Renato Sablich - Academia.edu (original) (raw)
Papers by Renato Sablich
Scientific Reports
There are no prospective, head-to-head, controlled trials comparing the efficacy and safety of In... more There are no prospective, head-to-head, controlled trials comparing the efficacy and safety of Infliximab (IFX) and Vedolizumab (VDZ) for the treatment of moderate-to-severe ulcerative colitis (UC), while only a few real-life retrospective studies have been published so far. We assessed the efficacy of IFX vs. VDZ in two cohorts of biologic-naïve outpatients with moderate-to-severe UC or mild, but refractory, disease. Data were extracted from patients’ files and reviewed. The duration of follow-up (FU) was 52 weeks. The primary endpoint was the clinical remission (CR) at the end of FU. Secondary endpoints were: drug persistency, time to obtain CR, clinical response at the end of the induction phase (IP), steroid-free CR (compared to patients who used steroids at baseline) at the end of FU, need for drug optimization, adverse events (AEs), and normalization of C-reactive protein (CRP). We also analyzed the causes of dropping out (primary non-response), or secondary loss of response (...
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Alimentary Pharmacology & Therapeutics
SummaryBackgroundVedolizumab registration trials were the first to include elderly patients with ... more SummaryBackgroundVedolizumab registration trials were the first to include elderly patients with moderate‐to‐severe ulcerative colitis (UC) or Crohn’s disease (CD), but few real‐life data have been reported in this population.AimsWe investigated the effectiveness and safety of vedolizumab in matched cohorts of elderly and nonelderly UC and CD patients.MethodsThe Long‐term Italian Vedolizumab Effectiveness (LIVE) study is a retrospective‐prospective study including UC and CD patients who started vedolizumab from April 2016 to June 2017. Elderly patients (≥65 years) were matched clinically 1:2 to nonelderly patients (18–64 years); the 2 groups were followed until drug discontinuation or June 2019.ResultsThe study included 198 elderly (108 UC, 90 CD) and 396 matched nonelderly patients (205 UC, 191 CD). Nonelderly UC patients had a significantly higher persistence on vedolizumab compared to elderly patients (67.6% vs. 51.4%, p = 0.02). No significant difference in effectiveness was obs...
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Supplemental material, sj-pdf-1-tag-10.1177_17562848211031420 for A propensity score-weighted com... more Supplemental material, sj-pdf-1-tag-10.1177_17562848211031420 for A propensity score-weighted comparison between adalimumab originator and its biosimilars, ABP501 and SB5, in inflammatory bowel disease: a multicenter Italian study by Brigida Barberio, Linda Cingolani, Cristina Canova, Giulia Barbieri, Renato Sablich, Maria Teresa Urbano, Lorenzo Bertani, Francesco Costa, Giorgia Bodini, Maria Giulia Demarzo, Antonio Ferronato, Andrea Buda, Piera Melatti, Davide Massimi, Edoardo Vincenzo Savarino and Fabiana Zingone in Therapeutic Advances in Gastroenterology
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Therapeutic Advances in Gastroenterology, 2021
Background: Adalimumab is an effective and safe biological drug for the treatment of inflammatory... more Background: Adalimumab is an effective and safe biological drug for the treatment of inflammatory bowel disease (IBD). Nowadays, several biosimilar agents are available, but data regarding their efficacy and safety in patients with IBD are still lacking. We aimed to compare the effectiveness and tolerability between adalimumab originator, ABP501 and SB5 biosimilars in patients with IBD in the short term (after induction and after 6 months of treatment) through a propensity score-weighted multicenter cohort study. Methods: We included 156 patients with IBD, 69 patients with ulcerative colitis and 87 patients with Crohn’s disease (CD) receiving ABP501 or SB5 biosimilars from January 2019 to April 2020 for moderate-to-severe disease. For comparison, a group of age- and sex-matched patients treated with adalimumab originator was used. We collected clinical and biochemical data after induction and at 6 months of treatment. Endoscopic data were recorded only at baseline. Results: Overall,...
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United European Gastroenterology Journal, 2021
BackgroundFew data exist regarding the long‐term effectiveness of golimumab in ulcerative colitis... more BackgroundFew data exist regarding the long‐term effectiveness of golimumab in ulcerative colitis. No data have been reported on real‐world continuous clinical response.ObjectiveThis study aimed to describe the long‐term outcomes in a large cohort of patients on golimumab who had ulcerative colitis.MethodsConsecutive 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.ResultsA 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 t...
