scholarly journals The Efficacy of Infliximab Monotherapy versus Infliximab-Azathioprine Sequential Treatment in Crohn’s Disease: Experience from a Tertiary Medical Center in China

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Tianyu Zhang ◽  
Zhengting Wang ◽  
Rong Fan ◽  
Maochen Zhang ◽  
Yun Lin ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Remission Rate ◽  
Therapy Group ◽  
Sequential Therapy ◽  
Sequential Treatment ◽  
Monotherapy Group ◽  
Endoscopic Remission ◽  
Remission Rates

Objective.To evaluate the efficacy of infliximab (IFX) monotherapy versus infliximab-azathioprine sequential treatment in Crohn’s disease (CD) patients.Methods.Patients newly diagnosed with CD using IFX as induction therapy were enrolled. After 6 times of IFX infusions, they were divided into IFX monotherapy group and IFX-AZA sequential therapy group. Clinical remission rates were assessed at weeks 57, 84, 111, and 138 while endoscopic remission rates were assessed at weeks 84 and 138 to evaluate the efficacy of these two groups.Results.A total of seventy-nine patients had accomplished 138-week follow-up. At weeks 84 and 138, the deep remission rate (18/22 and 17/22) of IFX monotherapy group was significantly higher compared to IFX-AZA sequential therapy group (26/57 and 21/57) (P=0.004and 0.001, resp.). Similar findings were found in complete endoscopic remission rate. The clinical remission rates of IFX monotherapy group were similar to that of IFX-AZA sequential therapy group (P>0.05). At weeks 84 and 138, the endoscopic remission rate and the endoscopic improvement rate between these two groups displayed no significant difference (P>0.05).Conclusion.IFX monotherapy provides higher deep remission rate compared with IFX-AZA sequential therapy in two-year maintenance therapy. For patients who could not receive prolonged IFX therapy, IFX-AZA sequential therapy is acceptable, though long-term efficacy remains to be seen.

scholarly journals Ustekinumab Exposure-outcome Analysis in Crohn’s Disease Only in Part Explains Limited Endoscopic Remission Rates

2019 ◽  
Vol 13 (7) ◽  
pp. 864-872 ◽  
Author(s):  
Bram Verstockt ◽  
Erwin Dreesen ◽  
Maja Noman ◽  
An Outtier ◽  
Nathalie Van den Berghe ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Real Life ◽  
Outcome Analysis ◽  
Faecal Calprotectin ◽  
Exposure Response ◽  
Patient Reported ◽  
Endoscopic Remission ◽  
Remission Rates

Abstract Background and Aims Ustekinumab, an anti-IL12/23p40 monoclonal antibody, has been approved for Crohn’s disease [CD]. Real-life data in CD patients receiving ustekinumab intravenously [IV] during induction, followed by subcutaneous [SC] maintenance, are lacking. We assessed efficacy of ustekinumab and studied exposure-response correlations. Methods We performed a prospective study in 86 CD patients predominantly refractory or intolerant to anti-tumour necrosis factor agents and/or vedolizumab. All received ustekinumab 6 mg/kg IV induction, with 90 mg SC every 8 weeks thereafter. Endoscopic response (50% decrease in Simple Endoscopic Score for CD [SES-CD] at Week 24), endoscopic remission [SES-CD ≤2], and clinical remission [daily stool frequency ≤2.8 and abdominal pain score ≤1] were assessed at weeks 4,8,16, and 24. Further serial analyses included patient-reported outcomes [PRO2], faecal calprotectin [fCal], and ustekinumab serum levels. Results SES-CD decreased from 11.5 [8.0–18.0] at baseline to 9.0 [6.0–16.0] at week [w]24 [p = 0.0009], but proportions of patients achieving endoscopic response [20.5%] or endoscopic remission [7.1%] were low. Clinical remission rates were 39.5% at w24. After IV induction, fCal dropped from baseline [1242.9 μg/g] to w4 [529.0 μg/g] and w8 [372.2 μg/g], but increased again by w16 [537.4 μg/g] and w24 [749.0 μg/g]. A clear exposure-response relationship was observed, both during induction and during maintenance therapy, with different thresholds depending on the targeted outcome. Conclusions In this cohort of refractory CD patients, ustekinumab showed good clinical remission rates but limited endoscopic remission after 24 weeks. Our data suggest that higher doses may be required to achieve better endoscopic outcomes.

