Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 113
Filter
2.
Article in English | MEDLINE | ID: mdl-38556033

ABSTRACT

BACKGROUND & AIMS: Pouchitis is the most common complication after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC); however, clinical and environmental risk factors for pouchitis remain poorly understood. We explored the relationship between specific clinical factors and the incidence of pouchitis. METHODS: We established a population-based cohort of all adult persons in Denmark undergoing proctocolectomy with IPAA for UC from 1996-2020. We used Cox proportional hazard modeling to assess the impact of antibiotic, nonsteroidal anti-inflammatory drug (NSAID) exposure, and appendectomy on diagnosis of acute pouchitis in the first 2 years after IPAA surgery. RESULTS: Among 1616 eligible patients, 46% developed pouchitis in the first 2 years after IPAA. Antibiotic exposure in the 12 months before IPAA was associated with an increased risk of pouchitis (adjusted hazard ratio [aHR], 1.41; 95% confidence interval [CI], 1.22-1.64) after adjusting for anti-tumor necrosis factor alpha use and sex. Compared with persons without any antibiotic prescriptions in the 12 months before IPAA, the risk of pouchitis was increased in those with 1 or 2 courses of antibiotics in that period (aHR, 1.30; 95% CI, 1.11-1.52) and 3 or more courses (aHR, 1.77; 95% CI, 1.41-2.21). NSAID exposure in the 12 months before IPAA and appendectomy were not associated with risk of acute pouchitis (P = .201 and P = .865, respectively). CONCLUSIONS: In this population-based cohort study, we demonstrated that antibiotic exposure in the 12 months before IPAA is associated with an increased risk of acute pouchitis. Future prospective studies may isolate specific microbial changes in at-risk patients to drive earlier interventions.

4.
Dis Colon Rectum ; 67(5): 674-680, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38276963

ABSTRACT

BACKGROUND: IPAA is considered the procedure of choice for restorative surgery after total colectomy for ulcerative colitis. Previous studies have examined the rate of IPAA within individual states but not at the national level in the United States. OBJECTIVE: This study aimed to assess the rate of IPAA after total colectomy for ulcerative colitis in a national population and identify factors associated with IPAA. DESIGN: This was a retrospective cohort study. SETTINGS: This study was performed in the United States. PATIENTS: Patients who were aged 18 years or older and who underwent total colectomy between 2009 and 2019 for a diagnosis of ulcerative colitis were identified within a commercial database. This database excluded patients with public insurance, including all patients older than 65 years with Medicare. MAIN OUTCOME MEASURES: The primary outcome was IPAA. Multivariable logistic regression was used to assess the association between covariates and the likelihood of undergoing IPAA. RESULTS: In total, 2816 patients were included, of whom 1414 (50.2%) underwent IPAA, 928 (33.0%) underwent no further surgery, and 474 (16.8%) underwent proctectomy with end ileostomy. Younger age, lower comorbidities, elective case, and laparoscopic approach in the initial colectomy were significantly associated with IPAA but socioeconomic status was not. LIMITATIONS: This retrospective study included only patients with commercial insurance. CONCLUSIONS: A total of 50.2% of patients who had total colectomy for ulcerative colitis underwent IPAA, and younger age, lower comorbidities, and elective cases are associated with a higher rate of IPAA placement. This study emphasizes the importance of ensuring follow-up with colorectal surgeons to provide the option of restorative surgery, especially for patients undergoing urgent or emergent colectomies. See Video Abstract . FACTORES ASOCIADOS CON LA REALIZACIN DE ANASTOMOSIS ANALBOLSA ILEAL DESPUS DE UNA COLECTOMA TOTAL POR COLITIS ULCEROSA: ANTECEDENTES:La anastomosis ileo-anal se considera el procedimiento de elección para la cirugía reparadora tras la colectomía total por colitis ulcerosa. Estudios previos han examinado la tasa de anastomosis ileo-anal dentro de los estados individuales, pero no a nivel nacional en los Estados Unidos.OBJETIVO:Evaluar la tasa de anastomosis bolsa ileal-anal después de la colectomía total para la colitis ulcerosa en una población nacional e identificar los factores asociados con la anastomosis bolsa ileal-anal.DISEÑO:Se trata de un estudio de cohortes retrospectivo.LUGAR:Este estudio se realizó en los Estados Unidos.PACIENTES:Los pacientes que tenían ≥18 años de edad que se sometieron a colectomía total entre 2009 y 2019 para un diagnóstico de colitis ulcerosa fueron identificados dentro de una base de datos comercial. Esta base de datos excluyó a los pacientes con seguro público, incluidos todos los pacientes >65 años con Medicare.MEDIDAS DE RESULTADO PRINCIPALES:El resultado primario fue la anastomosis ileal bolsa-anal. Se utilizó una regresión logística multivariable para evaluar la asociación entre las covariables y la probabilidad de someterse a una anastomosis ileal.RESULTADOS:En total, se incluyeron 2.816 pacientes, de los cuales 1.414 (50,2%) se sometieron a anastomosis ileo-anal, 928 (33,0%) no se sometieron a ninguna otra intervención quirúrgica y 474 (16,8%) se sometieron a proctectomía con ileostomía terminal. La edad más joven, las comorbilidades más bajas, el caso electivo, y el abordaje laparoscópico en la colectomía inicial se asociaron significativamente con la anastomosis ileal bolsa-anal, pero no el estatus socioeconómico.LIMITACIONES:Este estudio retrospectivo incluyó sólo pacientes con seguro comercial.CONCLUSIONES:Un 50,2% de los pacientes se someten a anastomosis ileo-anal y la edad más joven, las comorbilidades más bajas y los casos electivos se asocian con una mayor tasa de colocación de anastomosis ileo-anal. Esto subraya la importancia de asegurar el seguimiento con cirujanos colorrectales para ofrecer la opción de cirugía reparadora, especialmente en pacientes sometidos a colectomías urgentes o emergentes. (Traducción-Dr. Yolanda Colorado ).


