scholarly journals P379 Variations in disease monitoring between Inflammatory Bowel Disease patients on intravenous and subcutaneous biologic agents

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S393-S393
Author(s):  
P Hilley ◽  
C Li Wai Suen ◽  
A Srinivasan ◽  
M C Choy ◽  
P De Cruz
Keyword(s):  
Disease Activity ◽  
Biologic Therapy ◽  
Objective Assessment ◽  
Assessment Tools ◽  
Disease Assessment ◽  
Disease Monitoring ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Activity Assessment ◽  
Inflammatory Bowel

Abstract Background The availability of subcutaneous (SC) administration devices of biologics in addition to intravenous (IV) administration has influenced patients’ and clinicians’ preferences towards initiating or transitioning to SC administration particularly during the COVID-19 pandemic. Whilst SC administration improves patient convenience and reduces demands on infusion centres we hypothesised that the reduction in healthcare contact associated with SC therapies may reduce the opportunities available for objective disease assessment. We aimed to compare the uptake of objective assessment of disease activity between patients receiving IV and SC biologic therapy. Methods Patients on maintenance infusion-based or subcutaneous biologic therapy for IBD between 09/2020 and 02/2021 were identified from a prospectively maintained database at an Australian tertiary IBD centre. Patients scheduled for review in IBD clinic for a prescription of maintenance biologic therapy during the follow-up period were included. Clinic records were reviewed to determine whether patients had undergone objective disease assessment including: biochemical investigation (C-Reactive protein) and Faecal Calprotectin (FCP) within the preceding 8 weeks and/or endoscopic/imaging assessment within the preceding 6 months of clinic review. Frequency of objective disease assessment was compared between patients who received IV versus SC maintenance biologic therapy. Results A total of 307 patients were included: IV maintenance n=195 (Infliximab n=135; Vedolizumab n= 60) and SC maintenance n=112 (Adalimumab n=54; Ustekinumab n=54; Golimumab n=4). Patients who received IV biologics were more likely than the SC cohort to have had biochemical assessment in the form of CRP (90% vs 72%, p<0.001) and FCP (54% vs 46%, p=0.16). Patients in the SC biologic cohort were more likely not to have had investigations completed prior to their clinical review (20% versus 4%, p<0.001). There was no difference in the overall rates of complete objective disease assessment (CRP/FCP and endoscopy/imaging) between the IV and SC cohort (28% vs 30% (p=0.74). Conclusion Patients on subcutaneous biologic therapies in our cohort were less likely to have had objective disease monitoring than those receiving intravenous biologics prior to scheduled IBD clinic review. Route of of biologic administration may influence rates of uptake of objective disease activity assessment. Tools that safeguard against the disparity of monitoring uptake, including messaging prompts and patient-centric mobile applications may help standardise the approach to objective disease assessment independent of the route of biologic administration.

Switching From Originator Adalimumab to the Biosimilar SB5 in Patients With Inflammatory Bowel Disease: Short-term Experience From a Single Tertiary Clinical Centre

2020 ◽  
Vol 14 (7) ◽  
pp. 915-919 ◽  
Author(s):  
Martin Lukas ◽  
K Malickova ◽  
M Kolar ◽  
M Bortlik ◽  
M Vasatko ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Control Group ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Mayo Score ◽  
Serum Trough ◽  
Inflammatory Bowel ◽  
Trough Levels

Abstract Background and Aims Patients’ perspectives after switching from originator to biosimilar adalimumab have yet to be assessed. We evaluated the efficacy of switching from the originator adalimumab to a biosimilar compound [SB5] in patients with inflammatory bowel disease [IBD]. Methods Data on IBD patients who were switched from the originator to biosimilar adalimumab [SB5] at IBD Center ISCARE were analysed. Disease activity was assessed using standard clinical indices (Harvey-Bradshaw index [HBI] for Crohn’s disease [CD] and partial Mayo score for ulcerative colitis [UC]), and laboratory parameters (C-reactive protein [CRP] and faecal calprotectin [FC]). Trough levels and anti-drug antibodies were measured. Patients were evaluated 10 weeks [W10] after the switch, and results were compared with the control group of patients on originator compound. Results A total of 93 patients switched to biosimilar adalimumab were included [CD 86%] and were matched to 93 controls for age, gender, diagnosis, and disease activity. There was no difference in the disease activity in either SWITCH or ORIGINATOR cohorts between Weeks 0 and 10. Similarly, no difference was found between cohorts at both prespecified time points. Moreover, no significant differences in CRP or FC concentrations were seen between W0 and W10 either in the SWITCH, or in the ORIGINATOR cohort [p >0.05]. Adalimumab serum trough levels remained stable after the switch. No new safety signals were detected. Conclusions Our study confirmed that switching IBD patients from the originator adalimumab to a biosimilar compound [SB5] does not affect treatment efficacy.