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

2017 ◽  
Vol 10 (5) ◽  
pp. 397-406 ◽  
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.

P089 REAL-WORLD EXPERIENCE: CLINICAL AND ENDOSCOPIC EFFECTIVENESS OF STANDARD VEDOLIZUMAB DOSING AND MODIFIED MAINTENANCE DOSING IN PATIENTS WITH MODERATE-SEVERE CROHN’S DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S75-S75
Author(s):  
Scott D Lee ◽  
Anand Singla ◽  
Caitlin Kerwin ◽  
Kindra Clark-Snustad
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Real World ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Clinical Disease ◽  
Endoscopic Remission ◽  
Starting Dose

Abstract Background Vedolizumab (VDZ) is an effective treatment for Crohn’s disease (CD); however, inadequate and loss of response is common. Pivotal VDZ trials evaluated alternative dosing intervals, demonstrating numeric but not statistical superiority in efficacy as compared to FDA-approved dosing. The safety and effectiveness of FDA-approved and modified-dosing schedules in a real-world population are unknown. We aimed to evaluate clinical and endoscopic effectiveness & safety of standard and modified maintenance VDZ dosing in a real world cohort. Methods We retrospectively reviewed CD patients (pts) treated with &gt;3 months VDZ, assessing Harvey Bradshaw Index (HBI), Simple Endoscopic Score for Crohn’s disease (SESCD), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), C-reactive protein (CRP), albumin and hematocrit prior to and following standard VDZ dosing, and prior to and following modified VDZ maintenance dosing. We measured duration on therapy and adverse events. Results We identified 226 eligible pts, mean age 41.5 years, 55.3% female, median disease duration 10 years, 88.9% with prior biologic exposure. Mean duration on VDZ was 28.3 months. Standard VDZ dosing: 61.5% of pts with active clinical disease and adequate follow up data achieved clinical response after 3–12 months; 41.0% had clinical remission. 51.9% of pts with active endoscopic disease and adequate follow up data achieved mucosal improvement; 42.3% had endoscopic remission; 26.0% had mucosal healing after 3–24 months. 50.0% of pts with elevated CRP and adequate follow up data normalized CRP after 3–12 months. Modified maintenance dosing: 72 non-remitters to standard VDZ dosing received modified VDZ maintenance dosing. 51.5% of pts with active clinical disease prior to starting dose modification and adequate follow up data achieved clinical response after 3–12 months of modified maintenance dosing; 42.4% had clinical remission. 22.2% of pts with SESCD ≥3 prior to starting dose modification achieved mucosal improvement after 3–24 months; 22.2% had mucosal healing. 26.7% of pts with SESCD ≥4 prior to starting modified dosing had endoscopic remission after 3–24 months. 50.0% of pts with elevated CRP and adequate follow up data normalized their CRP after 3–12 months. Safety: 82.7% of pts reported ≥1 adverse events, most commonly infection and worsening CD symptoms. Discussion Standard VDZ dosing resulted in clinical and endoscopic improvement in pts with moderate-severe CD, with prior exposure to multiple advanced therapies. For non-remitters to standard dosing, modified VDZ maintenance dosing improved clinical disease activity in ∼50% of pts and improved endoscopic disease activity in ∼20% of pts, suggesting that for pts who did not achieve remission with standard VDZ dosing, modified VDZ dosing may result in clinical and endoscopic improvement.

scholarly journals The effect of early versus delayed initiation of adalimumab on remission rates in patients with Crohn’s disease with poor prognostic factors: The MODIFY study

2021 ◽  
Author(s):  
Gerassimos J Mantzaris ◽  
Christos Zeglinas ◽  
Angeliki Theodoropoulou ◽  
Ioannis Koutroubakis ◽  
Eleni Orfanoudaki ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Prognostic Factors ◽  
Crohn's Disease ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Remission Rate ◽  
Intestinal Resection ◽  
Steroid Dependent ◽  
Remission Rates ◽  
Necrosis Factor

