The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease

Abstract Background Exclusive enteral nutrition (EEN) is an effective solution in inducing remission in patients with active Crohn’s disease (CD). However, the underlying mechanism is not completely clear. Evidence is accumulating that potential beneficial in regulating the inflammatory immune response of CD, a chronic inflammation dominated by pathogenic TH1 and TH17 cells. We investigated the relationship between changes of circulating helper T cell and clinical response in CD during treatment with EEN. Methods Sixty-eight adults with active CD treated successfully with EEN were prospectively study. Peripheral helper T cell (Th1, Th2, Th17 and Treg) were evaluated using flow cytometry from baseline to Weeks 4 and 12. We also determine the prognostic value of the ratio of delta Th cell at Weeks 4 to baseline (△Th w4-w0) in patients receiving EEN. Mucosal healing was assessed with endoscopy at baseline and Week 12. Results Treatment with EEN significantly improved disease activity scores and laboratory biochemical markers measured at Weeks 4 and 12 compared with baseline (p < 0.05 and p < 0.001). After the initiate of EEN, we observe early modulating effects of EEN on helper T-cell percentages, especially in Treg cell. Furthermore, we found a long-term increase in Treg cell percentages in patients who sustained response to EEN during follow-up. Mean increases of Treg cell from baseline in patients sustained response were significantly larger in a patient who loss of response (p < 0.01). Receiver operating characteristic (ROC) analysis to predict sustained response at 12 weeks showed area under the curve (95% confidence interval) of Treg cell at 4 weeks (Treg w4) and change in Treg cell from baseline to 4 weeks (△Treg w4-w0) to be 0.75 (0.56–0.87) and 0.84 (0.63–0.92), respectively. Logistic regression analysis confirmed that △Treg w4-w0 (31.8%) after the EEN was significant independent predictive factors for sustained response. Mucosal healing at Week 12 was achieved by 97.1% of patients who long-term increase of Treg cell compared with 51.5% of those temporary raise (p < 0.001). Conclusion EEN resulted in rapid improvements in laboratory markers and early increase in Th subsets percentages. Early increase of Treg cell predicts a sustained response to EEN and mucosal healing. Monitoring of Treg cell may help predicts the sustained clinical response and course.

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P387 Real-world clinical outcomes of biologic-naïve non-complicated Crohn’s disease patients treated with vedolizumab: Results from the EVOLVE study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.516 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S360-S361

Author(s):

A Yarur ◽

G J Mantzaris ◽

U Kopylov ◽

M Bassel ◽

N Brett ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Response ◽

Real World ◽

Clinical Remission ◽

Complex Disease ◽

Clinical Effectiveness ◽

Mucosal Healing ◽

Kaplan Meier ◽

The Usa

Abstract Background Crohn’s disease (CD) can lead to complications that impact treatment (Tx) decisions and its clinical effectiveness. The objective of this analysis was to compare clinical effectiveness outcomes of CD patients treated with first-line biologic vedolizumab (VDZ) who did not have a complicated disease phenotype (non-complicated) to VDZ patients who had complications (complex disease). Methods This was a retrospective real-world cohort study of biologic-naïve CD patients (≥18 years old) in Canada, Greece and the USA who initiated VDZ Tx between May 2014 and March 2018. Data were collected from Tx initiation to the earliest of chart abstraction date or death. The non-complicated CD was defined as patients who had mild or moderate disease severity and no active fistula at Tx initiation, had no prior CD-related surgeries since diagnosis and no CD-related hospitalisations within 12 months prior to Tx initiation. The complex disease cohort encompassed all other CD patients. Cumulative rates of clinical effectiveness outcomes over 24 months (Tx persistence, clinical response and clinical remission) were estimated using the Kaplan–Meier method. Using pre-defined hierarchical algorithms, clinical response and clinical remission were assessed from standard disease measures reported in the medical records. Results This analysis included 218 CD patients treated with VDZ (non-complicated: 64 (29.3%); complex: 154 (70.6%) from 37 sites. Mean (SD) age at Tx initiation: non-complicated, 46.2 (15.8); complex, 54.0 (16.7); male: non-complicated, 45.3%; complex, 55.2%. Cumulative rates of clinical response were significantly greater in non-complicated than complex disease patients over 24 months (non-complicated: 93.0%, complex: 76.0%, p < 0.01) (Figure 1). Tx persistence (non-complicated: 76.7%, complex: 66.6%, p = 0.68) (Figure 2) and clinical remission (non-complicated: 81.9%, complex: 73.5%, p = 0.36) (Figure 1) were not significantly different between the two cohorts over 24 months. Fewer patients had data for mucosal healing over 24 months, and it was also not significantly different between groups at 12 months (non-complicated: 66.4%, complex: 60.2%, p = 0.95). Conclusion A high proportion of patients (70%) had a complex disease when VDZ Tx was initiated but those with non-complicated phenotype had a higher response rate. To help guide physicians in positioning the optimal Tx for biologic-naïve CD patients, it is important to identify the sub-group of patients who can most benefit from VDZ Tx. The results of this real-world study suggest that the biologic-naïve, non-complicated CD patients benefit more from VDZ treatment compared with those with disease complications.

