scholarly journals P222 Heart rate variability is a predictor to disease exacerbation in paediatric Inflammatory Bowel Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S275-S276
Author(s):  
A Yerushalmy-Feler ◽  
S Cohen
Keyword(s):  
Inflammatory Bowel Disease ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Normal Serum ◽  
Disease Exacerbation ◽  
Autonomic Instability ◽  
Inflammatory Bowel

Abstract Background Previous studies have shown a lower level of parasympathetic activity in patients with inflammatory bowel disease (IBD) compared to healthy subjects. Heart rate variability (HRV) oscillations are used to detect autonomic instability and was found to be lower in adults with IBD compared to controls. Nevertheless, the data on the relation between the autonomic function and IBD outcome are scarce. The aim of the study was to evaluate HRV as a predictor to paediatric IBD outcome. Methods Children (<18 years of age) with IBD were prospectively recruited. For each patient, a 10-minute measurement of HRV was conducted by Pulse Oximeter (BM1000A/Shanghai Berry Electronic Tech Co., Ltd). The square root of the mean squared differences of successive RR intervals (RMSSD) was calculated. Clinical data, including demographic variables, disease activity and course, medications and laboratory results were collected during a follow-up of 12 months. The relation between RMSSD and clinical measures was evaluated. Results Overall, 34 IBD children with an average age of 15.32±2.18 years were included: 21 (61.8%) children with Crohn’s disease and 13 (38.2%) with ulcerative colitis. Children in clinical remission had a significantly higher RMSSD compared to patients with active disease (67.72±27.81 and 45.76±22.04, respectively, p=0.022). In addition, patients with normal serum C-reactive protein (<5 mg/L), patients with normal serum hemoglobin and patients with long duration of IBD (more than a year from diagnosis) had a significantly higher RMSSD (Figure 1). Children that experienced disease exacerbation during the follow-up had a significantly lower RMSSD compared to children that kept clinical remission (Figure 2). In a multivariate analysis, higher RMSSD was a significant and independent predictor of lower risk of IBD exacerbation [OR (odd ratio) = 0.941, 95% CI (confidence interval) 0.887–0.998, p=0.044)]. Conclusion HRV may not only reflect IBD activity, but also serve as a predictor to disease exacerbation in paediatric IBD.

scholarly journals P378 Mucosal healing is achieved in most of the inflammatory bowel disease patients in clinical remission with vedolizumab: a real-life single-centre experience

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S355-S355
Author(s):  
M I Calvo Moya ◽  
I Omella Usieto ◽  
M I Vera Mendoza ◽  
V Matallana Royo ◽  
I Gonzalez Partida ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Practice ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Real Life ◽  
Mucosal Healing ◽  
Surveillance Colonoscopy ◽  
Previously Treated ◽  
Inflammatory Bowel

Abstract Background Current therapeutic goals in inflammatory bowel disease (IBD) include not only the mere absence of symptoms but also the resolution of endoscopic lesions, so-called mucosal healing (MH), which has been related to better outcomes. Data regarding the achievement of MH with vedolizumab (VDZ) in real-life clinical practice is still scarce. Methods Retrospective cohort study was carried out in a tertiary hospital between January 2015 and April 2019 including patients with a basal colonoscopy showing activity and who achieved clinical remission under treatment with VDZ, defined by partial Mayo score <2 for ulcerative colitis (UC) and Harvey–Bradshaw Index score (HBI) <4 for Crohn’s disease (CD). Surveillance colonoscopy was performed along with the follow-up according to clinical practice. In UC patients, MH was defined as Mayo Endoscopic Subscore (MES) = 0; the endoscopic response was defined by a decrease in MES ≥1 point. In CD, MH was defined by achievement SES-CD = 0–3 or Rutgeerts index i0; the endoscopic response was defined by a decrease of SES-CD of 50% or Rutgeerts index <i2 with at least 1 point of decease compared with baseline. Results In total, 118 patients treated with VDZ were analysed, but only 45 met inclusion criteria with a median follow-up of 21 (IQR: 14–19) months. Surveillance colonoscopy was performed after a median time of 12 months (IQR:9–17) of treatment. MH achieved in 33/45 patients (73%): 17/23 CD patients (74%) and 16/22 UC patients (73%). The endoscopic response was achieved in 9 of the remaining 12 patients: 3/6 CD patients and 6/6 UC patients. Only 3 (7%) of patients included showed no endoscopic benefit at the time of surveillance endoscopy. In multivariate analysis, probability of not achieving MH was 75% in patients previously treated with immunosuppressants (ISS) (HR 0.25, 0.11–0.55 IC95; p = 0.001) and 60% in patients previously treated with anti-TNFα (HR 0.40, 0.18–0.90 95% CI; p = 0.026). Type of IBD, concomitant ISS, corticosteroid use at induction, baseline endoscopy score or duration of disease before VDZ treatment were not associated with the achievement of MH. Conclusion In our experience, most of the patients who achieve clinical remission with VDZ also achieve MH. Refractory patients were less likely to achieve MH despite having achieved clinical remission.

