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  • Fumery, M  (18)
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  • 1
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 13, No. Supplement_1 ( 2019-01-25), p. S476-S477
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 2
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2023
    In:  Journal of Crohn's and Colitis Vol. 17, No. Supplement_1 ( 2023-01-30), p. i166-i167
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 17, No. Supplement_1 ( 2023-01-30), p. i166-i167
    Abstract: While the effect of anti-TNFs on postoperative outcomes in patients with Crohn’s disease (CD) has been widely studied, the impact of vedolizumab and ustekinumab on the risk of postoperative complications remains poorly known. Methods All consecutive patients who underwent intestinal resection for CD between July 2014 and April 2022 within 22 French centers were included in a retrospective cohort. The risk of early post-operative complications (≤30days) in patients exposed to biologics was compared to patients not exposed by logistic regression and propensity score-matched analysis adjusted for age, previous intestinal resection, corticosteroids or immunosuppressants exposure, disease activity, presence of abscess, urgent surgery and initial stoma (preoperative contra-indication to anastomosis). Results Among the 1201 patients included, respectively 491 (41%), 76 (6.3%) and 57 (4.7%) were exposed to anti-TNFs, ustekinumab, or vedolizumab within six months before surgery. A total of 317 (26.4%) patients had at least one complication of which 123 (38%) were considered as severe (DINDO III/IV). New surgery was necessary in 69 (5.7%) patients and secondary stoma in 23 (1.9%). Three deaths were observed (0.25%). The rates of overall complications in patients not exposed to biologics, exposed to anti-TNFs, ustekinumab or vedolizumab were respectively 26.1%, 25.1%, 34.7% and 29.8%. The risks of intra-abdominal infectious complications in these four groups were respectively 13.5%, 11.1%, 13.3% and 8.8%. In multivariate analysis, age [OR, 1.02 (1.01-1.04); p=0.004], disease activity [OR, 8.36 (1.79 – 149); p=0.037] , the presence of an abscess [OR, 2.01 (1.25-3.20); p=0.004] and initial stoma [OR, 1.70 (1.10 –2.61); p=0.016] were significantly associated with intra-abdominal infectious complications. Conversely, preoperative enteral nutrition [OR, 0.12 (0.01 -0.59); p=0.040] was associated with a reduction in this risk. Exposure to anti-TNFs [OR, 0.80 (0.51-1.24); p=0.31] , ustekinumab [OR, 1.17 (0.39-3.51); p=0.78] and vedolizumab [OR, 1.28 (0.32-5.17); p=0.72] within the 3 months before surgery were not associated with the risk of intra-abdominal infectious complications. Similar results were observed in patients exposed to these treatments in the month before surgery. Conclusion In this large cohort, a quarter of patients operated on for CD presented an early postoperative complication and 10% a severe complication. Preoperative exposure to anti-TNFs, vedolizumab or ustekinumab was not associated with an increased risk of early postoperative complications. Preoperative enteral nutrition was associated with a reduced risk of intra-abdominal infectious complication.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 3
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 14, No. Supplement_1 ( 2020-01-15), p. S337-S338
    Abstract: The multiplication of therapeutic options with close efficacy and safety, leads to consider acceptability of treatment regimen as a key point for therapeutic decision in inflammatory bowel disease (IBD). We aimed to compare acceptability of IBD treatment regimen and to identify its associated factors. Methods From a nationwide prospective study conducted in 24 public or private centres, IBD patients were consecutively included for 6 weeks. A dedicated questionnaire was developed, tested and validated for the study. It was administered to each included patient and his/her related physician. Acceptability was graded with an acceptability numerical scale (ANS) from 0 (absolutely not acceptable) to 10 (totally acceptable). Results Overall, 1850 patients were included (65.9% with Crohn’s disease (CD), mean age = 41.0 ± 14.7, 22.2% experiencing IBD flare at inclusion). The medications at inclusion were none in 9.0%, oral (PO) monotherapy in 17.3%, subcutaneous (SC) injections in 29.2% and intra-venous (IV) infusions in 44.5% of the patients. The ANS were 8.68 ± 2.52 for PO, 7.67 ± 2.94 for SC and 6.79 ± 3.31 for IV (p & lt; 0.001 for each comparison). The patients reported PO, SC and IV as their first choice in 65.8%, 21.4% and 12.8%, respectively. The reasons for reduced acceptability were the need to come to the hospital (63.0%) for IV infusion, none for