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1.
Arq Gastroenterol ; 61: e24017, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39046005

RESUMO

BACKGROUND: Inflammatory bowel disease (IBD), represented by Crohn's disease (CD) and ulcerative colitis (UC), is a chronic condition that affects all age groups, predominantly in young individuals. Currently, an increase in the prevalence of IBD has been documented, in parallel with the increase in the elderly population. The scarce number of studies that better characterize the impact of IBD on Quality of Life (QoL) in the elderly motivated the present study. OBJECTIVE: To evaluate the impact of IBD on the QoL of elderly people treated at a Tertiary IBD Center. METHODS: Prospective cross-sectional study that included elderly patients (age ≥60 years) with quiescent or mildly active IBD treated at the HU-UFJF IBD Center between March 2019 and December 2022. Elderly companions without severe comorbidities who attended the consultation with the patients were included as a control group. Sociodemographic and IBD-related characteristics were recorded. QoL was assessed using previously validated questionnaires (WHOQOL-BREF and IBDQ). Patients with IBD with moderate to severe activity, history of recent or imminent hospitalization, serious or opportunistic infections in the last 6 months, previous neoplasia, dementia, and difficulty understanding/fulfilling the questionnaires were excluded. RESULTS: A total of 123 patients were included (74 with IBD and 49 in the control group), with a mean age of 67±6.2 years, 52.7% with CD, and 47.3% with UC. Mild disease activity was observed in 31.1%. Both groups (IBD patients and control) were comparable based on age, sex, BMI, and the Charlson Comorbidity Index. Patients with IBD and controls had similar QoL scores in the different domains assessed by the WHOQOL-BREF. On the other hand, when evaluating the general facet of QoL, IBD patients had significantly lower scores in General QoL (3.71±0.87 versus 4.02±0.62, respectively; P=0.021) and General Health (3.32±1.05 versus 3.69±0.94, respectively; P=0.035). The presence of mildly active IBD negatively impacted the general health score (2.91±0.99 versus 3.47±1.04, respectively; P=0.035) and the physical domain of the WHOQOL-BREF (12.27±2.63 versus 13.86±2.61, respectively; P=0.019) when compared to patients in remission. Conversely, no impact on QoL was observed with the Application of the IBDQ questionnaire regarding the type of the disease (161±38.5 versus 163.1±42.6 for CD and UC, respectively; P=0.84) or the presence of activity (152.5±38.8 versus 166.4±40.5, respectively; P=0.17). CONCLUSION: No statistically significant differences were found between elderly patients with mildly active or quiescent IBD and elderly patients without IBD when observing global QoL scores. However, IBD negatively impacted the general facet of QoL, just as mild activity was associated with lower scores in general health and the physical domain assessed by the WHOQOL-BREF. Patients with IBD treated with biological therapy had better Qol than those on conventional therapy. Future studies are needed to choose the most appropriate tool for assessing QoL in this population.


Assuntos
Qualidade de Vida , Índice de Gravidade de Doença , Humanos , Feminino , Masculino , Estudos Transversais , Idoso , Estudos Prospectivos , Pessoa de Meia-Idade , Inquéritos e Questionários , Colite Ulcerativa/psicologia , Colite Ulcerativa/complicações , Doença de Crohn/psicologia , Doença de Crohn/complicações , Doenças Inflamatórias Intestinais/psicologia , Doenças Inflamatórias Intestinais/complicações , Estudos de Casos e Controles , Idoso de 80 Anos ou mais , Indução de Remissão
2.
World J Gastroenterol ; 30(24): 3022-3035, 2024 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-38983953

RESUMO

Managing inflammatory bowel disease (IBD) is becoming increasingly complex and personalized, considering the advent of new advanced therapies with distinct mechanisms of action. Achieving mucosal healing (MH) is a pivotal therapeutic goal in IBD management and can prevent IBD progression and reduce flares, hospitalization, surgery, intestinal damage, and colorectal cancer. Employing proactive disease and therapy assessment is essential to achieve better control of intestinal inflammation, even if subclinical, to alter the natural course of IBD. Periodic monitoring of fecal calprotectin (FC) levels and interval endoscopic evaluations are cornerstones for evaluating response/remission to advanced therapies targeting IBD, assessing MH, and detecting subclinical recurrence. Here, we comment on the article by Ishida et al Moreover, this editorial aimed to review the role of FC and endoscopic scores in predicting MH in patients with IBD. Furthermore, we intend to present some evidence on the role of these markers in future targets, such as histological and transmural healing. Additional prospective multicenter studies with a stricter MH criterion, standardized endoscopic and histopathological analyses, and virtual chromoscopy, potentially including artificial intelligence and other biomarkers, are desired.