scholarly journals Heart rate variability and inflammatory bowel disease in humans

Medicine ◽  
2020 ◽  
Vol 99 (48) ◽  
pp. e23430
Author(s):  
Kyu-Nam Kim ◽  
Yao Yao ◽  
Sang-Yhun Ju
Keyword(s):  
Inflammatory Bowel Disease ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Bowel Disease ◽  
Inflammatory Bowel

scholarly journals High Patient Activation Is Associated With Remission in Patients With Inflammatory Bowel Disease

2018 ◽  
Vol 25 (7) ◽  
pp. 1248-1254 ◽  
Author(s):  
Edward L Barnes ◽  
Millie D Long ◽  
Michael D Kappelman ◽  
Christopher F Martin ◽  
Robert S Sandler
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Strong Association ◽  
Patient Activation ◽  
Measurement Information ◽  
Patient Reported ◽  
Education Status ◽  
Inflammatory Bowel

Abstract Background High levels of patient activation (having the knowledge, skills, and confidence to effectively manage one’s care), have been associated with improved outcomes in many chronic conditions. There have been few studies of the effects of activation in patients with inflammatory bowel disease (IBD). We performed a large, prospective Internet-based study to assess the relationship between patient activation level and clinical remission in patients with Crohn’s disease or ulcerative colitis. Methods We administered the Patient Activation Measure (Insignia Health) to 1486 cohort participants. Patients completed a follow-up survey within 13 months (median, 189 days). We collected demographic and clinical data; anxiety and depression were assessed using Patient-Reported Outcomes Measurement Information System instruments. We used bivariate analyses and multivariable logistic regression to identify characteristics associated with low or high patient activation and to evaluate the association between levels of patient activation and subsequent disease activity. Results Higher anxiety (adjusted odds ratio [aOR], 0.32; 95% confidence interval [CI], 0.29–0.36) and depression (aOR, 0.33; 95% CI, 0.29–0.37) scores were associated with a decreased odds of high patient activation. After we adjusted for education status, smoking, medication use, and other confounders, we found that patients with high activation at baseline were more likely to be in clinical remission during the follow-up period (aOR, 1.71; 95% CI, 1.20–2.45). Conclusions In a large, prospective Internet-based cohort of patients with IBD, we found a strong association between patient activation and clinical remission. These findings suggest that patient activation affects disease outcomes.

P082 ANTI-TNF EFFICACY AFTER PRIMARY VEDOLIZUMAB FAILURE IN PEDIATRIC INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S71-S72
Author(s):  
Michael Dolinger ◽  
Priya Rolfes ◽  
Becky Phan ◽  
Stephanie Pan ◽  
Marla Dubinsky
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Median Duration ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Inflammatory Bowel ◽  
Pediatric Ibd