Subject(s)
Colitis, Ulcerative , Humans , Aged , United States/epidemiology , Colitis, Ulcerative/epidemiology , Colitis, Ulcerative/surgery , Retrospective Studies , Medicare , Colectomy , Ileum/surgery , Postoperative Complications/epidemiology , Postoperative Complications/surgery
5.
Inflamm Bowel Dis ; 30(2): 196-202, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-37043649

ABSTRACT

BACKGROUND: Anastomotic strictures occur in up to 38% of patients after ileal pouch-anal anastomosis (IPAA). We sought to compare the safety, effectiveness, and durability of mechanical dilation using a Hegar dilator to endoscopic through-the-scope balloon dilation (EBD) among IPAA patients with a rectal or ileoanal anastomotic stricture. METHODS: We identified adult patients with an IPAA for ulcerative colitis (UC) who underwent a pouchoscopy between January 1, 2015, and December 31, 2019, at a single institution. We compared the effectiveness (median maximum diameter of dilation [MMD]), safety, and durability of mechanical and balloon dilation using standard statistical comparisons. RESULTS: A total 74 patients had a stricture at the ileoanal anastomosis and underwent at least 1 mechanical or balloon dilation. The MMD with mechanical dilation was 19 (interquartile range [IQR], 18-20) mm for the first dilation and 20 (IQR, 18-20) mm for the second and third dilations. With balloon dilation, the MMD was 12 (IQR, 12-18) mm for the first dilation, 15 (IQR, 12-16.5) mm for the second dilation, and 18 (IQR, 15-18.5) mm for the third dilation. Patients undergoing mechanical dilation experienced a longer duration to second dilation (median 191 days vs 53 days: P < .001), with no difference in complications such as bleeding or perforation noted. CONCLUSIONS: Among patients with ileoanal and rectal strictures, mechanical and balloon approaches to dilation demonstrated similar safety profiles and effectiveness. Mechanical dilation with Hegar dilators appears to be an effective and safe approach to the treatment of distal strictures after IPAA.


Distal strictures are common in patients after ileal pouch­anal anastomosis. We demonstrated that both mechanical dilation with Hegar dilators and balloon dilation are safe and effective approaches to rectal or ileoanal strictures after ileal pouch­anal anastomosis.


