Crohn's & Colitis 360最新文献

Background: Precision-guided dosing (PGD) is a personalized tool that optimizes clinical decision-making in the treatment of inflammatory bowel disease (IBD) with infliximab (IFX) and its biosimilars. PGD employs nonlinear mixed-effect models using patient-specific pharmacokinetic parameters to predict infliximab trough concentrations without the need to wait until the actual trough measurement. This approach calculates patient-specific clearance (CL) and provides tailored IFX dosing and administration intervals aimed at achieving target trough levels. Implementing PGD can enhance treatment outcomes in IBD patients and may potentially reduce healthcare expenditures.

Methods: We conducted a multicenter, retrospective study as a follow up to our previous clinical experience program (CEP). We aimed to evaluate the impact of PGD on clinical decision-making, patient outcomes, healthcare utilization, and expenditures. Treatment decisions included: IFX dose intensification, reduction, discontinuation, or continuation. Disease activity and healthcare resource utilization and costs in the 12 months pre- and post-test were compared. Disease activity was measured using the physician global assessment (PGA) as follows: remission (0), mild (1), moderate (2), and severe (3). Costs were calculated based on modeling pre-established literature data.

Results: Analysis of data from 82 patients across 7 states and Puerto Rico showed that PGD-driven therapeutic decision making led to IFX treatment intensification (27%) or discontinuation (7%) in patients with low forecasted trough IFX concentrations, high clearance, and presence of antidrug antibody. Conversely, IFX dosage was reduced (18%) or unchanged (48%) for patients with high IFX concentrations and low clearance. There was a significant association between forecasted trough IFX levels and treatment modifications (P < .001). High clearance (> 0.294 L/day) was significantly associated with therapy intensification (OR 6.22, 95% CI: 2.19-19.8; P < .001). Following PGD, disease activity improved significantly (observed mean difference in physician global assessment: 0.378, P = 0.008) and healthcare resource utilization decreased. Across the entire patient population, hospitalizations decreased from 30 events pretest to 5 events posttest (P < .001), leading to overall cost saving.

Conclusions: HCPs used the PGD test to guide treatment decisions. PGD-driven optimization of IFX therapy led to improved patient outcomes, lower healthcare utilization, and cost savings.

Treatment of pediatric inflammatory bowel disease (IBD) is significantly hindered by the lack of US Food and Drug Administration-approved biologic and small-molecule medications. This review explains the burdens faced by children with IBD because of this problem and appraises the marked historical timeline differences in medication approval between adults and children with IBD. The authors follow with an in-depth focus on the pointed disparity in approved therapies for children with IBD compared to children with rheumatologic immune-mediated diseases, highlighting the differences in stringency of evidence that has been used to gain medication approval for children with rheumatologic diseases. The editorial concludes with a call for change in regulatory agency protocols, to adopt a modernized strategy that will expedite the approval of advanced therapies for children with IBD.

Background: Fecal calprotectin (FC) and C-reactive protein (CRP) are noninvasive biomarkers used in ulcerative colitis (UC) clinical trials; however, thresholds defined as "normal" in trials may be higher than "normal" thresholds typically used in clinical practice. We assessed the relationship between FC and CRP improvement in the "normal" range across different cutoff thresholds for patients with moderately to severely active UC treated with mirikizumab.

Methods: Patients achieving clinical response to mirikizumab in LUCENT-1 (Weeks 0-12) proceeded to LUCENT-2 (Weeks 12-52 [52 weeks of continuous mirikizumab]). Associations between FC and CRP levels at multiple thresholds and histologic-endoscopic mucosal improvement (HEMI) and histologic-endoscopic mucosal remission (HEMR) at Weeks 12 and 52 were assessed by Fisher's exact test. Least squares means of FC and CRP changes from baseline at Weeks 12 and 52 were calculated using analysis of covariance with HEMI or HEMR status as factors and baseline FC or CRP values as covariates.

Results: At Weeks 12 and 52, greater proportions of patients with FC thresholds of ≤250, ≤150, ≤100, and ≤50 µg/g, and CRP thresholds of ≤6 and ≤5 mg/L, achieved HEMI and HEMR compared with those not achieving HEMI and HEMR. Changes from baseline in FC and CRP at Week 12 and FC at Week 52 were greater in patients who achieved HEMI and HEMR compared with those not achieving these endpoints.

Conclusions: These results show that FC and CRP analyses may contribute to a noninvasive monitoring strategy in clinical practice.ClinicalTrials.gov numbers: NCT03518086, NCT03524092.

Background: Inflammatory bowel disease (IBD) management has become increasingly complex and specialized education for advanced practice providers (APPs) is limited. The Crohn's & Colitis Foundation's Advanced Practice Provider Preceptorship was developed to educate IBD APPs to minimize this knowledge gap.