Abstract Background Vedolizumab (VDZ) is less effective in Inflammatory Bowel Disease (IBD) when used in anti-Tumor Necrosis Factor (TNF) failures as compared to anti-TNF naïve patients. However, the outcomes of sequencing anti-TNF after VDZ failure remain unknown. We report on the effectiveness and safety of anti-TNF as a second-line biologic after VDZ failure in pediatric IBD patients. Methods Data was collected as part of an ongoing pediatric IBD observational treatment registry and included demographics, disease behavior, location, disease activity (Harvey Bradshaw index (HBI) for Crohn’s disease (CD) or partial Mayo score (pMS) for ulcerative colitis (UC) and IBD-unspecified (IBD-U)), adverse events, treatment and surgical history. Primary outcome was steroid-free clinical remission at last follow up. Secondary outcomes were CRP normalization and adverse events including infusion reactions, infections, hospitalizations, and IBD related surgeries. Descriptive statistics summarized the data (median [interquartile range (IQR)]) and univariate analyses tested associations. Results A total of 21 children and young adults (6 CD:14 UC:1 IBD-U; 19/21 colonic only disease) were treated with VDZ for a median [IQR] duration of 25 [11–59] weeks. VDZ was discontinued due to primary non-response (57%), secondary loss of response (38%), or an adverse event (5%). Nineteen (90%) patients were induced with infliximab (IFX), 1 with adalimumab, and 1 with golimumab and were followed for a median of 100 [35–148] weeks after anti-TNF induction (Table 1). Fifteen (71%) patients remained on anti-TNF therapy at last follow up for a median duration of 53 [34–112] weeks. All 15 patients achieved steroid-free clinical remission, and 9 (60%) patients also had a normal CRP (Figure 1). Remission rates were numerically higher in UC/IBD-U vs. CD (80% vs. 50% P = 0.27). All 6 (28%) patients (3 CD and 3 UC) who discontinued anti-TNF therapy after a median duration of 15 [7–24] weeks initially had a primary non-response to VDZ. Three patents had a primary non-response to anti-TNF, 2 had a secondary loss of response, and 1 had an anaphylactic infusion reaction. No serious adverse events, hospitalizations or serious infections attributable to anti-TNF therapy occurred. Conclusions Our results suggest that anti-TNF therapy is efficacious and safe after primary failure with VDZ in pediatric IBD patients and this was particularly so in patients with colonic disease location, regardless of IBD classification.

scholarly journals P552 Withdrawal of immunomodulator medications (IM) in children with inflammatory bowel disease on combination therapy of IM and biologics

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S468-S470
Author(s):  
A Chandrakumar ◽  
M Carroll ◽  
J deBruyn ◽  
K Jacobson ◽  
H Huynh ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Combination Therapy ◽  
Median Duration ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Factors Associated ◽  
Pediatric Study ◽  
First Relapse ◽  
Inflammatory Bowel

Abstract Background Anti-tumor necrosis factor (anti-TNF) antagonists such as infliximab (IFX) are widely used for the treatment of inflammatory bowel disease (IBD). Early studies suggested that combination therapy with IFX and an immunomodulator drug (IM) such as azathioprine (AZA) or methotrexate (MTX) may help in optimising biologic pharmacokinetics, minimising immunogenicity, and improving outcomes. On the other hand, IM especially AZA, may increase infection and cancer risks with no clear evidence on long-term benefits of combination therapy. As such, stopping IM and continuation of an anti-TNF agent as a monotherapy in patients in remission seem to be a sensible strategy. However, there is no evidence to prove the efficacy of this strategy. The aim of this work was to examine frequency and factors associated with the first relapse after IM withdrawal in a cohort of children with IBD on combination therapy. Methods In a retrospective multicenter pediatric study, we determined the percentage of patients and investigated potential factors associated with the first relapse in a cohort of children and young adults with IBD on combination therapy of anti-TNF and IM after stopping IM. Cox regression analysis was used to assess factors associated with IBD relapse following IM withdrawal. Results A total of 79 patients (42, males, 62 Crohn’s disease) with 74 (93.7%) on IFX were included. In addition to the anti-TNF agent, 33 (41.8%) were on AZA and the rest were on MTX. The median duration of combination therapy was 2.0 (IQR 1.2–2.8) years. All participants were in clinical remission at the time of IM withdrawal. The median duration of follow-up after IM withdrawal was 11.0 (IQR 5.0–16.2) months. Only 8 (10.1%) patients relapsed over that period of follow-up. Age, sex, disease phenotype at diagnosis, family history of IBD, type of IM, and biochemical markers and clinical disease activity indices prior to IM stoppage did not predict a future relapse. Among those with CD on IFX who maintained remission, the median last IFX trough level before IM withdrawal was 6.25 Ug/ml (IQR: 4.04–8.70) vs. 3.8 Ug/ml (IQR: 2.40–11.6) in those who relapsed (p = 0.4). Conclusion Over short-term follow-up, the majority of children on combination therapy of IM and an anti-TNF agent remain in clinical remission after IM withdrawal.

