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OBJECTIVES: Treatment of patients with inflammatory bowel disease (IBD) should aim at achieving mucosal healing. However, monitoring schedules to support this goal remain undefined. We aimed to identify patients' and physicians' preferences regarding monitoring strategy and investigated the feasibility of such a strategy. METHODS: Elements considered relevant for monitoring were identified in questionnaire surveys among 1) patients with IBD receiving biologic agents (n = 172) and 2) their physicians (n = 87). Adherence to a monitoring strategy incorporating these elements was investigated in a retrospective cohort of patients with IBD treated with biologic agents (n = 139). RESULTS: Patients considered blood and stool samples, endoscopies, and magnetic resonance imaging (MRI) to be relevant aspects of monitoring their disease. However, patients also considered stool samples and endoscopies unpleasant. Physicians considered blood samples (99%), medical consultations (99%), fecal calprotectin (85%), endoscopy (78%), and MRI (71%) to be important aspects of IBD monitoring but considered endoscopies and MRI relevant only at clinical signs of relapse. A review of the clinical use of monitoring strategies including the elements identified above revealed high adherence for blood samples and disease activity indices (92%), but low adherence for fecal calprotectin (38%), therapeutic drug monitoring (38%), and endoscopies (32%). CONCLUSION: Important tools for evaluating mucosal healing (e.g., endoscopy) were rated highly unpleasant by patients, and physicians found endoscopies/MRI relevant only in case of relapse. These findings were reflected by low rates of adherence to use of these monitoring tools. In defining monitoring schedules to help achieve treatment goals, these important barriers must be addressed.
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Enfermedades Inflamatorias del Intestino , Médicos , Terapia Biológica , Biomarcadores , Heces , Humanos , Enfermedades Inflamatorias del Intestino/diagnóstico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Complejo de Antígeno L1 de Leucocito , Estudios RetrospectivosRESUMEN
BACKGROUND: Fatigue is a common symptom reported by patients with chronic immunoinflammatory diseases and with profound negative implications on health-related quality of life. This study aimed to delineate underlying components contributing to fatigue in patients with inflammatory bowel disease (IBD) receiving biologic therapy. METHODS: Cross-sectional questionnaire study of all patients with IBD receiving any biologic therapy at a tertiary IBD center. Fatigue was assessed by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Disease activity and quality of life were evaluated by generic questionnaires. Principal component analysis (PCA) was used to identify components of variables explaining fatigue. RESULTS: Three hundred patients with IBD were included. Moderate-to-severe fatigue defined as FACIT-F ≤ 39 was present in half of the included patients. PCA condensed variables associated with fatigue into three main components contributing to 49% of observed fatigue. The first component, explaining 21% of fatigue, included factors related to disease chronicity, e.g., long disease duration, high number of previously used biologic therapies, presence of previous intestinal surgery, and increasing age. The second component explained 14% of fatigue and comprised disease activity-related aspects, e.g., disease activity indices and C-reactive protein. The third explained 14% of fatigue and comprised various nutritional deficiencies. CONCLUSION: Fatigue can partly be explained by chronicity, disease activity, and nutritional deficits. However, the cause of fatigue is unexplained in approximately half of the patients with IBD supporting that fatigue can be an independent, systemic extraintestinal disease manifestation in IBD.
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Productos Biológicos , Enfermedades Inflamatorias del Intestino , Desnutrición , Productos Biológicos/efectos adversos , Enfermedad Crónica , Estudios Transversales , Fatiga/diagnóstico , Humanos , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/diagnóstico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Desnutrición/complicaciones , Calidad de Vida , Índice de Severidad de la Enfermedad , Encuestas y CuestionariosRESUMEN
OBJECTIVE: TNF inhibitors are effective in the treatment of ulcerative colitis. Adalimumab (ADL), a fully human TNF inhibitor, is increasingly used both as primary anti-TNF agent and in patients switching from another TNF inhibitor due to treatment failure or side effects. This study investigated clinical outcomes of ADL therapy in a clinical setting where infliximab (IFX) had been used as first choice of anti-TNF agent, and followed by ADL as second line agent. METHODS: Retrospective, observational single-center cohort study including all ulcerative colitis patients treated with ADL at a tertiary Danish inflammatory bowel disease center until 2014. Clinical outcomes were assessed after 12 and 52 weeks and classified according to physician's global evaluation. RESULTS: The study population comprised 33 patients. Main reasons for switching from IFX to ADL were infusion reactions to IFX (45%) or IFX treatment failure (33%). Short-term efficacy of ADL after 12 weeks revealed 15 patients (45%) with clinical response, and 6 (18%) in clinical remission. Twenty-three patients continued ADL for more than 12 weeks, and at long-term follow-up after 1 year of ADL treatment, eight of these (34%) had clinical response (24% of the entire cohort) and six (26%) were in clinical remission (18% of the entire cohort). A total of five patients (15%) were colectomized mainly due to primary ADL failure (four of five patients). CONCLUSION: Efficacy of ADL therapy in ulcerative colitis patients previously treated with IFX appears to be modest in clinical practice, and with higher colectomy rates than reported for anti-TNF-naive patients in the registration trials.