scholarly journals Surrogate Markers of Intestinal Inflammation in Paediatric Patients with Inflammatory Bowel Disease

Folia Medica ◽  
2020 ◽  
Vol 62 (2) ◽  
pp. 271-275
Author(s):  
Rayna Shentova ◽  
Mila Baycheva ◽  
Denitza Kofinova ◽  
Petio Hadjiiski ◽  
Penka Yaneva
Keyword(s):  
Disease Activity ◽  
Intestinal Inflammation ◽  
C Reactive Protein ◽  
Endoscopic Evaluation ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Erythrocyte Sedimentation ◽  
Paediatric Patients ◽  
Endoscopic Score ◽  
Inflammatory Bowel

Background: Endoscopic evaluation is the gold standard for monitoring the disease activity in inflammatory bowel disease (IBD) but the procedure is invasive and not appropriate for frequent use, especially in the paediatric population. The aim of the present study was to assess the correlation between the levels of several inflammatory biomarkers and the degree of intestinal inflammation in paediatric patients with IBD. Materials and methods: A single center study including 31 children with ulcerative colitis (UC) and 22 children with Crohn&rsquo;s disease (CD) with different disease duration and activity. All participants provided blood samples to measure the levels of white blood cell count, platelets, C-reactive protein, erythrocyte sedimentation rate, albumin and fibrinogen, and faecal samples for measurement of faecal calprotectin and faecal alpha-1 antitrypsin. All participants underwent endoscopic evaluation. Endoscopic disease activity was assessed according to the Mayo Endoscopic Subscore and Simple Endoscopic Score for Crohn&lsquo;s Disease in UC and CD patients, respectively. Results: 135 visits were included: 73 for UC patients and 62 for CD patients. In UC patients the strongest correlation was between the Mayo Endoscopic Subscore and the faecal calprotectin (r=0.867, p<0.001) followed by the albumin (r=0.523, p<0.001) and the&nbsp;C-reactive protein (r=0.487, p<0.001). In CD the strongest correlation was between the Simple Endoscopic Score for Crohn&rsquo;s disease and the faecal calprotectin (r=0.872, p<0.001) followed by the C-reactive protein (0.708, p<0.001) and the erythrocyte sedimentation rate (0.605, p<0.001). Conclusions: The faecal calprotectin is a valuable surrogate marker of intestinal inflammation that is useful for monitoring of a disease activity in paediatric patients with IBD.

scholarly journals Disease monitoring of biologic treatment in IBD: early impact and future implications of COVID-19 pandemic

2020 ◽  
pp. flgastro-2020-101563
Author(s):  
Stephanie Shields ◽  
Allan Dunlop ◽  
John Paul Seenan ◽  
Jonathan Macdonald
Keyword(s):  
Clinical Care ◽  
Chronic Illnesses ◽  
Therapeutic Drug ◽  
Disease Monitoring ◽  
Biologic Treatment ◽  
Faecal Calprotectin ◽  
Routine Clinical Care ◽  
Risk Of Disease ◽  
Inflammatory Bowel ◽  
The Impact

COVID-19 has dominated life in 2020 with, at the time of writing, over 4.9M global cases and >320 000 deaths. The impact has been most intensely felt in acute and critical care environments. However, with most UK elective work postponed, laboratory testing of faecal calprotectin halted due to potential risk of viral transmission and non-emergency endoscopies and surgeries cancelled, the secondary impact on chronic illnesses such as inflammatory bowel disease (IBD) is becoming apparent. Data from the Scottish Biologic Therapeutic Drug Monitoring (TDM) service shows a dramatic drop in TDM testing since the pandemic onset. April 2020 saw a 75.6% reduction in adalimumab testing and a 36.2% reduction in infliximab testing when compared with February 2020 data, a reduction coinciding with the widespread cancellation of outpatient and elective activity. It is feared that disruption to normal patterns of care and disease monitoring of biologic patients could increase the risk of disease flare and adverse clinical outcomes. Urgent changes in clinical practice have been instigated to mitigate the effects of the pandemic on routine clinical care. Further transformations are needed to maintain safe, effective, patient-centred IBD care in the future.

