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  • 1
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    GP88 Serum Level Is Increased in Breast Cancer Patients with Disease Progression.
    American Association for Cancer Research (AACR) ; 2009
    In:  Cancer Research Vol. 69, No. 24_Supplement ( 2009-12-15), p. 6040-6040
    Details
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 69, No. 24_Supplement ( 2009-12-15), p. 6040-6040
    Abstract: GP88 (progranulin) is an 88-kDa glycoprotein autocrine growth factor that plays a critical role in breast tumorigenesis. GP88 is expressed in human BC tumors in a positive correlation with their tumorigenicity. In estrogen receptor positive (ER+) cells, GP88 expression is low and is stimulated by estradiol whereas in ER negative (ER-) cells, it is constitutively overexpressed. In ER+ cells, increased GP88 expression was found to be associated with resistance to anti-estrogen therapy. In Her-2 overexpressing breast tumors, increased GP88 expression was associated with Herceptin resistance. Inhibition of GP88 expression in human breast adenocarcinoma cells resulted in a drastic reduction of tumor incidence and tumor growth in nude mice. Immunohistochemical studies carried out with 206 paraffin-embedded human breast biopsies have shown that GP88 is expressed in invasive ductal carcinomas in correlation with expression of markers of poor prognosis whereas normal tissues and benign breast lesions were negative. Importantly, high GP88 expression in tissue biopsies was accompanied by decreased disease-free and overall survival. Since GP88 contains a signal peptide for secretion, we have shown that GP88 can be found in serum. An IRB approve blood sampling study of 189 patients (Race: Caucasian- 91, African American-92, Asian-6; median age- 51 with a range from 26 to 81) established at the University of Maryland demonstrated that GP88 was measurable in serum and that GP88 serum level was statistically elevated in breast cancer patients when compared to healthy individuals. Median level of GP88 was 40.7 ng/ml (range 6.4-80) in early stage (stage 1 –3) BC pts (p- value = 0.007) and 45.3 ng/ml (range 9.8 to 158.4) in stage 4 metastatic BC patients (p-value= 0.0007). Statistically significant increase in circulating GP88 level was found in early stages as well as in metastatic disease when compared to healthy individuals.Since we have shown that GP88 tissue expression was associated with increased disease recurrence, the present study was focused on examining whether GP88 serum level was also increased in disease progression and could be used to monitor disease recurrence. Our data show that patients with disease recurrence or progression presented a 5 to 10 fold increase in their GP88 serum levels.This study identifies GP88 as a measurable biomarker for recurrence or disease progression not only at the tissue but also at the serum level.This study is supported by grants from MIPS, the Avon Foundation and from the National Cancer Institute. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 6040.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
    URL: Article
    DOI: 10.1158/0008-5472.SABCS-09-6040
    RVK:
    XA 36000
    RVK:
    XA 10000
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2009
    detail.hit.zdb_id: 2036785-5
    detail.hit.zdb_id: 1432-1
    detail.hit.zdb_id: 410466-3
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  • 2
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    DOP89 Impact of biologics on the risk of early postoperative complications in Crohn’s disease: a French nationwide study
    Oxford University Press (OUP) ; 2023
    In:  Journal of Crohn's and Colitis Vol. 17, No. Supplement_1 ( 2023-01-30), p. i166-i167
    Details
    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
    URL: Article
    DOI: 10.1093/ecco-jcc/jjac190.0129
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 3
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    Infliximab is an effective option in patients with ulcerative colitis previously exposed to full subcutaneous anti-TNF agent: Results from a real-world multicenter study
    Elsevier BV ; 2024
    In:  Digestive and Liver Disease ( 2024-1)
    Details
    In: Digestive and Liver Disease, Elsevier BV, ( 2024-1)
    Type of Medium: Online Resource
    ISSN: 1590-8658
    URL: Article
    DOI: 10.1016/j.dld.2024.01.181
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
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  • 4
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    DOP74 Efficacy of ustekinumab in perianal Crohn’s disease: the BioLAP multi-centre observational study
    Oxford University Press (OUP) ; 2019
    In:  Journal of Crohn's and Colitis Vol. 13, No. Supplement_1 ( 2019-01-25), p. S074-S075
    Details