SC injections and the fear to forget to take pills (30.5%), the number of daily dose (28.4%) and daily medication as a reminder of disease every day (24.8%) for PO therapy. In multivariable analyses, the following factors were associated with a better acceptability of IV infusion (current IBD flare: p = 0.003 and current IV therapy for IBD: p & lt; 0.001), SC injections (Private practice: p = 0.006 and current SC injections for IBD: p & lt; 0.001) and PO medication (male gender: p = 0.018, higher studies level: p & lt; 0,001 and current oral medication: p = 0.002). The mean ANS for all IBD treatment regimen were compared in the 1850 patients (Figure 1). No difference was observed between CD and UC. In biologics-naïve patients (n = 315), the treatment regimens were ranked in the following order: PO once daily (8.8 ± 2.2), SC/12 weeks (week) (7.9 ± 3.0), SC/8 week and PO twice daily (7.2 ± 3.2 et 6.9 ± 3.4; ns), SC/4 week (6.2 ± 3.4), SC/2 week et IV/8 week (5.1 ± 3.4 and 5.0 ± 3.5; ns)(p & lt; 0.001 except if ns was mentioned). For the patients, the acceptable loss of efficacy to receive a more convenient medication was 5.2% (non-inferiority trial limit). Conclusion While PO administration was preferred by most of IBD patients, the acceptability of treatment regimen is highly impacted by the interval between two doses and the previous medications. Our data could be helpful to guide therapeutic decision in daily practice in IBD.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 4
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 17, No. Supplement_1 ( 2023-01-30), p. i572-i572
    Abstract: Breast cancer is the most common malignancy observed in patients with inflammatory bowel diseases (IBD) unrelated to the disease or its treatment (Poullenot F et al. JCC 2022). The main aim of our study was to assess the risk of incident cancer according to the IBD treatment given in patients with prior breast cancer. Methods Consecutive IBD patients with prior breast cancer diagnosis were included in a multicenter retrospective cohort from 25 tertiary centres. Inclusion date corresponded to the diagnosis of index cancer. Follow up was calculated from the first administration of immunomodulator after cancer diagnosis (or cancer diagnosis date in absence of treatment) to the occurrence of incident cancer, corresponding to recurrence of breast cancer or de novo cancer, or to the last follow-up visit. Patients were categorized according to the use or not of immunomodulator after cancer diagnosis: thiopurines, methotrexate, anti-TNF, vedolizumab, ustekinumab. Crude incidence rates were compared between patients receiving at least one immunomodulator and those without immunomodulator before and after matching on age, lymph node, and metastasis extension and tumor’s grade, using a propensity-score analysis with a 1:1 ratio. Results Among the 151 identified patients, 80 patients with full available data were analyzed: 76 (95%) women; mean age at index cancer diagnosis: 51.5 years [standard deviation (SD): 11.5 years]; 44 (55%) with Crohn’s disease, 35 (44 %) ulcerative colitis and 1 (1 %) indeterminate colitis; median IBD duration at inclusion was 13 years [interquartile range (IQR) 6-21] . After a median follow up of 84 months [IQR 49-154], 16 (20%) incident cancers were observed: 12 (15%) recurrences and 4 (5%) cancer de novo. Three (4%) patients died from cancer related cause during the follow up. 39 (49%) patients received no immunomodulator and, 11 (14%) were treated with thiopurines, 6 (7.5%) with methotrexate, 18 (22.5%) with anti-TNF, 5 (6%) with vedolizumab and one (1%) with ustekinumab. Those treatments were initiated with a median interval of 24 months [IQR 7-48] after cancer diagnosis. Crude incidence rate per 1000 person-years were 47.97 for patients not exposed to any immunomodulator and 12.61 for the others (p=0.0248). After matching, adjusted crude incidence rates per 1000 person-years were 50 and 27.27, respectively (p=0.3798). Rates of survival without incident cancer were not different between the two groups after matching on age, lymph node, metastasis extension, and tumor’s grade (p=0.17) (Figure 1). Conclusion In the present multicenter retrospective cohort, incident cancer risk among patient with IBD and prior breast cancer was not increased in patients subsequently exposed to immunomodulators.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 5
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2020
    In:  Journal of Crohn's and Colitis Vol. 14, No. Supplement_1 ( 2020-01-15), p. S272-S272
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 14, No. Supplement_1 ( 2020-01-15), p. S272-S272