Abstract Background Data on the effectiveness of anti–tumour necrosis factor medications in patients with Crohn’s disease with poor prognostic factors are scarce. This study aimed to generate real-world evidence on the effect of early (≤24 months after diagnosis) versus delayed (&gt;24 months) initiation of adalimumab on the 26-week remission rate (Harvey-Bradshaw Index ≤4) in these patients. Methods This multicentre, retrospective, chart-review study performed in 10 Greek hospitals enrolled adult patients with moderate to severe Crohn’s disease (Harvey-Bradshaw Index ≥8) with ≥3 poor prognosis factors who were initiated on adalimumab ≥12 months before enrolment. A sample size of 164 patients (early:delayed cohort allocation ratio, 30:70) was required to address the primary endpoint. Results Eligible patients (n=171) were consecutively enrolled. In the early versus delayed cohorts, the 26-week remission rates (off steroids) using the last-observation-carried-forward imputation method were 60.7% (37/61) versus 47.2% (50/106), respectively (Δ=13.5%, p=0.044). The respective remission rates were 61.2% versus 42.4% among anti–tumour necrosis factor–naive patients (p=0.023) and 58.3% versus 53.2% among anti–tumour necrosis factor–experienced patients (p=0.374). The 52-week remission rates using as-observed data were 78.8% and 60.3%, and the intestinal resection rates were 6.5% and 11.9% in the early versus delayed ADL cohorts, respectively. Conclusions Patients with Crohn’s disease with poor prognostic factors who received early versus delayed treatment with adalimumab achieved higher clinical response and remission rates. This effect was more pronounced in those patients who were bio-naive and steroid-dependent/refractory with concurrent extraintestinal manifestations than those who were not.

scholarly journals DOP80 Effectiveness of ustekinumab and vedolizumab in patients with Crohn’s disease refractory to anti-tumour necrosis factor: A multi-centre comparative study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S118-S120 ◽  
Author(s):  
H Alric ◽  
A Amiot ◽  
J Kirchgesner ◽  
X Tréton ◽  
M Allez ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Propensity Scores ◽  
Remission Rate ◽  
University Hospitals ◽  
Clinical Remission Rate ◽  
Paris Area ◽  
History Of

Abstract Background There is no head-to-head trial comparing ustekinumab and vedolizumab in patients with Crohn’s disease (CD) refractory to anti-TNF. In France between May 2014 and November 2016, vedolizumab (and not ustekinumab) was reimbursed for patients who had failed anti-TNF. Then, between December 2016 and August 2018, ustekinumab (and not vedolizumab) was reimbursed for this category of patients. Since September 2018, both ustekinumab and vedolizumab are reimbursed in patients who are refractory to anti-TNF. The aim of this study was to compare effectiveness and safety of ustekinumab and vedolizumab in patients with CD refractory to anti-TNF. Methods We studied all consecutive patients with active CD who were refractory to at least one anti-TNF, and were treated either with vedolizumab or ustekinumab, in five university hospitals of the Paris area, between May 2014 and August 2018. The primary endpoint was clinical remission rate at week 48. Adjustment according to propensity scores with inverse probability of treatment weighting was performed. Results 239 patients were included, 107 received ustekinumab and 132 received vedolizumab. After propensity scoring with IPTW, there was no difference between the two groups (Figure 1). At week 48, the clinical remission rate was higher with ustekinumab than with vedolizumab (54.4% vs. 38.3%; OR =1.92, 95% CI [1.09–3.39]). At week 48, corticosteroid-free remission rate tended to be numerically higher with ustekinumab than with vedolizumab (44.7% vs. 34.0%; OR = 1.57, 95% CI [0.88–2.79]). Treatment persistence was significantly more frequent in the ustekinumab group (71.5% vs. 49.7%; OR = 2.54, 95% CI [1.40–4.62]). The dose optimisation rate at week 48 was higher with vedolizumab than with ustekinumab (53.5% vs. 30.1%; OR = 0.37, 95% Cl [0.21–0.67]). Subgroup analyses showed that ustekinumab was associated with higher clinical remission rates at week 48 in patients with ileal CD (OR = 3.49; 95% CI [1.33–9.17]), a penetrating phenotype (OR = 6.58; 95% CI [1.91–22.68]) and a history of perianal disease (OR = 2.48; 95% CI [1.04–5.93]). Regardless of treatment group, combotherapy was associated with a higher clinical remission rate at week 48 (OR = 1.93; 95% CI [1.09–3.43]). Conclusion This study suggests that, after 1 year of follow-up, ustekinumab is associated with a higher rate of clinical remission than vedolizumab in CD patients refractory to anti-TNF, particularly in those with ileal and penetrating disease.