Does Disease Activity After Induction Treatment With Biologics Predict Short-Term Outcome in Crohn’s Disease and Ulcerative Colitis?

2022 ◽  
Author(s):  
Michael Due Larsen ◽  
Bente Mertz Nørgård ◽  
Jens Kjeldsen
Keyword(s):  
Disease Activity ◽  
Induction Therapy ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Biologic Therapy ◽  
C Reactive Protein ◽  
Short Term ◽  
Term Outcome ◽  
Reactive Protein ◽  
Short Term Outcome

Abstract Background Secondary loss of response to biological therapy is a challenge when treating Crohn’s disease (CD) and ulcerative colitis (UC). Currently, no single marker has been found to be valid as a prognostic indicator of response to biologic therapy in patients with CD and UC. In this study, we aimed to assess whether disease activity after 14 weeks of biologic therapy has a prognostic impact on surgery and steroid-free remission during 6 months following completion of induction therapy. Methods In an unselected cohort study based on data from 4 national Danish health registries, we identified 493 patients with UC and 620 patients with CD who completed induction therapy with biologics from 2016 to 2019. Following induction therapy with biologics, we defined disease activity based on C-reactive protein and clinical scores of disease activity. The composite endpoint, “not being well treated,” included surgery or use of corticosteroid within 6 months following induction therapy. Results In patients with UC with disease activity following induction therapy, the adjusted odds ratio for surgery or steroid treatment during 6 months of follow-up was 3.9 (95% CI, 1.6-9.3) compared with patients without disease activity, and in patients with CD, the adjusted odds ratio was 3.6 (95% CI, 1.7-7.6). Conclusions A positive treatment response to biologic treatment after induction therapy (measured by C-reactive protein and clinical scores) predicts a better short-term outcome in patients with CD and UC.

scholarly journals The Relationship between C-Reactive Protein/Albumin Ratio and Disease Activity in Patients with Inflammatory Bowel Disease

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Yi-Han Chen ◽  
Li Wang ◽  
Shu-Yi Feng ◽  
Wei-Min Cai ◽  
Xiao-Fu Chen ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Inflammatory Markers ◽  
C Reactive Protein ◽  
Distribution Width ◽  
Albumin Ratio ◽  
Lymphocyte Ratio ◽  
Reactive Protein ◽  
Inflammatory Bowel

Objectives. The aims of this study were to evaluate the C-reactive protein/albumin ratio (CRP/ALB), inflammatory markers, and parameters from the complete blood count (CBC) in patients with inflammatory bowel disease (IBD) and their associations with disease activity. Methods. A total of 876 IBD patients, composed of 275 patients with ulcerative colitis (UC) and 601 patients with Crohn’s disease (CD), were included in this retrospective study, and the serum C-reactive protein (CRP), albumin (ALB), erythrocyte sedimentation rate (ESR), and CBC parameters were measured. To explore the disease activity, the Mayo score and Crohn disease activity index were used to assess UC and CD patients, respectively. Results. The CRP/ALB ratio, CRP, ESR, platelet to lymphocyte ratio (PLR), red blood cell distribution width (RDW), and neutrophil to lymphocyte ratio (NLR) levels in active IBD patients were significantly higher than those in inactive IBD patients, whereas ALB and lymphocyte to monocyte ratio (LMR) levels were significantly decreased (P<0.001). The receiver operating characteristic analysis showed that the optimum cut-off values of the CRP/ALB ratio for active UC and CD were 0.18 and 0.43, with sensitivities of 67.8% and 75.8% and specificities of 86.7% and 92.0%, respectively. Multivariable logistic analysis revealed that after adjusting for these inflammatory markers (ESR, NLR, PLR, and LMR), the CRP/ALB ratio was a statistically significant parameter capable of differentiating the disease activity of UC and CD. Conclusions. This study indicated that the CRP/ALB ratio was closely related to the IBD disease activity. Compared with CBC parameters, the CRP/ALB ratio had a higher discriminative capacity for active IBD.