Subject(s)
Colitis, Ulcerative , Colonic Pouches , Proctocolectomy, Restorative , Adult , Humans , Constriction, Pathologic/therapy , Constriction, Pathologic/surgery , Dilatation/adverse effects , Proctocolectomy, Restorative/adverse effects , Anastomosis, Surgical/adverse effects , Colitis, Ulcerative/surgery , Colitis, Ulcerative/complications , Colonic Pouches/adverse effects , Postoperative Complications/therapy , Postoperative Complications/surgery , Treatment Outcome , Retrospective Studies
6.
Am J Gastroenterol ; 2024 Feb 16.
Article in English | MEDLINE | ID: mdl-37975591

ABSTRACT

INTRODUCTION: There is a paucity of data on the real-world effectiveness of therapies in patients with Crohn's disease of the pouch. METHODS: This was a prospective multicenter study evaluating the primary outcome of remission at 12 months of therapy for Crohn's disease of the pouch. RESULTS: One hundred thirty-four patients were enrolled. Among the 77 patients with symptoms at baseline, 35 (46.7%) achieved remission at 12 months. Of them, 12 (34.3%) changed therapy. There was no significant association between therapy patterns and remission status. DISCUSSION: Approximately 50% with symptoms at enrollment achieved clinical remission at 12 months, most of whom did so without a change in therapy.

7.
Clin Transl Gastroenterol ; 15(3): e00669, 2024 03 01.
Article in English | MEDLINE | ID: mdl-38131617

ABSTRACT

INTRODUCTION: We previously reported the results of tofacitinib induction therapy in the prospective multisite US real-world Tofacitinib Response in Ulcerative Colitis registry. We now assessed patient-reported outcomes (PROs) and predictors of success during tofacitinib maintenance therapy. METHODS: Tofacitinib Response in Ulcerative Colitis included 103 patients with refractory ulcerative colitis (UC); 67% had failed ≥ 2 biologics. Patients reported the Simple Clinical Colitis Activity Index (SCCAI), Patient-Reported Outcome Measurement Information System measures for anxiety, depression, social satisfaction, and adverse events between weeks 8 and 52 using a web-based system. Paired t test and P for trend were used to compare changes in PRO measures over time. Bivariate analyses and logistic regression models were used to determine factors associated with response (SCCAI <5) or remission (SCCAI <2) at week 52. RESULTS: Of 103 patients, 82.5% entered the maintenance phase and 43.7% remained on tofacitinib at week 52. Tofacitinib de-escalation to 5 mg BID occurred in 15% of patients. At week 52, 42.7% and 31.1% of all patients reported an SCCAI <5 and SCCAI ≤2, respectively. Normalization of bowel frequency, rectal bleeding, and urgency occurred in 79%, 61%, and 48% of patients remaining on maintenance therapy. Social satisfaction improved significantly ( P < 0.001), while anxiety and depression scores only numerically improved. No consistent predictors for tofacitinib long-term treatment efficacy were identified, and safety findings were consistent with the known safety profile of tofacitinib. DISCUSSION: Tofacitinib is an effective maintenance therapy in patients with refractory UC. Dose reductions infrequently occurred during maintenance. Unmet needs in UC maintenance include improvement of urgency and psychosocial factors (NCT03772145).


Subject(s)
Colitis, Ulcerative , Pyrimidines , Humans , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/drug therapy , Prospective Studies , Piperidines/adverse effects , Registries
8.
Clin Transl Gastroenterol ; 15(2): e00670, 2024 02 01.
Article in English | MEDLINE | ID: mdl-38146854