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Digestive and Liver Disease, 2020
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Digestive and Liver Disease, 2018
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Gastroenterology, 2020
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Gastroenterology, 2020
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Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, Jan 18, 2017
Perception of quality of care is important in the management of patients with chronic diseases, p... more Perception of quality of care is important in the management of patients with chronic diseases, particularly inflammatory bowel disease. This longitudinal study aimed to investigate variations of the Quality of Care through the Patients' Eyes (QUOTE-IBD) questionnaire scores one year after the basal evaluation in the Studio Osservazionale quaLità cUre malatTIe crOniche intestiNali (SOLUTION-1) study. Of the cohort of 992 patients, 936 were evaluable. The QUOTE-IBD score overcame satisfactory levels of more than the 80%, overall and in all subdomains except for the "Continuity of Care" sub-dimension (mean, 8.3; standard deviation, 1.49), scored satisfactory only by 34% of the patients. No significant changes in satisfaction were recorded overall, or considering patients subgroups. Significant differences were found at the end of the follow-up between physicians' and patients' perceptions of quality of care, with the former over-rating their performance in "...
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Journal of Crohn's and Colitis Supplements, 2007
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Minerva dietologica e gastroenterologica
Smoking habit has been evaluated in 108 patients with gastric or duodenal ulcer diagnosed by endo... more Smoking habit has been evaluated in 108 patients with gastric or duodenal ulcer diagnosed by endoscopy and in a control group of 147 endoscopically normal subjects. We found a positive association for both the gastric and duodenal ulcer (relative risk of 3.5). Furthermore, an increasing risk was associated both with the duration of smoking and with the amount of cigarettes smoked daily. Conversely, no significant association was demonstrated between peptic ulcer and the more os less precocious age at starting smoking or with the nicotine and tar content of the cigarettes usually smoked. Among ex-smokers, an increasing risk (relative risk of 2.0) was observed for gastric ulcer only.
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Acta chirurgica Scandinavica
A symptomatic leiomyoma of the upper esophagus was successfully removed through a fiberoptic endo... more A symptomatic leiomyoma of the upper esophagus was successfully removed through a fiberoptic endoscope in an 84-year-old man. Endoscopic resection via flexible endoscope may be considered as an option in treating selected cases of esophageal leiomyoma and for high surgical risk patients.
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Digestive and Liver Disease, 2014
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Surgical Endoscopy, 1991
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Journal of Clinical Apheresis, 2011
Leukocytes are thought to play an important role in the pathogenesis of inflammatory bowel diseas... more Leukocytes are thought to play an important role in the pathogenesis of inflammatory bowel diseases; granulocyte–monocyte adsorptive (GMA) apheresis, an extracorporeal technique aimed at removing activated circulating leukocytes from the blood, may represent a safe and effective therapeutic tool in these patients. The Italian Registry of Therapeutic Apheresis performed an observational, multicentric study involving 24 Gastroenterology Units. In this study, laboratory data and clinical outcomes of 230 patients (148 males, mean age 43.5 years) affected with ulcerative colitis (UC, n = 194) or Crohn's disease (CD, n = 36) who underwent one or more cycles of GMA were analyzed. Each cycle consisted of five GMA treatments. The patients were followed up for a mean of 8.7 (min. 3 to max. 12) months. At 3 months, positive outcome was achieved in 77.7% of UC patients (72.0% remission, 5.7% clinical response) and 61.3% of CD patients (54.8% remission, 6.5% clinical response). The cumulativ...
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Digestive Diseases and Sciences, 2002
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International Journal of Cancer, 2001
Barrett's esophagus (BE) is an acquired disorder due to chronic gastroesophageal reflux. Envi... more Barrett's esophagus (BE) is an acquired disorder due to chronic gastroesophageal reflux. Environmental factors seem to play an important role in the pathogenesis of BE, especially in Western society. A multicenter case‐control study was carried out between February 1995 and April 1999 in 8 Italian Departments of Gastroenterology gathered in a study group (GOSPE), in order to analyze the influence of some individual characteristics and life‐style habits on the occurrence of BE. Three groups of patients were studied: 149 patients with BE, 143 patients with esophagitis (E) and 308 hospital controls (C) with acute, non‐neoplastic, non‐gastroenterological conditions. The diagnosis of BE was based on endoscopy and histology. E was defined by the Savary classification (grade I–III). Data collection was performed by using a questionnaire that focused on smoking, coffee and alcohol consumption, medical history, drugs history, gastroesophageal reflux disease (GERD) symptoms (heartburn, re...
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Gastroenterology, 2001
... Articles In Press; Supplements. Collections: AGA Policy and Position Papers; Clinical Challen... more ... Articles In Press; Supplements. Collections: AGA Policy and Position Papers; Clinical Challenges and Images in GI; Correspondence; ... Mara Formasarig ,; Andrea Veronesi ,; Ettore Bidoli ,; Concetta Paolello ,; Renato Cannizzaro ,; Simon Spazzapan ,; Alessandro Vram ,; Mario Frezza ...
