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Article: Controversies in the management of anti-TNF therapy in patients with Crohn's disease: a Delphi consensus.

González-Lama, Yago / Ricart, Elena / Carpio, Daniel / Bastida, Guillermo / Ceballos, Daniel / Ginard, Daniel / Marin-Jimenez, Ignacio / Menchen, Luis / Muñoz, Fernando

BMJ open gastroenterology

2024 Volume 11, Issue 1

Abstract: Background: Despite research, there are still controversial areas in the management of Crohn's disease (CD).: Objective: To establish practical recommendations on using anti-tumour necrosis factor (TNF) drugs in patients with moderate-to-severe CD.!## ...

Abstract	Background: Despite research, there are still controversial areas in the management of Crohn's disease (CD). Objective: To establish practical recommendations on using anti-tumour necrosis factor (TNF) drugs in patients with moderate-to-severe CD. Methods: Clinical controversies in the management of CD using anti-TNF therapies were identified. A comprehensive literature review was performed, and a national survey was launched to examine current clinical practices when using anti-TNF therapies. Their results were discussed by expert gastroenterologists within a nominal group meeting, and a set of statements was proposed and tested in a Delphi process. Results: Qualitative study. The survey and Delphi process were sent to 244 CD-treating physicians (response rate: 58%). A total of 14 statements were generated. All but two achieved agreement. These statements cover: (1) use of first-line non-anti-TNF biological therapy; (2) role of HLA-DQA105 in daily practice; (3) attitudes in primary non-response and loss of response to anti-TNF therapy due to immunogenicity; (4) use of ustekinumab or vedolizumab if a change in action mechanism is warranted; (5) anti-TNF drug level monitoring; (6) combined therapy with an immunomodulator. Conclusion:* This document sought to pull together the best evidence, experts' opinions, and treating physicians' attitudes when using anti-TNF therapies in patients with CD.
MeSH term(s)	Humans ; Crohn Disease/drug therapy ; Tumor Necrosis Factor Inhibitors/therapeutic use ; Delphi Technique ; Necrosis
Chemical Substances	Tumor Necrosis Factor Inhibitors
Language	English
Publishing date	2024-01-23
Publishing country	England
Document type	Review ; Journal Article
ISSN	2054-4774
ISSN	2054-4774
DOI	10.1136/bmjgast-2023-001246
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Medical consultation in ulcerative colitis: Key elements for improvement.

González-Lama, Yago / Ricart, Elena / Cábez, Ana / Fortes, Pilar / Gómez, Susana / Casellas, Francesc

World journal of gastroenterology

2023 Volume 29, Issue 6, Page(s) 917–925

Abstract: Ulcerative colitis (UC) is a chronic inflammatory disease with a high impact. In order to improve patient outcomes, the clinician-patient relationship in daily practice is critical. Clinical guidelines provide a framework for UC diagnosis and treatment. ... ...

Abstract	Ulcerative colitis (UC) is a chronic inflammatory disease with a high impact. In order to improve patient outcomes, the clinician-patient relationship in daily practice is critical. Clinical guidelines provide a framework for UC diagnosis and treatment. However, standard procedures and the medical content focused upon medical consultations in UC patients has not yet been defined. Moreover, UC is a complex disease, given that patient characteristics and patient needs have been proven to vary during clinical consultation since establishing the diagnosis and upon the course of the disease. In this article, we have discussed the key elements and specific objectives to consider in medical consultation, such as diagnosis, first visits, follow-up visits, active disease patients, patients on topical therapies, new treatment initiation, refractory patients, extra-intestinal manifestations, as well as challenging situations. The key elements have been mentioned to comprise effective communication techniques, motivational interviewing (MI), as well as information and educational aspects, or organizational issues. The key elements to be implemented in daily practice were reported to comprise several general principles like duly prepared consultations, in addition to honesty and empathy with patients, as well as effective communication techniques, MI, information and educational points, or organizational issues. The role of other healthcare professionals such as specialized nurses, psychologists, or the use of checklists was also discussed and commented on.
MeSH term(s)	Humans ; Colitis, Ulcerative/diagnosis ; Colitis, Ulcerative/therapy ; Referral and Consultation
Language	English
Publishing date	2023-02-20
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2185929-2
ISSN	2219-2840 ; 1007-9327
ISSN (online)	2219-2840
ISSN	1007-9327
DOI	10.3748/wjg.v29.i6.917
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Article ; Online: Current status of mesenchymal stem cell therapy and bone marrow transplantation in IBD.

