Dataset Information

Impact of Biological Agents on Postsurgical Complications in Inflammatory Bowel Disease: A Multicentre Study of Geteccu.

ABSTRACT: The impact of biologics on the risk of postoperative complications (PC) in inflammatory bowel disease (IBD) is still an ongoing debate. This lack of evidence is more relevant for ustekinumab and vedolizumab. To evaluate the impact of biologics on the risk of PC. A retrospective study was performed in 37 centres. Patients treated with biologics within 12 weeks before surgery were considered "exposed". The impact of the exposure on the risk of 30-day PC and the risk of infections was assessed by logistic regression and propensity score-matched analysis. A total of 1535 surgeries were performed on 1370 patients. Of them, 711 surgeries were conducted in the exposed cohort (584 anti-TNF, 58 vedolizumab and 69 ustekinumab). In the multivariate analysis, male gender (OR: 1.5; 95% CI: 1.2-2.0), urgent surgery (OR: 1.6; 95% CI: 1.2-2.2), laparotomy approach (OR: 1.5; 95% CI: 1.1-1.9) and severe anaemia (OR: 1.8; 95% CI: 1.3-2.6) had higher risk of PC, while academic hospitals had significantly lower risk. Exposure to biologics (either anti-TNF, vedolizumab or ustekinumab) did not increase the risk of PC (OR: 1.2; 95% CI: 0.97-1.58), although it could be a risk factor for postoperative infections (OR 1.5; 95% CI: 1.03-2.27). Preoperative administration of biologics does not seem to be a risk factor for overall PC, although it may be so for postoperative infections.

SUBMITTER: Garcia MJ

PROVIDER: S-EPMC8509475 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Impact of Biological Agents on Postsurgical Complications in Inflammatory Bowel Disease: A Multicentre Study of Geteccu.

García María José MJ Rivero Montserrat M Miranda-Bautista José J Bastón-Rey Iria I Mesonero Francisco F Leo-Carnerero Eduardo E Casas-Deza Diego D Cagigas Fernández Carmen C Martin-Cardona Albert A El Hajra Ismael I Hernández-Aretxabaleta Nerea N Pérez-Martínez Isabel I Fuentes-Valenzuela Esteban E Jiménez Nuria N Rubín de Célix Cristina C Gutiérrez Ana A Suárez Ferrer Cristina C Huguet José María JM Fernández-Clotet Agnes A González-Vivó María M Del Val Blanca B Castro-Poceiro Jesús J Melcarne Luigi L Dueñas Carmen C Izquierdo Marta M Monfort David D Bouhmidi Abdel A Ramírez De la Piscina Patricia P Romero Eva E Molina Gema G Zorrilla Jaime J Calvino-Suárez Cristina C Sánchez Eugenia E Nuñez Andrea A Sierra Olivia O Castro Beatriz B Zabana Yamile Y González-Partida Irene I De la Maza Saioa S Castaño Andrés A Nájera-Muñoz Rodrigo R Sánchez-Guillén Luis L Riat Castro Micaela M Rueda José Luis JL Benítez José Manuel JM Delgado-Guillena Pedro P Tardillo Carlos C Peña Elena E Frago-Larramona Santiago S Rodríguez-Grau María Carmen MC Plaza Rocío R Pérez-Galindo Pablo P Martínez-Cadilla Jesús J Menchén Luis L Barreiro-De Acosta Manuel M Sánchez-Aldehuelo Rubén R De la Cruz María Dolores MD Lamuela Luis Javier LJ Marín Ignacio I Nieto-García Laura L López-San Román Antonio A Herrera José Manuel JM Chaparro María M Gisbert Javier P JP On Behalf Of The Young Group Of Geteccu

Journal of clinical medicine 20210926 19

<h4>Background</h4>The impact of biologics on the risk of postoperative complications (PC) in inflammatory bowel disease (IBD) is still an ongoing debate. This lack of evidence is more relevant for ustekinumab and vedolizumab.<h4>Aims</h4>To evaluate the impact of biologics on the risk of PC.<h4>Methods</h4>A retrospective study was performed in 37 centres. Patients treated with biologics within 12 weeks before surgery were considered "exposed". The impact of the exposure on the risk of 30-day P ...[more]