ABSTRACT

INTRODUCTION: Our understanding of the epidemiology of inflammatory conditions of the pouch and effectiveness of treatment is largely based on selected populations. We created a state-level registry to evaluate the incidence of pouchitis and the effectiveness of treatments used in an initial episode of pouchitis. METHODS: In a state-level retrospective cohort of all patients undergoing proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis between January 1, 2018, and December 31, 2020, we evaluated the incidence of pouchitis and compared the proportion of patients developing recurrent pouchitis and chronic antibiotic-dependent pouchitis according to initial antibiotic therapy. RESULTS: A total of 177 patients underwent surgery with 49 (28%) developing pouchitis within the 12 months after the final stage of IPAA. Patients with extraintestinal manifestations of inflammatory bowel disease (IBD) were significantly more likely to develop pouchitis within the first 12 months after IPAA (adjusted odds ratio 2.45, 95% confidence interval 1.03-5.81) after adjusting for family history of IBD (adjusted odds ratio 3.50, 95% 1.50-8.18). When comparing the proportion of patients who developed recurrent pouchitis or chronic antibiotic-dependent pouchitis with those who experienced an isolated episode of pouchitis, there were no significant differences among the initial antibiotic regimens used. DISCUSSION: In a state-level examination of outcomes after IPAA for ulcerative colitis, patients with extraintestinal manifestations of IBD were more likely to develop pouchitis; however, the initial antibiotic regimen chosen did not seem to affect long-term outcomes.


Subject(s)
Colitis, Ulcerative , Inflammatory Bowel Diseases , Pouchitis , Humans , Pouchitis/epidemiology , Pouchitis/etiology , Colitis, Ulcerative/epidemiology , Colitis, Ulcerative/surgery , Colitis, Ulcerative/complications , Retrospective Studies , Risk Factors , Postoperative Complications/epidemiology , Inflammatory Bowel Diseases/epidemiology , Inflammatory Bowel Diseases/surgery , Inflammatory Bowel Diseases/complications , Anti-Bacterial Agents/therapeutic use
9.
Inflamm Bowel Dis ; 2023 Dec 27.
Article in English | MEDLINE | ID: mdl-38150318

ABSTRACT

BACKGROUND: Antibiotics are a cornerstone in management of intra-abdominal abscesses in Crohn's disease (CD). Yet, the optimal route of antibiotic administration is poorly studied. We aimed to compare surgical and nonsurgical readmission outcomes for patients hospitalized for intra-abdominal abscesses from CD discharged on oral (PO) or intravenous (IV) antibiotics. METHODS: Data for patients with CD hospitalized for an intra-abdominal abscess were obtained from 3 institutions from January 2010 to December 2020. Baseline patient characteristics were obtained. Primary outcomes of interest included need for surgery and hospital readmission within 1 year from hospital discharge. We used multivariable logistic regression models and Cox regression analysis to adjust for abscess size, history of prior surgery, history of penetrating disease, and age. RESULTS: We identified 99 patients discharged on antibiotics (PO = 74, IV = 25). Readmissions related to CD at 12 months were less likely in the IV group (40% vs 77% PO, P = .01), with the IV group demonstrating a decreased risk for nonsurgical readmissions over time (hazard ratio, 0.376; 95% confidence interval, 0.176-0.802). Requirement for surgery was similar between the groups. There were no differences in time to surgery between groups. CONCLUSIONS: In this retrospective, multicenter cohort of CD patients with intra-abdominal abscess, surgical outcomes were similar between patients receiving PO vs IV antibiotics at discharge. Patients treated with IV antibiotics demonstrated a decreased risk for nonsurgical readmission. Further prospective trials are needed to better delineate optimal route of antibiotic administration in patients with penetrating CD.

10.
Gastro Hep Adv ; 2(8): 1044-1049, 2023.
Article in English | MEDLINE | ID: mdl-38125203

ABSTRACT

BACKGROUND AND AIMS: There is a paucity of validated measures to evaluate how patients feel and function after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis. We performed a systematic review to evaluate all published patient reported outcomes (PROs) to assess symptom burden, functional status, and quality of life (QoL) after IPAA. METHODS: An electronic literature search on PubMed, Embase, and Web of Science was performed from inception through October 12, 2021. Eligible full texts were further characterized by the type of assessment as well as the individual domains assessed by questions in the PRO measure. RESULTS: Among the 129 full texts analyzed, 51 specific PRO measures were utilized. In the evaluation of all PRO measures, 46% included an assessment of disease-specific QoL with 27% evaluating more general QoL, and 15% assessing symptoms related to pouch function. Among the studies using disease-specific instruments, the Cleveland Clinic Global Quality of Life (42%) and the Inflammatory Bowel Disease Questionnaire (21%) were the most commonly used PRO measures. PRO questions were mapped to individual domains using binning methodology, with the greatest number of questions from individual PRO measures mapped to the bowel function domain (122). CONCLUSION: In our assessment of PRO measures among patients after IPAA, the studies and individual measures varied widely in both the patient populations being evaluated as well as outcomes and specific domains being assessed. A valid measure that assesses the range of outcomes after IPAA could standardize assessment and advance the study of patients after IPAA.