Ricart, Elena

Digestive diseases (Basel, Switzerland)

2012 Volume 30, Issue 4, Page(s) 387–391

Abstract: Cellular therapy is a promising new approach to address unmet medical needs in patients with IBD, mainly Crohn's disease (CD). Two series have reported autologous hematopoietic stem cell transplantation (HSCT) for CD. The largest one is a phase I study ... ...

Abstract	Cellular therapy is a promising new approach to address unmet medical needs in patients with IBD, mainly Crohn's disease (CD). Two series have reported autologous hematopoietic stem cell transplantation (HSCT) for CD. The largest one is a phase I study from Chicago including 24 patients with active CD refractory to conventional therapies. All patients went into remission with a CD Activity Index (CDAI) <150. The percentage of clinical relapse-free survival was 91% at 1 year, 63% at 2 years, 57% at 3 years, 39% at 4 years and 19% at 5 years. The percentage of patients in remission (CDAI <150), steroid-free or medication-free at any post-transplantation evaluation interval remained ≥70, ≥80 and ≥60%, respectively. In Europe and Canada, a currently ongoing randomized trial hopes to answer the question of whether autologous HSCT adds any benefit to the effect of immunosuppression used during mobilization. Although promising, HSCT for CD is still experimental and its toxicity leaves this option for a considerably reduced number of refractory patients in whom the disease is not amenable to surgical resection. A more recently developed, less aggressive approach involves the use of mesenchymal stem cells (MSCs). Successful pre-clinical studies using MSCs in models of autoimmunity, inflammation or tissue damage have paved the way for clinical trials. Two phase I studies on autologous bone marrow-derived MSCs for the treatment of active refractory CD have been published recently; one using systemic administration in patients with luminal CD and the other assessing the effects of local injection of MSCs for the treatment of fistulizing CD, showing that application of autologous MSCs is feasible, well tolerated and might produce clinical benefits.
MeSH term(s)	Animals ; Bone Marrow Transplantation ; Hematopoietic Stem Cell Transplantation ; Humans ; Inflammatory Bowel Diseases/therapy ; Mesenchymal Stem Cell Transplantation ; Mesenchymal Stromal Cells/cytology
Language	English
Publishing date	2012
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	632798-9
ISSN	1421-9875 ; 0257-2753
ISSN (online)	1421-9875
ISSN	0257-2753
DOI	10.1159/000338134
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Article ; Online: Magnetic resonance enterography findings 46 weeks after initiation of biological therapy predict long-term adverse outcomes in Crohn's disease.

Fernández-Clotet, Agnès / Ordás, Ingrid / Masamunt, Maria Carme / Caballol, Berta / Rodríguez, Sonia / Gallego, Marta / Barastegui, Rebeca / Saavedra, Anny Carolina / Panés, Julián / Ricart, Elena / Rimola, Jordi

Alimentary pharmacology & therapeutics

2024 Volume 59, Issue 11, Page(s) 1435–1445

Abstract: Background and aims: Magnetic resonance enterography (MRE) depicts transmural changes in response to biological treatment for Crohn's disease (CD); however, the long-term prognostic significance of these findings is unknown. The primary objective of ... ...

