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Article: Real-world experience of vedolizumab use in Colombian patients with inflammatory bowel disease-EXVEDOCOL.

Parra, Viviana / Cifuentes, Sandra / Avendaño, Sandra / Ponce de León, Enrique / Florez, Cristian / Reyes, Gustavo / Puentes, Fabian / Ballesteros, Manuel / Nuñez, Edilberto / Gómez, Federico / Márquez, Juan Ricardo

Gastroenterologia y hepatologia

2024

Abstract: Background: Real-world studies about the effectiveness and safety of vedolizumab (VDZ) in the treatment of inflammatory bowel disease (IBD) in Latin America are scarce. Our study describes the effectiveness and safety of VDZ in Colombian patients with ... ...

Abstract	Background: Real-world studies about the effectiveness and safety of vedolizumab (VDZ) in the treatment of inflammatory bowel disease (IBD) in Latin America are scarce. Our study describes the effectiveness and safety of VDZ in Colombian patients with IBD. Methods: EXVEDOCOL (EXperience of VEDOlizumab in COLombia) was a retrospective, multicenter, observational study. Adults with IBD receiving a first dose of VDZ between July 2016 and October 2018 were included. The co-primary outcomes clinical response, and remission, were determined at week 14 and last visit during the maintenance phase (LVMP). The secondary outcomes, deep remission and loss of response were recorded at LVMP. Results: Thirty-one patients (25 ulcerative colitis (UC), 6 Crohn's disease (CD)) were included. At week 14, clinical response was achieved by 87.1% (27/31) of the patients treated with VDZ, while loss of response was reported in 6.7% (2/30). The remission rate at week 14 was 65.5% (19/29) and 75.9% (22/29) at LVMP. Prior anti-TNF exposure was reported in 61.3% (19 patients) of whom 84.2% (16/19) achieved clinical response at week 14 and 89.5% (17/19) at LVMP. For anti-TNF naïve patients, clinical response was recorded in 91.7% (11/12) at week 14 and 100% (12/12) at LVMP. Conclusions: High clinical remission rates and safety profile highlight VDZ as a valuable treatment option for IBD patients. Anti-TNF naïve patients may derive greater benefit from therapy. Studies with larger cohorts could confirm these findings.
Language	Spanish
Publishing date	2024-02-02
Publishing country	Spain
Document type	Journal Article
ZDB-ID	632502-6
ISSN	0210-5705
ISSN	0210-5705
DOI	10.1016/j.gastrohep.2024.01.009
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Article: Clinical and therapeutic characterisation of a multicentre cohort of patients with inflammatory bowel disease in Colombia.

Parra-Izquierdo, Viviana / Flórez Sarmiento, Cristian / Frías-Ordoñez, Juan Sebastián / Vargas, Melquicedec / Kock, Joshua / Lozano Escobar, Natalia / Márquez, Juan Ricardo

Gastroenterologia y hepatologia

2022 Volume 46, Issue 8, Page(s) 585–593

Abstract: Introduction: In Latin America and Colombia there are few studies about the clinical and therapeutic characteristics of patients with inflammatory bowel disease (IBD). The objective of this study is to obtain an approximation to these data from a sample ...

