scholarly journals P335 Real-life effectiveness and safety of tofacitinib treatment in patients with ulcerative colitis: A KASID multicenter cohort study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S359-S361
Author(s):  
K Oh ◽  
S N Hong ◽  
E S Kim ◽  
S Y Na ◽  
S B Kang ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Deep Vein Thrombosis ◽  
Herpes Zoster ◽  
Adverse Events ◽  
Clinical Remission ◽  
Real Life ◽  
The Real ◽  
Vein Thrombosis ◽  
Endoscopic Remission ◽  
Deep Vein

Abstract Background Tofacitinib is a small molecule which inhibits janus kinase and has been shown to be effective for patients with active ulcerative colitis (UC). We investigated the real-life therapeutic effectiveness and safety of tofacitinib treatment for Korean patient with UC. Methods We retrospectively analyzed the data of patients with UC who received tofacitinib treatment at 10 hospitals in Korea. The primary outcome was clinical remission at week 16 which was defined as a partial Mayo score ≤2 with a combined rectal bleeding subscore and stool frequency subscore ≤1. The secondary outcome was endoscopic remission (Mayo endoscopic subscore ≤1) at week 16. Adverse events including herpes zoster and deep vein thrombosis were also evaluated. Results Between January 2018 and November 2020, a total of 123 patients with UC received tofacitinib treatment (Table 1). Clinical effectiveness was evaluated for those who had completed or stopped the tofacitinib therapy by week 16, week 24 and week 52, respectively (Figure 1). Clinical remission and response rates at week 16 were 65.3% and 73.7%, respectively (Figure 2A). Ninety-one out of 123 patients (74.0%) were followed up to week 52. Their clinical remission and response rates at week 52 were 49.5% and 58.2%, respectively (Figure 2A). Among 117 patients with baseline Mayo endoscopic subscore ≥2, endoscopic remission rate at week 16 was 55.6% (Figure 2C). Any adverse events occurred in 15 patients (12.2%) and serious adverse events occurred in 9 patients (7.3%). Herpes zoster occurred in 4 patients (3.3%) and one patient (0.8%) suffered from deep vein thrombosis (Table 2). Conclusion Tofacitinib was effective with an acceptable safety profile for Korean patients with UC in the real world.

scholarly journals Intravascular leiomyoma misdiagnosed as deep vein thrombosis: A case report

2021 ◽  
Vol 5 (2) ◽  
pp. 042-045
Author(s):  
Zhang Yiheng ◽  
Wen Feng ◽  
Liu Zhen ◽  
Lu Zaiming
Keyword(s):  
Deep Vein Thrombosis ◽  
Case Report ◽  
Rare Disease ◽  
Antithrombotic Treatment ◽  
Case Presentation ◽  
The Real ◽  
Vein Thrombosis ◽  
Initial Imaging ◽  
Contrast Ct ◽  
Deep Vein

Background: Leiomyoma itself is not a rare disease, but it is rarely found intravascularly. Case presentation: A 54-year old female sought medical help after noticing her leg being swelling. A diagnosis of deep vein thrombosis (DVT) was made and antithrombotic treatment was given after her initial imaging exam. Several days later, a contrast CT and sequential pathology revealed the real diagnosis was intravascular leiomyoma. The patient was discharged after a successful surgery. Conclusion: Intravascular leiomyoma should not be confused with DVT.

scholarly journals TWO CASES OF ULCERATIVE COLITIS WITH DEEP VEIN THROMBOSIS

2007 ◽  
Vol 68 (2) ◽  
pp. 379-383
Author(s):  
Yoshifumi SHIMADA ◽  
Tsuneo IIAI ◽  
Satoshi MARUYAMA ◽  
Tatsuo TANI ◽  
Katsuyoshi HATAKEYAMA
Keyword(s):  
Ulcerative Colitis ◽  
Deep Vein Thrombosis ◽  
Vein Thrombosis ◽  
Deep Vein

scholarly journals Deep Vein Thrombosis of the Left Lower Limb in a 12 Year-Old Female Child with Ulcerative Colitis – Case Report