Abstract	Background and aims: Magnetic resonance enterography (MRE) depicts transmural changes in response to biological treatment for Crohn's disease (CD); however, the long-term prognostic significance of these findings is unknown. The primary objective of this study was to identify findings on MRE 46 weeks after initiating biological treatment that predict adverse long-term outcomes. Methods: Patients with CD underwent MRE 46 weeks after initiating biological treatment and were prospectively followed for 2 years. A logistic regression analysis was performed to assess the prognostic value of different radiologic findings for various predefined adverse outcomes. Results: Of the 89 patients included, 46 (51.7%) had ≥1 adverse outcome during follow-up: 40 (44.9%) had clinical recurrence; 18 (20.2%) required surgery, 8 (9%) endoscopic balloon dilation, 12 (13.5%) hospitalization and 7 (7.8%) required corticosteroids. In the multivariate analysis, persistence of severe lesions (MaRIA ≥11) in any intestinal segment was associated with an increased risk of surgery [OR 11.6 (1.5-92.4)], of surgery and/or endoscopic balloon dilation [OR 6.3 (1.3-30.2)], and of clinical relapse [OR 4.6 (1.6-13.9)]. Penetrating lesions were associated with surgery [OR 3.4 (1.2-9.9)]. Creeping fat with hospitalization [OR 5.1 (1.1-25.0)] and corticosteroids requirement [OR 16.0 (1.2-210.0)]. The presence of complications (stricturing and/or penetrating lesions) was associated with having ≥1 adverse outcome [OR 3.35 (1.3-8.5)]. Conclusion: MRE findings at week-46 after initiating biological therapy can predict long-term adverse outcomes in CD. Therapeutic intervention may be required in patients with persistence of severe inflammatory lesions, CD-associated complications, or creeping fat.
MeSH term(s)	Humans ; Crohn Disease/diagnostic imaging ; Crohn Disease/drug therapy ; Female ; Male ; Adult ; Magnetic Resonance Imaging/methods ; Prospective Studies ; Middle Aged ; Prognosis ; Treatment Outcome ; Young Adult ; Recurrence ; Biological Therapy/adverse effects ; Biological Therapy/methods ; Follow-Up Studies
Language	English
Publishing date	2024-04-23
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639012-2
ISSN	1365-2036 ; 0269-2813 ; 0953-0673
ISSN (online)	1365-2036
ISSN	0269-2813 ; 0953-0673
DOI	10.1111/apt.17968
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Article ; Online: Can we Monitor a Patient with Inflammatory Bowel Disease and Adapt Treatment without Endoscopy?

Panes, Julian / Ricart, Elena

Current drug targets

2016 Volume 19, Issue 7, Page(s) 777–781

Abstract: Background: While predictors of disease course in inflammatory bowel diseases (IBD) are not accurate, we adapt therapies reactively, after objective demonstration of the presence of active disease, complications, or an inadequate response to a ... ...

Abstract	Background: While predictors of disease course in inflammatory bowel diseases (IBD) are not accurate, we adapt therapies reactively, after objective demonstration of the presence of active disease, complications, or an inadequate response to a therapeutic intervention. In this context, adequate monitoring is essential to make timely management decisions. Objective: To review the role of clinical assessment, biomarkers, radiology and endoscopy in monitoring patients with IBD. Results: Assessment of clinical symptoms is the cornerstone of monitoring in IBD; in ulcerative colitis (UC) there is acceptable correspondence between mucosal lesions and presence of symptoms, but in Crohn's disease (CD) there is a considerable disconnection between these two, and monitoring requires complementary tests. Blood and stool markers such as C-reactive protein and fecal calprotectin are increasingly used. However, the operating properties of these biomarkers are different according to disease type (UC vs. CD), age (pediatric or adult), and disease location (small bowel vs. colonic disease). Cross-sectional imaging has a similar accuracy to endoscopy to detect inflammation in CD, and a higher accuracy to detect stenosing and penetrating complications. It has also been shown that magnetic resonance imaging is accurate for measuring response to therapeutic interventions. Conclusion: Cross-sectional imaging is one of the preferred monitoring options in patients with CD. Endoscopy continues to be the preferred examination for assessing UC, and should still be considered in patients with CD who have symptoms or altered biomarkers and cross-sectional imaging is negative.
MeSH term(s)	Adult ; Biomarkers/metabolism ; C-Reactive Protein/analysis ; Child ; Colitis, Ulcerative/diagnosis ; Colitis, Ulcerative/physiopathology ; Colitis, Ulcerative/therapy ; Crohn Disease/diagnosis ; Crohn Disease/physiopathology ; Crohn Disease/therapy ; Endoscopy, Gastrointestinal/methods ; Feces/chemistry ; Humans ; Leukocyte L1 Antigen Complex/analysis ; Magnetic Resonance Imaging/methods
Chemical Substances	Biomarkers ; Leukocyte L1 Antigen Complex ; C-Reactive Protein (9007-41-4)
Language	English
Publishing date	2016-01-25
Publishing country	United Arab Emirates
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2064859-5
ISSN	1873-5592 ; 1389-4501
ISSN (online)	1873-5592
ISSN	1389-4501
DOI	10.2174/1389450117666160401125642
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Zs.A 5578: Show issues