Title translation	Caracterización clínica y terapéutica de una cohorte multicéntrica de pacientes con enfermedad inflamatoria intestinal en Colombia.
Abstract	Introduction: In Latin America and Colombia there are few studies about the clinical and therapeutic characteristics of patients with inflammatory bowel disease (IBD). The objective of this study is to obtain an approximation to these data from a sample of patients from different reference centres in Colombia. Patients and methods: Cross-sectional study in adult and paediatric patients, with IBD, attended ambulatory in 6 institutions in different cities, between 2017 and 2020 information was collected on different dates, about demographic, clinical, and therapeutic aspects. Results: Six hundred and five subjects, 565 (93.4%) adults, mean age 43 years (SD 12.78), 64% with ulcerative colitis (UC). The age at diagnosis of UC was 41.9 years, while in Crohn's disease (CD) it was 47.9 years. In UC, there was greater left involvement (47.2%), and in CD, 42.8% ileocolonic (L3). More than 50% were in mild activity or clinical remission. In UC, the biologic requirement was 27.2%, while in CD, 78%. Overall hospitalisation requirement was 39.5%, and the need for surgery was 37.5% in UC and 62.5% in CD. Also, 40 pediatric patients, 90% female, with UC being more frequent (80%). In UC, 83.3% presented extensive colitis, and in CD, all with ileocolonic localization (L3). More than 95% were in mild activity or remission. Biologic therapy was required in 16.6% and 75% for UC and CD, respectively. The frequency of hospitalisations and surgery was 2.7%. Conclusions: This study shows some unique characteristics of patients with IBD in Colombia. An earlier diagnosis is required, with a better therapeutic approach.
MeSH term(s)	Adult ; Humans ; Female ; Child ; Male ; Colombia/epidemiology ; Cross-Sectional Studies ; Inflammatory Bowel Diseases/epidemiology ; Inflammatory Bowel Diseases/therapy ; Crohn Disease/diagnosis ; Crohn Disease/epidemiology ; Crohn Disease/therapy ; Colitis, Ulcerative/therapy ; Colitis, Ulcerative/drug therapy
Language	Spanish
Publishing date	2022-12-01
Publishing country	Spain
Document type	Multicenter Study ; Journal Article
ZDB-ID	632502-6
ISSN	0210-5705
ISSN	0210-5705
DOI	10.1016/j.gastrohep.2022.11.006
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Article ; Online: Calidad de vida relacionada con la salud por IBDQ-32 en pacientes colombianos con enfermedad inflamatoria intestinal en remisión: Un estudio de corte transversal.

Parra-Izquierdo, Viviana / Frías-Ordoñez, Juan Sebastián / Márquez, Juan Ricardo / Puentes-Manosalva, Fabián Eduardo / Sarmiento, Fernando / García-Duperly, Rafael / Vargas, Melquisedec / Reyes, Gustavo / Samper, Carolina / Barreiro-de-Acosta, Manuel

Revista de gastroenterologia del Peru : organo oficial de la Sociedad de Gastroenterologia del Peru

2023 Volume 43, Issue 2, Page(s) 95–103

Abstract: In Colombia there are no data about perception of quality of life (QoL) in inflammatory bowel disease (IBD). The aim of this study was to determine the perception of QoL by means of the IBDQ-32 questionnaire in patients with IBD from a sample of patients ...

Title translation	Health-related quality of life by IBDQ-32 in colombian patients with inflammatory bowel disease in remission: A cross-sectional study.
Abstract	In Colombia there are no data about perception of quality of life (QoL) in inflammatory bowel disease (IBD). The aim of this study was to determine the perception of QoL by means of the IBDQ-32 questionnaire in patients with IBD from a sample of patients from different referral centers. We carried out a cross-sectional study in adults with IBD in clinical remission, in outpatient follow-up, in 3 institutions in different cities, between June 2022 and November 2022, eligible subjects were identified, information was collected on different dates, about socio-demographic and clinical aspects, and the IBDQ-32 questionnaire was evaluated on one occasion. Descriptive and analytical analysis of the variables evaluated was performed. 80 patients, 70% women, mean age 38.5(range 18-72; SD 13.25) years. 67.5% ulcerative colitis (UC), 32.5% Crohn's disease (CD). Moderate QoL involvement (median 150 points, interquartile range118.3-181.5) was found in IBD, in UC median 151 (interquartile range120-174.75) points, while in CD 133 (interquartile range106.25-186.25) points. There was greater involvement in the systemic domain, with median 21 (interquartile range 15.8-27) points, and 18.5 (interquartile range 12.8-25.3) points, for UC and CD, respectively. The least affected corresponded to the digestive domain and social function, in median UC 48.5 (interquartile range 40-58.3), and 27(interquartile range 20.8-33); in median CD 43 (interquartile range 35.5-61.75) and 24.5(interquartile range 18-32.5), respectively. No statistically significant differences were found. This study provides unique information about QoL of patients with IBD in Colombia. It is necessary to continue reinforcing the accompaniment, support, and education of patients with IBD.
MeSH term(s)	Adult ; Humans ; Female ; Male ; Quality of Life ; Cross-Sectional Studies ; Colombia ; Inflammatory Bowel Diseases ; Colitis, Ulcerative ; Crohn Disease
Language	Spanish
Publishing date	2023-08-18
Publishing country	Peru
Document type	English Abstract ; Journal Article
ZDB-ID	2058591-3
ISSN	1609-722X ; 1609-722X
ISSN (online)	1609-722X
ISSN	1609-722X
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Article: The impact of clinical experience on decision-making regarding the treatment and management of mild-to-moderate ulcerative colitis.