11.
Inflamm Bowel Dis ; 2023 Aug 22.
Article in English | MEDLINE | ID: mdl-37607334

ABSTRACT

BACKGROUND: Our understanding of outcomes after proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) is largely based on analyses of selected populations. We created a state-level registry to evaluate the epidemiology of IPAA surgery and pouch-related outcomes across the major healthcare systems performing these surgeries in our state. METHODS: We created a retrospective cohort of all patients undergoing restorative proctocolectomy with IPAA for UC at 1 of 4 centers between January 1, 2018, and December 31, 2020. The primary outcomes of this study were the rate of complications and all-cause readmissions within the first 30 days of the final stage of IPAA surgery. RESULTS: During the study period, 177 patients underwent IPAA surgery with 66 (37%) experiencing a complication within 30 days. After adjusting for the number of stages in IPAA surgery, patients with extensive UC (odds ratio, 3.61; 95% confidence interval, 1.39-9.33) and current or former smokers (odds ratio, 2.98; 95% confidence interval, 1.38-6.45) were more likely to experience a complication. Among all patients, 57 (32%) required readmission within 30 days. The most common reasons for readmission were ileus/small bowel obstruction (22%), peripouch abscess (19%), and dehydration (16%). CONCLUSION: In this first state-level examination of the epidemiology of IPAA for UC, we demonstrated that the complication rate after IPAA for UC was 37%, with one-third of patients being readmitted within 30 days. Extensive disease at the time of colectomy appears to be an indicator of more severe disease and may portend a worse prognosis after IPAA.

12.
Crohns Colitis 360 ; 5(3): otad039, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37519405

ABSTRACT

Background: Evidence-based recommendations regarding the influence of diet on inflammatory conditions of the pouch after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) are limited. Methods: We analyzed dietary patterns at enrollment in a prospective registry of patients with 1 of 4 inflammatory conditions of the pouch (acute pouchitis, chronic antibiotic-dependent pouchitis, chronic antibiotic refractory pouchitis, and Crohn's disease of the pouch). We analyzed dietary intake by disease activity at enrollment and then compared dietary patterns among patients who remained in remission throughout the 12-month follow-up to those patients who experienced a disease relapse. We also compared dietary patterns among patients with inflammatory conditions of the pouch to the United States Department of Agriculture (USDA) recommended daily goals. Results: Among 308 patients, there were no differences in dietary patterns among patients with 1 of the 4 disease states at enrollment. Additionally, among the 102 patients in remission at baseline, there were no significant differences noted among patients who went on to experience a disease flare in the 12 months after enrollment compared to those patients who remained in remission. However, patients with inflammatory conditions of the pouch demonstrated decreased intake of several food groups and macronutrients including dairy, fruits, vegetables, whole grains, and fiber when compared to USDA recommendations. Conclusions: In a prospective cohort, we demonstrated no impact of dietary patterns on disease activity. The relative deficiencies in several food groups and macronutrients among patients after IPAA indicate the potential role of targeted nutritional counseling in this population.