scholarly journals Changes in Plasma Itaconate Elevation in Early Rheumatoid Arthritis Patients Elucidates Disease Activity Associated Macrophage Activation

Metabolites ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. 241 ◽  
Author(s):  
Rónán Daly ◽  
Gavin Blackburn ◽  
Cameron Best ◽  
Carl S. Goodyear ◽  
Manikhandan Mudaliar ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clear Correlation ◽  
Strategy Study ◽  
Reactive Protein ◽  
Score Following ◽  
Activity Assessment ◽  
Ultrasound Assessment ◽  
First Time ◽  
Rheumatic Drug

Changes in the plasma metabolic profile were characterised in newly diagnosed rheumatoid arthritis (RA) patients upon commencement of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy. Plasma samples collected in an early RA randomised strategy study (NCT00920478) that compared clinical (DAS) disease activity assessment with musculoskeletal ultrasound assessment (MSUS) to drive treatment decisions were subjected to untargeted metabolomic analysis. Metabolic profiles were collected at pre- and three months post-commencement of nonbiologic cDMARD. Metabolites that changed in association with changes in the DAS44 score were identified at the three-month timepoint. A total of nine metabolites exhibited a clear correlation with a reduction in DAS44 score following cDMARD commencement, particularly itaconate, its derived anhydride and a derivative of itaconate CoA. Increasing itaconate correlated with improved DAS44 score and decreasing levels of C-reactive protein (CRP). cDMARD treatment effects invoke consistent changes in plasma detectable metabolites, that in turn implicate clinical disease activity with macrophages. Such changes inform RA pathogenesis and reveal for the first time a link between itaconate production and resolution of inflammatory disease in humans. Quantitative metabolic biomarker-based tests of clinical change in state are feasible and should be developed around the itaconate pathway.

scholarly journals P562 5-ASA in ulcerative colitis: Are they really needed in the biological therapy era?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S474-S474
Author(s):  
C Arieira ◽  
F Dias de Castro ◽  
T Cúrdia Gonçalves ◽  
M J Moreira ◽  
J Cotter
Keyword(s):  
Colorectal Cancer ◽  
Ulcerative Colitis ◽  
Biologic Therapy ◽  
Fecal Calprotectin ◽  
Inflammatory Biomarkers ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Maintenance Of Remission ◽  
Treatment Escalation

Abstract Background Biologic therapy has demonstrated efficacy for induction and maintenance of remission in ulcerative colitis (UC). However, it remains unclear whether oral aminosalicylates (5-ASA) should be continued or stopped after treatment escalation to biologics. The aim of the study was to evaluate differences in inflammatory biomarkers or the occurrence of complications in UC patients being treated with a combination of 5-ASA and biologics vs. biologics alone. Methods Retrospective study, including patients with UC and on biologic therapy with a minimum follow-up of 6 months. Collected inflammatory biomarkers were faecal calprotectin, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). The occurrence of complications was defined as the need of hospitalisation, need of corticosteroids or other top-up therapy, surgery and the occurrence of dysplasia or colorectal cancer. Results We included 65 patients with UC, 56.9% female with a mean age of 32.8 (±12.8) years. The median follow-up was 30 (6–132) months. Regarding extension, 61.5% were E3, 35.4% E2 and 3.1% E1. While 44 patients (67.7%) were on 5-ASA and biologics (infliximab = 32, adalimumab = 6, vedolizumab = 6), 21 (32.3%) were on biologics alone (infliximab = 13, adalimumab = 3, vedolizumab = 5). The median duration of biologic therapy was 30 (6–126) months. Regarding baseline characteristics, including age, gender, duration of the disease or biologic therapy and age at UC diagnosis, there were no differences between groups. No differences regarding inflammatory biomarkers were observed – fecal calprotectin (p = 0.39), CRP (p = 0.9) and ESR (p = 0.61). No differences were found regarding complications, namely the need of hospitalisation (p = 0.06) or need of corticosteroids (p = 0.89). Only one patient developed dysplasia (under infliximab and 5-ASA). Any of the included patients needed surgery or developed colorectal cancer. Conclusion About two-thirds of the UC patients under biologics are co-treated with 5-ASA. No differences between UC patients under combination biologics+5-ASA vs. biologics alone were found regarding inflammatory biomarkers or the occurrence of complications. These results raise the question if continuing 5-ASA in UC patients under biologics is really necessary.

