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1.
BMJ Open ; 14(7): e081787, 2024 Jul 20.
Artículo en Inglés | MEDLINE | ID: mdl-39032928

RESUMEN

INTRODUCTION: A substantial proportion of patients with inflammatory bowel disease (IBD) on intravenous infliximab require dose intensification. Accessing additional intravenous infliximab is labour-intensive and expensive, depending on insurance and pharmaceutical reimbursement. Observational data suggest that subcutaneous infliximab may offer a convenient and safe alternative to maintain disease remission in patients requiring dose-intensified infliximab. A prospective, controlled trial is required to confirm that subcutaneous infliximab is as effective as dose-intensified intravenous infliximab, to identify predictors of disease flare and to establish the role of subcutaneous infliximab therapeutic drug monitoring. METHODS AND ANALYSIS: The DISCUS-IBD trial is an investigator-initiated, prospective, multicentre, randomised, open-label non-inferiority study comparing the rate of disease flares in participants randomised to continue dose-intensified intravenous infliximab to those switched to subcutaneous infliximab after 48 weeks. Participants are adult patients with IBD in sustained corticosteroid-free remission on any regimen of dose-intensified infliximab up to a maximum of 10 mg/kg 4-weekly intravenously. Participants allocated to intravenous infliximab will continue infliximab at the same dose-intensified regimen they were receiving at study enrolment. Subcutaneous infliximab dosing will be stratified by prior intravenous infliximab dosing. Clinical (Harvey-Bradshaw Index, partial Mayo score), biochemical (C reactive protein, faecal calprotectin), pharmacokinetic (drug-level±antidrug antibodies) and qualitative data are collected 12-weekly until study conclusion at week 48. 13 sites across Australia will participate in recruitment to reach a calculated sample size of 120 participants. ETHICS AND DISSEMINATION: Multisite ethics approval was obtained from the Health District Human Research Ethics Committee (HREC) at The Alfred Hospital under a National Mutual Acceptance (NMA) agreement (HREC/90559/Alfred-2022; Local Reference: Project 618/22, version 1.6, 2 March 2023). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals. DISCUS-IBD was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) prior to commencing recruitment. TRIAL REGISTRATION NUMBER: ACTRN12622001458729.


Asunto(s)
Fármacos Gastrointestinales , Enfermedades Inflamatorias del Intestino , Infliximab , Humanos , Infliximab/administración & dosificación , Infliximab/uso terapéutico , Infliximab/farmacocinética , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Estudios Prospectivos , Fármacos Gastrointestinales/administración & dosificación , Fármacos Gastrointestinales/uso terapéutico , Inyecciones Subcutáneas , Administración Intravenosa , Estudios Multicéntricos como Asunto , Adulto , Australia , Monitoreo de Drogas/métodos , Femenino , Masculino
4.
Intern Med J ; 54(1): 104-107, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-36938780

RESUMEN

BACKGROUND AND AIMS: To evaluate the safety and patient experience of a hospital-initiated home-based iron infusion service in patients with iron deficiency with or without anaemia. METHODS: Retrospective cohort study, including adult patients who received intravenous iron through a Hospital in The Home service in a single tertiary centre between August 2020 and 2021. A chart review was conducted for documented adverse events (AEs). A telephone survey assessed patient acceptance with three questions on a 5-point Likert scale: (i) How do you perceive the experience of having your infusion given in the home? (ii) Would you like to have the infusion in the same location if you require one in the future? and (iii) Do you feel safe having your infusion at home? OUTCOME MEASURES: Percentage of patients experiencing AEs and patient acceptance of a home-based iron infusion strategy. RESULTS: One hundred ninety-seven patients were included (181 ferric carboxymaltose and 16 ferric derisomaltose). Six (3%) patients (2 of 181 patients who received ferric carboxymaltose compared with 4 of 16 patients who received ferric derisomaltose, P < 0.001, Fisher's exact) experienced AEs, mostly headache and pruritus. Most patients who participated in the telephone survey had a positive experience (57/58 (98%)), felt safe (57/58 (98%)) and preferred future infusions to occur at home (52/58 (90%)). CONCLUSION: A home-based iron infusion strategy was safe and well accepted by patients. Larger studies evaluating the safety profile of different iron formulations in the home setting are required.


