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Article ; Online: Tumor Necrosis Factor's Pathway in Crohn's Disease: Potential for Intervention.

Pagnini, Cristiano / Cominelli, Fabio

International journal of molecular sciences

2021 Volume 22, Issue 19

Abstract: Crohn's disease (CD) is a chronic disorder characterized by full thickness patchy inflammation of the gastrointestinal tract. The pathogenesis is multifactorial and involves defective innate immune responses, microbiome alterations, and dysregulated ... ...

Abstract	Crohn's disease (CD) is a chronic disorder characterized by full thickness patchy inflammation of the gastrointestinal tract. The pathogenesis is multifactorial and involves defective innate immune responses, microbiome alterations, and dysregulated activation of the acquired component of mucosal immunity. One of the molecular mediators that is involved at different levels in the initiation and progression of intestinal inflammation characteristic of CD is tumor necrosis factor (TNF). The present manuscript provides a comprehensive review focused on the potential role of TNF in the different phases of CD pathogenesis, particularly in light of its potential clinical implications. Currently available drugs blocking TNF are evaluated and discussed, specifically for open issues that still remain utilizing such therapy. TNF exerts a paramount role in the established phase of intestinal inflammation that characterizes CD patients, and anti-TNF biologics have definitely changed patient management, offering effective and safe options of treatment. Nonetheless, many patients still do not respond to anti-TNF therapy or experience unwanted side-effects. This could partially be due to the role that TNF plays in intestinal homeostasis that is particularly important during the early phase of the inflammatory process. In fact, emerging evidence supporting the dichotomous role of TNF and the identification of molecular markers will guide a more tailored and refined therapy for CD patients in the near future.
MeSH term(s)	Adalimumab/therapeutic use ; Anti-Inflammatory Agents/therapeutic use ; Certolizumab Pegol/therapeutic use ; Crohn Disease/etiology ; Crohn Disease/immunology ; Crohn Disease/therapy ; Humans ; Immunosuppressive Agents/therapeutic use ; Infliximab/therapeutic use ; Molecular Targeted Therapy/methods ; Tumor Necrosis Factor Inhibitors/therapeutic use ; Tumor Necrosis Factor-alpha/antagonists & inhibitors ; Tumor Necrosis Factor-alpha/immunology
Chemical Substances	Anti-Inflammatory Agents ; Immunosuppressive Agents ; TNF protein, human ; Tumor Necrosis Factor Inhibitors ; Tumor Necrosis Factor-alpha ; Infliximab (B72HH48FLU) ; Adalimumab (FYS6T7F842) ; Certolizumab Pegol (UMD07X179E)
Language	English
Publishing date	2021-09-24
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms221910273
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Article ; Online: Tumor Necrosis Factor’s Pathway in Crohn’s Disease

Cristiano Pagnini / Fabio Cominelli

International Journal of Molecular Sciences, Vol 22, Iss 10273, p

Potential for Intervention

2021 Volume 10273

Abstract: Crohn’s disease (CD) is a chronic disorder characterized by full thickness patchy inflammation of the gastrointestinal tract. The pathogenesis is multifactorial and involves defective innate immune responses, microbiome alterations, and dysregulated ... ...

Abstract	Crohn’s disease (CD) is a chronic disorder characterized by full thickness patchy inflammation of the gastrointestinal tract. The pathogenesis is multifactorial and involves defective innate immune responses, microbiome alterations, and dysregulated activation of the acquired component of mucosal immunity. One of the molecular mediators that is involved at different levels in the initiation and progression of intestinal inflammation characteristic of CD is tumor necrosis factor (TNF). The present manuscript provides a comprehensive review focused on the potential role of TNF in the different phases of CD pathogenesis, particularly in light of its potential clinical implications. Currently available drugs blocking TNF are evaluated and discussed, specifically for open issues that still remain utilizing such therapy. TNF exerts a paramount role in the established phase of intestinal inflammation that characterizes CD patients, and anti-TNF biologics have definitely changed patient management, offering effective and safe options of treatment. Nonetheless, many patients still do not respond to anti-TNF therapy or experience unwanted side-effects. This could partially be due to the role that TNF plays in intestinal homeostasis that is particularly important during the early phase of the inflammatory process. In fact, emerging evidence supporting the dichotomous role of TNF and the identification of molecular markers will guide a more tailored and refined therapy for CD patients in the near future.
Keywords	Crohn’s disease ; tumor necrosis factor ; anti-TNF ; infliximab ; adalimumab ; certolizumab ; Biology (General) ; QH301-705.5 ; Chemistry ; QD1-999
Subject code	610
Language	English
Publishing date	2021-09-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Safety and Potential Role of

Pagnini, Cristiano / Di Paolo, Maria Carla / Urgesi, Riccardo / Pallotta, Lorella / Fanello, Gianfranco / Graziani, Maria Giovanna / Delle Fave, Gianfranco

Microorganisms

2023 Volume 11, Issue 6

Abstract: Probiotics are microorganisms that confer benefits to the host, and, for this reason, they have been proposed in several pathologic states. Specifically, probiotic bacteria have been investigated as a therapeutic option in ulcerative colitis (UC) ... ...