    Abstract: The IBD-disk is a 10-item visual tool assessing inflammatory bowel diseases (IBD)-related disability. It could be a valuable tool in daily practice but it has not been validated. In a cohort of patients with IBD, we aimed to determine the correlation between the IBD-disk and each of its components with the IBD daily-life burden. Methods A 1-week cross-sectional study has been conducted in 42 centres affiliated to the GETAID in France and Belgium in November 2018. Patients were asked to fulfil the IBD-disk questionnaire and an IBD daily-life burden visual analogic scale (VAS: 0 = no burden; 10 = maximal burden). The validation included for internal consistency, correlation analysis and diagnostic performance assessment. In addition, we evaluated the completion rate as well as patient satisfaction for IBD-disk. Multivariate analysis was performed to determine predictors of moderate-to-severe IBD-related disability. Results Among the 2011 IBD outpatients who responded to the survey (67.8% of patients with Crohn’s disease), 49.9% were in clinical remission. The full completion rate of the IBD-disk was 73.8%. It was considered easy to fulfil by 88.4% of patients. The mean IBD-disk score was 39.0 ± 23.2 (best score 0, worst 100). The IBD-disk score was well correlated with IBD daily-life burden VAS (r = 0.62; p & lt; 0.001). With the optimal IBD-disk cut-off of 40, AUROC for high IBD daily-life burden was 0.81 (CI95%: 0.79–0.83; p & lt; 0.001). Using multiple logistic regression, a shortened IBD-disk score using only 5 items (abdominal pain + regulating defecation x2 + work and education x3 + emotions + energy) of the IBD-disk had similar correlation and diagnosis performance than the complete IBD-disk score (AUROC=0.82 [0.79–0.83]; p & lt; 0.001) for assessing IBD daily-life burden. In multivariate analysis, moderate-to-severe disability (overall IBD-disk score & gt; 40) was significantly increased in patients with frequent sick leave & gt; 0.3 per year, with general practitioner appointment & gt; 2 per year, with concerns about the lack of efficacy of their current treatment, perceived need of psychotherapist or IBD-nurse whereas it was decreased in patients with clinical remission assessed by patient global assessment and employed or student occupational status. Conclusion The IBD-disk had a good completion rate and demonstrated a close correlation with daily-life IBD burden and good internal consistency, in a large multicentre cohort of IBD patients. Our results suggest that the IBD-disk could be a valuable tool in routine practice to assess daily-life IBD burden. Although a simplified 5-item IBD-disk demonstrated better performance to assess IBDdaily-life burden, the overall score, the IBD-disk allows exploring all dimensions of IBD daily-life burden.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 6
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2020
    In:  Journal of Crohn's and Colitis Vol. 14, No. Supplement_1 ( 2020-01-15), p. S587-S588
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 14, No. Supplement_1 ( 2020-01-15), p. S587-S588
    Abstract: Endoscopic balloon dilation (EBD) is widely used to manage Crohn’s disease (CD) ileal stricture. However, data of EBD on inflammatory bowel diseases (IBD) colorectal strictures are scarce. Methods We performed a retrospective study in 9 tertiary centres, including all consecutive IBD patients who underwent EBD for native or anastomotic colorectal stricture between 1999 and 2018. Outcomes were rate of technical success defined by a passable stricture at the end of the EBD, clinical success defined by a passable and asymptomatic stricture and colonic resection at the end of follow-up. Factors associated with EBD success were also investigated by logistic regression. Results Fifty-seven patients (25 women, median age: 36 years, InterQuartile Range, 31–48) were included. All patients had CD and 42 (74%) had symptomatic stricture. Regarding the 60 strictures, 52 (87%) were native and the most frequent location was left colon (27%). 39 (65%) measured less than 5 cm, 57 (95%) were non-passable by the scope and 35 (58%) ulcerated. Among the 161 EBD performed (median number of dilatations per strictures: 1, IQR 1–3), technical success was observed in 123 (76%) EBD. One perforation occurred (0.6% per EDB and 2% per patient). After a median follow-up of 4.3 years [IQR 2.0–8.4], 24 patients (42%) underwent colonic resection, 9 (16%) had symptomatic strictures non-passable by the scope, 11 (19%) had asymptomatic non-passable strictures and 13 (23%) had asymptomatic strictures passable by the scope. One colon lymphoma and one colorectal cancer were diagnosed (3.5% of patients), respectively on endoscopic biopsies and at the time of surgery. None factor was associated with technical, clinical success, or surgery including therapeutic modification. Conclusion EBD of CD-associated colorectal strictures is feasible, efficient and safe as more than 50% of patients avoid surgery.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 7
