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Novel Insight into the Diagnosis and Management of Crohn’s Disease

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A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Gastroenterology & Hepatopancreatobiliary Medicine".

Deadline for manuscript submissions: closed (31 December 2021) | Viewed by 30047

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Prof. Dr. Uri Kopylov

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Department of Gastroenterology, Sheba Medical Center, Ramat Gan, Israel
Interests: inflammatory bowel disease; capsule endoscopy; biomarkers; machine learning; therapeutic drug monitoring
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

In recent years, huge progress has been made in both the diagnosis and monitoring of Crohn’s disease. Non-invasive, patient-friendly, and remote monitoring techniques such as capsule endoscopy, intestinal ultrasound, and home-based fecal calprotectin are gaining increased acceptance, replacing more traditional and invasive monitoring techniques. The ongoing COVID-19 pandemic has caused significant restrictions on patient mobility, which along with reluctance to visit medical facilities further enhances this paradigm shift. Novel and more ambitious treatment goals such as transmural healing and histological healing are being evaluated in clinical trials and observational studies. Although these treatment goals are not yet considered as major therapeutic goals, they are routinely included in clinical trials as secondary endpoints.

The therapeutic armamentarium in IBD has been rapidly expanding in the last decade. In addition to monoclonal antibodies targeting novel mechanisms (leukocyte adhesion, JAK/STAT pathway, interleukin 12 and 23), biosimilar therapies are changing the biological therapy market, causing significant cost reductions for well-established molecules such as infliximab and adalimumab. In addition, there is increasing evidence to support subcutaneous use of previously IV-only medications (infliximab and vedolizumab), this trend being particularly important during the COVID-19 era.

The current Special Issue will focus on novel diagnostic and therapeutic strategies in CD, including but not limited to novel biomarkers, remote monitoring of disease activity, novel drug combinations, and therapeutic targets.

Prof. Dr. Uri Kopylov
Guest Editor

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Keywords

therapeutic drug monitoring
inflammatory biomarkers
non-invasive monitoring
capsule endoscopy
intestinal ultrasound
transmural healing
histological healing

Published Papers (9 papers)

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Editorial

Jump to: Research, Review

3 pages, 183 KiB

Open AccessEditorial

Comprehensive Management of Inflammatory Bowel Disease: What’s Next

by Asaf Levartovsky and Uri Kopylov

J. Clin. Med. 2022, 11(15), 4584; https://doi.org/10.3390/jcm11154584 - 05 Aug 2022

Viewed by 983

Abstract

In the last 20 years, the treatment and management of patients with Crohn’s disease (CD) and ulcerative colitis (UC) have been revolutionized by the introduction of biological therapies and small molecules [...] Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

Research

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14 pages, 2034 KiB

Open AccessArticle

Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study

by Ido Veisman, Oranit Barzilay, Liora Bruckmayer, Ola Haj-Natour, Uri Kopylov, Rami Eliakim, Shomron Ben-Horin and Bella Ungar

J. Clin. Med. 2021, 10(18), 4265; https://doi.org/10.3390/jcm10184265 - 20 Sep 2021

Cited by 3 | Viewed by 1945

Abstract

Infliximab and vedolizumab are effective treatments for inflammatory bowel disease (IBD), although associated with adverse events (AE). While low or non-existent drug levels and positive antidrug antibodies have been associated with therapeutic failure, there is no clear association between higher drug levels and AE. A cross-sectional study consisting of Crohn’s disease (CD) and ulcerative colitis (UC) patients receiving infliximab or vedolizumab at the Sheba Medical Center was performed. Patients completed a questionnaire regarding AEs related to biological therapy. Serum trough levels obtained on the same day were analyzed. Objective measures of outcomes were retrieved from medical records. Questionnaires were completed by infliximab (n = 169) and vedolizumab (n = 88)-treated therapy patients. Higher infliximab levels were only numerically associated with the occurrence of at least one AE (p = 0.08). When excluding fatigue and abdominal pain, higher infliximab levels were statistically associated with the occurrence of at least one AE (p = 0.03). Vedolizumab drug levels > 18 μg/mL were also linked with the occurrence of more AEs. No specific association was observed between the increased levels of either infliximab or vedolizumab and specific AEs (neurological symptoms, upper GI symptoms, infectious complications, and musculoskeletal symptoms). As significant AEs are very rare, additional multi-center studies are required. Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