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Infliximab Preferentially Induces Clinical Remission and Mucosal Healing in Short Course Crohn’s Disease with Luminal Lesions through Balancing Abnormal Immune Response in Gut Mucosa

Mediators of Inflammation ◽

10.1155/2015/793764 ◽

2015 ◽

Vol 2015 ◽

pp. 1-9 ◽

Cited By ~ 12

Author(s):

Lijuan Yu ◽

Xuehua Yang ◽

Lu Xia ◽

Jie Zhong ◽

Wensong Ge ◽

...

Keyword(s):

Immune Response ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Response ◽

Clinical Remission ◽

Disease Duration ◽

Activity Index ◽

Mucosal Healing ◽

Short Course ◽

Short Disease Duration

This study was undertaken to evaluate the efficacy of infliximab (IFX) in treatment of Crohn’s disease (CD) patients. 106 CD patients were undergoing treatment with IFX from five hospitals in Shanghai, China. Clinical remission to IFX induction therapy was defined as Crohn’s disease activity index (CDAI) < 150. Clinical response was assessed by a decrease in CDAI ≥ 70, and the failure as a CDAI was not significantly changed or increased. Ten weeks after therapy, 61 (57.5%) patients achieved clinical remission, 17 (16.0%) had clinical response, and the remaining 28 (26.4%) were failed. In remission group, significant changes were observed in CDAI, the Simple Endoscopic Score for Crohn’s Disease (SES-CD), and serum indexes. Patients with short disease duration (22.2 ± 23.2 months) and luminal lesions showed better effects compared to those with long disease duration (71.0 ± 58.2 months) or stricturing and penetrating lesions. IFX markedly downregulated Th1/Th17-mediated immune response but promoted IL-25 production in intestinal mucosa from remission group. No serious adverse events occurred to terminate treatment. Taken together, our studies demonstrated that IFX is efficacious and safe in inducing clinical remission, promoting mucosal healing, and downregulating Th1/Th17-mediated immune response in short course CD patients with luminal lesions.

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Thalidomide induces clinical remission and mucosal healing in adults with active Crohn’s disease: a prospective open-label study

Therapeutic Advances in Gastroenterology ◽

10.1177/1756283x17698910 ◽

2017 ◽

Vol 10 (5) ◽

pp. 397-406 ◽

Cited By ~ 8

Author(s):

Yao He ◽

Ren Mao ◽

Fang Chen ◽

Ping-Ping Xu ◽

Bai-Li Chen ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Remission ◽

Remission Rate ◽

Time Frame ◽

Mucosal Healing ◽

Adult Patients ◽

Optimal Time ◽

Open Label ◽

Endoscopic Remission

Background: Thalidomide is effective in inducing and maintaining clinical remission in children and adolescents with refractory Crohn’s disease (CD). However, little is known about the efficacy and safety of thalidomide for adult patients with CD. Methods: We conducted a prospective open-label cohort study between January 2013 and April 2015. A total of 47 adult patients with active CD who were dependent/resistant or intolerant to corticosteroids and/or immunomodulators or biologics received 50–100 mg of thalidomide daily. Primary outcome was clinical remission evaluated at week 8. Endoscopic assessment was performed at week 24 and defined as endoscopic response (decrease in Crohn’s Disease Endoscopic Index of Severity [CDEIS] score > 5 points from baseline CDEIS of 6 or more), complete endoscopic remission (CDEIS score < 3), and mucosal healing (MH) (no ulceration). Results: A total of 47 adults with active CD were enrolled. The clinical remission rate was 14.9% and 23.4% at week 4 and week 8, but increased to 46.8% at week 12 and 53.2% at week 24 out of all the 47 patients included (intention-to-treat analysis). Altogether 32 patients consented and underwent ileocolonoscopy at week 24. The rate of endoscopic response and complete endoscopic remission were 68.4% and 43.8%. MH (no ulceration) was achieved in 28.1% of patients. Adverse events occurred in 27/47 (57.4%) patients but necessitated therapy discontinuation in only 5/47 (10.6%) of patients. Conclusions: Low-dose thalidomide was effective and tolerated for inducing and maintaining clinical remission in adult patients with active CD, but the optimal time frame for thalidomide to induce clinical remission may be longer than previously appreciated and is probably optimal at 12 weeks. MH could reasonably be achievable with thalidomide.