Cheon, Jae Hee / Paridaens, Kristine / Awadhi, Sameer Al / Begun, Jakob / Fullarton, John R / Louis, Edouard / Magro, Fernando / Marquez, Juan Ricardo / Moschen, Alexander R / Narula, Neeraj / Rydzewska, Grazyna / Dignass, Axel U / Travis, Simon Pl

Intestinal research

2022 Volume 21, Issue 1, Page(s) 161–167

Language	English
Publishing date	2022-04-18
Publishing country	Korea (South)
Document type	Journal Article
ZDB-ID	3018469-1
ISSN	2288-1956 ; 1598-9100
ISSN (online)	2288-1956
ISSN	1598-9100
DOI	10.5217/ir.2022.00006
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Article: Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis.

Louis, Edouard / Paridaens, Kristine / Al Awadhi, Sameer / Begun, Jakob / Cheon, Jae Hee / Dignass, Axel U / Magro, Fernando / Márquez, Juan Ricardo / Moschen, Alexander R / Narula, Neeraj / Rydzewska, Grazyna / Freddi, Matthew J / Travis, Simon Pl

BMJ open gastroenterology

2022 Volume 9, Issue 1

Abstract: Objectives: 5-aminosalicylate (mesalazine; 5-ASA) is an established first-line treatment for mild-to-moderate ulcerative colitis (UC). This study aimed to model the benefits of optimising 5-ASA therapy.: Methods: A decision tree model followed 10 000 ...

Abstract	Objectives: 5-aminosalicylate (mesalazine; 5-ASA) is an established first-line treatment for mild-to-moderate ulcerative colitis (UC). This study aimed to model the benefits of optimising 5-ASA therapy. Methods: A decision tree model followed 10 000 newly diagnosed patients with mild-to-moderately active UC through induction and 1 year of maintenance treatment. Optimised treatment (maximising dose of 5-ASA and use of combined oral and rectal therapy before treatment escalation) was compared with standard treatment (standard doses of 5-ASA without optimisation). Modelled data were derived from published meta-analyses. The primary outcomes were patient numbers achieving and maintaining remission, with an analysis of treatment costs for each strategy conducted as a secondary outcome (using UK reference costs). Results: During induction, there was a 39% increase in patients achieving remission through the optimised pathway without requiring systemic steroids and/or biologics (6565 vs 4725 for standard). Potential steroidal/biological adverse events avoided included: seven venous thromboembolisms and eight serious infections. Out of the 6565 patients entering maintenance following successful induction on 5-ASA, there was a 21% reduction in relapses when optimised (1830 vs 2311 for standard). This translated into 297 patients avoiding further systemic steroids and 214 biologics. Optimisation led to an average net saving of £272 per patient entering the model for the induction and maintenance of remission over 1 year. Conclusion: Modelling suggests that optimising 5-ASA therapy (both the inclusion of rectal 5-ASA into a combined oral and rectal regimen and maximisation of 5-ASA dose) has clinical and cost benefits that supports wider adoption in clinical practice.
MeSH term(s)	Administration, Oral ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Biological Products/therapeutic use ; Colitis, Ulcerative/chemically induced ; Colitis, Ulcerative/drug therapy ; Humans ; Mesalamine/adverse effects ; Mesalamine/therapeutic use ; Neoplasm Recurrence, Local/chemically induced ; Neoplasm Recurrence, Local/drug therapy ; Remission Induction ; Sulfasalazine/adverse effects
Chemical Substances	Anti-Inflammatory Agents, Non-Steroidal ; Biological Products ; Sulfasalazine (3XC8GUZ6CB) ; Mesalamine (4Q81I59GXC)
Language	English
Publishing date	2022-02-07
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2054-4774
ISSN	2054-4774
DOI	10.1136/bmjgast-2021-000853
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Article: Tofacitinib in the treatment of moderate to severe ulcerative colitis in Colombia: Real world experience.