Asunto(s)
Anemia Ferropénica , Disacáridos , Compuestos Férricos , Hierro , Maltosa/análogos & derivados , Adulto , Humanos , Hierro/efectos adversos , Anemia Ferropénica/tratamiento farmacológico , Estudios Retrospectivos , Administración Intravenosa , Infusiones Intravenosas
5.
Aliment Pharmacol Ther ; 59(4): 504-514, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38095246

RESUMEN

BACKGROUND: Thiopurines are established treatments for inflammatory bowel disease (IBD), yet concerns remain regarding their safety. AIM: To evaluate the use of thiopurine-allopurinol combination therapy compared to standard thiopurine therapy in IBD. METHODS: We performed a multicentre, randomised, placebo-controlled trial to compare the efficacy and safety of thiopurine-allopurinol versus thiopurine with placebo for adults commencing a thiopurine for IBD. Patients had active disease at baseline; dosing of therapy was based on a pre-specified regimen and subsequent metabolites. The primary outcome was the proportion of patients achieving a composite of symptomatic disease activity remission (Harvey Bradshaw Index <5 for Crohn's disease, Simple Clinical Colitis Activity Index <4 for ulcerative colitis) and a faecal calprotectin <150 µg/g after 26 weeks of treatment. RESULTS: The trial was terminated early due to slow recruitment. We randomised 102 participants (54 thiopurine-allopurinol, 48 thiopurine with placebo) with similar age (median 42 vs 48 years) and sex distribution (46% women per group). A higher proportion achieved the primary outcome in the thiopurine-allopurinol group (50% vs 35%, p = 0.14) and fewer participants stopped their allocated therapy due to adverse events (11% vs 29%, p = 0.02). Also, within the thiopurine-allopurinol group, thiopurine dose adjustments were less frequent (69% vs 92%, p = 0.03), a higher proportion achieved an early therapeutic 6-TGN level at week 6 (71% vs 53%, p = 0.19), and adverse events attributed to therapy were less frequent (15% vs 44%, p = 0.002). CONCLUSION: Thiopurine-allopurinol therapy is safe and mitigates thiopurine adverse effects, thus enhancing tolerability without compromising efficacy (ACTRN12613001347752).


Asunto(s)
Azatioprina , Enfermedades Inflamatorias del Intestino , Purinas , Compuestos de Sulfhidrilo , Adulto , Humanos , Femenino , Persona de Mediana Edad , Masculino , Azatioprina/efectos adversos , Alopurinol/efectos adversos , Mercaptopurina , Inmunosupresores/efectos adversos , Resultado del Tratamiento , Quimioterapia Combinada , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/inducido químicamente , Factores Inmunológicos/uso terapéutico
6.
Intern Med J ; 54(1): 26-34, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37490496

RESUMEN

Iron deficiency is the most common nutritional deficiency worldwide, with significant adverse health consequences in the presence or absence of anaemia. Total dose intravenous iron replacement is recommended for replacement of iron in patients with severe iron deficiency, especially in the presence of anaemia, intolerance or inefficacy following oral iron, or states of inflammation where upregulation of hepcidin may impair gastrointestinal absorption of iron. Currently, available intravenous iron formulations have been demonstrated to have an excellent overall safety profile, but potential adverse effects, including skin staining, infusion-related reactions and hypophosphataemia, have been described. Knowledge of differences in administration and safety profiles of currently available iron formulations will allow appropriate prescription, counselling, as well as recognition and management of adverse events in patients requiring intravenous iron.