Abstract	Probiotics are microorganisms that confer benefits to the host, and, for this reason, they have been proposed in several pathologic states. Specifically, probiotic bacteria have been investigated as a therapeutic option in ulcerative colitis (UC) patients, but clinical results are dishomogeneous. In particular, many probiotic species with different therapeutic schemes have been proposed, but no study has investigated probiotics in monotherapy in adequate trials for the induction of remission.
Language	English
Publishing date	2023-05-24
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms11061381
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Article ; Online: Corticosteroids in Inflammatory Bowel Disease Patients: A Practical Guide for Physicians.

Di Paolo, Maria Carla / Pagnini, Cristiano / Graziani, Maria Giovanna

Current reviews in clinical and experimental pharmacology

2020 Volume 16, Issue 3, Page(s) 210–218

Abstract: Inflammatory Bowel Diseases (IBDs) are chronic conditions characterized by unknown etiology and pathogenesis with deregulation of mucosal immunity. Among possible treatments, corticosteroids, already available from the '50s, are still the mainstay of ... ...

Abstract	Inflammatory Bowel Diseases (IBDs) are chronic conditions characterized by unknown etiology and pathogenesis with deregulation of mucosal immunity. Among possible treatments, corticosteroids, already available from the '50s, are still the mainstay of treatment for moderate to severe disease. Nonetheless, the use of steroids is still largely empirical and solid evidence about therapeutic schemes are lacking. Moreover, due to the important side-effects and for the unsatisfactory impact on the long-term natural history of the disease, the steroid-sparing has become an important therapeutic goal in IBD management. Besides conventional steroids, the so-called "low bioavailability" steroids, which are steroids with high affinity for peripheral receptors and elevated hepatic first-pass metabolism, have demonstrated efficacy and a more favorable safety profile. In the present review of the literature evidence of efficacy and safety of conventional and low bioavailability steroids in IBD patients are evaluated, and practical suggestions for a correct use in clinical practice are presented according to the current clinical guidelines.
MeSH term(s)	Adrenal Cortex Hormones/adverse effects ; Chronic Disease ; Colitis ; Humans ; Inflammatory Bowel Diseases/drug therapy ; Physicians
Chemical Substances	Adrenal Cortex Hormones
Language	English
Publishing date	2020-07-10
Publishing country	Netherlands
Document type	Journal Article ; Review
ISSN	2772-4336
ISSN (online)	2772-4336
DOI	10.2174/1574884715666200714114044
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Article ; Online: Fighting the Battle against SARS-CoV-2 as Gastroenterologists in Italy.

Pagnini, Cristiano / Urgesi, Riccardo / Di Paolo, Maria Carla / Graziani, Maria Giovanna

Gastroenterology

2020 Volume 159, Issue 4, Page(s) 1619

MeSH term(s)	Betacoronavirus ; COVID-19 ; Coronavirus Infections ; Gastroenterologists ; Humans ; Italy/epidemiology ; Pandemics ; Pneumonia, Viral ; SARS Virus ; SARS-CoV-2
Keywords	covid19
Language	English
Publishing date	2020-04-02
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	80112-4
ISSN	1528-0012 ; 0016-5085
ISSN (online)	1528-0012
ISSN	0016-5085
DOI	10.1053/j.gastro.2020.03.067
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Article ; Online: Histologic disease activity control as a therapeutic target in Crohn's disease patients: A word of caution.

Pagnini, Cristiano / Di Paolo, Maria Carla / Giordano, Marco / Graziani, Maria Giovanna

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

2020 Volume 52, Issue 5, Page(s) 591–592

MeSH term(s)	Colitis, Ulcerative/pathology ; Colon/pathology ; Colonoscopy ; Crohn Disease/pathology ; Humans ; Reproducibility of Results ; Retrospective Studies
Language	English
Publishing date	2020-02-11
Publishing country	Netherlands
Document type	Letter
ZDB-ID	1459373-7
ISSN	1878-3562 ; 1125-8055
ISSN (online)	1878-3562
ISSN	1125-8055
DOI	10.1016/j.dld.2020.01.003
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Article: Novel Pharmacological Therapy in Inflammatory Bowel Diseases: Beyond Anti-Tumor Necrosis Factor.