Parra-Izquierdo, Viviana / Frías-Ordoñez, Juan Sebastián / Márquez, Juan Ricardo / Juliao-Baños, Fabián / Galindo, Pablo / Cuadros, Carlos / Rojas, Carlos / Rojas, Nelson / Ardila, Oscar / Tovar-Fierro, German / García-Duperly, Rafael / Vargas, Melquicedec / Flórez-Sarmiento, Cristian

Gastroenterologia y hepatologia

2022 Volume 46, Issue 7, Page(s) 512–521

Abstract: Introduction: There are no studies on efficacy of tofacitinib for ulcerative colitis (UC) in Latin America. The aim of this study was to describe the efficacy and safety, in the real world, of patients with moderate-severe UC treated with tofacitinib in ...

Title translation	Tofacitinib en el tratamiento de la colitis ulcerosa moderada a grave en Colombia: experiencia en mundo real.
Abstract	Introduction: There are no studies on efficacy of tofacitinib for ulcerative colitis (UC) in Latin America. The aim of this study was to describe the efficacy and safety, in the real world, of patients with moderate-severe UC treated with tofacitinib in our setting. Materials and methods: Multicenter descriptive observational study, in patients with UC who received treatment with tofacitinib in induction phase for 8 weeks and then, maintenance therapy, between June 2019 and June 2022. Results: Thirty-four adult patients, 50% female, mean age 38.1 (range 22-72) years. 76.5% pancolitis, and 20.6% left colitis. 79.4% failure to tumor necrosis factor inhibitors (anti-TNFs), and 35.3% to vedolizumab. 14.7% naïve to biologic therapy. 23.5% had previous extraintestinal manifestations. During induction, 58.8% of patients achieved clinical, biochemical and endoscopic remission. During maintenance, 76.9% of patients at 26 weeks and 66.6% at 52 weeks presented clinical remission. Eight patients presented adverse events, none of them cardiovascular or thromboembolic. 44.1% were steroid-dependent, and 23.5% required steroids as rescue therapy. 38.3% required an increase in tofacitinib to 10mg every 12h during maintenance. In 17.6% tofacitinib was discontinued due to lack of efficacy. We included three pediatric-aged female patients, mean age 15.3 (range 14-17) years, 2/3 with pancolitis and 1/3 with left colitis, all with prior exposure to biologic therapy, who had clinical, biologic and endoscopic remission at induction. Conclusions: In this first Latin American study with tofacitinib in UC, efficacy and safety are demonstrated in the treatment of our patients with moderate to severe activity.
MeSH term(s)	Adult ; Humans ; Female ; Child ; Aged ; Young Adult ; Middle Aged ; Adolescent ; Male ; Colitis, Ulcerative/drug therapy ; Colitis, Ulcerative/chemically induced ; Colombia ; Piperidines/therapeutic use ; Piperidines/adverse effects ; Colitis/drug therapy ; Treatment Outcome
Chemical Substances	tofacitinib (87LA6FU830) ; Piperidines
Language	Spanish
Publishing date	2022-11-11
Publishing country	Spain
Document type	Observational Study ; Multicenter Study ; Journal Article
ZDB-ID	632502-6
ISSN	0210-5705
ISSN	0210-5705
DOI	10.1016/j.gastrohep.2022.10.020
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Article ; Online: Multinational evaluation of clinical decision-making in the treatment and management of mild-to-moderate ulcerative colitis.

Dignass, Axel U / Paridaens, Kristine / Al Awadhi, Sameer / Begun, Jakob / Cheon, Jae Hee / Fullarton, John R / Louis, Edouard / Magro, Fernando / Marquez, Juan Ricardo / Moschen, Alexander R / Narula, Neeraj / Rydzewska, Grazyna / Travis, Simon P L

Scandinavian journal of gastroenterology

2021 Volume 57, Issue 4, Page(s) 424–431

Abstract: Objectives: To understand current thinking and clinical decision-making in the treatment and management of patients with mild-to-moderate ulcerative colitis (UC).: Methods: This multinational, survey-based study was conducted in 2021. Two meetings ... ...