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Article: Current Status of Mesenchymal Stem Cell Therapy and Bone Marrow Transplantation in IBD

Ricart, Elena

Digestive Diseases

2012 Volume 30, Issue 4, Page(s) 387–391

Abstract: Cellular therapy is a promising new approach to address unmet medical needs in patients with IBD, mainly Crohn’s disease (CD). Two series have reported autologous hematopoietic stem cell transplantation (HSCT) for CD. The largest one is a phase I study ... ...

Institution	Gastroenterology Department, Hospital Clinic, Barcelona, Spain
Abstract	Cellular therapy is a promising new approach to address unmet medical needs in patients with IBD, mainly Crohn’s disease (CD). Two series have reported autologous hematopoietic stem cell transplantation (HSCT) for CD. The largest one is a phase I study from Chicago including 24 patients with active CD refractory to conventional therapies. All patients went into remission with a CD Activity Index (CDAI) <150. The percentage of clinical relapse-free survival was 91% at 1 year, 63% at 2 years, 57% at 3 years, 39% at 4 years and 19% at 5 years. The percentage of patients in remission (CDAI <150), steroid-free or medication-free at any post-transplantation evaluation interval remained ≥70, ≥80 and ≥60%, respectively. In Europe and Canada, a currently ongoing randomized trial hopes to answer the question of whether autologous HSCT adds any benefit to the effect of immunosuppression used during mobilization. Although promising, HSCT for CD is still experimental and its toxicity leaves this option for a considerably reduced number of refractory patients in whom the disease is not amenable to surgical resection. A more recently developed, less aggressive approach involves the use of mesenchymal stem cells (MSCs). Successful pre-clinical studies using MSCs in models of autoimmunity, inflammation or tissue damage have paved the way for clinical trials. Two phase I studies on autologous bone marrow-derived MSCs for the treatment of active refractory CD have been published recently; one using systemic administration in patients with luminal CD and the other assessing the effects of local injection of MSCs for the treatment of fistulizing CD, showing that application of autologous MSCs is feasible, well tolerated and might produce clinical benefits.
Keywords	Mesenchymal stem cells ; Cell therapy ; Bone marrow transplantation ; Crohn’s disease
Language	English
Publishing date	2012-07-12
Publisher	S. Karger AG
Publishing place	Basel, Switzerland
Document type	Article
Note	Innovative Treatments Will Offer a Better Outcome for Patients with IBD
ZDB-ID	632798-9
ISBN	978-3-318-02185-1 ; 978-3-318-02186-8 ; 3-318-02185-7 ; 3-318-02186-5
ISSN	1421-9875 ; 0257-2753
ISSN (online)	1421-9875
ISSN	0257-2753
DOI	10.1159/000338134
Database	Karger publisher's database

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Article ; Online: Avoiding contrast-enhanced sequences does not compromise the precision of the simplified MaRIA for the assessment of non-penetrating Crohn's disease activity.

Fernàndez-Clotet, Agnès / Sapena, Víctor / Capozzi, Nunzia / Rodríguez, Sonia / Masamunt, Maria-Carme / Ricart, Elena / Ordás, Ingrid / Panés, Julian / Rimola, Jordi

European radiology

2022 Volume 32, Issue 5, Page(s) 3334–3345

Abstract: Objectives: Patients with Crohn's disease (CD) require multiple assessments with magnetic resonance enterography (MRE) from a young age. Standard MRE protocols for CD include contrast-enhanced sequences. Gadolinium deposits in brain tissue suggest ... ...