2016 ◽  
Vol 81 ◽  
pp. 65-68
Author(s):  
Elżbieta Krzesiek ◽  
Urszula Zaleska- Dorobisz ◽  
Barbara Iwańczak ◽  
Andrzej T. Dorobisz
Keyword(s):  
Ulcerative Colitis ◽  
Deep Vein Thrombosis ◽  
Case Report ◽  
Lower Limb ◽  
Female Child ◽  
Vein Thrombosis ◽  
Left Lower Limb ◽  
Deep Vein

scholarly journals P719 Effectiveness and safety of ustekinumab induction therapy in ulcerative colitis: A GETAID real-world cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S579-S579
Author(s):  
A Amiot ◽  
A Vered ◽  
J Filippi ◽  
G Cadiot ◽  
D Laharie ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cohort Study ◽  
Adverse Events ◽  
Rectal Bleeding ◽  
Mayo Clinic ◽  
Clinical Remission ◽  
Real Life ◽  
Therapeutic Failure ◽  
Stool Frequency ◽  
History Of

Abstract Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but no real-life data is currently available. Methods Between January and September 2019, all consecutive patients with UC treated with ustekinumab in 20 French GETAID centres were included. The primary outcome was steroid-free clinical remission (partial Mayo Clinic score ≤ 2) at weeks 12–16 without rectal bleeding subscore > 1. Results One hundred and three patients were included with a median age and disease duration of 39.3 [interquartile range (IQR), 29.1–52.3] and 7.6 [3.6–12.9] years, respectively. Most of the patients had left sided colitis (41.8%) or pancolitis (52.4%). History of immunomodulator, anti-TNF and vedolizumab therapies was noted in 84.5%, 99.0% and 85.4% of the cases, respectively. Steroid-free clinical remission and clinical remission rates were 35.0% and 39.8% at weeks 12–16, respectively. Normalisation of rectal bleeding and stool frequency (subscore 0 for both outcomes) was noted in 19.4% of patients whereas normalisation of rectal bleeding (subscore 0) with a stool frequency subscore of 0 or 1 was noted in 39.8%. Two patients discontinued ustekinumab before the weeks 12–16 visit and were referred to surgery. Predictors of therapeutic failure at weeks 12–16 were a partial Mayo Clinic score > 6 at week 0 (HR = 10.0, 95%CI [1.11––100.0], p = 0.04) and an history of previous use of anti-TNF and vedolizumab (HR = 33.3, 95%CI [2.4–100.0], p = 0.01). Improvement in endoscopic activity of UC at weeks 12–16 was observed according to Ulcerative Colitis Endoscopic Index of Severity (5.0 ± 1.2 vs. 3.8 ± 1.9, p < 0.001). Adverse events occurred in 7.8% and serious adverse events in 3.9%. Conclusion In this first real-life cohort study of refractory UC patients treated with ustekinumab, clinical remission without corticosteroids was observed in one-third of cases at weeks 12–16. Clinical severity and previous use of anti-TNF and vedolizumab were associated with therapeutic failure.

scholarly journals Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 2031
Author(s):  
Giuseppe Gallelli ◽  
Giulio Di Mizio ◽  
Caterina Palleria ◽  
Antonio Siniscalchi ◽  
Paolo Rubino ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Vascular Surgery ◽  
Venous Insufficiency ◽  
Life Support ◽  
Real Life ◽  
Vascular Diseases ◽  
Vein Thrombosis ◽  
Protease Enzyme ◽  
Superficial Vein Thrombosis ◽  
Deep Vein

Nattokinase (NK) is a serine protease enzyme with fibrinolytic activity. Even if it could be used for the treatment of several diseases, no data have been published supporting its use patients who underwent vascular surgery. In this study, we evaluated both the efficacy and the safety of nattokinase (100 mg/day per os) in patients admitted to vascular surgery. Patients were of both sexes, >18 years of age, with vascular diseases (i.e., deep vein thrombosis, superficial vein thrombosis, venous insufficiency), and naïve to specific pharmacological treatments (anticoagulants or anti-platelets). Patients were divided into three groups. Group 1: patients with deep vein thrombosis, treated with fondaparinux plus nattokinase. Group 2: patients with phlebitis, treated with enoxaparin plus nattokinase. Group 3: patients with venous insufficiency after classical surgery, treated with nattokinase one day later. During the study, we enrolled 153 patients (age 22–92 years), 92 females (60.1%) and 61 males (39.9%;), and documented that nattokinase was able to improve the clinical symptoms (p < 0.01) without the development of adverse drug reactions or drug interactions. Among the enrolled patients, during follow-up, we did not record new cases of vascular diseases. Attention to patients’ clinical evolution, monitoring of the INR, and timely and frequent adjustment of dosages represent the cornerstones of the safety of care for patients administered fibrinolytic drugs as a single treatment or in pharmacological combination. Therefore, we can conclude that the use of nattokinase represents an efficient and safe treatment able to both prevent and treat patients with vascular diseases.