scholarly journals Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort

2019 ◽  
Vol 13 (9) ◽  
pp. 1111-1120 ◽  
Author(s):  
N Plevris ◽  
C S Chuah ◽  
R M Allen ◽  
I D Arnott ◽  
P N Brennan ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Inflammatory Bowel

Abstract Background & Aims Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn’s disease and ulcerative colitis. The aims of this study were to establish the real-world effectiveness and safety of vedolizumab for the treatment of inflammatory bowel disease. Methods This was a retrospective study involving seven NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included: a diagnosis of ulcerative colitis or Crohn’s disease with objective evidence of active inflammation at baseline (Harvey–Bradshaw Index[HBI] ≥5/Partial Mayo ≥2 plus C-reactive protein [CRP] >5 mg/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/magnetic resonance imaging [MRI]); completion of induction; and at least one clinical follow-up by 12 months. Kaplan–Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, and deep remission [clinical remission plus mucosal healing]. Rates of serious adverse events were described quantitatively. Results Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn’s disease. Combined median follow-up was 52 weeks (interquartile range [IQR] 26–52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 57.4%, 47.3%, and 38.5%, respectively. In Crohn’s disease, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 58.4%, 38.9%, and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient-years of follow-up. Conclusions Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn’s disease.

scholarly journals P368 Proactive Therapeutic Drug Monitoring is more effective than Conventional Management in Inducing Fecal Calprotectin remission in Inflammatory Bowel Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S386-S386
Author(s):  
J Pedro ◽  
I Rodrigues ◽  
S Fernandes ◽  
A R Gonçalves ◽  
S Bernardo ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Clinical Outcomes ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Clinical Remission ◽  
Therapeutic Drug ◽  
Conventional Management ◽  
Inflammatory Bowel

Abstract Background Proactive therapeutic drug monitoring (pTDM) may potentially improve disease control and treatment outcomes in inflammatory bowel disease. Methods Using a prospectively maintained database we compared 135 patients following a pTDM protocol aiming at an Infliximab trough level (IFXTL) between 5-10 µg/mL with sequential measurements of Fc, with 108 patients from a retrospective group under conventional management (noTDM). We evaluated the rates of Fc remission (<250 µg/g), and other clinical outcomes at 2-years of follow up. Results pTDM associated with higher rates of Fc remission (69.6% vs 50.0%; P=0.002), and steroid-free clinical remission (78.4% vs 55.2%, P=0.028) with a trend for clinical remission (79.3% vs 68.5%, P=0.075). There was no difference in treatment discontinuation (P=0.195), hospitalization (P=0.156), and surgery (P=0.110). Higher IFXTL associated with Fc remission at week 14 (6.59 vs 2.96 µg/mL, P<0.001), and at the end follow-up (8.10 vs 5.03 μg/mL, P=0.001). Fc remission associated with higher rates of clinical remission (85.8% vs 56.8% P<0.001), steroid-free clinical remission (86.9% vs 50.0% P<0.001), and lower rates of IFX discontinuation (8.8% vs 36.8%, P<0.001), and hospitalization (13.5% vs 33.7%, P<0.001) with a non-significant trend for surgery (6.1% vs 12.6%, P=0.101). Conclusion PTDM was more effective than conventional management in inducing Fc remission which associated with improved clinical outcomes.