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13 pages, 1158 KiB

Open AccessArticle

Effectiveness of Third-Class Biologic Treatment in Crohn’s Disease: A Multi-Center Retrospective Cohort Study

by Ahmad Albshesh, Joshua Taylor, Edoardo V. Savarino, Marie Truyens, Alessandro Armuzzi, Davide G. Ribaldone, Ariella Bar-Gil Shitrit, Morine Fibelman, Pauliina Molander, Claire Liefferinckx, Stephane Nancey, Mohamed Korani, Mariann Rutka, Manuel Barreiro-de Acosta, Viktor Domislovic, Gerard Suris, Carl Eriksson, Catarina Alves, Afroditi Mpitouli, Caroline di Jiang, Katja Tepeš, Marina Coletta, Kalliopi Foteinogiannopoulou, Javier P. Gisbert, Hadar Amir-Barak, Mohamed Attauabi, Jakob Seidelin, Waqqas Afif, Carla Marinelli, Triana Lobaton, Daniela Pugliese, Nitsan Maharshak, Anneline Cremer, Jimmy K. Limdi, Tamás Molnár, Borja Otero-Alvarin, Zeljko Krznaric, Fernando Magro, Konstantinos Karmiris, Tim Raine, David Drobne, Ioannis Koutroubakis, Maria Chaparro, Henit Yanai, Johan Burisch and Uri Kopylov Show full author list Hide full author list

J. Clin. Med. 2021, 10(13), 2914; https://doi.org/10.3390/jcm10132914 - 29 Jun 2021

Cited by 9 | Viewed by 3716

Abstract

Background: Multiple studies have described the effectiveness of ustekinumab (UST) and vedolizumab (VDZ) in patients with Crohn’s disease (CD) failing anti- Tumor necrosis factors (TNFs); however, the effectiveness of VDZ or UST as a third-class biologic has not yet been described. Aims and Methods: In this retrospective multicenter cohort study, we aimed to investigate the effectiveness of VDZ and UST as a third-class biologic in patients with CD. Results: Two-hundred and four patients were included; 156/204 (76%) patients received VDZ as a second- and UST as a third-class therapy (group A); the remaining 48/204 (24%) patients received UST as a second- and VDZ as a third-class therapy (group B). At week 16–22, 87/156 (55.5%) patients and 27/48 (56.2%) in groups A and B, respectively, responded to treatment (p = 0.9); 41/156 (26.2%) and 15/48 (31.2%) were in clinical remission (p = 0.5). At week 52; 89/103 (86%) patients and 25/29 (86.2%) of the patients with available data had responded to third-class treatment in groups A and B, respectively (p = 0.9); 31/103 (30%) and 47/29 (24.1%) were in clinical remission (p = 0.5). Conclusion: Third-class biological therapy was effective in more than half of the patients with CD. No differences in effectiveness were detected between the use of VDZ and UST as a third-class agent. Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

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19 pages, 1343 KiB

Open AccessArticle

Incidence, Clinical Characteristics and Management of Inflammatory Bowel Disease in Spain: Large-Scale Epidemiological Study

by María Chaparro, Ana Garre, Andrea Núñez Ortiz, María Teresa Diz-Lois Palomares, Cristina Rodríguez, Sabino Riestra, Milagros Vela, José Manuel Benítez, Estela Fernández Salgado, Eugenia Sánchez Rodríguez, Vicent Hernández, Rocío Ferreiro-Iglesias, Ángel Ponferrada Díaz, Jesús Barrio, José María Huguet, Beatriz Sicilia, María Dolores Martín-Arranz, Xavier Calvet, Daniel Ginard, Inmaculada Alonso-Abreu, Luis Fernández-Salazar, Pilar Varela Trastoy, Montserrat Rivero, Isabel Vera-Mendoza, Pablo Vega, Pablo Navarro, Mónica Sierra, José Luis Cabriada, Mariam Aguas, Raquel Vicente, Mercè Navarro-Llavat, Ana Echarri, Fernando Gomollón, Elena Guerra del Río, Concepción Piñero, María José Casanova, Katerina Spicakova, Jone Ortiz de Zarate, Emilio Torrella Cortés, Ana Gutiérrez, Horacio Alonso-Galán, Álvaro Hernández-Martínez, José Miguel Marrero, Rufo Lorente Poyatos, Margalida Calafat, Lidia Martí Romero, Pilar Robledo, Orencio Bosch, Nuria Jiménez, María Esteve Comas, José María Duque, Ana María Fuentes Coronel, Manuela Josefa Sampedro, Eva Sesé Abizanda, Belén Herreros Martínez, Liliana Pozzati, Hipólito Fernández Rosáenz, Belén Crespo Suarez, Pilar López Serrano, Alfredo J. Lucendo, Margarita Muñoz Vicente, Fernando Bermejo, José Joaquín Ramírez Palanca, Margarita Menacho, Amalia Carmona, Raquel Camargo, Sandra Torra Alsina, Nuria Maroto, Juan Nerín de la Puerta, Elena Castro, Ignacio Marín-Jiménez, Belén Botella, Amparo Sapiña, Noelia Cruz, José Luis F. Forcelledo, Abdel Bouhmidi, Carlos Castaño-Milla, Verónica Opio, Isabel Nicolás, Marcos Kutz, Alfredo Abraldes Bechiarelli, Jordi Gordillo, Yolanda Ber, Yolanda Torres Domínguez, María Teresa Novella Durán, Silvia Rodríguez Mondéjar, Francisco J. Martínez-Cerezo, Lilyan Kolle, Miriam Sabat, Cesar Ledezma, Eduardo Iyo, Óscar Roncero, Rebeca Irisarri, Laia Lluis, Isabel Blázquez Gómez, Eva María Zapata, María José Alcalá, Cristina Martínez Pascual, María Montealegre, Laura Mata, Ana Monrobel, Alejandro Hernández Camba, Luis Hernández, María Tejada, Alberto Mir, María Luisa Galve, Marta Soler, Daniel Hervías, José Antonio Gómez-Valero, Manuel Barreiro-de Acosta, Fernando Rodríguez-Artalejo, Esther García-Esquinas, Javier P. Gisbert and on behalf of the EpidemIBD study group of GETECCU Show full author list Hide full author list

