scholarly journals P664 Adherence to mesalazine and identification of patients with ulcerative colitis in healthcare administrative databases of Tuscany (Italy)

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S588-S589
Author(s):  
L Bertani ◽  
C Bartolini ◽  
S Ferraro ◽  
I Convertino ◽  
S Giometto ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Medication Possession Ratio ◽  
Study Data ◽  
Sensitivity Analyses ◽  
Administrative Databases ◽  
Statistical Measures ◽  
Step Procedure ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Abstract Background Drug supply can be used to identify patients with a specific disease in healthcare administrative databases (HAD), particularly when they have a univocal indication. For drugs with multiple indications, other elements must be considered, such as dosing or scheduled regimen. This is the case of mesalazine (MZ), a drug indicated for ulcerative colitis (UC), but also for Crohn’s disease and other not classifiable inflammatory bowel diseases. The aim of the present study was to explore adherence trajectories to MZ, in the attempt of identifying variables useful to detect patients with UC in HAD Methods In this retrospective cohort study, data was retrieved from administrative healthcare databases in Tuscany. Patients who had at least a first MZ dispensation between 6/1/2011 and 6/30/2016 (index date, ID) were included. We performed four sub-group analyses: 1) Patients with at least 1 MZ dispensation in the follow-up (FUP); 2) Patients with at least 2 MZ dispensations in the first 3 months of FUP; 3) Patients with MZ dosage >1.5 grams between the 1st and the 2nd dispensation; 4) Patients with MZ dosage >2.5 grams between the 1st and the 2nd dispensation. Each sub-group was stratified by age: ≤65 and >65, separately. We estimated adherence to MZ monthly, through the Medication Possession Ratio and computed adherence trajectories with a 3 step-procedure: 1) computation of 24 statistical measures; 2) factor analysis; 3) cluster analysis. We performed two sensitivity analyses: 1) Patients >65 years old with UC ICD-9 code, 2) Patients ≤65 years old with the UC exemption code. Results The sub-groups 1, 2, 3 and 4 included 47.750, 34.037, 29.730 and 26.165 MZ users, respectively. In all the sub-groups and stratification by age, 3 clusters of adherence were identified: high, medium low and low. The high adherence trajectory showed a mean adherence over 40% in the FUP, while patients in the low and medium low trajectories discontinued MZ within 5 and 15 months, respectively. The first and second sensitivity analysis included 409 and 1514 patients, respectively. Two clusters were identified in both analyses: high, around 80%, and moderate, up to 30% at the end of FUP. No MZ discontinuation was observed in the sensitivity analyses on ascertained UC patients. Conclusion In the main analyses, two out of three trajectories were characterized by MZ discontinuation, while in the trajectories calculated for the patients with UC codes, no MZ use interruption was detected. This finding could help the identification of true UC patients in the overall population of MZ users.

scholarly journals Articular manifestations in patients with inflammatory bowel disease treated with vedolizumab

Rheumatology ◽  
2020 ◽  
Vol 59 (11) ◽  
pp. 3275-3283 ◽  
Author(s):  
Anastasia Dupré ◽  
Michael Collins ◽  
Gaétane Nocturne ◽  
Franck Carbonnel ◽  
Xavier Mariette ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Inflammatory Bowel Diseases ◽  
Bowel Disease ◽  
Bowel Diseases ◽  
History Of ◽  
Musculoskeletal Manifestations ◽  
Inflammatory Bowel

Abstract Objective Vedolizumab (VDZ) has been incriminated in the occurrence of articular manifestations in patients with inflammatory bowel diseases (IBDs). The aim of this study was to describe musculoskeletal manifestations occurring in IBD patients treated by VDZ and to identify risk factors. Methods In this retrospective monocentric study, we included all consecutive patients treated by VDZ for IBD in our hospital. Incident musculoskeletal manifestations occurring during VDZ treatment were analysed and characteristics of patients with and without articular inflammatory manifestations were compared. Results Between 2013 and 2017, 112 patients were treated with VDZ for IBD: ulcerative colitis (n = 59), Crohn’s disease (n = 49) and undetermined colitis (n = 4). Four patients (3.6%) had a history of SpA, whereas 13 (11.6%) had a history of peripheral arthralgia. Some 102 (91.1%) patients had previously received anti-TNF. After a mean (S.d.) follow-up of 11.4 (8.6) months, 32 (28.6%) patients presented 35 musculoskeletal manifestations, of which 18 were mechanical and 17 inflammatory. Among the latter, 11 had axial or peripheral SpA, 5 had early reversible arthralgia and 1 had chondrocalcinosis (n = 1). Among the 11 SpA patients, only 3 (2.6%) had inactive IBD and may be considered as paradoxical SpA. The only factor associated with occurrence of inflammatory manifestations was history of inflammatory articular manifestation [7/16 (43.8%) vs 10/80 (12.5%), P = 0.007]. Conclusion Musculoskeletal manifestations occurred in almost 30% of IBD patients treated with VDZ, but only half of them were inflammatory. Since most of the patients previously received anti-TNF, occurrence of inflammatory articular manifestations might rather be linked to anti-TNF discontinuation than to VDZ itself.