13.
Dig Dis Sci ; 68(7): 3139-3147, 2023 07.
Article in English | MEDLINE | ID: mdl-37148442

ABSTRACT

INTRODUCTION: Chronic inflammatory conditions of the pouch are common after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC). AIMS: We aimed to investigate the relationship between acute pouchitis within 180 days of the final stage of IPAA surgery (very early pouchitis) and the future development of chronic antibiotic dependent pouchitis (CADP) and Crohn's-like disease of the pouch (CLDP). METHODS: We performed a retrospective cohort study, evaluating patients who underwent proctocolectomy with IPAA between January 1, 2004 and December 31, 2016. Multivariable logistic regression was used to evaluate the relationship between very early pouchitis and the development of CADP and CLDP. RESULTS: Among 626 patients undergoing IPAA for UC, 137 (22%) developed very early pouchitis, 75 (12%) developed CADP, and 59 (9%) developed CLDP in a median follow-up of 5.18 years (interquartile range 0.94-10.8 years). Very early pouchitis was associated with a significant increase in the odds of developing CADP (adjusted odds ratio [aOR3.65, 95% CI 2.19-6.10) as was primary sclerosing cholangitis (aOR 3.97, 95% CI 1.44-11.0). Very early pouchitis was associated with increased odds for developing CLDP (aOR 2.77, 95% CI 1.54-4.98) along with a family history of inflammatory bowel disease (aOR 2.10, 95% CI 1.11-3.96). CONCLUSION: In this cohort, very early pouchitis was associated with an increased risk of developing CADP and CLDP. These findings highlight very early pouchitis as a unique risk factor for chronic inflammatory conditions of the pouch and the need for future studies evaluating potential strategies for secondary prophylaxis strategies in this population.


Subject(s)
Colitis, Ulcerative , Colonic Pouches , Crohn Disease , Pouchitis , Proctocolectomy, Restorative , Humans , Pouchitis/diagnosis , Pouchitis/epidemiology , Pouchitis/etiology , Retrospective Studies , Proctocolectomy, Restorative/adverse effects , Colitis, Ulcerative/surgery , Colitis, Ulcerative/complications , Crohn Disease/epidemiology , Chronic Disease , Colonic Pouches/adverse effects
14.
Am J Gastroenterol ; 118(11): 2080-2083, 2023 11 01.
Article in English | MEDLINE | ID: mdl-37216596

ABSTRACT

INTRODUCTION: Patients with medically refractory ulcerative colitis who previously would have undergone surgery can now elect for subsequent medical therapy. METHODS: In a commercially insured population, we evaluated the proportion of patients initiating second-line, third-line, or fourth-line treatment who underwent colectomy in the following 12 months. RESULTS: Among 3,325 patients with ulcerative colitis, the colectomy rate within 12 months of a switch in therapy increased from 12% with the first switch to 17% and 19% with the second and third switches, respectively ( P < 0.001). DISCUSSION: Treatment effectiveness declines with successive switching; however, even after initiating fourth-line therapy, most patients remain surgery-free.


Subject(s)
Colitis, Ulcerative , Humans , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/surgery , Colitis, Ulcerative/etiology , Retrospective Studies , Colectomy/adverse effects , Treatment Outcome , Infliximab
16.
Gastroenterology ; 165(1): 149-161.e7, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37004887

ABSTRACT

BACKGROUND & AIMS: Tumor necrosis factor inhibitors, including infliximab and adalimumab, are a mainstay of pediatric Crohn's disease therapy; however, nonresponse and loss of response are common. As combination therapy with methotrexate may improve response, we performed a multicenter, randomized, double-blind, placebo-controlled pragmatic trial to compare tumor necrosis factor inhibitors with oral methotrexate to tumor necrosis factor inhibitor monotherapy. METHODS: Patients with pediatric Crohn's disease initiating infliximab or adalimumab were randomized in 1:1 allocation to methotrexate or placebo and followed for 12-36 months. The primary outcome was a composite indicator of treatment failure. Secondary outcomes included anti-drug antibodies and patient-reported outcomes of pain interference and fatigue. Adverse events (AEs) and serious AEs (SAEs) were collected. RESULTS: Of 297 participants (mean age, 13.9 years, 35% were female), 156 were assigned to methotrexate (110 infliximab initiators and 46 adalimumab initiators) and 141 to placebo (102 infliximab initiators and 39 adalimumab initiators). In the overall population, time to treatment failure did not differ by study arm (hazard ratio, 0.69; 95% CI, 0.45-1.05). Among infliximab initiators, there were no differences between combination and monotherapy (hazard ratio, 0.93; 95% CI, 0.55-1.56). Among adalimumab initiators, combination therapy was associated with longer time to treatment failure (hazard ratio, 0.40; 95% CI, 0.19-0.81). A trend toward lower anti-drug antibody development in the combination therapy arm was not significant (infliximab: odds ratio, 0.72; 95% CI, 0.49-1.07; adalimumab: odds ratio, 0.71; 95% CI, 0.24-2.07). No differences in patient-reported outcomes were observed. Combination therapy resulted in more AEs but fewer SAEs. CONCLUSIONS: Among adalimumab but not infliximab initiators, patients with pediatric Crohn's disease treated with methotrexate combination therapy experienced a 2-fold reduction in treatment failure with a tolerable safety profile. CLINICALTRIALS: gov, Number: NCT02772965.