J. Clin. Med. 2021, 10(13), 2885; https://doi.org/10.3390/jcm10132885 - 29 Jun 2021

Cited by 38 | Viewed by 9747 | Correction

Abstract

(1) Aims: To assess the incidence of inflammatory bowel disease (IBD) in Spain, to describe the main epidemiological and clinical characteristics at diagnosis and the evolution of the disease, and to explore the use of drug treatments. (2) Methods: Prospective, population-based nationwide registry. Adult patients diagnosed with IBD—Crohn’s disease (CD), ulcerative colitis (UC) or IBD unclassified (IBD-U)—during 2017 in Spain were included and were followed-up for 1 year. (3) Results: We identified 3611 incident cases of IBD diagnosed during 2017 in 108 hospitals covering over 22 million inhabitants. The overall incidence (cases/100,000 person-years) was 16 for IBD, 7.5 for CD, 8 for UC, and 0.5 for IBD-U; 53% of patients were male and median age was 43 years (interquartile range = 31–56 years). During a median 12-month follow-up, 34% of patients were treated with systemic steroids, 25% with immunomodulators, 15% with biologics and 5.6% underwent surgery. The percentage of patients under these treatments was significantly higher in CD than UC and IBD-U. Use of systemic steroids and biologics was significantly higher in hospitals with high resources. In total, 28% of patients were hospitalized (35% CD and 22% UC patients, p < 0.01). (4) Conclusion: The incidence of IBD in Spain is rather high and similar to that reported in Northern Europe. IBD patients require substantial therapeutic resources, which are greater in CD and in hospitals with high resources, and much higher than previously reported. One third of patients are hospitalized in the first year after diagnosis and a relevant proportion undergo surgery. Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

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13 pages, 697 KiB

Open AccessArticle

Impact of BMGIM Music Therapy on Emotional State in Patients with Inflammatory Bowel Disease: A Randomized Controlled Trial

by Vicente Alejandro March-Luján, Vicente Prado-Gascó, José María Huguet, Xavier Cortés, José María Paredes Arquiola, María Capilla-Igual, María Josefa-Rodríguez-Morales, Ana Monzó-Gallego, José Luis Platero Armero and José Enrique de la Rubia Ortí

J. Clin. Med. 2021, 10(8), 1591; https://doi.org/10.3390/jcm10081591 - 09 Apr 2021

Cited by 5 | Viewed by 2950

Abstract

Background. Patients with inflammatory bowel disease (IBD) have a high prevalence of emotional disturbances which worsen the symptoms of the disease. As a therapeutic alternative that is part of a comprehensive care alongside medication, the Bonny Method of Guided Imagery and Music (BMGIM) music-assisted therapy has achieved promising emotional improvements in patients with chronic diseases. The objective of the study was to determine the impact of a treatment based on a BMGIM group adaptation on patients with inflammatory bowel disease (IBD) and their emotional state, therefore analyzing state of mind, quality of life, anxiety, depression, immunocompetence as a marker of well-being, and levels of acute and chronic stress. Methods. Longitudinal, prospective, quantitative, and experimental study including 43 patients with IBD divided into an intervention group (22 patients), who received eight sessions over eight weeks, and a control group (21 patients). A saliva sample was taken from each patient before and after each session in order to determine cortisol and IgA levels. Similarly, a hair sample was taken before the first and after the last session to determine the cumulative cortisol level. All molecules were quantified using the ELISA immunoassay technique. In addition, patients completed several emotional state questionnaires: HADS, MOOD, and CCVEII. Results. An improvement was observed in the following states of mind: sadness, fear, anger, and depression. No significant effect was observed in state of mind in terms of happiness or anxiety, in the levels of cortisol in hair, and in patients’ perceived quality of life. A reduction in cortisol was observed in saliva, although this did not significantly affect the IgA titer. Conclusions. BMGIM seems to improve the emotional state of patients with IBD. Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

