scholarly journals P.08.4 EFFICACY AND SAFETY OF BIOLOGIC THERAPY IN PEDIATRIC CROHN'S DISEASE PATIENTS FOLLOWED AT A SINGLE TERTIARY CENTER

2013 ◽  
Vol 45 ◽  
pp. S144
Author(s):  
F. Nuti ◽  
F. Viola ◽  
F. Civitelli ◽  
C. Alessandri ◽  
M. Aloi ◽  
...  
2021 ◽  
Vol 14 ◽  
pp. 175628482110531
Author(s):  
Asaf Levartovsky ◽  
Yiftach Barash ◽  
Shomron Ben-Horin ◽  
Bella Ungar ◽  
Shelly Soffer ◽  
...  

Background: Intra-abdominal abscess (IA) is an important clinical complication of Crohn’s disease (CD). A high index of clinical suspicion is needed as imaging is not routinely used during hospital admission. This study aimed to identify clinical predictors of an IA among hospitalized patients with CD using machine learning. Methods: We created an electronic data repository of all patients with CD who visited the emergency department of our tertiary medical center between 2012 and 2018. We searched for the presence of an IA on abdominal imaging within 7 days from visit. Machine learning models were trained to predict the presence of an IA. A logistic regression model was compared with a random forest model. Results: Overall, 309 patients with CD were hospitalized and underwent abdominal imaging within 7 days. Forty patients (12.9%) were diagnosed with an IA. On multivariate analysis, high C-reactive protein (CRP) [above 65 mg/l, adjusted odds ratio (aOR): 16 (95% CI: 5.51–46.18)], leukocytosis [above 10.5 K/μl, aOR: 4.47 (95% CI: 1.91–10.45)], thrombocytosis [above 322.5 K/μl, aOR: 4.1 (95% CI: 2–8.73)], and tachycardia [over 97 beats per minute, aOR: 2.7 (95% CI: 1.37–5.3)] were independently associated with an IA. Random forest model showed an area under the curve of 0.817 ± 0.065 with six features (CRP, hemoglobin, WBC, age, current biologic therapy, and BUN). Conclusion: In our large tertiary center cohort, the machine learning model identified the association of six clinical features (CRP, hemoglobin, WBC, age, BUN, and biologic therapy) with the presentation of an IA. These may assist as a decision support tool in triaging CD patients for imaging to exclude this potentially life-threatening complication.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S529-S531
Author(s):  
S Bachour ◽  
R Shah ◽  
R Lyu ◽  
F Rieder ◽  
B Cohen ◽  
...  

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% > 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.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S372-S372
Author(s):  
M Sładek ◽  
M Krucka-Kawalec ◽  
E Wojtas ◽  
P Jagielski ◽  
A Stochel-Gaudyn

Abstract Background It is still unclear how SARS-CoV-2 infection affect Crohn’s disease (CD) patients and how seroconversion against the virus might take place depending upon disease states and treatments. While the clinical guidance recommended to continue the biological maintenance therapy, some suggestions advice postponing the start of biologic agents. Materials and methods Medical records of all patients undergoing biologic therapy with infliximab, adalimumab, or vedolizumab for mild-to moderate CD followed in our institution were enrolled in the analysis. Demographic parameters, disease characteristics, clinical course, concomitant medications, COVID-19 related symptoms were examined. A naso-pharyngeal swab based RT-PCR testing for SARS-CoV-2 was taken and SARS-CoV-2 serology test was performed using SARS-CoV-2 Immunoassay (Abbott Core Laboratory) in children treated between March 4th 2020 and March 3rd 2021. Every time before hospital admission parents or patients completed a questionnaire exploring the presence of symptoms suggestive of SARS-CoV-2 infection. Results Of the 62 children (35 boys, 56%) aged 2-19 years, median 15 ±3,51 years, 47 (76%) were treated with infliximab, 12 (19%) with adalimumab, and 3 (5%) with vedolizumab including 23 (37%) patients on the induction regiment. Of the entire cohort 11 (18%) patients were on a concomitant immunemodulator, including 6 (55%) on thiopurines, and 5 (45%) on methotrexate. A total of 19 (30%) CD patients tested positively for SARS-CoV-2. Only 5 (26%) patients reported symptoms including fever (n=3, 16%), sore throat (n=1, 5%), cough (n=2, 11%), loss of smell (n=2, 11%), loss of taste (n=1, 5%), and 14 (74%) were asymptomatic. All symptomatic patients had mild clinical presentation, and no patients required hospitalization. Swab test was positive in 8 (13%) patients, including 3 (5%) patients with nonreactive antibody titers. Of the 19 patients, 5 (23%) had elevated SARS-CoV-2 IgG titers, while 14 (74%) had elevated SARS-CoV-2 IgM. Four had elevated both IgG and IgM titers, and 2 of them had acute, mild and resolved symptoms. Biologic agent administration was postponed for 6±5,4 days in 6 patients due to positive swab test, but no other management alteration was needed. No exacerbation of CD was observed attributed to SARS-CoV-2 infection during either induction or maintenance therapy in the studied cohort Conclusion Many patients with SARS-CoV-2 infection remained asymptomatic or presented mild symptoms, and did not develop COVID-19. Biologic therapy did not worsen CD course. Serological testing might provide an accurate estimate of the cumulative prevalence of SARS-CoV-2 infection by detecting subclinical and asymptomatic infected individuals.