Highly Bioavailable Curcumin Derivative Ameliorates Crohn’s Disease Symptoms: A Randomized, Double-Blind, Multicenter Study

2020 ◽  
Vol 14 (12) ◽  
pp. 1693-1701 ◽  
Author(s):  
Ken Sugimoto ◽  
Kentaro Ikeya ◽  
Shigeki Bamba ◽  
Akira Andoh ◽  
Hiroshi Yamasaki ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Nuclear Factor Κb ◽  
Blood Levels ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Endoscopic Remission ◽  
Remission Rates ◽  
Anal Lesions ◽  
Curcumin Derivative

Abstract Background & Aims The new curcumin derivative Theracurmin® has a 27–fold higher absorption rate than natural curcumin powder. Theracurmin® is an inhibitor of nuclear factor-κB, which mediates the expression of inflammatory cytokines. The effect of Theracurmin® on inflammatory bowel disease in humans has not been explored; therefore, we investigated the efficacy and safety of Theracurmin® in patients with Crohn’s disease. Methods In this randomized, double-blinded study performed at 5 independent medical centers in Japan, Theracurmin® (360 mg/day, n = 20) or placebo (n = 10) was administered to patients with active mild-to-moderate Crohn’s disease for 12 weeks. The agent’s efficacy was assessed by evaluating clinical and endoscopic remission, healing of anal lesions, and blood levels of inflammatory markers. Results In the Theracurmin® group, a significant reduction in clinical disease activity was observed in week 12 relative to that in week 0 (p = 0.005). On intention-to-treat analysis, clinical remission rates were 35%, 40%, and 40% at weeks 4, 8, and 12, respectively, which were significantly higher than those in the placebo group (all 0%; p = 0.033, p = 0.020, and p = 0.020, respectively). Furthermore, reduction in endoscopic Crohn’s disease severity (p = 0.032) was observed at week 12 in the Theracurmin® group. The endoscopic remission rates were 15% and 0% in the Theracurmin® and placebo groups, respectively. Significant healing of anal lesions (p = 0.017) was observed at week 8 in the Theracurmin® group. No serious adverse events were observed in either group throughout the study. Conclusions Theracurmin® shows significant clinical and endoscopic efficacy together with a favorable safety profile in patients with active mild-to-moderate Crohn’s disease. Clinical trial UMIN registration ID UMIN000015770.

scholarly journals Effectiveness of Third-Class Biologic Treatment in Crohn’s Disease: A Multi-Center Retrospective Cohort Study

2021 ◽  
Vol 10 (13) ◽  
pp. 2914
Author(s):  
Ahmad Albshesh ◽  
Joshua Taylor ◽  
Edoardo V. Savarino ◽  
Marie Truyens ◽  
Alessandro Armuzzi ◽  
...  
Keyword(s):  
Cohort Study ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Remission ◽  
Therapy Group ◽  
Multicenter Cohort Study ◽  
Biologic Treatment ◽  
Tumor Necrosis Factors ◽  
Group A ◽  
Group B