Method: APP applicants were chosen based on their limited IBD knowledge and experience. Accepted applicants spent 3 days in an IBD center observing and learning. Pre- and post-surveys evaluated satisfaction, increase in knowledge, and confidence to manage IBD. A 3-month survey assessed mentorship and changes in practice.

Results: Data measurement assessed satisfaction, knowledge, and confidence. The program grew from one participant in 2017 to 15 participants in 2023, with the maximum number of participants at 16 in 2021. From 2018 to 2023, knowledge and confidence from pre- to post-program improved. From 2018 to 2022, more than 75% of participants reported feeling "well-versed" to "extremely well-versed" in IBD knowledge after completion of the program. From 2019 to 2023, greater than 90% of participants reported feeling "moderately to very confident" or "completely confident" post-program.

Conclusions: The Crohn's & Colitis Foundation's APP Preceptorship, a program for APPs with limited IBD knowledge and experience, is associated with program satisfaction and improved knowledge and confidence in treating IBD. Unexpected outcomes include changes in individual practices and ongoing mentorship. Continuation of this program will further enhance the IBD education of future APPs.

Introduction: The objective of the study was to investigate the characteristics of patients who underwent surgery for dysplasia detected during chromoendoscopy (CE) surveillance for inflammatory bowel disease (IBD) and the incidence of cancer in the surgical specimen.

Methods: A retrospective review of medical records of all patients with dysplasia on a background of underlying IBD diagnosed through CE was carried out at a tri-site enterprise tertiary referral center between 2006 and 2019. We aimed to assess the clinical characteristics of patients requiring surgery for dysplasia and the incidence of cancer in the surgical specimen.

Results: Out of 219 patients with dysplasia on CE, 35 underwent surgery for dysplasia (16%). Indications for surgery were multifocal disease (n = 6), endoscopically unresectable lesions (n = 13), visible HGD (n = 7) and unifocal invisible LGD (n = 9). Out of 35 patients requiring surgery, 5 were found to have adenocarcinoma, one of whom with stage IIIB disease received postoperative chemotherapy. No patient with a pathologic diagnosis of adenocarcinoma had any evidence of recurrent disease after a mean postoperative follow-up of 32 months.

Conclusions: While the incidence of cancer at the time of surgery for IBD-related dysplasia is not negligible, the rate of node-positive disease is low.

Background: There are currently no standardized guidelines for optimizing 5-aminosalicylic acid (5-ASA) maintenance treatment, particularly in patients with ulcerative colitis (UC) who have achieved clinical remission (CR). Therefore, this study examined the perspectives of patients and physicians regarding 5-ASA dose reduction and medication adherence to optimize maintenance treatment.

Methods: This cross-sectional study was conducted from February 2023 to May 2023 at 19 institutions and included patients with UC and physicians. The participants' perspectives were assessed using an anonymous questionnaire.

Results: This study included 369 patients with UC (female, 43.1%; age, > 60 years, 29.3%; CR, 88.9%). Preference to reduce the 5-ASA dose and low medication adherence were observed in 46.1% and 16.0% of patients, respectively. Low medication adherence (odds ratio [OR]: 3.43, 95% confidence interval [CI]: 1.67-7.03) was associated with the preference to reduce the 5-ASA dose. Multivariate analysis for factors associated with low medication adherence revealed age < 60 years (OR: 10.25, 95% CI: 3.58-29.38), no intractable disease subsidy (OR: 2.63, 95% CI: 1.09-6.35), dosing frequency ≥ 2 times/day (OR: 9.04, 95% CI: 3.67-22.25), and preference to reduce the 5-ASA dose (OR: 2.57, 95% CI: 1.16-5.70) as significant. Among 153 physicians, 62.7% had > 10 years of experience, and 51.0% regularly verified adherence, with experience being a significant factor (OR: 2.01, 95% CI: 1.10-3.68).

Conclusions: Factors influencing medication adherence with 5-ASA included patients' desire for dose reduction and physicians' lack of experience. Improving communication with patients and enhancing education for physicians could help optimize treatment with 5-ASA.

Background: Diagnostic delay (DD) is a common finding in inflammatory bowel diseases (IBD). The reasons and effects of this delay are frequently underestimated, particularly in the context of sex. Our aims were to examine the impact of delayed diagnosis in IBD, with a particular focus on sex disparities.

Methods: We performed a single-center, cross-sectional study at a tertiary referral center, including patients with IBD. The data was collected between August 2020 and June 2024.