Subject(s)
Methotrexate , Tumor Necrosis Factor Inhibitors , Child , Humans , Female , Adolescent , Male , Methotrexate/adverse effects , Adalimumab/adverse effects , Antibodies, Monoclonal/adverse effects , Infliximab/adverse effects , Tumor Necrosis Factor-alpha , Treatment Outcome
17.
Clin Gastroenterol Hepatol ; 21(1): 192-199.e7, 2023 01.
Article in English | MEDLINE | ID: mdl-35525393

ABSTRACT

BACKGROUND & AIMS: Current knowledge regarding the epidemiology of pouchitis is based on highly selected, mostly single-center, patient cohorts. Our objective was to prospectively determine the population-based incidence of pouchitis in patients with ulcerative colitis in the first 2 years after ileal pouch-anal anastomosis and analyze time trends of the incidence of pouchitis. METHODS: Using national registries, we established a population-based cohort of all Danish patients undergoing proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis between 1996 and 2018. The primary outcome was the development of pouchitis within the first 2 years after surgery, evaluated by time period. We used Kaplan-Meier and Cox proportional hazard modeling to evaluate the time to development of pouchitis. RESULTS: Overall, 1664 patients underwent an ileal pouch-anal anastomosis. The cumulative incidence of pouchitis in the 2 years after ileal pouch-anal anastomosis increased throughout the study period, from 40% in the period from 1996 to 2000 (95% CI, 35%-46%) to 55% in the period from 2015 to 2018 (95% CI, 48%-63%). Patients undergoing surgery between 2015 and 2018 also showed an increased risk of pouchitis compared with the earliest study period (1996-2000) after adjusting for sex, age, and socioeconomic status (hazard ratio, 1.57; 95% CI, 1.20-2.05). CONCLUSIONS: This population-based study showed a 15% absolute and 38% relative increase in the incidence of pouchitis among patients undergoing surgery between 1996 and 2018, with the greatest cumulative incidence of pouchitis shown in the most recent era (2015-2018). The striking increase in the incidence of pouchitis highlights the need for further research into causes and prevention of pouchitis.


Subject(s)
Colitis, Ulcerative , Colonic Pouches , Pouchitis , Proctocolectomy, Restorative , Humans , Pouchitis/epidemiology , Pouchitis/etiology , Colitis, Ulcerative/complications , Incidence , Cohort Studies , Proctocolectomy, Restorative/adverse effects , Denmark/epidemiology , Colonic Pouches/adverse effects
18.
Inflamm Bowel Dis ; 29(4): 570-578, 2023 04 03.
Article in English | MEDLINE | ID: mdl-35700276

ABSTRACT

BACKGROUND: Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Using a novel electronic reporting tool, we aimed to prospectively describe the onset of tofacitinib efficacy during induction therapy in a real-world study. METHODS: Patient-reported outcome data (PROs) including the simple clinical colitis activity index (SCCAI), PRO Measurement Identification Systems (PROMIS) measures, and adverse events were collected daily for the first 14 days and at day 28 and 56. Paired t tests and P for trend were utilized to compare changes in SCCAI over time. Bivariate analyses and logistic regression models were performed to describe response (SCCAI <5) and remission (SCCAI ≤2) by clinical factors. RESULTS: Of all included patients (n = 96), 67% had failed ≥2 biologics, and 61.5% were on concomitant steroids. Starting at day 3, PROs showed significant and persistent decline of the mean SCCAI (-1.1, P < 000.1) including significantly lower SCCAI subscores for stool frequency (-0.3; P < .003), bleeding (-0.3; P < .0002) and urgency (-0.2; P < .001). Steroid-free remission at day 14, 28, and 56 was achieved in 25%, 30.2%, and 29.2% of patients, respectively. Neither prior biologics nor endoscopic severity were independently predictive of response or remission in multivariate models. Numeric improvements in all PROMIS measures (anxiety, depression, social satisfaction) were seen through day 56. Rates of discontinuation due to adverse events were low. CONCLUSIONS: In this prospective real-world study, tofacitinib resulted in a rapid and persistent improvement in UC disease activity PROs. The safety findings were consistent with the established safety profile of tofacitinib.


