Genomic DNA was extracted from peripheral venous blood leucocytes with standard methods. PCR was used to amplify the coding regions of the CB1 and CB2 genes with specific primers.

Results: CB1 was markedly expressed in hepatocytes and biliary epithelial cells in the livers of patients with PBC; conversely in control liver samples, it was virtually absent. CB2 was expressed in hepatocytes and in cholangiocytes, whereas it was absent from mesenchymal cells. The mRNA of both CB1 and CB2 was detected in the PBC liver samples, as demonstrated by RT-PCR. The CB1 polymorphism (1359 G/A) was present in 26.5% of Italian patients, in 22.9% of healthy controls, and in 27.4% of patients from the US (p = n.s.). The CB2 polymorphism (188-189 AA/GG) was present in 24.4 versus 30.4% of Italian and US patients with PBC, respectively, and in 28.0% of Italian controls samples (p = n.s.). Logistic regression analysis showed that advanced histological stage and the lack of response to ursodeoxycholic acid treatment were significantly correlated with the CB1 polymorphism.

Conclusions: The EC system is markedly up-regulated in the livers of patients with PBC and it may exert a role regulating adaptive mechanisms in cholestasis.
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http://dx.doi.org/10.1007/s00535-009-0122-yDOI Listing
April 2010

A novel multidrug-resistance protein 2 gene mutation identifies a subgroup of patients with primary biliary cirrhosis and pruritus.

Hepatology 2006 May;43(5):1152-4

Department of Surgical and Gastroenterological Sciences, University of Padova, Italy.

A single nucleotide polymorphism characterized by the substitution of valine for glutamate (V1188E) in exon 25 of the multidrug resistance protein 2 gene was found in a group of patients with primary biliary cirrhosis. This heterozygous mutation was significantly associated with the presence of pruritus.
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http://dx.doi.org/10.1002/hep.21165DOI Listing
May 2006
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