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Scientific Reports
There are no prospective, head-to-head, controlled trials comparing the efficacy and safety of In... more There are no prospective, head-to-head, controlled trials comparing the efficacy and safety of Infliximab (IFX) and Vedolizumab (VDZ) for the treatment of moderate-to-severe ulcerative colitis (UC), while only a few real-life retrospective studies have been published so far. We assessed the efficacy of IFX vs. VDZ in two cohorts of biologic-naïve outpatients with moderate-to-severe UC or mild, but refractory, disease. Data were extracted from patients’ files and reviewed. The duration of follow-up (FU) was 52 weeks. The primary endpoint was the clinical remission (CR) at the end of FU. Secondary endpoints were: drug persistency, time to obtain CR, clinical response at the end of the induction phase (IP), steroid-free CR (compared to patients who used steroids at baseline) at the end of FU, need for drug optimization, adverse events (AEs), and normalization of C-reactive protein (CRP). We also analyzed the causes of dropping out (primary non-response), or secondary loss of response (...
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Alimentary Pharmacology & Therapeutics
SummaryBackgroundVedolizumab registration trials were the first to include elderly patients with ... more SummaryBackgroundVedolizumab registration trials were the first to include elderly patients with moderate‐to‐severe ulcerative colitis (UC) or Crohn’s disease (CD), but few real‐life data have been reported in this population.AimsWe investigated the effectiveness and safety of vedolizumab in matched cohorts of elderly and nonelderly UC and CD patients.MethodsThe Long‐term Italian Vedolizumab Effectiveness (LIVE) study is a retrospective‐prospective study including UC and CD patients who started vedolizumab from April 2016 to June 2017. Elderly patients (≥65 years) were matched clinically 1:2 to nonelderly patients (18–64 years); the 2 groups were followed until drug discontinuation or June 2019.ResultsThe study included 198 elderly (108 UC, 90 CD) and 396 matched nonelderly patients (205 UC, 191 CD). Nonelderly UC patients had a significantly higher persistence on vedolizumab compared to elderly patients (67.6% vs. 51.4%, p = 0.02). No significant difference in effectiveness was obs...
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Supplemental material, sj-pdf-1-tag-10.1177_17562848211031420 for A propensity score-weighted com... more Supplemental material, sj-pdf-1-tag-10.1177_17562848211031420 for A propensity score-weighted comparison between adalimumab originator and its biosimilars, ABP501 and SB5, in inflammatory bowel disease: a multicenter Italian study by Brigida Barberio, Linda Cingolani, Cristina Canova, Giulia Barbieri, Renato Sablich, Maria Teresa Urbano, Lorenzo Bertani, Francesco Costa, Giorgia Bodini, Maria Giulia Demarzo, Antonio Ferronato, Andrea Buda, Piera Melatti, Davide Massimi, Edoardo Vincenzo Savarino and Fabiana Zingone in Therapeutic Advances in Gastroenterology
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Therapeutic Advances in Gastroenterology, 2021
Background: Adalimumab is an effective and safe biological drug for the treatment of inflammatory... more Background: Adalimumab is an effective and safe biological drug for the treatment of inflammatory bowel disease (IBD). Nowadays, several biosimilar agents are available, but data regarding their efficacy and safety in patients with IBD are still lacking. We aimed to compare the effectiveness and tolerability between adalimumab originator, ABP501 and SB5 biosimilars in patients with IBD in the short term (after induction and after 6 months of treatment) through a propensity score-weighted multicenter cohort study. Methods: We included 156 patients with IBD, 69 patients with ulcerative colitis and 87 patients with Crohn’s disease (CD) receiving ABP501 or SB5 biosimilars from January 2019 to April 2020 for moderate-to-severe disease. For comparison, a group of age- and sex-matched patients treated with adalimumab originator was used. We collected clinical and biochemical data after induction and at 6 months of treatment. Endoscopic data were recorded only at baseline. Results: Overall,...
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United European Gastroenterology Journal, 2021
BackgroundFew data exist regarding the long‐term effectiveness of golimumab in ulcerative colitis... more BackgroundFew data exist regarding the long‐term effectiveness of golimumab in ulcerative colitis. No data have been reported on real‐world continuous clinical response.ObjectiveThis study aimed to describe the long‐term outcomes in a large cohort of patients on golimumab who had ulcerative colitis.MethodsConsecutive 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.ResultsA 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 t...
