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  • 1
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 12, No. supplement_1 ( 2018-01-16), p. S023-S025
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
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  • 2
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 12, No. supplement_1 ( 2018-01-16), p. S301-S302
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
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  • 3
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 16, No. Supplement_1 ( 2022-01-21), p. i322-i323
    Abstract: Ulcerative proctitis may have a mild and less aggressive course, although evidence is scarce because these patients are excluded from participation in randomized controlled clinical trials. The aim is to identify clinical characteristics and complications associated with ulcerative proctitis refractory to conventional therapy. Methods Patients included in the prospectively maintained ENEIDA registry from GETECCU with ulcerative proctitis were included. Socio-demographic data were evaluated. We defined ulcerative proctitis based on ECCO guidelines and immunosuppression as the use of immunomodulators and/or biologics. Logistic regression was used to identify the independent factors associated with immunosuppressive therapy among the different socio-demographic data. Results From a total of 34.716 patients with ulcerative colitis, 6281 (18%) patients with ulcerative proctitis were identified. Mean age was 53 ±15 years and mean duration of illness was 12 ± 9 years. Surgery was necessary only in 2% of patients, 31 (0.5%) panprotocolectomy or subtotal colectomy. The clinical characteristics of the patients with and without immunosupressive therapy are summarized at table 1. A total of 3691 patients received oral 5-ASA (58.8%) and 4652 (74.1%) topic 5ASA. 636 (10.1%) were refractory to 5-ASA and corticosteroids, necessitating immunosuppression: 459 patients with azathioprine (7%), 28 with 6-mercaptopurine (0.4%), 49 with methothrexate (0.8%), 191 with infliximab (9%), 125 with adalimumab (2%), 50 with golimumab (0.8%), 57 with vedolizumab (0.9%), 6 with ustekinumab (0.1%) and 3 with tofacitinib (0.0). 316 (5%) patients needed one biologic therapy, 95 (1.5%) needed 2 biologics and 40 (0.6%) at least three different biologics. Longer duration of illness and use of corticosteroids were associated with higher risk of immunosuppression. Conclusion Good clinical outcomes were recorded in ulcerative proctitis, with only 10% of patients treated with immunosuppression therapy. The risk factors of immunosuppression were longer duration of illness and use of corticosteroids.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2389631-0
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  • 4
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 16, No. Supplement_1 ( 2022-01-21), p. i474-i475
    Abstract: Aims: 1) to compare persistence on adalimumab treatment over time in inflammatory bowel disease (IBD) patients who maintained adalimumab reference [non-switch cohort (NC)] vs. those who switched from adalimumab reference to adalimumab biosimilar [switch cohort (SC)] ; 2) to compare loss of effectiveness of adalimumab treatment in the NC vs. SC; 3) to identify factors associated with discontinuation of adalimumab therapy; 4) to identify the factors associated with relapse in both cohorts; and 5) to evaluate the safety of both strategies. Methods Retrospective, observational, multicentre study. Patients under adalimumab reference who were in clinical remission at standard dose of adalimumab reference, and in whom adalimumab was the first anti-TNF administered, were included. Clinical remission was defined as a Harvey-Bradshaw index ≤4 points in Crohn’s disease, a partial Mayo score ≤2 in ulcerative colitis, and the absence of fistula drainage despite gentle finger compression in perianal disease. The follow-up time was at least 6 months since start of study observation period. The Kaplan-Meier method with log-rank test was used to evaluate the cumulative incidence of treatment discontinuation. Cox regression model was used to investigate factors potentially associated with therapy discontinuation. Results A total of 505 patients were included (45% women, 87% Crohn’s disease): 229 in the SC and 276 in the NC. The median follow-up was 12 months in the SC and 23 months in the NC (p & lt;0.01). The incidence rate of adalimumab discontinuation was 10% [95% confidence interval (95%CI)=6–14%], and 7% (95%CI=5–10%) per patient-year in the SC and in the NC, respectively (p=0.035). The probability of maintaining adalimumab was 92% at 12 months and 77% at 24 months in the SC, and 97% at 12 months and 86% at 24 months in the NC. In the multivariable analysis, the switch to adalimumab biosimilar, adjusted for the level of C-reactive protein at baseline, was not associated with therapy discontinuation. 