Abstract	Objectives: Patients with Crohn's disease (CD) require multiple assessments with magnetic resonance enterography (MRE) from a young age. Standard MRE protocols for CD include contrast-enhanced sequences. Gadolinium deposits in brain tissue suggest avoiding gadolinium could benefit patients with CD. This study aimed to compare the accuracy of the simplified Magnetic Resonance Index of Activity (sMaRIA) calculated with and without contrast-enhanced sequences in determining the response to biologic drugs in patients with CD. Methods: This post hoc analysis of a prospective study included patients with CD with endoscopic ulceration in ≥ 1 intestinal segment starting biologic drug therapy. Two blinded radiologists used the sMaRIA to score images obtained at baseline and week 46 of treatment first using only unenhanced sequences (T2-sMaRIA) and 1 month later using both unenhanced and enhanced images (CE-sMaRIA). We calculated the rates of agreement between T2-sMaRIA, CE-sMaRIA, and ileocolonoscopy for different conceptualizations of therapeutic response. Results: A total of 46 patients (median age, 36 years [IQR: 28-47]) were included. Agreement with ileocolonoscopy was similar for CE-sMaRIA and T2-sMaRIA in identifying ulcer healing (kappa = 0.74 [0.55-0.93] and 0.70 [0.5-0.9], respectively), treatment response (kappa = 0.53 [0.28-0.79] and 0.44 [0.17 - 0.71]), and remission (kappa = 0.48 [0.22-0.73] and 0.43 [0.17-0.69]). The standardized effect size was moderate for both CE-sMaRIA = 0.63 [0.41-0.85] p < 0.001 and T2-sMaRIA = 0.58 [0.36-0.80] p < 0.001. Conclusions: sMaRIA with and without contrast-enhanced images accurately classified the response according to different therapeutic endpoints determined by ileocolonoscopy. Key points: • The simplified Magnetic Resonance Index of Activity is accurate for the assessment of Crohn's disease activity, severity, and therapeutic response, using four dichotomic components that can be evaluated without the need of using contrast-enhanced sequences, representing a practical and safety advantage, but concerns have been expressed as to whether the lack of contrast sequences may compromise precision. • The simplified Magnetic Resonance Index of Activity can assess the response to biologic therapy in patients with Crohn's disease without the need for intravenous contrast agents obtaining comparable results without and with contrast-enhanced sequences. • Avoiding intravenous contrast agents could reduce the duration of the MRE examination and its cost and would increase the acceptance and safety of MRE in clinical research in patients with Crohn's disease.
MeSH term(s)	Adult ; Contrast Media/pharmacology ; Crohn Disease/diagnosis ; Gadolinium/pharmacology ; Humans ; Magnetic Resonance Imaging/methods ; Prospective Studies
Chemical Substances	Contrast Media ; Gadolinium (AU0V1LM3JT)
Language	English
Publishing date	2022-01-15
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1085366-2
ISSN	1432-1084 ; 0938-7994 ; 1613-3749
ISSN (online)	1432-1084
ISSN	0938-7994 ; 1613-3749
DOI	10.1007/s00330-021-08392-w
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Zs.A 3300: Show issues

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Article: De-escalating therapy in inflammatory bowel disease: Results from an observational study in clinical practice.

Arenas, Alex / Moreta, María José / Ordás, Ingrid / Fernández-Clotet, Agnès / Caballol, Berta / Gallego, Marta / Vara, Alejandro / Barastegui, Rebeca / Giner, Angel / Prieto, Cristina / Masamunt, Maria Carme / Candia, Roberto / Ricart, Elena

Gastroenterologia y hepatologia

2023

Abstract: Background and objectives: Combination therapy with an immunomodulator (IMM) and an anti-TNF is commonly recommended in Crohn's disease (CD) and ulcerative colitis (UC) patients. However, little is known about relapse rates after therapeutic de- ... ...