Pagnini, Cristiano / Pizarro, Theresa T / Cominelli, Fabio

Frontiers in pharmacology

2019 Volume 10, Page(s) 671

Abstract: Inflammatory bowel diseases (IBDs) are chronic conditions of the gastrointestinal tract in which dysregulated immune responses cause persistent inflammation of the gut mucosa. Biologic therapy with anti-TNF blockers has revolutionized the therapeutic ... ...

Abstract	Inflammatory bowel diseases (IBDs) are chronic conditions of the gastrointestinal tract in which dysregulated immune responses cause persistent inflammation of the gut mucosa. Biologic therapy with anti-TNF blockers has revolutionized the therapeutic management of IBD for their remarkable efficacy and potential impact on disease course and for many years has represented the sole treatment option for patients refractory or intolerant to conventional therapy. In recent years, more molecules, both biologically and chemically synthetized, have been developed as potential therapeutic options for IBD that target different molecular pathways aside from TNF blockade, and which have been proposed as targets for novel drugs. This is particularly relevant for the present, as well as future, management of IBD, considering that some patients are refractory to anti-TNF. This review will summarize the pharmacological options, either currently available or in the pipeline, for market approval to treat IBD, besides anti-TNF strategies, based on their mechanism(s) of action. We will also analyze the current evidence for effectiveness and safety, as well as offer perspective, regarding the potential implementation for such therapies in the future.
Language	English
Publishing date	2019-06-18
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2019.00671
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Article ; Online: Safety and Potential Role of Lactobacillus rhamnosus GG Administration as Monotherapy in Ulcerative Colitis Patients with Mild–Moderate Clinical Activity

Cristiano Pagnini / Maria Carla Di Paolo / Riccardo Urgesi / Lorella Pallotta / Gianfranco Fanello / Maria Giovanna Graziani / Gianfranco Delle Fave

Microorganisms, Vol 11, Iss 1381, p

2023 Volume 1381

Abstract	Probiotics are microorganisms that confer benefits to the host, and, for this reason, they have been proposed in several pathologic states. Specifically, probiotic bacteria have been investigated as a therapeutic option in ulcerative colitis (UC) patients, but clinical results are dishomogeneous. In particular, many probiotic species with different therapeutic schemes have been proposed, but no study has investigated probiotics in monotherapy in adequate trials for the induction of remission. Lactobacillus rhamnosus GG (LGG) is the more intensively studied probiotic and it has ideal characteristics for utilization in UC patients. The aim of the present study is to investigate the clinical efficacy and safety of LGG administration in an open trial, delivered in monotherapy at two different doses, in UC patients with mild–moderate disease. The UC patients with mild–moderate disease activity (Partial Mayo score ≥ 2) despite treatment with oral mesalamine were included. The patients stopped oral mesalamine and were followed up for one month, then were randomized to receive LGG supplement at dose of 1.2 or 2.4 × 10 10 CFU/day for one month. At the end of the study, the clinical activity was evaluated and compared to that at the study entrance (efficacy). Adverse events were recorded (safety). The primary end-point was clinical improvement (reduction in the Partial Mayo score) and no serious adverse events, while the secondary end-points were the evaluation of different efficacies and safeties between the two doses of LGG. The patients with disease flares dropped out of the study and went back to standard therapy. The efficacy data were analyzed in an intention-to-treat (ITT) and per-protocol (PP) analysis. Out of the 76 patients included in the study, 75 started the probiotic therapy ( n = 38 and 37 per group). In the ITT analysis, 32/76 (42%) responded to treatment, 21/76 (28%) remained stable, and 23/76 (30%) had a worsening of their clinical condition; 55 (72%) completed the treatment and were analyzed in a PP ...
Keywords	microbiota ; probiotics ; inflammatory bowel diseases ; ulcerative colitis ; Biology (General) ; QH301-705.5
Subject code	610
Language	English
Publishing date	2023-05-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Probiotics and Vitamin D/Vitamin D Receptor Pathway Interaction: Potential Therapeutic Implications in Inflammatory Bowel Disease.

