The intra-individual variability of faecal calprotectin: A prospective study in patients with active ulcerative colitis

Abstract Background Loss of response (LOR) to infliximab (IFX) remains a challenge in routine management of IBD patients. We evaluated IFX high-resolution pharmacokinetics (PK) during induction with intermediate and peak PK levels. Methods This is a prospective, multicentre (n = 9), interventional study approved by EC (P2017/484). Fourteen blood samples were collected per patient from baseline to week 30. All patients were IFX naïve with active disease according to clinical, biological and endoscopy criteria. The primary outcome evaluated the inter-individual variability of IFX PK during induction and correlation with remission at week 30. In addition to trough levels (TLs), intermediate (ILs) and peak levels (PLs) were also measured and defined as drug level between two infusions and drug level early on after infusion (+2h), respectively. Remission was defined as having a Harvey Bradshaw Index (HBI) ≤ 4 and C-Reactive Protein (CRP) ≤5 for Crohn’s disease (CD), and as a clinical Mayo score ≤2 and faecal calprotectin <250 µg/g for ulcerative colitis (UC). IFX samples were measured by ELISA (Apdia) while a drug-tolerant affinity capture elution anti-infliximab assay was used to measure anti-infliximab antibodies (ATI) at weeks 6, 22 and 30. Results Demographic and baseline data of the study population are presented in Table 1. Among the 62 patients enrolled, 33.9% of patients (n = 21/62) were in remission at week 30. Eight patients dropped out due to disease worsening. Median TLs at week 6 were higher among patients in clinical remission at week 30 (p = 0.02) confirming previous observations. However, ILs at day 3 as well as PLs after the third infusion were also significantly higher in patients in clinical remission at week 30 (Figure 1a–c). ATI were detected as soon as week 6. At week 2, infliximab levels were significantly lower among patients in which ATI developed at a later time point (p = 0.006) and this observation was confirmed when measuring ILs at day 17 (p = 0.002), TLs at week 6 (p = 0.002) and ILs at week 10 (p = 0.001). Conclusion This multicentre prospective study demonstrates that intermediate levels as early as day 3 predict remission at week 30 in IBD patients. Low IFX levels during induction were correlated to future ATI development. PK modelling may allow to better select patients early on for sustained remission with infliximab.

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P152. Faecal calprotectin 100 ug/g and 50 ug/g predict endoscopic and histologic remission: a prospective study in quiescent ulcerative colitis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjw019.271 ◽

2016 ◽

Vol 10 (suppl 1) ◽

pp. S167.1-S167

Keyword(s):

Ulcerative Colitis ◽

Prospective Study ◽

Faecal Calprotectin ◽

A Prospective Study

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P594. Infliximab for active ulcerative colitis: a prospective study on patients’ short-term response and long-term outcome.

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjw019.713 ◽

2016 ◽

Vol 10 (suppl 1) ◽

pp. S401.2-S401

Keyword(s):

Ulcerative Colitis ◽

Prospective Study ◽

Active Ulcerative Colitis ◽

Short Term ◽

Term Outcome ◽

Long Term Outcome ◽

A Prospective Study ◽

Term Response

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Longitudinal Trajectory of Fatigue in Patients With Inflammatory Bowel Disease: A Prospective Study

Inflammatory Bowel Diseases ◽

10.1093/ibd/izaa338 ◽

2020 ◽

Author(s):

Nienke Z Borren ◽

Millie D Long ◽

Robert S Sandler ◽

Ashwin N Ananthakrishnan

Keyword(s):

Ulcerative Colitis ◽

Inflammatory Bowel Disease ◽

Chronic Illness ◽

Prospective Study ◽

Functional Assessment ◽

Bowel Disease ◽

Symptom Resolution ◽

Chronic Illness Therapy ◽

Inflammatory Bowel ◽

A Prospective Study

Abstract Background Fatigue is a disabling symptom in patients with inflammatory bowel disease (IBD). Its prevalence, mechanism, and impact remain poorly understood. We determined changes in fatigue status over time and identified predictors of incident or resolving fatigue. Methods This was a prospective study nested within the IBD Partners cohort. Participants prospectively completed the Multidimensional Fatigue Inventory and the Functional Assessment of Chronic Illness Therapy-Fatigue at baseline, 6 months, and 12 months. A Functional Assessment of Chronic Illness Therapy-Fatigue score ≤43 defined significant fatigue. Multivariable regression models using baseline covariates were used to identify risk factors for incident fatigue at 6 months and to predict the resolution of fatigue. Results A total of 2429 patients (1605 with Crohn disease, 824 with ulcerative colitis) completed a baseline assessment, and 1057 completed a second assessment at 6 months. Persistent fatigue (at baseline and at 6 months) was the most common pattern, affecting two-thirds (65.8%) of patients. One-sixth (15.7%) of patients had fatigue at 1 timepoint, whereas fewer than one-fifth (18.5%) of patients never reported fatigue. Among patients not fatigued at baseline, 26% developed fatigue at 6 months. The strongest predictor of incident fatigue was sleep disturbance at baseline (odds ratio, 2.91; 95% confidence interval, 1.48–5.72). In contrast, only 12.3% of those with fatigue at baseline had symptom resolution by month 6. Resolution was more likely in patients with a diagnosis of ulcerative colitis, quiescent disease, and an absence of significant psychological comorbidity. Conclusions Fatigue is common in patients with IBD. However, only a few fatigued patients experience symptom resolution at 6 or 12 months, suggesting the need for novel interventions to ameliorate its impact.

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