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Early Mucosal Healing with Exclusive Enteral Nutrition is Associated with Improved Outcomes in Newly Diagnosed Children with Luminal Crohn’s disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjw075 ◽

2016 ◽

Vol 10 (10) ◽

pp. 1159-1164 ◽

Cited By ~ 45

Author(s):

Z. Grover ◽

C. Burgess ◽

R. Muir ◽

C. Reilly ◽

P. J. Lewindon

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Enteral Nutrition ◽

Mucosal Healing ◽

Newly Diagnosed ◽

Exclusive Enteral Nutrition ◽

Improved Outcomes

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P094 COMPARING ORAL CORTICOSTEROIDS ≥30 MG/DAY USE AMONG PEDIATRIC AND ADULT PATIENTS WITH NEWLY DIAGNOSED CROHN’S DISEASE

Inflammatory Bowel Diseases ◽

10.1093/ibd/izy393.102 ◽

2019 ◽

Vol 25 (Supplement_1) ◽

pp. S45-S45

Author(s):

Theresa Hunter ◽

April Naegeli ◽

Wendy Komocsar ◽

Amy Larkin ◽

Krista Schroeder ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Adult Patients ◽

Newly Diagnosed ◽

Oral Corticosteroids

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P249 What’s the role of anti-TNF α in correcting anemia in Crohn’s disease?

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.375 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S289-S290

Author(s):

A Hassine ◽

A Hammami ◽

H Jaziri ◽

N Elleuch ◽

M Ksiaa ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Disease Activity ◽

Clinical Response ◽

Therapeutic Efficacy ◽

Hypochromic Anemia ◽

Mucosal Healing ◽

Erythroid Progenitors ◽

Tnf Α ◽

The Mean

Abstract Background Anemia is the most common extra intestinal complication in Inflamatory Bowel Diseases (IBD) affecting the quality of life of patients. Iron deficiency and inflammation are the two most common mechanisms. It has been suggested that controlling disease activity is sufficient to correct well-tolerated anemia. Anti-TNF α by their powerful anti-inflammatory action and their role in increasing the growth of erythroid progenitors can lead to correction of anemia. The aim of this work was to determine the effect of anti-TNFα on the course of anemia in Crohn’s disease (CD). Methods This is a single-center retrospective study including patients followed for CD, between 2011 and 2017, on anti-TNF. Anemia was tested in these patients before the initiation of anti-TNF. After six months of treatment, a correlation between the achievement of therapeutic efficacy and the correction of the anemia was sought. The judgment criteria adopted were: clinical response (CDAI score <150 points), mucosal healing at endoscopy (absence of ulcerations), and normalization of the C-reactive protein (CRP <5mg / l). Results 120 patients were included, 60% of whom are female. The mean age at diagnosis was 29.8 years [12–56 years]. The mean duration of the disease was 7.42 ± 4.8 years. The disease phenotype was penetrating in 55% of cases and structuring in 45% of patients. Anoperineal manifestations (PAD) were noted in 20% of patients. 50% of patients were on Adalimumab, 50% on Infliximab and 45% of cases were on combination therapy. The indications for Biotherapy were: the presence of anoperineal manifestations (20%), failure of immunosuppressants (25%), postoperative recurrence (20%), intolerance to immunosuppressants (20%), and extradigestive manifestations in particular articular (15%). Pre-therapy, anemia was noted in 84 patients (70%), most of whom had chronic microcytic hypochromic anemia. The presence of anemia was well correlated with disease activity (p = 0.038). During the control, correction of anemia was obtained in 72 patients (60%), with a statistically significant association with the therapeutic efficacy criteria (clinical response: p <10–3, mucosal healing: p = 0.009, normalization of CRP: p <10–3). Conclusion Our study showed the effectiveness of anti-TNF alpha agents in correcting anemia in Crohn’s disease. Larger scale studies are needed to confirm our results.

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