Pagnini, Cristiano / Di Paolo, Maria Carla / Graziani, Maria Giovanna / Delle Fave, Gianfranco

Frontiers in pharmacology

2021 Volume 12, Page(s) 747856

Abstract: Inflammatory bowel diseases (IBD) are chronic conditions of unknown etiology and immunomediated pathogenesis. In the last years, the comprehension of the complex mechanisms involved in the intestinal mucosal homeostasis, and the analysis of the ... ...

Abstract	Inflammatory bowel diseases (IBD) are chronic conditions of unknown etiology and immunomediated pathogenesis. In the last years, the comprehension of the complex mechanisms involved in the intestinal mucosal homeostasis, and the analysis of the alterations potentially leading to inflammatory pathologic states, has consistently increased. Specifically, the extraordinary impulse in the field of research of the intestinal microbiome has opened the door to the investigation of possible novel approaches to the diagnosis, management and therapeutic applications in IBD. In line with that, administration of probiotic bacteria has been intensely evaluated, leading to much more exciting results in experimental models than in clinical practice. Considering the consistent heterogeneity of the available studies on probiotics, the increased knowledge of the properties of the single bacterial species would ideally lead to unravel potential mechanisms of action that may bring therapeutic applications in specific pathologic condition. Among the relevant molecular pathways for mucosal homeostasis maintenance, the vitamin D/vitamin D receptor (VDR) pathway has been intensely studied in the very last years. In fact, besides osteometabolic functions, the vitamin D exerts important homeostatic effects in the organism at multiple levels, such as immunomodulation, inflammation control, and microbiota regulation, which are likely to play a relevant role in intestinal mucosa protection. In the present review, recent findings about probiotic applications in IBD and mechanisms of action linking vitamin D/VDR pathway to IBD are reported. Available evidence for probiotic effect on vitamin D/VDR are reviewed and potential future application in IBD patients are discussed. At present, many aspects of IBD pathogenesis are still obscure, and current therapeutic options for IBD treatment are at best suboptimal. The increasing comprehension of the different pathways involved in IBD pathogenesis will lead to novel findings ideally leading to potential clinical applications. Microbiota manipulation and vitamin/VDR pathway appear a promising field for future research and therapeutic developments.
Language	English
Publishing date	2021-11-24
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2021.747856
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Article: Systematic Review with Network Meta-Analysis: Efficacy of Induction Therapy with a Second Biological Agent in Anti-TNF-Experienced Crohn's Disease Patients.

Pagnini, Cristiano / Siakavellas, Spyros I / Bamias, Giorgos

Gastroenterology research and practice

2018 Volume 2018, Page(s) 6317057

Abstract: Background and aim: Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract with the potential to progress to a severe debilitating state. Treatment with biological agents is highly efficient, improving both short-term ... ...

Abstract	Background and aim: Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract with the potential to progress to a severe debilitating state. Treatment with biological agents is highly efficient, improving both short-term outcomes and long-term prognosis. Nonetheless, up to 60% of patients receiving biological therapy will exhibit nonresponse at some point. The optimal management of such patients is not clearly defined. Besides traditional anti-TNF agents (infliximab, adalimumab, and certolizumab), alternative biological therapies (natalizumab, vedolizumab, and ustekinumab) are currently available for the treatment of CD. Our aim was to analyze all available evidence regarding efficacy of a second biological in "biological-treatment-experienced" patients. Methods: A systematic review of the literature was conducted using specific criteria for selecting relevant randomized clinical trials evaluating response to administration of secondary biological therapy in "anti-TNF-experienced" CD patients. Data from these studies was used to perform (a) traditional meta-analysis to ascertain the effect of secondary treatment versus placebo and (b) network meta-analysis to compare indirectly the efficacy of available biological agents. Results: Out of initially 977 studies, only eight were included for analysis, providing a total of 1281 treated and 733 placebo-receiving CD patients. Treatment with a second biological was found to be superior to placebo for both induction of remission (OR 2.2, 95% CI 1.7 to 3) and response (OR 1.9, 95% CI 1.5 to 2.5), with global rates of 24% and 42%, respectively (placebo rate: 11% and 27%, Conclusion: In anti-TNF-experienced CD patients, secondary biological administration may be efficient, while no specific agent seems to outperform the others. Further research is needed to identify optimal management strategies for this challenging subset of patients.
Language	English
Publishing date	2018-07-17
Publishing country	Egypt
Document type	Journal Article ; Review
ZDB-ID	2435460-0
ISSN	1687-630X ; 1687-6121
ISSN (online)	1687-630X
ISSN	1687-6121
DOI	10.1155/2018/6317057
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