scholarly journals P430 Feasibility and reliability of gastrointestinal ultrasound in pregnant inflammatory bowel disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S391-S393
Author(s):  
F de Voogd ◽  
H Joshi ◽  
E Van Wassenaer ◽  
G D’Haens ◽  
K Gecse
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Terminal Ileum ◽  
Bowel Disease ◽  
Activity Index ◽  
Third Trimester ◽  
Faecal Calprotectin ◽  
Gastrointestinal Ultrasound ◽  
Inflammatory Bowel ◽  
Active Disease

Abstract Background Disease activity during pregnancy in women with inflammatory bowel disease (IBD) is associated with miscarriage, preterm delivery and low birth weight. Monitoring disease activity throughout the pregnancy is therefore important. Gastrointestinal ultrasound (GIUS) has a high potential as a point-of-care tool for monitoring disease activity in IBD as it has been shown to correlate well with endoscopy and magnetic resonance imaging. However, data are scarce on the use of GIUS in IBD throughout pregnancy. The aim of this prospective study is to determine the feasibility and reliability of GIUS in pregnant IBD patients. Methods Patients were included when visiting the outpatient IBD pregnancy clinic. At each trimester, clinical and biochemical disease activity was evaluated and GIUS was performed. Feasibility was assessed by the ability to visualise each bowel segment (terminal ileum (TI), ascending (AC), transverse (TC), descending (DC) and sigmoid colon (SC)). Reliability was evaluated by using clinical and biochemical disease activity as a gold standard. This was defined as a Harvey–Bradshaw Index ≥4 in Crohn’s disease (CD) or a Simple Clinical Colitis Activity Index ≥5 in ulcerative colitis and a faecal calprotectin (FCP)³ 250 mg/g. Bowel wall thickness (BWT) of &gt; 3 mm in the colon and &gt; 2mm in the terminal ileum was considered as signs of active inflammation on ultrasound. A Mann–Whitney U-test and chi-square were used for statistical analysis. Results Thirty-two IBD patients (54% CD) were studied. Both a GIUS and FCP was available in 18, 11 and 6 patients for the first, second and third trimester, respectively. Eleven of 32 (34%) patients had clinically active disease at least at one time point during the pregnancy. Table 1 shows the visibility per segment. When the active disease was defined as an FCP ≥ 250 mg/g, GIUS could distinguish active from the non-active disease in the first, second and third trimester with a sensitivity of 80%, 75% and 75% and specificity of 85%, 86% and 100%, respectively. FCP levels were significantly higher in patients with an active disease on GIUS regardless of the trimester (mean 1095.5 ± 1453.8 mg/g vs. 265.25 ± 649.8 mg/g, p &lt; 0.0001). Conclusion GIUS is accurate to distinguish active from the quiescent disease in pregnancy. Feasibility to visualise the TI and the SC decreased during the second and third trimester, although active disease could still be detected. Consequently, GIUS is feasible and reliable to assess disease activity throughout pregnancy in IBD.

scholarly journals Distinct Cutoff Values of Adalimumab Trough Levels Are Associated With Different Therapeutic Outcomes in Patients With Inflammatory Bowel Disease

2019 ◽  
Vol 1 (3) ◽  
Author(s):  
Sang Hyoung Park ◽  
Badr Al-Bawardy ◽  
Satimai Aniwan ◽  
Sunanda V Kane ◽  
Nayantara Coelho-Prabhu ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Cutoff Value ◽  
Reactive Protein ◽  
Therapeutic Outcomes ◽  
Inflammatory Bowel ◽  
Relationship Of ◽  
The Relationship ◽  
Trough Levels

Abstract Background and Aims We aimed to evaluate the relationship of serum adalimumab trough levels (ATL) with disease activity of inflammatory bowel disease (IBD) patients in a large, well-characterized referral center-based cohort. Methods We compared serum ATL between those with clinical, biochemical, or endoscopic/radiologic disease activity and those without. Results A total of 236 patients with IBD were included. Higher cutoff levels were associated with endoscopic and/or radiologic responses (cutoff value: 5.3 mcg/mL, P = 0.003) compared with improvement in C-reactive protein (cutoff value: 4.3 mcg/mL, P = 0.031). Conclusions Higher cutoff ATL was associated with endoscopic and/or radiologic response.

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