scholarly journals P453 Comparison of therapeutic effects between groups of thiopurine alone and combination of thiopurine with 5-ASA after remission introduced by oral tacrolimus for patients with severe ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S405-S406
Author(s):  
T Sato ◽  
K Kojima ◽  
R Koshiba ◽  
K Fujimoto ◽  
M Kawai ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Rank Test ◽  
Therapeutic Effects ◽  
Aminosalicylic Acid ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Time To Relapse

Abstract Background Although thiopurine is recommended to be used for maintenance after remission, the reliable data of maintenance introduced by tacrolimus is limited for patients with ulcerative colitis (UC). 5-aminosalicylic acid (5-ASA) is reported to induce 6-thioguanine nucleotides (6-TGN) levels higher in patients with inflammatory bowel diseases. However, the data of 5-ASA are few reported among East Asians. Methods A retrospective cohort study was conducted evaluating the 70 patients with severe UC who were primary responders to oral tacrolimus from April 2015 to March 2018. Twenty-seven patients were administered maintenance treatment with thiopurine. We evaluated the efficacy of thiopurines with and without 5-ASA in these patients, using ΔMCV, lowest WBC, highest 6TGN between groups of thiopurine alone and thiopurine+ 5-ASA. Kaplan–Meier analysis was used to assess time to relapse between groups of thiopurine and thiopurine+5-ASA. Results The median follow-up period was 430 days (interquartile range 207–952 days). The statistical significances were not found in patients background between groups of thiopurine and thiopurine+5-ASA. ΔMCV were significantly greater (p < 0.01), lowest WBC were significantly lower (p = 0.02) in the thiopurines+5-ASA group than in thiopurines alone group. The highest 6-TGN levels tended to be higher in thiopurine+5-ASA group than in thiopurine alone group (p = 0.09). The rate of relapse was significantly higher in the thiopurine alone group than in thiopurines+5-ASA group (p = 0.03). Kaplan–Meier curves confirmed that thiopurine+5-ASA group appeared to protect against relapse (log-rank test, p < 0.01). Conclusion Thiopurine+5-ASA induced significantly lower relapse than thiopurine alone after remission introduced by tacrolimus in the patients with severe UC, along with significantly greater the ΔMCV and lower the lowest WBC.

Effectiveness and Safety of Golimumab in Treating Outpatient Ulcerative Colitis: A Real-Life Prospective, Multicentre, Observational Study in Primary Inflammatory Bowel Diseases Centers

2017 ◽  
Vol 26 (3) ◽  
pp. 239-244 ◽  
Author(s):  
Antonio Tursi ◽  
Leonardo Allegretta ◽  
Nello Buccianti ◽  
Nicola Della Valle ◽  
Walter Elisei ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Diseases ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Background & Aims: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres.Methods: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score ≤2, at 6-month follow-up.Results: Ninety-three patients were enrolled. At 6-month follow-up, remission was obtained in 34 (36.5%) patients. Shorter duration of disease was the only significant predictive factor of remission. Clinical response was achieved in 60 (64.5%) patients, while mucosal healing (MH) was obtained in 18 (19.3%) patients. Sixteen (47.0%) patients under remission were still under therapy with steroids. C-reactive protein and fecal calprotectin significantly dropped during the follow-up (p<0.001 for both proteins). Adverse events occurred in 4 (4.3%) patients and 3 of them stopped treatment. Colectomy was performed in only one patient (1.1%).Conclusions: Golimumab seems to be safe and effective in inducing and maintaining remission in real life UC outpatients.Abbreviations: ADA: Adalimumab; CRP: C-reactive Protein; GOL: Golimumab; FC: Fecal calprotectin; IBD: Inflammatory Bowel Diseases; IFX: Infliximab; IQR: Interquartile range; MH: Mucosal Healing; SC: Subcutaneously; TBC: Tuberculosis; TNFα: Tumor necrosis factor α; UC: Ulcerative Colitis.    