PMID: 34640421

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Project description:BackgroundTelemonitoring for inflammatory bowel disease (IBD) has not consistently demonstrated superiority over standard care; however, noninferiority may be an acceptable outcome if remote care proves to be more efficient.ObjectiveThis study aims to compare the remission time and quality of life of patients with active IBD managed through standard care versus the TECCU (Telemonitoring of Crohn Disease and Ulcerative Colitis) app.MethodsA 2-arm, randomized, multicenter trial with a noninferiority design was conducted across 24 hospitals in Spain. The study included adult patients with IBD who were starting immunosuppressive or biological therapy. Participants were randomized into 2 groups: the telemonitoring group (G_TECCU) and the standard care group (G_Control). The follow-up schedule for the telemonitoring group (G_TECCU) was based on contacts via the TECCU app, while the control group (G_Control) adhered to standard clinical practice, which included in-person visits and telephone calls. In both groups, treatment adjustments were made based on the progression of disease activity and medication adherence, assessed using specific indices and biological markers at each check-up. The primary outcome was the duration of remission after 12 weeks, while secondary outcomes included quality of life, medication adherence, adverse events, and patient satisfaction.ResultsOf the 169 patients enrolled, 158 were randomized and 150 were analyzed per protocol: telemonitoring (n=71) and control (n=79). After 12 weeks, the time in clinical remission was not inferior in the telemonitoring group (mean 4.20, SD 3.73 weeks) compared with the control group (mean 4.32, SD 3.28 weeks), with a mean difference between arms of -0.12 weeks (95% CI -1.25 to 1.01; noninferiority P=.02). The mean reduction in C-reactive protein values was -15.40 mg/L (SD 90.15 mg/L; P=.19) in the G_TECCU group and -13.16 mg/L (SD 54.61 mg/L; P=.05) in the G_Control group, with no significant differences between the 2 arms (P=.73). Similarly, the mean improvement in fecal calprotectin levels was 832.3 mg/L (SD 1825.0 mg/L; P=.003) in the G_TECCU group and 1073.5 mg/L (SD 3105.7 mg/L; P=.03) in the G_Control group; however, the differences were not statistically significant (P=.96). Quality of life improved in both groups, with a mean increase in the 9-item Inflammatory Bowel Disease Questionnaire score of 13.44 points (SD 19.1 points; P<.001) in the G_TECCU group and 18.23 points (SD 22.9 points; P=.001) in the G_Control group. Additionally, the proportion of patients who adhered to their medication significantly increased from 35% (25/71) to 68% (48/71) in the G_TECCU group (P=.001) and from 46% (36/79) to 73% (58/79) in the G_Control group (P=.001). The satisfaction rate remained stable at around 90%, although noninferiority was not demonstrated for the secondary outcomes.ConclusionsTelemonitoring patients with active IBD is not inferior to standard care for achieving and maintaining short-term remission. The TECCU app may serve as a viable alternative follow-up tool, pending confirmation of improved health outcomes and cost-effectiveness over the long-term.Trial registrationClinicalTrials.gov NCT06031038; https://clinicaltrials.gov/ct2/show/NCT06031038.International registered report identifier (irrid)RR2-10.2196/resprot.9639.

Project description:BackgroundActive disease during conception and pregnancy in women with inflammatory bowel disease (IBD) increases the risk of pregnancy complications and adverse neonatal outcomes. The use of IBD treatments during pregnancy should be weighed against their adverse effects on the neonate, but longer-term safety data and data on serious infection rates and malignancies postnatally are lacking, particularly for newer drugs, such as tofacitinib, vedolizumab and ustekinumab.MethodsThis ongoing, prospective registry study being conducted at 70 centres in Spain is enrolling pregnant women who are ⩾18 years, are at any point in pregnancy up to the end of the second trimester and have a diagnosis of Crohn's disease, ulcerative colitis or unclassified IBD. Patients will receive treatment decided independently by their IBD specialist. Each incident gestation will be followed up through pregnancy and the first 4 years postnatally. Three cohorts will be compared: biologicals exposed, immunomodulatory exposed and non-exposed. The primary endpoint is the risk of severe infection in newborns postnatally up to 4 years of age; other endpoints include serious adverse events (SAEs) such as pregnancy and delivery complications, neonatal SAEs, development [Ages and Stages Questionnaire-3 (ASQ3)], and malignancy incidence, up to 4 years of age. IBD specialists will collect maternal data (baseline/end of each trimester/1 month post-delivery), neonatal birth data, and the SAE and ASQ3 data in children exposed during pregnancy, reported every 3 months by the mother. Statistical analysis will include summary statistics for quantitative variables, comparisons of qualitative variables with significance set at p < 0.025 and a binary logistic regression model to determine the risk factors for severe infections.ResultsEnrolment began in September 2019 and study completion is expected in September 2028.ConclusionsThis prospective, controlled study will provide evidence on the long-term safety profile in children after intrauterine and lactation exposure to biological and immunomodulatory IBD treatments, including data on postnatal severe infections, development and malignancies.Clinicaltrialsgov identifierNCT03894228.