Asunto(s)
Anemia Ferropénica , Deficiencias de Hierro , Humanos , Hierro/efectos adversos , Anemia Ferropénica/tratamiento farmacológico , Administración Intravenosa
7.
JGH Open ; 7(7): 482-486, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37496810

RESUMEN

Background and Aim: Acute severe ulcerative colitis (ASUC) remains a significant cause of morbidity and healthcare utilization. This study aimed to characterize the total healthcare costs of ASUC, explore factors associated with significant cost over the 12 months following an index admission, and document outcomes including corticosteroid exposure. Methods: Patients admitted from January 2016 until January 2021 for ASUC to a tertiary inflammatory bowel disease (IBD) center in Australia were identified via retrospective chart review. Costs were calculated over a 12-month period following index admission. Results: Seventy-two patients (30 [42%] female, median age 39 [IQR 27-54] years) were included. The median length of stay of index admission was 6 days (IQR 5-10 days). The median cost of index admission was 7829 AUD, which was driven by the initial length of stay (P < 0.01) and requirement for colectomy (P < 0.01). Median total healthcare cost over the first 12 months was 13 873 AUD (IQR 9684-19 936 AUD), again predominately driven by the length of stay (P < 0.01) and requirement for colectomy (P < 0.01). Median cumulative corticosteroid use over 12 months inclusive of index hospitalization was 1760 mg (IQR 1560-2350 mg). Requirement for inpatient medical salvage therapy with infliximab was associated with increased corticosteroid requirement (P = 0.01). Conclusion: Healthcare expense related to ASUC remains high, driven predominantly by the length of stay during initial hospitalization and need for colectomy. From a healthcare cost perspective, novel methods to reduce inpatient hospital stay as well as need for colectomy may help reduce the economic and steroid burden of ASUC.

11.
Eur J Gastroenterol Hepatol ; 35(7): 702-710, 2023 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-37115969

RESUMEN

INTRODUCTION: Fistulas are a debilitating complication of Crohn's disease and treatment options remain limited. There is a lack of head-to-head comparisons between treatments. To our knowledge, this is the first network meta-analysis on the efficacy of medical therapies in achieving fistula remission and maintenance of fistula closure in Crohn's disease. METHODS: Biomedical databases and the Cochrane Central Registry were searched between 1978 and 2022 for randomized controlled trials (RCTs) reporting on treatments. A network meta-analysis was performed using the frequentist model with pooled relative risks (RRs) and P -scores used to rank treatments. RESULTS: Twenty-five RCTs were included for analysis with 2239 patients included. At the 16-24 week time point, infliximab produced the only statistically significant result with the 5 mg/kg dose proving the most effective [RR, 2.30; 95% confidence interval (CI), 1.40-3.77]. At 44 weeks, ustekinumab was found to be most superior with it being 2.38 times (RR, 2.38; 95% CI, 1.24-4.56) more superior to placebo, with adalimumab (RR, 2.06; 95% CI, 1.06-3.99) and infliximab 5 mg/kg (RR, 1.68; 95% CI, 1.03-2.75) also producing a statistically significant result. CONCLUSION: Despite infliximab being favoured in international guidelines for the treatment of perianal fistulising Crohn's disease, biologics such as ustekinumab, vedolizumab and adalimumab show promising results.


Asunto(s)
Enfermedad de Crohn , Humanos , Adalimumab/efectos adversos , Anticuerpos Monoclonales/efectos adversos , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/tratamiento farmacológico , Inmunosupresores/efectos adversos , Infliximab/efectos adversos , Ustekinumab/efectos adversos
14.
Expert Opin Ther Targets ; 26(10): 897-909, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-36484415

RESUMEN

INTRODUCTION: The renin-angiotensin system (RAS) is an important homeostatic pathway, with emerging evidence for the impact of its components on inflammation and fibrosis in gastrointestinal tissues. This review aims to review current knowledge of the physiological mechanism of RAS in inflammatory bowel disease (IBD), and potential therapeutic implications. AREAS COVERED: An extensive online literature review including Pubmed, Medline, and Google Scholar was undertaken. Discussion on the components of the RAS, localization, and physiological functions in the gastrointestinal tract, preclinical, and clinical data in IBD, and the relation with SARS-Cov-2 are covered in this review. EXPERT OPINION: RAS inhibition may have a role as anti-fibrotic adjunct therapy. Targeting the local gastrointestinal RAS with novel modes of delivery may be a target for future therapeutics for IBD, given the widespread availability and safety of current options as utilized in other diseases. Further insight into the mechanism and downstream effects of gastrointestinal ACE2 may lead to a better understanding of the pathogenesis of IBD.