2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S72-S72
Author(s):  
Ahmed Elmoursi ◽  
Courtney Perry ◽  
Terrence Barrett

Abstract Background Stricturing Crohn’s disease (CD) constitutes a severe phenotype often associated with a high degree of morbidity (3). Surgical resection is first-line therapy for symptomatic strictures, but most patients relapse without subsequent medical therapy (4–5). Biologics are the mainstay for inducing and maintaining remission, but some cases are refractory despite maximum dosage of therapy. Reports of dual biological therapy (DBT) in refractory, stricturing CD are sparse, and prior case reports document only clinical remission (1). To contribute further knowledge regarding the use of DBT in stricturing CD, we present the case of a refractory CD patient who achieved deep remission with ustekinumab and vedolizumab. Case Presentation A 35 year old non-smoking, Caucasian male was referred to our clinic in 2014 for refractory CD complicated by multiple strictures. Prior to establishing care with us, he received two jejunal resections and a sigmoid resection. Previously failed therapies included azathioprine with infliximab, adalimumab, and certolizumab. He continued to progress under our care despite combination methotrexate/certolizumab, as well as methotrexate/golimumab. He underwent proctocolectomy with end ileostomy in 2015 and initiated vedolizumab q8weeks post-operatively. He reoccurred in 2018, when he presented with an ulcerated ileal stricture. He was switched from vedolizumab to ustekinumab q8weeks and placed on prednisone, but continued to progress, developing significant hematochezia requiring hospitalization and blood transfusions. Ileoscopy performed during hospital admission confirmed severe, ulcerating disease in the ileum with stricture. Ustekinumab dosing was increased to q4weeks, azathioprine was initiated, and he underwent stricturoplasty. Follow-up ileoscopy three months later revealed two ulcers in the neo- TI (Figure 1). Vedolizumab q8weeks was initiated in addition to ustekinumab q4weeks and azathioprine 125mg. After four months on this regimen the patient felt better, but follow-up ileoscopy showed two persistent ulcers in the neo-TI. Vedolizumab dosing interval was increased to q4weeks. After four months, subsequent ileoscopy demonstrated normal neo-TI (Figure 2). Histologic evaluation of biopsies confirmed deep remission of crohn’s disease. No adverse side effects have occurred with maximum doses of both ustekinumab and vedolizumab combination therapy. Discussion This case supports both the safety and efficacy of ustekinumab and vedolizumab dual biologic therapy for treatment of severe, refractory Crohn’s disease. While there are reports of DBT inducing clinical remission, this case supports efficacy for vedolizumab and ustekinumab combination therapy to induce deep histologic remission. Large practical clinical trials are needed to better investigate the safety and efficacy of DBT with vedolizumab and ustekinumab, but our case suggests this combination may be a safe and efficacious therapy for refractory CD patients.


2021 ◽  
Vol 160 (6) ◽  
pp. S-414-S-415
Author(s):  
Rogerio S. Parra ◽  
Julio Chebli ◽  
Liliana Chebli ◽  
Erika R. Bertges ◽  
Orlando Ambrogini Junior ◽  
...  

2008 ◽  
Vol 1 (1) ◽  
pp. 43-50 ◽  
Author(s):  
Gary R. Lichtenstein ◽  
Remo Panaccione ◽  
Gordon Mallarkey

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