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9 pages, 372 KiB

Open AccessArticle

Prediction of Recurrent Emergency Department Visits among Patients with Crohn’s Disease: A Retrospective Study

by Hussein Mahajna, Yiftach Barash, Bella Ungar, Shelly Soffer, Ahmad Albshesh, Asaf Levartovsky, Shomron Ben-Horin, Eyal Klang and Uri Kopylov

J. Clin. Med. 2020, 9(11), 3651; https://doi.org/10.3390/jcm9113651 - 13 Nov 2020

Cited by 2 | Viewed by 1355

Abstract

Patients with Crohn’s disease (CD) are frequently subject to symptoms causing them to seek medical care in emergency departments (ED). Recurrent ED visits are frequent after initial discharge. We aimed to identify the characteristics of patients with Crohn’s who tend to have recurrent visits to the ED. We created an electronic data repository of all patients with inflammatory bowel diseases who visited the ED in our tertiary medical center during the period 2012–2018. For this study, we retrieved consecutive Crohn’s patients who presented with CD-related symptoms to the ED and were eventually discharged. Patients who returned to the ED in 7 and 30 days were compared with those who did not. Overall, 2299 patients visited our ED with complaints related to Crohn’s disease exacerbation or complication. A total of 1259 (60% of the adult patients) were admitted for hospitalization. Of the 632 (33%) who were discharged from the ED, 53 (8.4%) and 110 (17.4%) re-visited the ED, in 7 and 30 days from discharge, respectively. In multivariable analysis, tachycardia (odds ratio (OR) = 2.19, 95% confidence interval (CI): 1.11–4.33, p value = 0.02), elevated alkaline phosphatase (OR = 2.09, 95% CI: 1.07–4.07, p value = 0.02), and hyponatremia (OR = 2.52, 95% CI: 1.24–5.10, p value = 0.01) were associated with revisiting the ED within 7 days. Tachycardia (OR 2.88 (95% CI 1.33–6.2)), anemia (OR 2.44 (95% CI 1.24–4.8)), and elevated alkaline phosphatase (OR 2.68 (95% CI 1.25–5.78)) were independently associated with ED returns in 30 days. Knowing these risk factors may assist in minimizing the burden of recurrent ED visits among patients with CD. Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

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11 pages, 1016 KiB

Open AccessArticle

Thromboprophylaxis for Hospitalized Patients with Inflammatory Bowel Disease—Are We There Yet?

by Asaf Levartovsky, Yiftach Barash, Shomron Ben-Horin, Bella Ungar, Eyal Klang, Shelly Soffer and Uri Kopylov

J. Clin. Med. 2020, 9(9), 2753; https://doi.org/10.3390/jcm9092753 - 26 Aug 2020

Cited by 6 | Viewed by 2217

Abstract

Patients with inflammatory bowel disease (IBD) have a high risk of venous thromboembolism (VTE) events in both hospitalized patients and outpatients. Although thromboprophylaxis is recommended for hospitalized patients with IBD, implementation is not universal, especially for non IBD-related hospitalizations. Our objective was to present VTE and thromboprophylaxis adherence rates among hospitalized patients with IBD. An electronic data repository was created of all patients with IBD who visited the emergency department (ED) of our tertiary medical center between 2012 and 2018. The data included tabular variables and free-text physician records. We searched the data for VTE events, using ICD10 coding. Overall, there were 7009 ED visits of 2405 patients with IBD, 1556 (64.7%) with Crohn’s disease (CD) and 849 (35.3%) with ulcerative colitis (UC). Thromboprophylaxis was administered in 463 hospitalizations (12.4% of IBD-related and 10.9% of non IBD-related hospitalizations, p = 0.13). Nineteen VTEs were diagnosed in the ED and seventeen were diagnosed during hospitalization (11 non IBD-related and 6 IBD-related hospitalizations, 0.6% and 0.28% respectively, p = 0.12). One patient died during hospitalization and an additional two in the 90 days post-discharge from hospitalization (unrelated to VTEs). In conclusion, thromboprophylaxis rates in hospitalized patients with IBD are low, despite possible implications and established guidelines. Thromboprophylaxis should be implemented in patients with IBD hospitalized for all indications. Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