scholarly journals Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease

2021 ◽  
Author(s):  
Shaden Mahmmod ◽  
Johannes P D Schultheiss ◽  
Ad A van Bodegraven ◽  
Gerard Dijkstra ◽  
Lennard P L Gilissen ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Gastrointestinal Symptoms ◽  
Study Data ◽  
Multicenter Cohort Study ◽  
Loss Of Response ◽  
Multicenter Cohort ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Predominantly Female

Abstract Background Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients, however, are “reverse switched” to treatment with the originator. Here we assess the prevalence of reverse switching, including its indication and outcomes. Methods In this retrospective multicenter cohort study, data on patients with IBD from 9 hospitals in the Netherlands were collected. All adult patients with IBD were included if they previously had been switched from originator infliximab to the biosimilar CT-P13 and had a follow-up time of at least 52 weeks after the initial switch. The reasons for reverse switching were categorized into worsening gastrointestinal symptoms, adverse effects, or loss of response to CT-P13. Drug persistence was analyzed through survival analyses. Results A total of 758 patients with IBD were identified. Reverse switching was observed in 75 patients (9.9%). Patients with reverse switching were predominantly female (70.7%). Gastrointestinal symptoms (25.5%) and dermatological symptoms (21.8%) were the most commonly reported reasons for reverse switching. In 9 patients (12.0%), loss of response to CT-P13 was the reason for reverse switching. Improvement of reported symptoms was seen in 73.3% of patients after reverse switching and 7 out of 9 patients (77.8%) with loss of response regained response. Infliximab persistence was equal between patients who were reverse-switched and those who were maintained on CT-P13. Conclusions Reverse switching occurred in 9.9% of patients, predominantly for biosimilar-attributed adverse effects. Switching back to originator infliximab seems effective in patients who experience adverse effects, worsening gastrointestinal symptoms, or loss of response after switching from originator infliximab to CT-P13.

scholarly journals P386 Two year follow up of children with Inflammatory Bowel Disease (IBD) treated with vedolizumab and ustekinumab

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S397-S398
Author(s):  
R Mardare ◽  
N Burgess ◽  
D Studart ◽  
P Deb ◽  
M Gasparetto ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Electronic System ◽  
Study Data ◽  
Efficacy And Safety ◽  
Single Centre ◽  
Database Analysis ◽  
Novel Treatments ◽  
Inflammatory Bowel

Abstract Background In 2018, our Trust approved the use of vedolizumab in children with Ulcerative Colitis (UC) and ustekinumab in children with Crohn’s Disease (CD). At the time, access to these drugs for children was only possible through research studies. Our aim was to assess the efficacy and safety of these novel treatments in our cohort. Methods We conducted an observational single centre cohort study. Data was obtained from our electronic system, Cerner Millennium, and Infoflex database. Analysis was performed using SPSS. Results 27 children were treated with vedolizumab or ustekinumab with 1 receiving both. All patients had failed anti-TNF medication, except 1 research patient who commenced on vedolizumab at diagnosis. Conclusion In children with refractory IBD failing anti-TNF treatment, vedolizumab and ustekinumab are effective and safe alternatives for inducing and maintaining remission, avoiding major invasive surgery.

scholarly journals Clinical and epidemiological characteristics and outcomes of inflammatory bowel diseases according to 8-year follow-up in a cohort of patients in the North-West region

2019 ◽  
pp. 24-33
Author(s):  
I. V. Gubonina ◽  
V. B. Grinevich ◽  
E. I. Tkachenko ◽  
N. B. Volga ◽  
O. S. Sharap ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Inflammatory Bowel Diseases ◽  
North West ◽  
The North ◽  
West Region ◽  
Bowel Diseases ◽  
Inflammatory Bowel