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 13, No. Supplement_1 ( 2019-01-25), p. S074-S075
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    URL: Article
    DOI: 10.1093/ecco-jcc/jjy222.108
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 5
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    P207 COVID-19: a prevalence rate two times lower than that of the general population in French patients with Inflammatory Bowel Disease treated with intravenous biologic agents
    Oxford University Press (OUP) ; 2022
    In:  Journal of Crohn's and Colitis Vol. 16, No. Supplement_1 ( 2022-01-21), p. i265-i266
    Details
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 16, No. Supplement_1 ( 2022-01-21), p. i265-i266
    Abstract: Patients with Inflammatory Bowel Disease (IBD), either Crohn’s Disease (CD) or Ulcerative Colitis (UC), treated with immunosuppressants and/or biotherapy might have an altered immune response to SARS-CoV-2 infection. The aim of this study was to evaluate the incidence of COVID-19 in a French cohort of IBD patients treated with infliximab or vedolizumab during the first epidemic wave and to identify factors associated with the risk of infection. Methods All patients with IBD treated with infliximab or vedolizumab from March to June 2020 in 16 French centres were included and followed for 6 months. At baseline, clinical, demographic, family and socio-professional data were collected. At each of their day hospitalization, patients reported the occurrence of symptoms of COVID-19, and the performance of a diagnostic test, if so. Serum was collected at each visit to detect immunisation by SARS-CoV-2 at the end of follow-up and to measure trough levels. Peripheral blood lymphocytes (PBLs) were frozen at each visit for 50% of patients to further analyse the immunological changes associated with COVID-19. Results 1079 patients were included (CD n=690, mean age 41.6 years, mean disease duration 13.3 years). Clinical and demographic data at baseline are detailed in Tables 1 and 2, respectively. 143 patients (13.3%) had one or more co-morbidities associated with a risk of severe COVID-19 (hypertension 5.6%, chronic lung disease 5%, diabetes 2.4%, obesity 0.3%). Over the 6 months of follow-up, 458 patients (42%) had active disease defined by an HBI score & gt;4 or Mayo score & gt;2 and/or treatment optimisation (dose increase, shortening of infusion interval, addition of an immunosuppressant or change of biotherapy). 111 patients (10.2%) received corticosteroids at least occasionally (self-medication was not excluded). 341 patients (32%) were tested for COVID-19 by nasal swab, of whom 23 were positive. Three patients were hospitalized. Regarding serology, in the first 13 centres analysed hitherto (886 patients), 20 patients were seropositive at the end of follow-up before the start of the vaccination campaign (January 2021), i.e. 2.2%, compared to 4.5% in the general population at the same period according to Santé Publique France data. Conclusion The preliminary analysis of this French cohort confirms that patients with IBD are not at higher risk of severe COVID-19 despite the use of biotherapy and repeated hospital stays. This population was significantly less infected than the general population. Clinical, demographic and immunological factors associated with SARS-CoV-2 infection are being analysed as well as factors associated with a lower incidence of infection compared to the general population.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    URL: Article
    DOI: 10.1093/ecco-jcc/jjab232.334
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 6
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    P140 Immunomodulators are protective against severe COVID 19: results from a large multicentre cohort of inflammatory bowel disease patients
    Oxford University Press (OUP) ; 2022
    In:  Journal of Crohn's and Colitis Vol. 16, No. Supplement_1 ( 2022-01-21), p. i222-i223
    Details
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 16, No. Supplement_1 ( 2022-01-21), p. i222-i223
    Abstract: In the context of the Sars-Cov2 pandemic, the management of patients with chronic diseases and/or receiving immunosuppressive drugs was of concern due to lack of data to dictate their management. The objectives of our study were to evaluate the characteristics and prognosis of COVID-19 among IBD patients and to study the factors associated with severe COVID-19. Methods We carried out a multicentre bispective study in 30 French GETAID centres. Participating centres were asked to report all consecutive COVID19 cases occurring in their IBD-cohort between March,1st and December,31st 2020. The cases had to be confirmed by a PCR test, or by a chest CT scan demonstrating COVID19 lesions. In addition to the baseline examination, patients were scheduled for a follow up visit within 3–6 months following their infection. Demographics, disease characteristics, treatments, and the clinical course of IBD were prospectively recorded. Severe COVID-19 was defined as admission to the hospital & gt;1 day and/or use of oxygen therapy and/or death. Predictive factors for developing severe COVID-19 were explored using univariate and multivariate logistic regression. Results A total of 719 IBD patients with COVID 19 were included; 54.2% were women, median age was 42 years, 64.4% had Crohn’s disease (CD), and median disease duration was 10.8 years. 