Assuntos
Biomarcadores , Fezes , Doenças Inflamatórias Intestinais , Mucosa Intestinal , Complexo Antígeno L1 Leucocitário , Humanos , Complexo Antígeno L1 Leucocitário/análise , Fezes/química , Mucosa Intestinal/patologia , Mucosa Intestinal/metabolismo , Biomarcadores/análise , Biomarcadores/metabolismo , Doenças Inflamatórias Intestinais/patologia , Doenças Inflamatórias Intestinais/metabolismo , Doenças Inflamatórias Intestinais/terapia , Índice de Gravidade de Doença , Cicatrização , Colonoscopia , Progressão da Doença , Recidiva , Endoscopia Gastrointestinal/métodos
3.
Rev Assoc Med Bras (1992) ; 70(6): e20231321, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39045949

RESUMO

OBJECTIVE: The aim of this study was to evaluate the prevalence and risk factors related to metabolic dysfunction-associated steatotic liver disease in inflammatory bowel disease patients. METHODS: This is a cross-sectional study conducted on adults with inflammatory bowel disease from 2019 to 2021. Metabolic dysfunction-associated steatotic liver disease encompasses patients with steatosis and at least one cardiometabolic risk factor. Patients with alcohol consumption ≥20 g/day, chronic liver diseases, or methotrexate use were excluded. RESULTS: Almost 140 patients were included: 67.1% were female, with a mean age of 49.7±13.7 years, and 63.6% had Crohn's disease. The mean duration of inflammatory bowel disease was 9.7±7.9 years. Metabolic dysfunction-associated steatotic liver disease was observed in 44.3% and advanced liver fibrosis was excluded in 63.5% by Fibrosis-4. Patients with metabolic dysfunction-associated steatotic liver disease were older (p = 0.003) and had a higher number of metabolic syndrome components (2.9±1.1 versus 1.6±1.0; p<0.001), greater abdominal circumference (p<0.001), and body mass index (p<0.001). The only factor related to inflammatory bowel disease associated with metabolic dysfunction-associated steatotic liver disease was disease duration (11.6±9.5 versus 8.3±6.2; p = 0.017). A higher number of metabolic syndrome components and obesity increase by 2.2 times and an altered waist circumference by 2.6 times the occurrence of metabolic dysfunction-associated steatotic liver disease. CONCLUSION: A high prevalence of metabolic dysfunction-associated steatotic liver disease was observed in patients with inflammatory bowel disease, with the main risk factors being associated with metabolic syndrome predicting it, but not with inflammatory bowel disease features and/or its treatment.


Assuntos
Doenças Inflamatórias Intestinais , Síndrome Metabólica , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Transversais , Prevalência , Adulto , Fatores de Risco , Síndrome Metabólica/epidemiologia , Síndrome Metabólica/complicações , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/epidemiologia , Centros de Atenção Terciária , Brasil/epidemiologia , Fígado Gorduroso/epidemiologia , Fígado Gorduroso/complicações , Índice de Massa Corporal , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/complicações
4.
World J Gastroenterol ; 30(12): 1644-1650, 2024 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-38617734