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Digestive and Liver Disease, 2020
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Digestive and Liver Disease, 2018
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Gastroenterology, 2020
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Gastroenterology, 2020
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Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, Jan 18, 2017
Perception of quality of care is important in the management of patients with chronic diseases, p... more Perception of quality of care is important in the management of patients with chronic diseases, particularly inflammatory bowel disease. This longitudinal study aimed to investigate variations of the Quality of Care through the Patients' Eyes (QUOTE-IBD) questionnaire scores one year after the basal evaluation in the Studio Osservazionale quaLità cUre malatTIe crOniche intestiNali (SOLUTION-1) study. Of the cohort of 992 patients, 936 were evaluable. The QUOTE-IBD score overcame satisfactory levels of more than the 80%, overall and in all subdomains except for the "Continuity of Care" sub-dimension (mean, 8.3; standard deviation, 1.49), scored satisfactory only by 34% of the patients. No significant changes in satisfaction were recorded overall, or considering patients subgroups. Significant differences were found at the end of the follow-up between physicians' and patients' perceptions of quality of care, with the former over-rating their performance in "...
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Journal of Crohn's and Colitis Supplements, 2007
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Minerva dietologica e gastroenterologica
Smoking habit has been evaluated in 108 patients with gastric or duodenal ulcer diagnosed by endo... more Smoking habit has been evaluated in 108 patients with gastric or duodenal ulcer diagnosed by endoscopy and in a control group of 147 endoscopically normal subjects. We found a positive association for both the gastric and duodenal ulcer (relative risk of 3.5). Furthermore, an increasing risk was associated both with the duration of smoking and with the amount of cigarettes smoked daily. Conversely, no significant association was demonstrated between peptic ulcer and the more os less precocious age at starting smoking or with the nicotine and tar content of the cigarettes usually smoked. Among ex-smokers, an increasing risk (relative risk of 2.0) was observed for gastric ulcer only.
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Acta chirurgica Scandinavica
A symptomatic leiomyoma of the upper esophagus was successfully removed through a fiberoptic endo... more A symptomatic leiomyoma of the upper esophagus was successfully removed through a fiberoptic endoscope in an 84-year-old man. Endoscopic resection via flexible endoscope may be considered as an option in treating selected cases of esophageal leiomyoma and for high surgical risk patients.
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Digestive and Liver Disease, 2014
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Surgical Endoscopy, 1991
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Journal of Clinical Apheresis, 2011
Leukocytes are thought to play an important role in the pathogenesis of inflammatory bowel diseas... more Leukocytes are thought to play an important role in the pathogenesis of inflammatory bowel diseases; granulocyte–monocyte adsorptive (GMA) apheresis, an extracorporeal technique aimed at removing activated circulating leukocytes from the blood, may represent a safe and effective therapeutic tool in these patients. The Italian Registry of Therapeutic Apheresis performed an observational, multicentric study involving 24 Gastroenterology Units. In this study, laboratory data and clinical outcomes of 230 patients (148 males, mean age 43.5 years) affected with ulcerative colitis (UC, n = 194) or Crohn's disease (CD, n = 36) who underwent one or more cycles of GMA were analyzed. Each cycle consisted of five GMA treatments. The patients were followed up for a mean of 8.7 (min. 3 to max. 12) months. At 3 months, positive outcome was achieved in 77.7% of UC patients (72.0% remission, 5.7% clinical response) and 61.3% of CD patients (54.8% remission, 6.5% clinical response). The cumulativ...
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Digestive Diseases and Sciences, 2002
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International Journal of Cancer, 2001
Barrett's esophagus (BE) is an acquired disorder due to chronic gastroesophageal reflux. Envi... more Barrett's esophagus (BE) is an acquired disorder due to chronic gastroesophageal reflux. Environmental factors seem to play an important role in the pathogenesis of BE, especially in Western society. A multicenter case‐control study was carried out between February 1995 and April 1999 in 8 Italian Departments of Gastroenterology gathered in a study group (GOSPE), in order to analyze the influence of some individual characteristics and life‐style habits on the occurrence of BE. Three groups of patients were studied: 149 patients with BE, 143 patients with esophagitis (E) and 308 hospital controls (C) with acute, non‐neoplastic, non‐gastroenterological conditions. The diagnosis of BE was based on endoscopy and histology. E was defined by the Savary classification (grade I–III). Data collection was performed by using a questionnaire that focused on smoking, coffee and alcohol consumption, medical history, drugs history, gastroesophageal reflux disease (GERD) symptoms (heartburn, re...
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Gastroenterology, 2001
... Articles In Press; Supplements. Collections: AGA Policy and Position Papers; Clinical Challen... more ... Articles In Press; Supplements. Collections: AGA Policy and Position Papers; Clinical Challenges and Images in GI; Correspondence; ... Mara Formasarig ,; Andrea Veronesi ,; Ettore Bidoli ,; Concetta Paolello ,; Renato Cannizzaro ,; Simon Spazzapan ,; Alessandro Vram ,; Mario Frezza ...
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