Background: Multiple studies have described the effectiveness of ustekinumab (UST) and vedolizumab (VDZ) in patients with Crohn’s disease (CD) failing anti- Tumor necrosis factors (TNFs); however, the effectiveness of VDZ or UST as a third-class biologic has not yet been described. Aims and Methods: In this retrospective multicenter cohort study, we aimed to investigate the effectiveness of VDZ and UST as a third-class biologic in patients with CD. Results: Two-hundred and four patients were included; 156/204 (76%) patients received VDZ as a second- and UST as a third-class therapy (group A); the remaining 48/204 (24%) patients received UST as a second- and VDZ as a third-class therapy (group B). At week 16–22, 87/156 (55.5%) patients and 27/48 (56.2%) in groups A and B, respectively, responded to treatment (p = 0.9); 41/156 (26.2%) and 15/48 (31.2%) were in clinical remission (p = 0.5). At week 52; 89/103 (86%) patients and 25/29 (86.2%) of the patients with available data had responded to third-class treatment in groups A and B, respectively (p = 0.9); 31/103 (30%) and 47/29 (24.1%) were in clinical remission (p = 0.5). Conclusion: Third-class biological therapy was effective in more than half of the patients with CD. No differences in effectiveness were detected between the use of VDZ and UST as a third-class agent.

scholarly journals P571 Optimal biologic management of endoscopic postoperative recurrence following ileocecal resection in Crohn’s disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S529-S531
Author(s):  
S Bachour ◽  
R Shah ◽  
R Lyu ◽  
F Rieder ◽  
B Cohen ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Biologic Therapy ◽  
Remission Rate ◽  
Management Strategies ◽  
Treatment Strategies ◽  
Postoperative Recurrence ◽  
Ileocecal Resection ◽  
Tertiary Center ◽  
Endoscopic Remission

Abstract Background Endoscopic postoperative recurrence (POR) of Crohn’s Disease (CD) following ileocolonic resection (ICR) is common; however, optimal treatment strategies of identified POR are unknown. We assessed the role of biologic therapy to treat endoscopic POR in a real-world cohort. Methods Retrospective cohort study of adult CD patients who underwent ICR from 2009–2020 at a tertiary center. Patients with endoscopic POR detected on postoperative colonoscopy and a subsequent follow-up colonoscopy were included. Patients were categorized by biologic therapy at time of POR and further sub-grouped by therapy modification after POR detection (no change, therapy optimization, or change in biologic class). Therapy optimization included: starting or modifying immunomodulator therapy, corticosteroids, or budesonide. POR was defined by Rutgeerts’ ≥ i2b. Results 203 CD patients (49.8% female, 15.4% &gt; 1 prior ICR, 49.0% pre-operative biologic exposure) were included. Of these, 137 (67%) patients were not on biologic therapy at POR detection: 43% subsequently started a biologic, 23% optimized therapy, and 34% had no change. 66 (33%) patients were on anti-TNF at POR identification: 24% subsequently changed biologic class, 48% optimized anti-TNF, and 27% had no change (Figure 1). There was no difference in median time from ICR to POR detection (483 days, p=0.08) or inter-colonoscopy interval (483 days, p=0.25) between groups. In patients not on biologics at POR detection, those who started a biologic saw a 21% increase in subsequent endoscopic remission compared to those who optimized therapy (49.2% vs 28.1%, p=0.09) and a 12% increase compared to those who received no change (49.2% vs 37%). In patients not on biologics with severe POR (i3/i4, n=62), there was significantly higher remission rate by starting biologic therapy compared to optimizing existing therapy (53.3% vs 16.7%) or no change (53.3% vs 35.7%), p=0.04. In individuals receiving anti-TNF at time of POR, there was a 25% increase in endoscopic remission in patients who switched biologic class compared to those who optimized therapy (56.2% vs 31.2%) and a 34% increase compared to those with no change (56.2% vs 22.2%), p=0.1. Furthermore, significantly higher rates of improved Rutgeerts’ score were observed in switching biologic class compared to therapy optimization (68.8% vs 43.8%) or no change (68.8% vs 27.8%), p=0.04. Conclusion After endoscopic POR detection following ICR, initiating biologic therapy in individuals not previously receiving it, and changing mechanism of action in those already receiving anti-TNF, may improve clinical outcomes compared to alternative management strategies. If confirmed, these findings may inform optimal management strategies for endoscopic POR.

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