Subject(s)
Biological Products , Colitis, Ulcerative , Colitis , Humans , Colitis, Ulcerative/drug therapy , Prospective Studies , Biological Factors/therapeutic use , Biological Products/therapeutic use
19.
Clin Gastroenterol Hepatol ; 21(6): 1663-1666.e3, 2023 06.
Article in English | MEDLINE | ID: mdl-35568303

ABSTRACT

Pouchoscopy provides a critical objective measure in the evaluation of patients with suspected inflammatory conditions of the pouch; however, there remain significant gaps in the reliability of the endoscopic scales used in the assessment of these conditions.1,2 Reliability and reproducibility in the assessment of patients after ileal pouch-anal anastomosis (IPAA) are critical, as evidenced by recent efforts to improve standardization in the evaluation of patients with pouch-related disorders.3.


Subject(s)
Colitis, Ulcerative , Colonic Pouches , Proctocolectomy, Restorative , Humans , Reproducibility of Results , Colonic Pouches/adverse effects , Endoscopy , Proctocolectomy, Restorative/adverse effects , Colitis, Ulcerative/surgery , Anastomosis, Surgical
20.
Inflamm Bowel Dis ; 29(6): 932-937, 2023 06 01.
Article in English | MEDLINE | ID: mdl-35905034

ABSTRACT

BACKGROUND: Recurrent or chronic antibiotic therapy is a therapeutic hallmark of chronic antibiotic-dependent pouchitis (CADP) or Crohn's-like disease of the pouch. Antibiotics alter the gut microbiome, which may increase the risk of Clostridioides difficile infection (CDI). The aim of this study was to determine the prevalence of CDI in patients with CADP and Crohn's-like disease of the pouch. METHODS: We conducted a retrospective cohort study of patients with CADP or Crohn's-like disease of the pouch at a tertiary academic medical center. The primary outcome was prevalence of CDI. Secondary outcomes included antibiotic therapy at the time of CDI diagnosis, treatment regimens for CDI, and subsequent outcomes. RESULTS: Overall, 18 of 198 (9.1%) included patients developed CDI. Treatment with antibiotics at the time of CDI diagnosis occurred in 7 of 18 (39%) patients. Preoperative history of CDI was significantly associated with increased risk of developing CDI following ileal pouch anal anastomosis (IPAA) compared with those with no prior history of CDI (12 of 18 [67%] vs 11 of 180 [6%]; P < .001). In 16 of 18 (89%) patients, CDI treatment was initiated with predominantly oral vancomycin (72%) or metronidazole (17%). CONCLUSION: Although chronic inflammatory conditions of the pouch arise postoperatively, the prevalence of CDI in this population appears to be similar compared with the general population of patients with inflammatory bowel disease prior to and post IPAA. Preoperative CDI appears to be the greatest risk for postoperative CDI and may require extra vigilance in the assessment of CDI after IPAA.


Subject(s)
Clostridium Infections , Colitis, Ulcerative , Colonic Pouches , Crohn Disease , Pouchitis , Proctocolectomy, Restorative , Humans , Proctocolectomy, Restorative/adverse effects , Pouchitis/drug therapy , Pouchitis/epidemiology , Pouchitis/etiology , Anti-Bacterial Agents/adverse effects , Prevalence , Retrospective Studies , Colonic Pouches/adverse effects , Crohn Disease/drug therapy , Crohn Disease/surgery , Crohn Disease/complications , Anastomosis, Surgical/adverse effects , Clostridium Infections/drug therapy , Clostridium Infections/epidemiology , Clostridium Infections/etiology , Colitis, Ulcerative/complications
SELECTION OF CITATIONS
SEARCH DETAIL
...