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Adalimumab/uso terapéutico , Antiinflamatorios/uso terapéutico , Colitis Ulcerosa/tratamiento farmacológico , Infliximab/uso terapéutico , Inhibidores del Factor de Necrosis Tumoral , Adulto , Colectomía , Dinamarca , Femenino , Humanos , Masculino , Persona de Mediana Edad , Inducción de Remisión , Estudios Retrospectivos , Centros de Atención Terciaria , Factores de Tiempo , Insuficiencia del Tratamiento , Resultado del TratamientoRESUMEN
OBJECTIVES: Exploring patients' perspectives for significant factors of relevance in living with a chronic disease is important to discover unmet needs and challenges. The primary objective of this study was to explore disease-related and treatment-related issues and concerns experienced by adults with spondyloarthropathies (SpA) and associated diseases. As a secondary objective, we wanted to explore whether these factors were generic or disease dependent. DESIGN: We used group concept mapping (GCM), a validated qualitative method, to identify disease-related and treatment-related issues and concerns. Participants generated statements in the GCM workshops and organised them into clusters to develop concepts. Furthermore, participants rated each statement for importance from 1: 'not important at all' to 5: 'of great importance'. SETTING: Participants were recruited during routine care at the outpatient clinic at the hospitals in the period from May 2018 to July 2022. PARTICIPANTS: Eligible participants were adults ≥18 years and diagnosed with axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), psoriasis (PsO) or inflammatory bowel disease -split into Crohn's disease (CD) and ulcerative colitis (UC). RESULTS: 52 patients participated in the 11 workshops divided into groups according to their diagnosis. They created a total of 1275 statements that generated 10 AxSpA concepts, 7 PsA concepts, 7 PsO concepts, 10 CD concepts and 11 UC concepts. The highest rated concepts within each disease group were: AxSpA, 'lack of understanding/to be heard and seen by healthcare professionals' (mean rating 4.0); PsA, 'medication (effects and side effects)' (mean rating 3.8); PsO, 'social and psychological problems, the shame' (mean rating 4.0); CD, 'positive attitudes' (mean rating 4.3) and UC; 'take responsibility and control over your life' (mean rating 4.0). CONCLUSION: People with SpA and associated diseases largely agree on which concepts describe their disease-related and treatment-related issues and concerns with a few of them being more disease-specific.
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Artritis Psoriásica , Espondiloartritis Axial , Colitis Ulcerosa , Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Psoriasis , Espondiloartritis , Adulto , Humanos , Artritis Psoriásica/tratamiento farmacológico , Espondiloartritis/terapia , Enfermedades Inflamatorias del Intestino/terapia , Psoriasis/terapiaRESUMEN
OBJECTIVE: Physicians tend to focus on biomedical targets while little is known about issues important to patients. We aimed to identify critical concepts impacting patients with inflammatory bowel disease (IBD). DESIGN: We performed a survey of patients with IBD in biologic therapy (n=172) and used a validated qualitative method called group concept mapping (GCM) in patient workshops. The survey included 13 questions on attitudes toward symptoms and issues related to IBD. In the eight workshops, patients (n=26) generated statements later clustered into concepts identifying issues impacting a patient's life. Patients ranked the statements. RESULTS: In the survey, patients' mean age were 40 years (SD 13), 53% were women, and 38% had ulcerative colitis. They identified fatigue (57%) and stool frequency (46%) as the most critical symptoms impacting their daily lives regardless of disease activity. In the GCM workshops with Crohn's disease (n=13) (median age 42 years (IQR 39-51) and 62% were women), 335 statements divided among 10 concepts were generated, and the three most important concepts were 'Positive attitudes', 'Accept and recognition', and 'Sharing knowledge and experiences in life with Crohn's disease'. In the workshops with ulcerative colitis (n=13) (median age 43 years (IQR 36-49) and 69% were women), 408 statements divided into 11 concepts were generated; the most important concepts were 'Take responsibility and control over your life', 'Medication', and 'Everyday life with ulcerative colitis'. CONCLUSION: Focusing solely on IBD symptoms, patients identified fatigue and stool frequency to impact daily life the most. However, when investigating the disease burden in a broader perspective beyond classic IBD symptoms, patients identified concepts with focus on emotional health to be most important. TRIAL REGISTRATION: The Copenhagen University Hospital, Herlev and Gentofte approved the questionnaire and methodology (work-zone no: 18015429).