scholarly journals Fecal Microbiota Transplantation as Therapy for Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Xiaolei Liu ◽  
Yan Li ◽  
Kaichun Wu ◽  
Yongquan Shi ◽  
Min Chen
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Remission ◽  
Fecal Microbiota Transplantation ◽  
Meta Analysis ◽  
Fecal Microbiota ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Endoscopic Remission

Aim. Increasing evidence supports the role of the gut microbiota in the etiology of ulcerative colitis (UC). Fecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridium difficile infection; however, its efficacy in UC is still controversial. A systematic review and meta-analysis was conducted to evaluate the efficacy and safety of FMT for treatment of active UC. Methods. We searched Cochrane, Medline, Web of Science, and Embase from inception to February 2020. Randomized controlled trials (RCTs) recruiting adults with active UC, which compared FMT with controls, were eligible. The primary outcome was combined clinical remission with endoscopic remission/response. Secondary outcomes included clinical remission, endoscopic remission, and serious adverse events. Relative risk (RR) with 95% confidence interval (CI) is reported. Results. Five RCTs with 292 participants were eligible for inclusion. When data were pooled for all patients, FMT was associated with a higher combined clinical remission with endoscopic remission/response; the RR of combined outcome not achieving after FMT vs. control was 0.79 (95% CI 0.70-0.88). FMT delivered via lower gastrointestinal route was superior to upper gastrointestinal route with regard to combined clinical remission with endoscopic remission/response ( RR = 0.79 , 95% CI 0.70-0.89). FMT with pooled donor stool ( RR = 0.69 , 95% CI 0.56-0.85) and higher frequency of administration ( RR = 0.76 , 95% CI 0.62-0.93) may be more effective with regard to clinical remission. There was no statistically significant difference in serious adverse events with FMT compared with controls ( RR = 0.98 , 95% CI 0.93-1.03). Conclusion. FMT shows a promising perspective with comparable safety and favorable clinical efficacy for the treatment of active UC in the short term. However, further larger, more rigorously conducted RCTs of FMT in UC are still needed in order to resolve the controversial questions.

scholarly journals Herpes zoster complicated by deep vein thrombosis : a case report

2009 ◽  
Vol 52 (5) ◽  
pp. 607
Author(s):  
Woo-Yeon Choi ◽  
Young-Kuk Cho ◽  
Jae-Sook Ma
Keyword(s):  
Deep Vein Thrombosis ◽  
Case Report ◽  
Herpes Zoster ◽  
Vein Thrombosis ◽  
Deep Vein

scholarly journals P504 Effectiveness and safety of ustekinumab maintenance therapy in 103 patients with real-world ulcerative colitis: A GETAID multicentre cohort study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S486-S487
Author(s):  
M Fumery ◽  
J Filippi ◽  
V Abitbol ◽  
A Biron ◽  
D Laharie ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Cohort Study ◽  
Adverse Events ◽  
Real World ◽  
Clinical Remission ◽  
Real Life ◽  
Phase Iii ◽  
Phase Iii Trials ◽  
One Year