The 8-year observation data of patients with ulcerative colitis and Crohn’s disease in the North West region are presented in the article. The patients were observed in the scientific and clinical center of Military Medical academy named after S. M. Kirov, specialized in the inflammatory bowel diseases (IBD). The aim of study is to assess the gender, age and clinical characteristics of patients with inflammatory bowel diseases, epidemiological features: factors of employment and place of residence, to study the outcomes of ulcerative colitis (UC) and Crohn’s disease (CD). Materials and methods. Retrospective analysis of 485 patient’s medical charts (373 patients with ulcerative colitis and 112 patients with Crohn’s disease) in the period from 2010 to 2018 was performed. Results. The onset of inflammatory bowel diseases is most common in the age group up to 40 years. The duration of the period before the diagnosis of ulcerative colitis and Crohn’s disease averaged 2.3 years. In UC the most frequent localization of the pathological process was left-side colon (51%), in CD - terminal ileitis (29%) and ileocolitis (27%). The anemia was the most frequent complication in both form of IBD, but structuring and penetrating complications were characteristic of CD. The most of patients (80.6%) had recurrent or continuous course of IBD. Small proportion of patients (19.4%) had sustained remission throughout the follow-up period. The frequency of surgical interventions in CD (27.6%) was comparable with the registers of the European study groups of IBD. In contrast, the frequency of colectomy in UC was significantly lower (0.8%) than in the published data of European countries, due to the predominance of mild and moderate forms of UC in the observed cohort. Mortality of patients with IBD was higher than in the General population of St. Petersburg due to the contribution of mortality from complicated forms of IBD (15.7%), while the structure of other causes of death was comparable to the General population

scholarly journals Efficacy of fidaxomicin therapy, after failure of vancomycin therapy, for treating a C. difficile colitis in a patient with ulcerative colitis

2015 ◽  
Vol 9 (1S) ◽  
pp. 7-10
Author(s):  
Carlo Tascini ◽  
Federico Corti ◽  
Gualtiero Bottari ◽  
Paola Lambelet
Keyword(s):  
Ulcerative Colitis ◽  
Vancomycin Therapy ◽  
Increased Risk ◽  
Days Of Therapy ◽  
Bowel Diseases ◽  
Fluconazole Therapy ◽  
Inflammatory Bowel ◽  
Inflammatory Diarrhea ◽  
Anti Fungal

Patients with inflammatory bowel diseases (IBDs) have greater risk of developing C. difficile infection (CDI). In these patients, CDI have worse outcome, may be associated with increased risk of bacteremia and candidemia and may be misdiagnosed as relapse of IBD, also because ofthe absence of typical findings of CDI at colonoscopy.A 58-year-old man with acute ulcerative colitis treated with steroids was hospitalized for feverand recrudescence of inflammatory diarrhea. During the hospitalization, the fever was treated with broad spectrum antibiotics and systemic anti-fungal therapy. Candida mannan antigenand the molecular screening for C. difficile resulted positive. A first course of vancomycin by mouthwas unsuccessful, therefore we started a 10-day course of fidaxomicin. After five days of therapy, diarrhea disappeared. A few-week course of fluconazole therapy was performed to complete the treatment of invasive candidiasis. At six-month follow-up no relapse of CDI was documented.

Features of the complex treatment of ulcerative colitis in clinical practice

2020 ◽  
pp. 6-11
Author(s):  
Svetlana Svetlana ◽  
Mikhail Klimentov ◽  
Olga Neganova ◽  
Alina Nazmieva ◽  
Anastasiya Kochurova
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Practice ◽  
Statistical Study ◽  
Age Groups ◽  
Length Of Hospital Stay ◽  
Unknown Etiology ◽  
Number Of Patients ◽  
First Republic ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Nowadays there are certain difficulties in the early diagnosis of ulcerative colitis, proceeding with minimal intestinal symptoms. The etiology of the disease remains unclear to this day; there is no exact information about the prevalence of the disease due to the large number of latent forms and the low number of patients seeking medical help. This article presents the results of a retrospective analysis of the incidence of ulcerative colitis in the coloproctology department of the First Republic Clinical Hospital of Izhevsk. The study was conducted to assess the frequency of occurrence and determine the internal picture of ulcerative colitis. To achieve this goal, we selected 34 patients with ulcerative colitis. A statistical study was conducted on the following criteria: gender composition, age groups, forms of the disease, localization, complications, and main complaints. The length of hospital stay often was not more than 20 days. The literature on this pathology was also studied and presented in the form of a theoretical basis, which consisted of the determination and etiology of inflammatory bowel diseases. Due to the unknown etiology, insufficiently studied pathogenesis, difficult differential diagnosis with other intestinal diseases and insufficiently perfect treatment methods, there are a large number of unresolved problems in the field of ulcerative colitis. That is why, in this article we tried to reveal the problem of the features of the course and complex therapy of that disease in clinical practice.

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