RESUMO

In this editorial, we comment on the article by Marangoni et al, published in the recent issue of the World Journal of Gastroenterology 2023; 29: 5618-5629, about "Diet as an epigenetic factor in inflammatory bowel disease". The authors emphasized the role of diet, especially the interaction with genetics, in promoting the inflammatory process in inflammatory bowel disease (IBD) patients, focusing on DNA methylation, histone modifications, and the influence of microRNAs. In this editorial, we explore the interaction between genetics, gut microbiota, and diet, in an only way. Furthermore, we provided dietary recommendations for patients with IBD. The Western diet, characterized by a low fiber content and deficiency the micronutrients, impacts short-chain fatty acids production and may be related to the pathogenesis of IBD. On the other hand, the consumption of the Mediterranean diet and dietary fibers are associated with reduced risk of IBD flares, particularly in Crohn's disease (CD) patients. According to the dietary guidance from the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD), the regular consumption of fruits and vegetables while reducing the consumption of saturated, trans, dairy fat, additives, processed foods rich in maltodextrins, and artificial sweeteners containing sucralose or saccharine is recommended to CD patients. For patients with ulcerative colitis, the IOIBD recommends the increased intake of natural sources of omega-3 fatty acids and follows the same restrictive recommendations aimed at CD patients, with the possible inclusion of red meats. In conclusion, IBD is a complex and heterogeneous disease, and future studies are needed to elucidate the influence of epigenetics on diet and microbiota in IBD patients.


Assuntos
Colite Ulcerativa , Doença de Crohn , Dieta Mediterrânea , Doenças Inflamatórias Intestinais , MicroRNAs , Humanos , Doenças Inflamatórias Intestinais/genética , Doença de Crohn/genética
5.
Crohns Colitis 360 ; 6(2): otae023, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38681979

RESUMO

Background: Real-world data on the effectiveness and safety of ustekinumab (UST) in ulcerative colitis (UC) are lacking in Latin America. In this study, we aimed to describe the effectiveness and safety of UST in a real-world multicenter cohort of Brazilian patients with UC. Methods: We conducted a multicenter retrospective observational cohort study, including patients with moderate-to-severe UC (total Mayo score 6-12, with an endoscopic subscore of 2 or 3) who received UST. The co-primary endpoints were clinical remission, defined as a total Mayo score ≤2 at 1 year, with a combined rectal bleeding and stool frequency subscore of ≤1, and endoscopic remission (endoscopic Mayo subscore of 0) within 1 year from baseline. Secondary endpoints included clinical response between weeks 12 and 16, endoscopic response within 1 year of starting UST, steroid-free clinical remission at week 52, and biochemical remission at week 52. We also evaluated UST treatment persistence and safety. Results: A total of 50 patients were included (female, n = 36, 72.0%), with a median disease duration of 9.2 years (1-27). Most patients had extensive colitis (n = 38, 76.0%), and 43 (86.0%) were steroid dependent at baseline. Forty patients (80.0%) were previously exposed to biologics (anti-TNF drugs, n = 31; vedolizumab [VDZ], n = 27). The co-primary endpoints of clinical remission at 1 year and endoscopic remission within 1 year were achieved by 50.0% and 36.0% of patients, respectively. Clinical response at weeks 12-16 was 56.0%, and endoscopic response, steroid-free clinical remission, and biochemical remission at week 52 were 68.0%, 46.5%, and 50.0%, respectively. The UST treatment persistence rate at 24 months was 73.7%. During the follow-up, 10 patients (20.0%) were hospitalized, mostly due to disease progression, and 3 patients required colectomy. Nine patients (18.0%) discontinued the drug mainly due to a lack of effectiveness. Twenty-seven adverse events (AEs) were reported, 16 of which were considered as serious AEs. Conclusions: In this real-world cohort of difficult-to-treat UC patients, UST was associated with improvements in clinical, biochemical, and endoscopic outcomes. The safety profile was favorable, consistent with the known profile of UST.