18% of the patients relapsed in the SC vs. 21% in the NC. The incidence of relapse was 17% (95%CI=13–23%) in the SC, and 12% (95%CI=10–16%) per patient-year in the NC (p=0.04). The cumulative incidence of relapse was 11% at 12 months and 38% at 24 months in the SC, and 11% at 12 months and 22% at 24 months in the NC. In the multivariable analysis, the switch to adalimumab biosimilar (adjusted by type of IBD) was associated with a higher risk of relapse (HR=1.5, 95%CI=1.008–2.36). 4% of the patients had adverse events in the SC vs. 8% in the NC (p & gt;0.05). Conclusion The incidence rate of relapse was slightly higher in the SC; however, this fact had no impact on persistence on the drug. Switching from adalimumab reference to adalimumab biosimilar was safe.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2389631-0
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  • 5
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 17, No. Supplement_1 ( 2023-01-30), p. i80-i81
    Abstract: The coexistence of immune-mediated diseases and non-pharmacological immunosuppression states are rare and might determine the natural history of the disease and therapeutic decisions of the physician. IBD guidelines recommend screening for human immunodeficiency virus (HIV) before starting immunosuppressive treatment, but data on the impact of HIV infection on IBD and its management in the era of biological drugs are scarce. Therefore, our aim was to describe IBD phenotype, immunosuppressive requirements, and prevalence of opportunistic infections (OI) in patients with IBD and coexistent HIV infection. Methods Case-control, retrospective, multicenter study including all IBD patients with available HIV serology on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD –GETECCU). IBD patients with positive HIV serology were selected (HIV+) and compared to HIV seronegative IBD patients (controls), matched 1:3 by year of IBD diagnosis, age, gender and type of IBD). Demographic, clinical IBD characteristics, therapeutic requirements, OI and IBD complications were registered. Results Eighty-eight HIV+ IBD patients and 264 controls were included. In the whole cohort, 81% were men, 56.8% had ulcerative colitis (UC), 36.4% Crohns’ disease (CD) and 6.8% IBD unclassified. Median age at IBD diagnosis was 38 years (IQR 30-47), median age at HIV infection diagnosis was 36 years (IQR 30-42), 46.3% being were firstly diagnosed of IBD. Among UC patients, HIV+ had a lower proportion of extensive disease (24.5% vs 44.8%; P=0.002), and a higher proportion of proctitis (38.8% vs. 16.6%; P=0.002) than controls, without differences on disease proximal progression (7.7% vs 7.9%). Among CD patients, HIV+ presented a higher proportion of colonic involvement than controls (40.6% vs 12,6%, P=0.002) and lower penetrating behavior (10.7% vs 25%; ns). HIV+ had a lower proportion of extraintestinal manifestations (10.7% vs 25.4%; P=0.005). Although it was not statistically significant, a trend towards a lower proportion of hospitalizations (25.6% vs 35.3%) and IBD complications (6.3% vs. 9.2%) in HIV+ was observed. Regarding IBD therapeutic requirements, immunosuppressant (40.5% vs 58.7%; P=0.003) and biological drugs (28.3% vs 42.8%; P=0.020) were used less frequently among HIV+ than among controls. Conversely, HIV+ had a higher rate of OI (38.3% vs 17.8%; P & lt;0.001) and malignancies (12.5% vs 8.3%, ns) than controls. Conclusion The coexistence of IBD and HIV infection seems to be associated with a less aggressive IBD phenotype and a lower use of immunosuppressants and biologicals but with a remarkable rate of OI.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 6
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 16, No. Supplement_1 ( 2022-01-21), p. i121-i123
    Abstract: Main aim: To evaluate the retention rate of ustekinumab compared to vedolizumab in Crohn’s disease patients who failed anti-TNF therapy in clinical practice. Secondary aims: To compare the short-term and long-term effectiveness, and the safety of both treatments. Methods Crohn’s disease patients who had received either vedolizumab or ustekinumab after failure or intolerance to anti-TNF agents from ENEIDA registry were included. ENEIDA is a prospectively maintained database promoted by GETECCU. A total of 755 patients from 30 centres were included at time of data extraction. Clinical activity was classified based on Harvey-Bradshaw index both at short (during induction) and in the long-term. Kaplan-Meier curves, Cox regression models, inverse probability weighting and propensity matching score analyses were performed to compare both drugs and to identify predictive factors of treatment effectiveness and durability. Results 755 patients were included (195 in the vedolizumab cohort and 560 in the ustekinumab cohort). After a median of 20 months (IQR 7.4–30) of follow-up, the survival rate for ustekinumab therapy was higher than vedolizumab (Figure 1). The propensity matching score verified the differences between both therapies. The short-term proportion of patients on clinical remission, steroid-free remission and clinical response was also superior in the ustekinumab cohort (Figure 2). In the long-term, significant differences were observed 2 years after the beginning of the treatments, although no differences in clinical response and remission rates were detected in patients who achieved clinical response at week 16 between both cohorts. Vedolizumab was discontinued in 142 patients and ustekinumab in 185, mainly due to primary non-response (52% in the vedolizumab and 58% in the ustekinumab cohort) and loss of response (34% and 25%, respectively) despite the fact that 35% of the patients required intensification. The predictive factors associated to the discontinuation of the therapy are described in table 1. Adverse events were observed, overall, in 12% of the patients, without differences between both groups (Table 2). Following the discontinuation of the treatment with vedolizumab/ustekinumab, other biologic agents were prescribed in 56% of the patients, and 27% underwent surgery. Conclusion In clinical practice, a relatively high proportion of Crohn’s disease patients who received ustekinumab or vedolizumab for anti-TNF failure, maintained these drugs in the medium-long term, although ustekinumab retention rate was higher in comparison with vedolizumab.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 7
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 17, No. Supplement_1 ( 2023-01-30), p. i519-i520
    Abstract: An increased risk of lymphoma has been described in patients with Inflammatory Bowel Disease (IBD). The aims of our study were to determine the clinical presentation of lymphoma, previous exposure to immunosuppressive and biologic therapies, and the management and evolution of lymphomas in patients with IBD. Methods IBD patients with diagnosis of lymphoma from October 2006 to June 2021 were identified from the prospectively maintained ENEIDA registry of the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (GETECCU). Investigators at each participating centre provided additional information on lymphomas. Results We identified 52 patients with lymphoma in 18 centres following 21,740 patients with IBD (2.4 cases of lymphoma/1,000 patients with IBD; 95% CI 1.8-3.1). 35 were men (67%) and 27 (52%) had Ulcerative Colitis. Non-Hodgkin lymphoma was the most common lymphoma (65%). The median age at diagnosis of lymphoma was 59 years old (IQR 48-67). 31 patients (60%) received thiopurines, and 20 (38%) an anti-TNF drug (one of them had not received thiopurines) before lymphoma diagnosis. Age at diagnosis of lymphoma was lower in those patients treated with thiopurines (53 ± 17 years old) and anti-TNF drugs (47 ± 17 years old) than in those patients not treated with thiopurines nor anti-TNF drugs before the diagnosis of lymphoma (63 ± 12 years old; p & lt;0.05 for both). The most common signs were adenopathy or mass (38%). Most of patients were treated with chemotherapy (77%). Median follow-up after lymphoma diagnosis was of 57 months (IQR 39-102 months). After diagnosis of lymphoma, IBD treatment was changed in 30 patients (58%), and 3 (5.8%) patients received thiopurines and 8 (15%) biologics during follow-up. Those patients who required to be treated with immunosuppressants or biologic therapies after lymphoma diagnosis had an IBD flare more frequently than those patients without these treatments (75% vs. 20%; p=0.01). 5 cases had relapse of lymphoma (incidence of 1.7 cases/100 patient-years; 95% CI 0.7-4.0), with a median of 38 months (IQR 23-84 months) from the diagnosis. 9 patients (17%) died after 19 months (IQR 0-48 months). Relapse and mortality were not related with the type of IBD or lymphoma, sex, smoking habit nor with the use and duration of thiopurines or biologic therapies. Conclusion Most IBD patients with lymphoma had been treated with thiopurines and/or anti-TNF agents before lymphoma diagnosis, and these patients were younger at diagnosis of lymphoma than those not treated with these drugs. IBD treatment was usually changed after a diagnosis of lymphoma. Relapse and mortality of lymphoma were not related to the use and duration of thiopurines or biologic therapies.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2389631-0
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  • 8
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 13, No. Supplement_1 ( 2019-01-25), p. S321-S322
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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