13.3% of the patients were active smokers;12.7% had a BMI & gt;30. With respect to the treatment, 72(10%) patients were not on any IBD medication, 75(10.4%) were only receiving 5-ASA, 164(22.8%) received conventional immunosuppressants, and 509(70.8%) biologics.21.6% of the patients developed either diarrhoea in remitters, or an exacerbation of diarrhoea in active patients. IBD treatments were maintained unchanged, suspended or discontinued in 73.4%, 25.5%, and 1.1% of the patients. Over the follow-up period, 13.2% of the patients had a flare. A total of 68 patients developed severe COVID 19, 67(9.3%) were hospitalized for a median duration of 6 days, and 4(0.6%) patients died. In multivariate analysis, age & gt; 50 years (OR: 2.0,CI:1.06–3.72; p=0.031), obesity (OR: 2.01,CI:1.05–4.09; p=0.037), and comorbidities (OR: 3.28,CI:1.76–6.09; p=0.0002) were factors associated with the occurrence of severe COVID 19; while immunomodulatory treatment (biologic and/or immunosuppressant) was a protective factor for developing severe COVID 19 (OR: 0.38,CI: 0.22–0.69; p=0.0012). Conclusion Rate of severe COVID 19 in this cohort of IBD patients was corresponding to the general population with similar risk factors for severity, i.e., age, obesity and comorbidities. Prescription of immunomodulators was protective against severe COVID 19, raising the hypothesis of their potential immunological effect on the immune storm phase of Sars-Cov2.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    URL: Article
    DOI: 10.1093/ecco-jcc/jjab232.268
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 7
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    P248 Validation of IBD-disk for the assessment of daily-life burden of patients with inflammatory bowel disease
    Oxford University Press (OUP) ; 2020
    In:  Journal of Crohn's and Colitis Vol. 14, No. Supplement_1 ( 2020-01-15), p. S272-S272
    Details
    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
    URL: Article
    DOI: 10.1093/ecco-jcc/jjz203.377
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 8
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    P142 Inflammatory bowel diseases associated with primary immunodeficiency: a multicenter study
    Oxford University Press (OUP) ; 2022
    In:  Journal of Crohn's and Colitis Vol. 16, No. Supplement_1 ( 2022-01-21), p. i223-i224
    Details
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 16, No. Supplement_1 ( 2022-01-21), p. i223-i224
    Abstract: Inflammatory bowel diseases (IBD) associated with primary immunodeficiency (PID) remain poorly known. We aimed to isolate characteristics of IBD associated with PID. Methods Using a GETAID register, we reviewed medical files of recorded patients with PID and IBD (Crohn’s disease, ulcerative colitis (UC) or microscopic colitis) followed in 9 adult university hospitals. Results of genetic investigations were available for 46 patients (62%). Results 74 patients (30 F, 44M) were included with a mean age of 26 years (median: 24 years) at diagnosis of IBD. Forty-four (59%) patients had Crohn’s disease with anoperineal lesions in 12, 26(35%) patients had microscopic (mainly lymphocytic) colitis and 4 patients had UC. PID was predominantly antibody deficiency in 40(54%) patients [34 common variable immunodeficiency, 4 X-linked agammaglobulinemia, 2 selective IgA deficiencies], disease of immune dysregulation in 18(24%) patients [CTLA4, LRBA, NFKB1, TNFAi3, XIAP deficiencies, STAT3 and STAT1 hyperactivation] , phagocytosis deficiency in 15(20%) patients (12 chronic granulomatous diseases (CGD), 3 congenital neutropenia] and C1s deficiency (n=1). In order of frequency, Crohn’s disease was associated with antibody deficiencies (52%), phagocytosis deficiencies (29%) and immune dysregulation (18%), microscopic colitis with antibody deficiencies (65%), immune dysregulation (27%) and more rarely with phagocytosis deficiencies (8%) and UC with antibody deficiencies (75%) and immune dysregulation (25%). 