6.
Arq. gastroenterol ; 61: e24017, 2024. tab, graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1563984

RESUMO

ABSTRACT Background: Inflammatory bowel disease (IBD), represented by Crohn's disease (CD) and ulcerative colitis (UC), is a chronic condition that affects all age groups, predominantly in young individuals. Currently, an increase in the prevalence of IBD has been documented, in parallel with the increase in the elderly population. The scarce number of studies that better characterize the impact of IBD on Quality of Life (QoL) in the elderly motivated the present study. Objective: To evaluate the impact of IBD on the QoL of elderly people treated at a Tertiary IBD Center. Methods: Prospective cross-sectional study that included elderly patients (age ≥60 years) with quiescent or mildly active IBD treated at the HU-UFJF IBD Center between March 2019 and December 2022. Elderly companions without severe comorbidities who attended the consultation with the patients were included as a control group. Sociodemographic and IBD-related characteristics were recorded. QoL was assessed using previously validated questionnaires (WHOQOL-BREF and IBDQ). Patients with IBD with moderate to severe activity, history of recent or imminent hospitalization, serious or opportunistic infections in the last 6 months, previous neoplasia, dementia, and difficulty understanding/fulfilling the questionnaires were excluded. Results: A total of 123 patients were included (74 with IBD and 49 in the control group), with a mean age of 67±6.2 years, 52.7% with CD, and 47.3% with UC. Mild disease activity was observed in 31.1%. Both groups (IBD patients and control) were comparable based on age, sex, BMI, and the Charlson Comorbidity Index. Patients with IBD and controls had similar QoL scores in the different domains assessed by the WHOQOL-BREF. On the other hand, when evaluating the general facet of QoL, IBD patients had significantly lower scores in General QoL (3.71±0.87 versus 4.02±0.62, respectively; P=0.021) and General Health (3.32±1.05 versus 3.69±0.94, respectively; P=0.035). The presence of mildly active IBD negatively impacted the general health score (2.91±0.99 versus 3.47±1.04, respectively; P=0.035) and the physical domain of the WHOQOL-BREF (12.27±2.63 versus 13.86±2.61, respectively; P=0.019) when compared to patients in remission. Conversely, no impact on QoL was observed with the Application of the IBDQ questionnaire regarding the type of the disease (161±38.5 versus 163.1±42.6 for CD and UC, respectively; P=0.84) or the presence of activity (152.5±38.8 versus 166.4±40.5, respectively; P=0.17). Conclusion: No statistically significant differences were found between elderly patients with mildly active or quiescent IBD and elderly patients without IBD when observing global QoL scores. However, IBD negatively impacted the general facet of QoL, just as mild activity was associated with lower scores in general health and the physical domain assessed by the WHOQOL-BREF. Patients with IBD treated with biological therapy had better Qol than those on conventional therapy. Future studies are needed to choose the most appropriate tool for assessing QoL in this population.


RESUMO Contexto: Doença inflamatória intestinal (DII), representada pela doença de Crohn (DC) e retocolite ulcerativa (RCU), é uma condição crônica e progressiva que afeta todas as faixas etárias, embora predomine em indivíduos jovens. Atualmente, tem sido documentado um aumento na prevalência de DII, de forma paralela ao aumento da população idosa. O escasso número de estudos que melhor caracterizem o impacto da DII na qualidade de vida (QV) em idosos motivou o presente estudo. Objetivo: Avaliar o impacto da DII na QV de idosos atendidos em um centro terciário de DII. Métodos: Estudo prospectivo transversal que incluiu pacientes idosos (idade ≥60 anos) com DII, atendidos pelo Centro de DII do HU-UFJF, entre março de 2019 a dezembro de 2022, e que apresentavam remissão clínica ou atividade leve de doença. Acompanhantes idosos sem comorbidades graves que compareceram à consulta com os pacientes foram incluídos como grupo controle. Foram registradas características sociodemográficas e relativas a DII. A QV foi avaliada por meio de questionários previamente validados (WHOQOL-BREF e IBDQ). Pacientes com DII com atividade moderada a grave, história de hospitalização recente ou iminente, infecções graves ou oportunistas nos últimos 6 meses, neoplasia prévia, demência, dificuldade de compreensão/ preenchimento dos questionários foram excluídos. Resultados: Foram incluídos 123 pacientes (74 com DII e 49 no grupo controle), com idade média de 67±6,2 anos, sendo 52,7% com DC e 47,3% com RCU. Atividade leve da doença foi observada em 31,1%. Ambos os grupos (pacientes com DII e controle) foram comparáveis com base na idade, sexo, IMC e Índice de Comorbidade de Charlson. Pacientes com DII e controle apresentaram escores de QV similares nos diferentes domínios avaliados pelo WHOQOL-BREF. Por outro lado, quando avaliada a faceta geral de QV, pacientes com DII apresentaram escores significativamente menores na QV geral (3,71±0,87 versus 4,02±0,62, respectivamente; P=0,021) e na saúde geral (3,32±1,05 versus 3,69±0,94, respectivamente; P=0,035). A presença de atividade leve impactou negativamente nos escores de saúde geral e de domínio físico do WHOQOL-BREF quando comparados com pacientes em remissão (2,91±0,99 versus 3.47±1,04, respectivamente; P=0,035 e 12,27±2.63 versus 13,86±2,61, respectivamente; P=0,019). Não foi observado impacto na QV com a aplicação do questionário IBDQ no que se refere ao tipo de DII (161±38.5 versus 163.1±42,6 para DC e RCU, respectivamente; P=0.84) ou a presença de atividade (152.5±38.8 versus 166.4±40.5, respectivamente; P=0.17). Conclusão: Não foram encontradas diferenças estatisticamente significativas entre pacientes idosos com DII em atividade leve ou quiescente e pacientes idosos sem DII quando observados os escores globais de QV. Porém, a DII impactou negativamente a faceta geral de QV, assim como a presença de atividade leve esteve associada a menores escores na saúde geral e no domínio físico avaliado pelo WHOQOL-BREF. Pacientes com DII tratados com terapia biológica apresentaram melhor QV do que aqueles em terapia convencional. Estudos futuros são necessários para escolha de ferramenta mais adequada para avaliação de QV nessa população.