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 15, No. Supplement_1 ( 2021-05-27), p. S486-S487
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 8
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 17, No. Supplement_1 ( 2023-01-30), p. i770-i770
    Abstract: Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn’s disease (CD), but no real-world data are currently available. We aimed to assess the short-term effectiveness and safety of risankizumab in patients with CD. Methods From May 2021 to May 2022, all patients with refractory luminal CD treated with risankizumab in 22 French GETAID centers were retrospectively included. The primary endpoint was steroid-free clinical remission at week 12 (Harvey-Bradshaw (HB) score & lt; 5). Secondary endpoints included clinical response (≥ 3-point decrease of HB score and/or (HB) score & lt; 5), biological remission (CRP ≤ 5 mg/L), need for CD-related surgery, and adverse events. Results Among the 100 patients included, all have been previously exposed to anti-TNF agents, 94 to vedolizumab, 98 to ustekinumab (all exposed to at least three biologics) and 61 had previous intestinal resection. All but three (97%) received a 600 mg risankizumab intravenous induction at weeks 0-4-8. At week 12, steroid-free clinical remission was observed in 45.8% of patients, clinical remission in 58% and clinical response in 78.5%. Absence/mild abdominal pain with normal stool frequency was noted in 50% of patients at week 12. Biological remission was observed in 50% of patients. Six patients discontinued risankizumab before the week 12 visit due to lack of efficacy. CD-related hospitalization was needed in six patients, and three underwent intestinal resection. In multivariable analysis, only a history of ustekinumab loss of response (vs primary failure) (Odds Ratio (OR), 2.80 ; 95%CI, 1.07 – 7.82; p=0.041) was significantly associated with clinical remission at week 12. Twenty adverse events (AE) occurred in 20 patients including 7 serious AE corresponding to 6 CD exacerbation and one severe hypertension. Conclusion In a cohort of highly refractory patients with luminal CD and multiple prior drug failures including ustekinumab, risankizumab induction provided clinical response in about 3 out of 4 patients and steroid-free clinical remission in about half of patients.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 9
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 12, No. supplement_1 ( 2018-01-16), p. S278-S278
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
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  • 10
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 16, No. 10 ( 2022-11-01), p. 1523-1530
    Abstract: Knowledge about the cancer risk when initiating a biologic in inflammatory bowel disease [IBD] patients with prior malignancy remains scarce, especially for vedolizumab. Our aim was to evaluate the rate of incident cancer in a cohort of IBD patients with prior non-digestive malignancy, according to the subsequent treatment given. Methods A multicentre retrospective study included consecutive IBD patients with prior non-digestive malignancy. Inclusion date corresponded to the diagnosis of index malignancy. Patients were categorized into different cohorts according to the first treatment [none, conventional immunosuppressant, anti-TNF, or vedolizumab] to which they were exposed after inclusion and before incident cancer [recurrent or new cancer] . Results Among the 538 patients {58% female; mean (standard deviation [SD]) age inclusion: 52 [15] years} analyzed, the most frequent malignancy was breast cancer [25%]. The first immunomodulator given after inclusion was a conventional immunosuppressant in 27% of patients, anti-TNF in 21%, or vedolizumab in 9%. With a median (interquartile range [IQR] ) follow-up duration of 55 [23-100] months, 100 incident cancers were observed. Crude cancer incidence rates per 1000 person-years were 47.0 for patients receiving no immunomodulator, 36.6 in the anti-TNF cohort, and 33.6 in the vedolizumab cohort [p = 0.23] . Incident-cancer free survival rates were not different between patients receiving anti-TNF and those receiving vedolizumab [p = 0.56]. After adjustment, incidence rates were not different between patients receiving no immunomodulator, anti-TNF, or vedolizumab. Conclusions In this large multicentre cohort study, there was no difference of cancer incidence in those IBD patients with prior non-digestive malignancy, treated with vedolizumab or anti-TNF.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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