Abstract Background Phase III trials have demonstrated the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis (UC), but no real-life long-term data is currently available. Methods From January to September 2019, all consecutive patients with active UC treated with ustekinumab in a GETAID centre were included. Patients were evaluated at week 52. Remission was defined by a partial Mayo Clinic score ≤ 2. The aim of the present study was to assess long-term effectiveness and safety of ustekinumab in UC. Results 103 UC patients (62 men; mean age: 41.2 ± 16.2 years; 52% pancolitis E3) were included in 21 centres. History of immunomodulator, anti-TNF and vedolizumab therapies was noted in 84.5%, 99.0% and 85.4% of the cases, respectively. At week 54, 44 (43%) patients discontinued ustekinumab, for lack of efficacy (n=41), pregnancy (n=1), persistence of eczematiform lesions (n=1) or personal decision (n=1). Cumulative probabilities of ustekinumab persistence were 96.1%, 81.6%, 71.7%, and 58.4% after 3, 6, 9, and 12 months, respectively. In multivariate analysis, a CRP&gt;5 mg/L at week 0 (OR=2.91, CI95%[1.15–7.36]; p=0.02) and concomitant steroids at week 0 (OR=3.05, CI95%[1.30–7.14]; p=0.01) were significantly associated with ustekinumab discontinuation within one year. The overall rate of steroid-free clinical remission at week 52 was 32% of whom 71% had null rectal bleeding and stool frequency subscores. Ten patients (9.7%) underwent colectomy within a median of 6.7 [4.3–10.6] months. Adverse events were observed in 15 (16.9%) patients, of whom 4 (4.5%) had severe adverse events including three patients with exacerbation of UC leading to hospitalization, and a 62 years-old men who died from a myocardial infarction four months after ustekinumab initiation. Conclusion In this real-world cohort study that included patients with refractory ulcerative colitis to multiple therapies, more than one-half of patients were still treated by ustekinumab and one-third were in steroid-free clinical remission, after 52 weeks.

scholarly journals Indications, Efficacy and Complications of Kcentra Use in Reversing Coagulopathy

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3820-3820 ◽  
Author(s):  
Nithya Sritharan ◽  
Darrell Triulzi
Keyword(s):  
Deep Vein Thrombosis ◽  
Ischemic Stroke ◽  
Adverse Events ◽  
Conflicts Of Interest ◽  
Oral Anticoagulants ◽  
Coagulation Factor ◽  
Invasive Procedure ◽  
Vein Thrombosis ◽  
Urgent Surgery ◽  
Deep Vein

Abstract Introduction Direct acting oral anticoagulants are rapidly replacing warfarin, the most commonly used anticoagulant for patients with atrial fibrillation, pulmonary embolism (PE) and deep vein thrombosis (DVT). However, there is limited data on the efficacy and adverse effects of the commercial Kcentra used in these patients. Kcentra, the only approved PCC in the USA, is FDA approved for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure. In this study we examine the indications for administration of Kcentra, efficacy of the PCC in several coagulopathies, incidence of adverse events including ischemic stroke and DVT/ PE, and overall mortality. Methods Retrospective analysis of inpatients at UPMC Presbyterian, Shadyside and Mercy, admitted between February 2016 and 2017 was done. A total of 213 patients, with history of stroke / DVT / PE who received Kcentra were grouped based on the cause of coagulopathy, sites of bleed (CNS or non-CNS) or the clinical setting of Kcentra administration. Definitions of the International Society on Thrombosis and Hemostasis (ISTH) / Scientific and Standardization Committee were used to assess the efficacy of management. Among the patients on Warfarin, only non-CNS and prophylactic administration group were included here as those with CNS bleeding were part of an earlier study. Adverse events measured were incidence of ischemic stroke and DVT/ PE during their hospital stay. Results The 213 patients who received Kcentra included those on warfarin (40%), apixaban (21%), Rivaroxaban (23%), with the remaining 16% including patients with hepatic cirrhosis, disseminated intravascular coagulation and those with coagulopathy related to heparin/ fondaparinux or antiplatelets (ASA, clopidogrel). The study group included those with CNS bleeds (33%), non-CNS bleeds (37%) and those in the prophylactic, pre-operative setting (30%). The majority of the non-CNS bleeds were patients with gastrointestinal bleeding (45%), with the rest including the musculoskeletal (31%) and intra-abdominal / intra-thoracic (16%) bleeding. Mortality was highest in patients with cirrhosis (n = 15), DIC (n = 8), and on anti-platelet medications (n = 2) at 100%, followed by 60% in patients on heparin / fondaparinux (n = 5). The mortality was markedly lower (~13%) in patients on Coumadin, Apixaban and Rivaroxaban. 2 of the patients, previously on rivaroxaban, developed multiple CNS infarcts. Thromboembolic events were significantly higher (40%) in patients with cirrhosis, with moderate effect in the Rivaroxaban group (14.5%) when compared to coumadin (2.3%) and apixaban (0%). Conclusions Kcentra was used in several off-label clinical settings, with comparable mortality among the coumadin, rivaroxaban and apixaban groups and no identifiable benefit in the setting of cirrhosis, DIC or antiplatelet medications, but with an increased incidence of deep vein thrombosis and stroke. Disclosures No relevant conflicts of interest to declare.

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