scholarly journals Fecal lactoferrin predicts primary non-response to biologic agents in inflammatory bowel disease

2021 ◽  
Author(s):  
Dario Sorrentino ◽  
Vu Q. Nguyen ◽  
Kim Love
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Biologic Agents ◽  
Fecal Lactoferrin ◽  
Inflammatory Bowel

Introduction: Fecal Lactoferrin (FL) is a timely and accurate marker of inflammation in ulcerative colitis (UC) and Crohn’s disease (CD). Aim of this study was to verify whether FL can predict primary non-response (PNR) to biologic agents during induction. Methods: Retrospective outcome review in 27 patients (13 with CD and 14 with UC) tested for baseline FL and re-tested within a week after the first and second induction doses. Clinical/biochemical outcomes were evaluated at end of induction and at follow up (3-24 months). Results: Compared to baseline, changes of the Harvey-Bradshaw (CD) and Partial Mayo Scoring (UC) indices at end of induction separated responders (18/27 or 67%) from non-responders (9/17 or 33%). In all patients the initial FL value at induction decreased compared to baseline, continuing to decrease after the following dose in clinical responders while bouncing back in the others. Models targeting the two consecutively decreased FL values or the second FL value compared to baseline or the second FL value compared to the first were able to accurately predict response at end of induction. Follow-up assessment confirmed clinical remission in initial responders (with FL values reduced on the average by 94±10% compared to baseline). Conclusions: In CD and UC patients during induction with biologic agents early FL measurements accurately separate clinical responders from those experiencing PNR. The method described here offers several potential advantages over other strategies to assess and manage these patients.

scholarly journals Maintenance of Remission Among Patients With Inflammatory Bowel Disease After Vedolizumab Discontinuation: A Multicentre Cohort Study

2020 ◽  
Vol 14 (7) ◽  
pp. 896-903 ◽  
Author(s):  
Antoine Martin ◽  
Maria Nachury ◽  
Laurent Peyrin-Biroulet ◽  
Yoram Bouhnik ◽  
Stephane Nancey ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Clinical Remission ◽  
First Year ◽  
Reactive Protein ◽  
Infusion Reactions ◽  
Inflammatory Bowel ◽  
Maintenance Of Remission ◽  
Risk Of Relapse

Abstract Background and Aim It is unclear whether vedolizumab therapy can be discontinued in patients with inflammatory bowel disease [IBD] after achieving steroid-free clinical remission. The aim was to assess the risk of relapse after vedolizumab therapy was discontinued. Methods This was a retrospective observational study, collecting data from 21 tertiary centres affiliated with the GETAID from January 2017 to April 2019. Consecutive patients with IBD, who were in steroid-free clinical remission for at least 3 months and were treated with vedolizumab for at least 6 months, were included at the time of vedolizumab discontinuation. Results A total of 95 patients [58 with Crohn’s disease] discontinued vedolizumab after a median duration of therapy of 17.5 [10.6–25.4] months. After a median follow-up period of 11.2 [5.8–17.7] months, 61 [64%] patients experienced disease relapse. The probabilities of relapse-free survival were 83%, 59%, and 36% at 6, 12, and 18 months, respectively. According to the multivariate analysis, a C-reactive protein level less than 5 mg/L at vedolizumab discontinuation (hazard ratio [HR] = 0.56, 95% confidence interval [CI] [0.33–0.95], p = 0.03) and discontinuation due to patients’ elective choice (HR = 0.41, 95% CI [0.21–0.80], p = 0.009) were significantly associated with a lower risk of relapse. Re-treatment with vedolizumab was noted in 24 patients and provided steroid-free clinical remission in 71% and 62.5% at Week 14 and after a median follow-up of 11.0 [5.4–13.3] months, respectively, without any infusion reactions. Conclusions In this retrospective study, two-thirds of patients with IBD treated with vedolizumab experienced relapse within the first year after vedolizumab discontinuation. Re-treatment with vedolizumab was effective in two-thirds of patients.

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