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

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.

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

Crohn's & Colitis 360 ◽

10.1093/crocol/otz047 ◽

2019 ◽

Vol 1 (3) ◽

Cited By ~ 1

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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The Relationship between Serum Bilirubin and Inflammatory Bowel Disease

Mediators of Inflammation ◽

10.1155/2019/5256460 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7 ◽

Cited By ~ 7

Author(s):

Xiaojing Zhao ◽

Linzhen Li ◽

Xueting Li ◽

Jiajia Li ◽

Di Wang ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Disease Activity ◽

Bowel Disease ◽

Control Group ◽

Serum Total Bilirubin ◽

Negatively Associated ◽

Mayo Score ◽

Inflammatory Bowel

The associations between serum total bilirubin (sTB) levels, inflammatory marker levels, and disease activity are not well understood in patients with inflammatory bowel disease (IBD). The present study investigated the association between sTB levels and disease activity in patients with IBD. We conducted a retrospective study with a total of 242 consecutive patients with Crohn’s disease (CD) and 211 consecutive patients with ulcerative colitis (UC). The Crohn’s Disease Activity Index (CDAI) score was used to assess disease activity in patients with CD and the Mayo score of patients with UC. 255 clinically healthy subjects comprised the control group, which come from the same geographic area as the IBD group. We retrieved the clinical and laboratory parameters of patients with IBD from the medical records. Patients with IBD displayed significantly lower sTB levels than controls. sTB levels were negatively associated with C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FC), and hemoglobin (Hb) levels in patients with IBD. Additionally, there was a negative association between sTB levels and the CDAI score of patients with CD. sTB levels were also negatively associated with the Mayo score of patients with UC. IBD patients had lower sTB levels when compared with controls, and there was a negative correlation between sTB levels and disease activity in patients with IBD. Increased reactive oxygen species production in IBD is likely to be responsible for increased consumption of bilirubin in patients with IBD, leading to further intestinal injury. Reducing oxidative stress may be therapeutic for these patients.

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Predictive value of fibrinogen in identifying inflammatory bowel disease in active stage

BMC Gastroenterology ◽

10.1186/s12876-021-02040-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Xiao-Fu Chen ◽

Yuan Zhao ◽

Yu Guo ◽

Zhi-Ming Huang ◽

Xie-Lin Huang

Keyword(s):

Inflammatory Bowel Disease ◽

Confidence Interval ◽

Disease Activity ◽

Bowel Disease ◽

Odds Ratio ◽

Activity Index ◽

Characteristic Curve ◽

Disease Activity Index ◽

Mayo Score ◽

Inflammatory Bowel

Abstract Background We aimed to externally validate for the first time the diagnostic ability of fibrinogen to identify active inflammatory bowel disease (IBD). Methods The research totally involved 788 patients with IBD, consisted of 245 ulcerative colitis (UC) and 543 Crohn’ s disease (CD). The Mayo score and Crohn disease activity index (CDAI) assessed disease activity of UC and CD respectively. The independent association between fibrinogen and disease activity of patients with UC or CD was investigated by multivariate logistic regression analyses. Area under the receiver operating characteristic curve (AUROC) assessed the performance of various biomarkers in discriminating disease states. Results The fibrinogen levels in active patients with IBD significantly increased compared with those in remission stage (P < 0.001). Fibrinogen was an independent predictor to distinguish disease activity of UC (odds ratio: 2.247, 95% confidence interval: 1.428–3.537, P < 0.001) and CD (odds ratio: 2.124, 95% confidence interval: 1.433–3.148, P < 0.001). Fibrinogen was positively correlated with the Mayo score (r = 0.529, P < 0.001) and CDAI (r = 0.625, P < 0.001). Fibrinogen had a high discriminative capacity for both active UC (AUROC: 0.806, 95% confidence interval: 0.751–0.861) and CD (AUROC: 0.869, 95% confidence interval: 0.839–0.899). The optimum cut-off values of fibrinogen 3.22 was 70% sensitive and 77% specific for active UC, and 3.87 was 77% sensitive and 81% specific for active CD respectively. Conclusions Fibrinogen is a convenient and practical biomarker to identify active IBD.

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

Gastroenterology Research and Practice ◽

10.1155/2020/3467419 ◽

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.

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

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.559 ◽

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 > 3 mm in the colon and > 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 < 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.

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Monitoring Inflammatory Bowel Disease in Pregnancy Using Gastrointestinal Ultrasonography

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjaa082 ◽

2020 ◽

Vol 14 (10) ◽

pp. 1405-1412 ◽

Cited By ~ 1

Author(s):

Emma Flanagan ◽

Emily K Wright ◽

Jakob Begun ◽

Robert V Bryant ◽

Yoon-Kyo An ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Disease Activity ◽

Wall Thickness ◽

Terminal Ileum ◽

Bowel Disease ◽

Bowel Wall ◽

Faecal Calprotectin ◽

Bowel Wall Thickness ◽

Inflammatory Bowel ◽

In Pregnancy

Abstract Background and Aims Inflammatory bowel disease [IBD] affects women during their childbearing years. Gastrointestinal ultrasonography [GIUS] accurately identifies disease activity in non-pregnant patients with IBD. The utility of GIUS in pregnancy has not been established. We aimed to determine the feasibility and accuracy of GIUS in the assessment of IBD during pregnancy progression. Methods A multicentre observational study of women with IBD undergoing GIUS during pregnancy. Clinicians assessed the adequacy of bowel views and disease activity in four colonic segments and the terminal ileum. Location[s] in which views were impeded by the uterus were documented. GIUS disease activity [bowel wall thickness >3 mm] was compared with biochemical disease activity [faecal calprotectin >100 μg/g]. Results Ninety patients and 127 GIUS examinations were included [median gestation 19 weeks, range 4–33]. Adequate colonic views were obtained in 116/127 [91%] scans. Adequate ileal views were obtained in 62/67 [93%] scans <20 weeks and 30/51 [59%] scans at 20–26 weeks. There was a positive correlation between bowel wall thickness and calprotectin [r = 0.26, p = 0.03]. GIUS delivered a specificity of 83%, sensitivity of 74%, and negative predictive value of 90% compared with calprotectin. Conclusions GIUS is a feasible and accurate modality for monitoring IBD in pregnancy. Adequate GIUS views of the colon and terminal ileum can be obtained in the majority of patients up to 20 weeks of gestation. Beyond 20 weeks, GIUS provides good views of the colon but the terminal ileum becomes difficult to assess.

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