Abstract	Objectives: To understand current thinking and clinical decision-making in the treatment and management of patients with mild-to-moderate ulcerative colitis (UC). Methods: This multinational, survey-based study was conducted in 2021. Two meetings were held, involving 11 IBD specialists, that used a series of questions and discussion to identify all factors possibly related to the management of UC. The importance of identified factors was assessed using an online questionnaire covering three scenarios - active disease, remission and patient empowerment. Each factor was scored on a scale of 0 (very-unimportant) to 100 (very-important) within each scenario, by a separate group of healthcare professionals working in IBD. Results: A total of 157 individual factors were identified by the 11 IBD specialists and scored in the three scenarios by 56 respondents (52; 93% specialist gastroenterologists) from Europe and North America (25; 45%), South America (19; 34%) and the Middle East, Asia and Australia (12; 21%). For all scenarios, factors related to educating patients regarding UC and its treatment and understanding of patient goals ranked highest, ahead of clinical considerations regarding disease activity and treatment history. Setting realistic short-term treatment targets was a key consideration. 5-ASA optimisation and use of faecal calprotectin monitoring were core strategies across the three scenarios tested. Support for patients during longer-term management of their disease, starting from initial flare, was an important recurring theme. Conclusion: The current management approach for mild-to-moderate UC was found to be guided primarily by the patient's perspectives and goals, alongside assessment of their medical and disease history.
MeSH term(s)	Clinical Decision-Making ; Colitis, Ulcerative/drug therapy ; Colitis, Ulcerative/therapy ; Humans ; Leukocyte L1 Antigen Complex ; Mesalamine/therapeutic use ; Mutation ; Severity of Illness Index
Chemical Substances	Leukocyte L1 Antigen Complex ; Mesalamine (4Q81I59GXC)
Language	English
Publishing date	2021-12-21
Publishing country	England
Document type	Journal Article
ZDB-ID	82042-8
ISSN	1502-7708 ; 0036-5521
ISSN (online)	1502-7708
ISSN	0036-5521
DOI	10.1080/00365521.2021.2015801
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Article ; Online: Clinical manifestations of colorectal cancer patients from a large multicenter study in Colombia.

Medicine

2016 Volume 95, Issue 40, Page(s) e4883

Abstract: Colorectal cancer (CRC) is a major public health problem, and its incidence is rising in developing countries. However, studies characterizing CRC clinicopathological features in cases from developing countries are still lacking. The goal of this study ... ...

Abstract	Colorectal cancer (CRC) is a major public health problem, and its incidence is rising in developing countries. However, studies characterizing CRC clinicopathological features in cases from developing countries are still lacking. The goal of this study was to evaluate clinicopathological and demographic features in one of the largest CRC studies in Latin America.The study involved over 1525 CRC cases recruited in a multicenter study in Colombia between 2005 and 2014 as part of ongoing genetic and epidemiological studies. We gathered clinicopathological data such as age at diagnosis, sex, body mass index, tobacco and alcohol consumption, family history of cancer, and tumor features including location, histological type, and stage. Statistical analyses were performed to test the association between age of onset, sex, and clinical manifestations.The average age at CRC diagnosis was 57.4 years, with 26.5% of cases having early-onset CRC (diagnosed by age 50 years). Most cases were women (53.2%; P = 0.009), 49.2% were overweight or obese, 49.1% were regular alcohol drinkers, 52% were smokers/former smokers, and 12.2% reported relatives with cancer. Most tumors in the study were located in the rectum (42.7%), were adenocarcinomas (91.5%), and had advanced stage (T3-T4, 79.8%). Comparisons by sex found that male cases were more likely to be obese (36.5% vs 31.1%; P = 0.001), less likely to have a family history of cancer (9.7% vs 15.3%; P = 0.016), and more likely to have advanced-stage tumors (83.9% vs 76.1%; P = 0.036). Comparisons by age of onset found that early-onset cases were more likely to be women (59.3% vs 51.0%; P = 0.005) and report a family history of cancer (17.4% vs 10.2%; P = 0.001).To our knowledge, our study is the largest report of clinicopathological characterization of Hispanic CRC cases, and we suggest that further studies are needed to understand CRC etiology in diverse Hispanic populations.
MeSH term(s)	Adenocarcinoma/pathology ; Adult ; Age Factors ; Age of Onset ; Aged ; Alcohol Drinking/epidemiology ; Body Mass Index ; Colombia/epidemiology ; Colorectal Neoplasms/epidemiology ; Colorectal Neoplasms/pathology ; Colorectal Neoplasms/physiopathology ; Female ; Genetic Predisposition to Disease ; Humans ; Incidence ; Male ; Middle Aged ; Retrospective Studies ; Sex Factors ; Smoking/epidemiology ; Young Adult
Language	English
Publishing date	2016-10-17
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Observational Study
ZDB-ID	80184-7
ISSN	1536-5964 ; 0025-7974
ISSN (online)	1536-5964
ISSN	0025-7974
DOI	10.1097/MD.0000000000004883
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