46% of patients received immunoglobulin supplementation, 70% steroids, equally corticosteroids and budesonide, 49% biotherapy mainly anti-TNF-alpha antibody (38%) and ustekinumab (16%), 23% immunosuppressive drugs, mainly azathioprine and sirolimus and 18% aminosalicylates. Three patients (2 CGD, 1 XIAP) had been treated with allogeneic stem cell transplantation (SCT) and one patient (TNFRS13B deficiency) with autologous SCT. Eleven (15%) patients had intestinal surgery, mainly ileocecal resection. During follow-up [mean: 16 years] , 51% of patients had transient or sustained clinical remission mainly with an anti-TNF-alpha antibody, ustekinumab, steroids (budesonide) and specific therapy (targeted therapy such as abatacept and ASCT), 41% of patients had severe infections, 22% developed neoplasia mainly gastrointestinal dysplasia and/or cancers (n=8), B cell lymphoma (n=3) and 4 patients died. Conclusion At adulthood in our series, IBD associated with PID are mainly Crohn’s disease and lymphocytic colitis. The first most frequent associated PID is antibody deficiency. Biotherapies (anti-TNF-alpha antibody, ustekinumab), steroids and specific therapies are commonly used to induce clinical remission.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    URL: Article
    DOI: 10.1093/ecco-jcc/jjab232.270
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 9
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    P355 Acceptability of treatment regimen in inflammatory bowel disease: Results from a prospective nationwide study (ACCEPT2)
    Oxford University Press (OUP) ; 2020
    In:  Journal of Crohn's and Colitis Vol. 14, No. Supplement_1 ( 2020-01-15), p. S337-S338
    Details
    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
    URL: Article
    DOI: 10.1093/ecco-jcc/jjz203.484
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 10
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    P447 No severe neonatal and maternal complications in inflammatory bowel diseases patients treated with ustekinumab or vedolizumab during pregnancy
    Oxford University Press (OUP) ; 2020
    In:  Journal of Crohn's and Colitis Vol. 14, No. Supplement_1 ( 2020-01-15), p. S402-S403
    Details
    In: Journal of Crohn's and Colitis, Oxford University Press (OUP), Vol. 14, No. Supplement_1 ( 2020-01-15), p. S402-S403
    Abstract: Inflammatory bowel diseases (IBD) have a high incidence in the female population of childbearing age. Ustekinumab (UST) and vedolizumab (VDZ) are used in IBD after failure of immunosuppressants and//or anti-TNF therapy. Data on the use and safety of these novel biologics in pregnancy are rare. Methods We conducted a retrospective cohort study in the GETAID and identified female IBD patients who received at least one injection of UST or VDZ during pregnancy or within the 2 months before conception. The aims of the study were to assess the maternal and neonatal complications in these patients and to assess the management of VDZ or UST during pregnancy. Results Seventy-three pregnancies in 68 patients were reported in 21 centres. The median time between UST or VDZ introduction and pregnancy was 11.8 months (IQR: 5.2–17.6) and 10 months (IQR: 5.7–19.5), respectively. Twenty-nine pregnancies occurred in 27 patients on UST resulting in 26 (90%) live births, two (7%) spontaneous abortions, and one (3%) elective termination. Maternal complications were reported in two patients (gestational diabetes and threat of preterm birth). Five (19%) neonatal complications were reported (3 preterm deliveries, one low birth weight and one cardiac malformation). Six (21%) patients received UST in the 2 months before conception and stopped UST with a relapse in one patient (17%). UST was maintained during pregnancy in 22 (79%) patients: 13 patients discontinued UST in the first trimester with a relapse in 4 (31%) patients and 9 patients maintained UST during all pregnancy with a relapse in 3 (33%) patients. Forty-four pregnancies occurred under VDZ resulting in 38 (86%) live births, 5 (11%) spontaneous abortions and one (3%) medical interruption. Maternal complications were reported in 5 women (4 pre-eclampsia and one pregnancy cholestasis). Fourteen (37%) neonatal complications were reported: 7 (18%) premature births, 6 (16%) low birth weights and one (3%) congenital corpus callosum hypoplasia. Fifteen (34%) patients received VDZ in the 2 months before conception and discontinued VDZ with a relapse in 8 (53%) patients. VDZ was maintained during pregnancy in 29 (66%) patients: 16 patients discontinued VDZ in the 1st trimester with a relapse in 8 (50%) patients and 13 patients maintained VDZ during all the pregnancy with a relapse in one (8%) patient. Conclusion We reported 73 pregnancies under VDZ or UST. Except one cardiac malformation on UST and one congenital corpus callosum hypoplasia on VDZ, no serious neonatal or maternal complications were observed. However, additional prospective evaluations regarding pregnancy outcomes with new biologics are needed.
    Type of Medium: Online Resource
    ISSN: 1873-9946 , 1876-4479
    URL: Article
    DOI: 10.1093/ecco-jcc/jjz203.576
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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