Results: A total of 247 individuals with IBD were included in this study, with 53% identifying as female and 51% having Crohn's disease. Probability estimators revealed an effect of a DD on the cumulative advanced drug therapy probability in women (p_Log-Rank = 0.045). Further analysis of the interaction between therapeutic regimens and DD revealed significant differences between the sexes. Women with a longer latency in their diagnosis were more frequently treated with steroids only compared to men. Entity-specific DD was further identified as a risk factor for steroid-only treatment in women with IBD (OR: 2.6; 95% CI, 1.11-5.98; P = .028). Additionally, a notable disparity in quality of life was observed between women who exhibited DD and men, with the former demonstrating a significantly reduced quality of life.

Conclusions: A delayed diagnosis has a significant impact on IBD treatment trajectories, with a notable sex-related effect observed especially in women. Therapeutic needs in female patients with IBD seem underestimated, particularly in instances where a DD is present.

Background: Research on psychiatric comorbidity in inflammatory bowel disease (IBD) has focused mostly on anxiety and depression. This study aimed to describe the spectrum of psychiatric disorders experienced by individuals with IBD and their overlap.

Methods: Participants were enrolled in a prospective 3-year longitudinal study that assessed psychiatric comorbidity in immune-mediated inflammatory disease. Lifetime prevalence of psychiatric comorbidity was assessed using the Structured Clinical Interview for DSM-IV Disorders (SCID-IV), as the DSM-IV was the prevailing classification at the time of study design. Diagnosis was aligned with DSM-5 categorization where possible with available data. Psychiatric burden was categorized as no psychiatric conditions, 1, 2 or 3 or more psychiatric conditions.

Results: Of 154 IBD participants (62%female, 63% Crohn's disease) 57% had at least one psychiatric comorbidity with 27% having >1 psychiatric diagnosis. The prevalence was major depressive disorder (MDD, 41.7%), anxiety disorders (39.6%; grouped as per DSM-5), substance use disorder (SUD, 16.2%), posttraumatic stress disorder (5.3%), obsessive-compulsive disorder (4.9%), and bipolar disorder (2.0%). Of participants with MDD and a comorbid psychiatric disorder, nearly half had SUD. Of those with >1 psychiatric disorder >70% had MDD and a comorbid anxiety disorder. Persons with ≥1 psychiatric comorbidity were more likely to be current smokers (P < .001) and to have higher IBD disease activity scores (P = .005) than those without a psychiatric comorbidity.

Conclusions: Over half of adults with IBD had >1 diagnosed psychiatric comorbidity from a range of 10 different psychiatric disorders identified. Further research should assess the temporal relationship of IBD and the various psychiatric presentations to better understand the trajectory of co-occurrence, and therapy which may concurrently address the psychiatric disorder and the IBD.

Background: This study evaluates the effectiveness of different methods to recruit patients with inflammatory bowel disease (IBD) into a randomized controlled trial (RCT).

Methods: 630 participants were recruited into a multicenter RCT using electronic medical record (EMR) bulk messaging, in-person study discussion with a clinician, or a hybrid method combining the above approaches.

Results: Bulk EMR messaging alone had the highest recruitment and response rates, required the least amount of time to implement, and incurred the lowest cost as compared to the in-person and hybrid recruitment methods.

Conclusions: Digital health technology can enhance the recruitment of patients with IBD into randomized controlled trials.

Background: This study examined Inflammatory Bowel Disease (IBD) management and outcomes during pregnancy in a tertiary care setting, focusing on disease activity, medication use, and maternal and neonatal outcomes.

Methods: A prospective cohort study followed 287 women with IBD through 291 pregnancies from 2017 to 2023 at a single tertiary care center, collecting data preconception, during each trimester, and postpartum.

Results: The study observed a 92.7% live birth rate. Seventy-four percent of individuals were in clinical remission preconception, and disease activity increased throughout pregnancy, particularly in ulcerative colitis (UC) patients (peaking at 37% in the second trimester), while remaining stable in CD patients. UC, disease duration <5 years, and preconception activity correlated with higher disease activity during pregnancy. Biologic use remained stable without significant impact on outcomes. Preterm delivery (6.7%) and small for gestational age infants (7%) rates reflected baseline population risk. Steroid use was associated with higher preterm delivery rates. Gestational hypertension (6.9%) and diabetes (9.4%) rates were similar to population norms. Maternal adverse events were higher in women 40 or older (OR 3.893).

Conclusions: This study reaffirms the safety of continued medical therapy for IBD throughout pregnancy in a tertiary care, prospective cohort. Increased disease activity throughout pregnancy was evident, particularly in UC. Despite higher rates of disease activity amongst those with UC, outcomes were similar in those with CD vs UC-suggesting that disease activity measures have limitations in CD and pregnancy, or there is some mild inherent risk of CD in pregnancy outcomes irrespective of disease activity.