7.
Rev. Assoc. Med. Bras. (1992, Impr.) ; 70(6): e20231321, 2024. tab, graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1565023

RESUMO

SUMMARY OBJECTIVE: The aim of this study was to evaluate the prevalence and risk factors related to metabolic dysfunction-associated steatotic liver disease in inflammatory bowel disease patients. METHODS: This is a cross-sectional study conducted on adults with inflammatory bowel disease from 2019 to 2021. Metabolic dysfunction-associated steatotic liver disease encompasses patients with steatosis and at least one cardiometabolic risk factor. Patients with alcohol consumption ≥20 g/day, chronic liver diseases, or methotrexate use were excluded. RESULTS: Almost 140 patients were included: 67.1% were female, with a mean age of 49.7±13.7 years, and 63.6% had Crohn's disease. The mean duration of inflammatory bowel disease was 9.7±7.9 years. Metabolic dysfunction-associated steatotic liver disease was observed in 44.3% and advanced liver fibrosis was excluded in 63.5% by Fibrosis-4. Patients with metabolic dysfunction-associated steatotic liver disease were older (p = 0.003) and had a higher number of metabolic syndrome components (2.9±1.1 versus 1.6±1.0; p<0.001), greater abdominal circumference (p<0.001), and body mass index (p<0.001). The only factor related to inflammatory bowel disease associated with metabolic dysfunction-associated steatotic liver disease was disease duration (11.6±9.5 versus 8.3±6.2; p = 0.017). A higher number of metabolic syndrome components and obesity increase by 2.2 times and an altered waist circumference by 2.6 times the occurrence of metabolic dysfunction-associated steatotic liver disease. CONCLUSION: A high prevalence of metabolic dysfunction-associated steatotic liver disease was observed in patients with inflammatory bowel disease, with the main risk factors being associated with metabolic syndrome predicting it, but not with inflammatory bowel disease features and/or its treatment.