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Review

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23 pages, 823 KiB

Open AccessReview

Primary Failure to an Anti-TNF Agent in Inflammatory Bowel Disease: Switch (to a Second Anti-TNF Agent) or Swap (for Another Mechanism of Action)?

by Javier P. Gisbert and María Chaparro

J. Clin. Med. 2021, 10(22), 5318; https://doi.org/10.3390/jcm10225318 - 15 Nov 2021

Cited by 29 | Viewed by 3807

Abstract

Background: About a third of patients with inflammatory bowel disease do not respond to anti-tumour necrosis factor (anti-TNF) therapy, which is challenging. Aim: To review the current data on the two main strategies when facing primary non-response to an anti-TNF agent in inflammatory bowel disease: changing to a second anti-TNF (switching) or to a drug with another mechanisms of action (swapping). Methods: We performed a bibliographic search to identify studies reporting on efficacy of any biologic treatment after primary anti-TNF non-response. Results: The efficacy of a second anti-TNF is lower when the reason to withdraw the first one is primary failure. Nevertheless, switching to another anti-TNF even after primary failure may still be effective in some patients. Both vedolizumab and ustekinumab have generally been shown to be less effective in anti-TNF exposed patients. However, despite primary anti-TNF failure, patients may respond to vedolizumab or ustekinumab in a limited but considerable number of cases. The cause for swapping (primary vs. secondary anti-TNF failure) seems to have limited effect on vedolizumab efficacy. Primary anti-TNF non-response seems to be a clearer predictor of treatment failure for ustekinumab. Unfortunately, the two main strategies to treat specifically a patient with primary non-response to an anti-TNF agent—switching to a second anti-TNF or swapping for vedolizumab/ustekinumab—have not been properly compared. Conclusion: The data reviewed in the present study clearly emphasise the imperative need to carry out head-to-head randomised trials in patients exposed to anti-TNF agents in general, and specifically in those with primary non-response to these agents. Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

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28 pages, 1315 KiB

Open AccessReview

Frequency and Effectiveness of Empirical Anti-TNF Dose Intensification in Inflammatory Bowel Disease: Systematic Review with Meta-Analysis

by Laura Guberna, Olga P. Nyssen, María Chaparro and Javier P. Gisbert

J. Clin. Med. 2021, 10(10), 2132; https://doi.org/10.3390/jcm10102132 - 14 May 2021

Cited by 12 | Viewed by 2363

Abstract

Loss of response to antitumor necrosis factor (anti-TNF) therapies in inflammatory bowel disease occurs in a high proportion of patients. Our aim was to evaluate the loss of response to anti-TNF therapy, considered as the need for dose intensification (DI), DI effectiveness and the possible variables influencing its requirements. Bibliographical searches were performed. Selection: prospective and retrospective studies assessing DI in Crohn’s disease and ulcerative colitis patients treated for at least 12 weeks with an anti-TNF drug. Exclusion criteria: studies using anti-TNF as a prophylaxis for the postoperative recurrence in Crohn’s disease or those where DI was based on therapeutic drug monitoring. Data synthesis: effectiveness by intention-to-treat (random effects model). Data were stratified by medical condition (ulcerative colitis vs. Crohn’s disease), anti-TNF drug and follow-up. Results: One hundred and seventy-three studies (33,241 patients) were included. Overall rate of the DI requirement after 12 months was 28% (95% CI 24–32, I2 = 96%, 41 studies) in naïve patients and 39% (95% CI 31–47, I2 = 86%, 18 studies) in non-naïve patients. The DI requirement rate was higher both in those with prior anti-TNF exposure (p = 0.01) and with ulcerative colitis (p = 0.02). The DI requirement rate in naïve patients after 36 months was 35% (95% CI 28–43%; I2 = 98%; 18 studies). The overall short-term response and remission rates of empirical DI in naïve patients were 63% (95% CI 48–78%; I2 = 99%; 32 studies) and 48% (95% CI: 39–58%; I2 = 92%; 25 studies), respectively. The loss of response to anti-TNF agents―and, consequently, DI―occurred frequently in inflammatory bowel disease (approximately in one-fourth at one year and in one-third at 3 years). Empirical DI was a relatively effective therapeutic option. Full article

(This article belongs to the Special Issue Novel Insight into the Diagnosis and Management of Crohn’s Disease)

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