Abstract	Background and objectives: Combination therapy with an immunomodulator (IMM) and an anti-TNF is commonly recommended in Crohn's disease (CD) and ulcerative colitis (UC) patients. However, little is known about relapse rates after therapeutic de-escalation. This study aimed to evaluate the risk of relapse in a cohort of UC and CD patients with long-standing clinical remission after discontinuation of IMM or anti-TNF and to identify predictive factors for relapse. Methods: This retrospective study included patients with UC or CD on combination therapy and clinical remission for at least 6 months. IMM or anti-TNF was stopped upon physician decision. Primary objective was to evaluate the relapse rates after discontinuation of IMM or anti-TNF and to analyze predictors of relapse. Results: The study included 88 patients, 48 patients (54.5%) discontinued IMM and 40 (45.5%) anti-TNF. During follow-up, relapse rates were 16.7% and 52.5% in the IMM discontinuation group and anti-TNF discontinuation group, respectively (p<0.001). Multivariate analysis showed that anti-TNF discontinuation (HR=3.01; 95% CI=1.22-7.43) and ileal CD location (HR=2.36; 95% CI=1.02-5.47) were predictive factors for relapse while inflammatory CD phenotype was a protective factor (HR=0.32; 95% CI=0.11-0.90). Reintroduction of anti-TNF upon relapse was effective and safe. Conclusion: Anti-TNF discontinuation led to significantly higher relapse rates compared to IMM discontinuation in UC and CD patients on combination therapy. Anti-TNF discontinuation and ileal CD location were identified as predictive factors for relapse while inflammatory CD phenotype was a protective factor. Retreatment after anti-TNF discontinuation was effective and safe.
Language	Spanish
Publishing date	2023-08-08
Publishing country	Spain
Document type	Journal Article
ZDB-ID	632502-6
ISSN	0210-5705
ISSN	0210-5705
DOI	10.1016/j.gastrohep.2023.07.005
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Article ; Online: ADC Values for Detecting Bowel Inflammation and Biologic Therapy Response in Patients With Crohn Disease: A Post Hoc Prospective Trial Analysis.

Rimola, Jordi / Fernandez-Clotet, Agnès / Capozzi, Nunzia / Caballol, Berta / Rodríguez, Sonia / Gallego, Marta / Masamunt, Maria Carme / Panés, Julian / Ricart, Elena / Ordás, Ingrid

AJR. American journal of roentgenology

2023 Volume 222, Issue 1, Page(s) e2329639

Abstract: BACKGROUND. ...

Abstract	BACKGROUND.
MeSH term(s)	Adult ; Female ; Humans ; Male ; Biological Therapy ; Crohn Disease ; Diffusion Magnetic Resonance Imaging/methods ; Inflammation ; Magnetic Resonance Imaging ; Prospective Studies ; Ulcer ; Clinical Trials as Topic
Language	English
Publishing date	2023-08-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	82076-3
ISSN	1546-3141 ; 0361-803X ; 0092-5381
ISSN (online)	1546-3141
ISSN	0361-803X ; 0092-5381
DOI	10.2214/AJR.23.29639
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Article ; Online: A Novel Strategy to Study the Invasive Capability of Adherent-Invasive

Mayorgas, Aida / Dotti, Isabella / Martínez-Picola, Marta / Esteller, Miriam / Bonet-Rossinyol, Queralt / Ricart, Elena / Salas, Azucena / Martínez-Medina, Margarita

Frontiers in immunology

2021 Volume 12, Page(s) 646906

Abstract: Over the last decades, Adherent- ... ...

Abstract	Over the last decades, Adherent-Invasive
MeSH term(s)	Algorithms ; Bacterial Adhesion ; Cell Culture Techniques/methods ; Crohn Disease/metabolism ; Crohn Disease/microbiology ; Epithelial Cells/metabolism ; Epithelial Cells/microbiology ; Escherichia coli/physiology ; Escherichia coli Infections/metabolism ; Escherichia coli Infections/microbiology ; Humans ; Intestinal Mucosa/cytology ; Intestinal Mucosa/metabolism ; Intestinal Mucosa/microbiology ; Models, Biological ; Organoids/cytology ; Organoids/metabolism ; Organoids/microbiology ; Reproducibility of Results
Language	English
Publishing date	2021-03-29
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2021.646906
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