Project description:Background and objectivesPrimary objectives: to compare the rates of sustained clinical remission at 12 months in patients treated with antitumour necrosis factor (anti-TNF) and immunomodulators who withdraw anti-TNF treatment versus those who maintain it.Secondary objectivesto evaluate the effect of anti-TNF withdrawal on relapse-free time, endoscopic and radiological activity, safety, quality of life and work productivity; and to identify predictive factors for relapse.DesignProspective, quadruple-blind, multicentre, randomised, controlled trial. Patients with ulcerative colitis or Crohn's disease in clinical remission for >6 months and absence of severe endoscopic (and radiological in Crohn's disease) lesions were randomised to maintain anti-TNF treatment (maintenance arm (MA)) or to withdraw it (withdrawal arm (WA)). All patients maintained immunomodulators. Patients were followed-up until month 12 or up to clinical relapse.ResultsOne-hundred forty patients were randomised: 70 were allocated to the MA and 70 to the WA. The proportion of patients with sustained clinical remission at 12 months was similar in the MA and WA: 59/70 (84%), 95% CI=74% to 92% versus 53/70 (76%), 95% CI=64% to 85%. The proportion of patients with significant endoscopic lesions at the end of follow-up was 8.5% in the MA and 19% in the WA (p=0.1); a higher proportion of patients had faecal calprotectin >250 µg/g at the end of follow-up in the WA (p=0.01). The same percentage of patients in both groups had at least one adverse event (69%). The proportion of patients with serious adverse events was also similar in both groups (4% in MA vs 7% in WA).ConclusionAnti-TNF withdrawal in selected patients with IBD in clinical, endoscopic and radiological remission has no impact on sustained clinical remission at 1 year although objective markers of activity were higher in patients who withdrew treatment.Trial registration numberhttps://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001410-10 https://clinicaltrials.gov/study/NCT02994836.

Project description:Background/Objectives: Therapeutic management of inflammatory bowel diseases (IBD) is rapidly evolving in the era of novel biological therapies. However, real-world data relating to the usage trends and treatment persistence remain inconsistent. This study aimed to investigate trends in biological use, dose intensification, and treatment persistence in IBD patients, who received treatment in a large tertiary center in Greece. Methods: Patients with IBD who underwent at least one biological treatment between 2018 and 2022 were included in this retrospective study. Data on patients' demographics, type of disease, use of biologicals, dose intensification, and treatment persistence were analyzed for time trends. Results: Data from 409 patients with IBD (mean age 39 (range 17-87), female 51%, 56.9% CD, mean duration of disease: 9.3 years) were included in the study. The number of patients on biologics was raised from 133 in 2018 to 368 in 2022 (a 28.1% yearly increase), while the percentage of patients who were treated with anti-TNF biosimilars increased to >60% of the total anti-TNF population in 2022. We observed a gradual increase in non-anti-TNF therapies in bio-naïve patients, in particular vedolizumab (46% of all biologicals in UC; 16% in CD) and ustekinumab (16.3% of all biologicals in UC, 31% in CD). The 3-year persistence rate of IFX was 64% in CD and 56% in UC, whereas it was 61% for ADA in CD. Dose intensification of anti-TNF was efficient in >50% of CD patients and >30% of UC patients; however, the majority of patients who required dose escalation within the first year eventually became unresponsive. The 3-year persistence of vedolizumab as a first-line treatment was 82% for CD and 69% for UC, respectively. The 3-year persistence of ustekinumab as first-line treatment for CD was 65%. No significant differences regarding the efficacy of anti-TNF, ustekinumab, or vedolizumab were detected when they were used as first-line treatments for Crohn's disease; similarly, no significant differences were detected between infliximab and vedolizumab as first-line treatments for UC. Conclusions: There was a gradual increase in the use of biologicals, including biosimilars, between the years 2018-2022, reflecting adherence to current guidance with adoption of an early escalation strategy. Newer, post-anti-TNF biologics such as vedolizumab and ustekinumab have been rapidly incorporated into therapeutic approaches for both CD and UC.

Dataset Information

Impact of Biological Agents on Postsurgical Complications in Inflammatory Bowel Disease: A Multicentre Study of Geteccu.

Publications

Impact of Biological Agents on Postsurgical Complications in Inflammatory Bowel Disease: A Multicentre Study of Geteccu.

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