Asunto(s)
COVID-19 , Enfermedades Inflamatorias del Intestino , Humanos , Sistema Renina-Angiotensina , SARS-CoV-2 , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Fibrosis
16.
Intern Med J ; 52(7): 1272-1275, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35879241

RESUMEN

Inflammatory bowel disease is a chronic gastrointestinal condition that necessitates life-long healthcare engagement and management. Empowering patients with knowledge is fundamental to enhance health literacy, improve health outcomes and facilitate complex decision-making regarding medication and potential surgery. A working group was formed to develop concise, comprehensive patient information sheets to meet this unmet need in the Australian setting.


Asunto(s)
Alfabetización en Salud , Enfermedades Inflamatorias del Intestino , Australia , Enfermedad Crónica , Humanos , Enfermedades Inflamatorias del Intestino/epidemiología , Enfermedades Inflamatorias del Intestino/terapia , Educación del Paciente como Asunto
19.
Frontline Gastroenterol ; 13(2): 168-170, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35300470

RESUMEN

In 2019, the European Crohn's and Colitis Organisation released guidelines for the medical management of Crohn's disease, concerning the induction of remission, the maintenance of remission and the treatment of fistulising perianal disease. This review summarises the key recommendations regarding the use of biologics in these settings.

20.
Turk J Gastroenterol ; 33(2): 103-110, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-35115287

RESUMEN

BACKGROUND: Inflammatory bowel disease is associated with poor quality of life. The aim of the cross-sectional study was to extend the common sense model to explore the impact of inflammatory bowel disease activity on quality of life and the potential mediating roles of illness perceptions, visceral sensitivity, coping styles, acceptance, and psychological distress. METHODS: A total of 141 inflammatory bowel disease patients (86 with Crohn's disease and 55 with ulcerative colitis; 74 males, 65 females, and 2 gender non-specific, mean age 40.43 years) from 2 metropolitan hospital inflammatory bowel disease outpatient clinics participated. Measures included disease activity (Crohn's Disease Activity Index, Simple Clinical Colitis Activity Index), illness perceptions (Brief Illness Perceptions Questionnaire), visceral sensitivity (Visceral Sensitivity Index), coping styles (Brief Coping Operations Preference Enquiry), acceptance (Acceptance and Action Questionnaire-II), psychological distress (Depression, Anxiety, and Stress Scale), and European Health Interview Survey-Quality of Life (EUROHIS-QoL). RESULTS: A structural equation model of the extended common sense model was found to have a good fit (χ2(10) = 10.07, P = .43, root mean square error of approximation = 0.01, standardized root mean residual = 0.04, comparative index fit = 1.00, Tucker-Lewis index = 1.00, goodness-of-fit = 0.98). After controlling for irritable bowel syndrome diagnosis, the impact of disease activity on quality of life was statistically mediated by illness perceptions, maladaptive coping styles, and psychological distress. In addition, visceral sensitivity bordered on influencing the impact of disease activity and illness perceptions on quality of life through psychological distress. CONCLUSIONS: This study demonstrates that together with illness perceptions and coping styles, visceral sensitivity plays an important role in an individual's adaption to living with inflammatory bowel disease.


Asunto(s)
Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Adulto , Enfermedad Crónica , Enfermedad de Crohn/psicología , Estudios Transversales , Depresión/psicología , Femenino , Humanos , Masculino , Calidad de Vida/psicología , Índice de Severidad de la Enfermedad , Estrés Psicológico/diagnóstico , Estrés Psicológico/psicología , Encuestas y Cuestionarios
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