8.
BMC Res Notes ; 16(1): 371, 2023 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-38115124

RESUMO

INTRODUCTION: Despite the advances in surgical and clinical approaches, there is no consensus regarding the best line of treatment from rectovaginal fistula (RVF). Faced with a challenging scenario in the approach of RVF, the fractional CO2 laser receives attention as a possible form of treatment. OBJECTIVES: A single-center, prospective, open-label study evaluating the effectiveness and safety of laser therapy for RVF treatment. SUBJECTS AND METHODS: The total of 15 patients was recruited at the Juiz de Fora University Hospital between August 2018 and July 2022. Inclusion criteria were presence of clinically suspects RVF of any etiology confirmed by pelvic magnetic resonance image (MRI) and gynecological examination. Five fractional CO2 laser sessions with monthly interval followed by complete evaluation through clinical examination and pelvic MRI were performed for all patients after the completion of treatment. Analysis of sexual function before and after the treatment was performed using Female Sexual Quotient (FSQ). RESULTS: The evaluation through physical examination showed no persistent inflammatory signs in the vagina for all patients. Additionally, 10 of out 15 (67.7%) patients achieved clinical remission of RVF symptoms, while 33.3% patients reported significant improvement. Of note, five patients who did not have previous sexual activity returned to regular sexual activity while seven patients who have baseline sexual activity had improvement in their sexual function as assessed by the FSQ. Three out of four ostomized patients had their ostomy reversed and remained without complains. All six patients with RVF secondary to Crohn's disease reported a marked improvement in symptoms and sexual function. In seven (47%) patients radiological remission was confirmed by pelvic MRI. CONCLUSION: CO2 fractional laser can be considered a promising and safe therapeutic alternative for the management of RVF.


Assuntos
Dióxido de Carbono , Fístula Retovaginal , Humanos , Feminino , Fístula Retovaginal/diagnóstico por imagem , Fístula Retovaginal/cirurgia , Fístula Retovaginal/etiologia , Seguimentos , Estudos Prospectivos , Vagina/diagnóstico por imagem , Vagina/cirurgia , Lasers , Resultado do Tratamento
9.
J Clin Med ; 12(21)2023 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-37959208

RESUMO

This study focuses on the use of thiopurines for treating inflammatory bowel diseases (IBD). These drugs undergo enzymatic changes within the body, resulting in active and inactive metabolites that influence their therapeutic effects. The research examines the role of genetic polymorphisms in the enzyme thiopurine S-methyltransferase (TPMT) in predicting the therapeutic response and adverse effects of thiopurine treatment. The TPMT genotype variations impact the individual responses to thiopurines. Patients with reduced TPMT activity are more susceptible to adverse reactions (AEs), such leukopenia, hepatotoxicity, pancreatitis, and nausea, which are common adverse effects of thiopurine therapy. The therapeutic monitoring of the metabolites 6-thioguanine nucleotides (6-TGN) and 6-methyl mercaptopurine (6-MMP) is proposed to optimize treatment and minimize AEs. Patients with higher 6-TGN levels tend to have better clinical responses, while elevated 6-MMP levels are linked to hepatotoxicity. Genotyping for TPMT before or during treatment initiation is suggested to tailor dosing strategies and enhance treatment efficacy while reducing the risk of myelosuppression. In conclusion, this study highlights the importance of considering genetic variations and metabolite levels in optimizing thiopurine therapy for IBD patients, focusing on balance therapeutic efficacy with the prevention of adverse effects and contributing to personalized treatment and better patient outcomes.

10.
Crohns Colitis 360 ; 5(4): otad053, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37859629

RESUMO

Background: In real-world experience, the number of patients using vedolizumab as first-line biological therapy was low. We aimed to evaluate the effectiveness and safety of vedolizumab in mild-to-moderate Crohn's disease (CD) biologic-naïve patients. Methods: We performed a retrospective multicentric cohort study with patients who had clinical activity scores (Harvey-Bradshaw Index [HBI]) measured at baseline and weeks 12, 26, 52, as well as at the last follow-up. Clinical response was defined as a reduction ≥3 in HBI, whereas clinical remission as HBI ≤4. Mucosal healing was defined as the complete absence of ulcers in control colonoscopies. Kaplan-Meier survival analysis was used to assess the persistence with vedolizumab. Results: From a total of 66 patients, 53% (35/66) reached clinical remission at week 12. This percentage increased to 69.7% (46/66) at week 26, and 78.8% (52/66) at week 52. Mucosal healing was achieved in 62.3% (33/53) of patients. Vedolizumab was well tolerated, and most adverse events were minor. During vedolizumab treatment, 3/66 patients underwent surgery. Conclusions: This study demonstrates the effectiveness and safety of vedolizumab as a first-line biological agent in patients with mild-to-moderate CD.

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