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Colitis Ulcerosa , Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Humanos , Femenino , Adulto , Masculino , Colitis Ulcerosa/epidemiología , Colitis Ulcerosa/diagnóstico , Enfermedad de Crohn/diagnóstico , Enfermedades Inflamatorias del Intestino/epidemiología , Costo de Enfermedad , Fatiga/epidemiologíaRESUMEN
BACKGROUND: Whether infliximab therapy can be successfully discontinued after patients with Crohn's disease have attained sustained, clinical, biochemical, and endoscopic remission is unknown. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled withdrawal study of infliximab in patients with Crohn's disease who were in clinical, biochemical, and endoscopic remission after standard infliximab maintenance therapy for at least 1 year. Patients were randomly assigned 1:1 to continue infliximab therapy or to receive matching placebo for 48 weeks. The primary end point was time to relapse. RESULTS: This study randomly assigned 115 patients to either the infliximab-continuation group or to the infliximab-discontinuation group. No relapses were observed among the 59 patients continuing infliximab, whereas 23 of 56 patients discontinuing infliximab experienced relapse. Time to relapse was significantly shorter among patients who discontinued infliximab than among those who continued infliximab (hazard ratio, 0.080; 95% confidence interval [CI], 0.035 to 0.186; P<0.001). At the end of the trial at week 48, relapse-free survival was 100% in the infliximab-continuation group and 51% in the infliximab-discontinuation group. The key secondary end point, time to loss of remission, was significantly shorter among patients discontinuing infliximab therapy than those continuing infliximab (hazard ratio, 0.025; 95% CI, 0.003 to 0.187; P<0.001). No unexpected adverse events were reported. CONCLUSIONS: Discontinuation of infliximab for patients with Crohn's disease receiving long-term infliximab therapy and in clinical, biochemical, and endoscopic remission leads to a considerable risk of relapse. (Funded by the Nordic Trial Alliance [NordForsk], the Medical Fund of the Danish Regions [Regionernes Medicin og Behandlingspulje], the Danish Colitis-Crohn Association, and the A.P. Moller Foundation; ClinicalTrials.gov number, NCT01817426; EudraCT number, 2012-002702-51.)
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Enfermedad de Crohn , Fármacos Gastrointestinales , Infliximab , Humanos , Infliximab/uso terapéutico , Infliximab/administración & dosificación , Infliximab/efectos adversos , Enfermedad de Crohn/tratamiento farmacológico , Femenino , Masculino , Adulto , Método Doble Ciego , Fármacos Gastrointestinales/uso terapéutico , Fármacos Gastrointestinales/administración & dosificación , Fármacos Gastrointestinales/efectos adversos , Persona de Mediana Edad , Recurrencia , Inducción de Remisión , Adulto Joven , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/efectos adversos , Privación de Tratamiento/estadística & datos numéricos , Resultado del TratamientoRESUMEN
BACKGROUND AND STUDY AIMS: In patients with Crohn's disease, the idea of biodegradable stents for treatment of bowel strictures with limited effect of endoscopic balloon dilation is tempting and initial results have been promising. The aim of this study was to evaluate the technical and clinical success of biodegradable stents for treatment of inflamed Crohn's strictures refractory to endoscopic balloon dilatation. PATIENTS AND METHODS: Consecutive patients treated with biodegradable stents due to Crohn's disease and inflamed bowel strictures refractory to endoscopic balloon dilatation were included. Technical and clinical success were evaluated. RESULTS: Six patients were included in the study. Technical success was obtained in five patients (83â%). Clinical success was limited to one patient (20â%); failure was observed due to mucosal overgrowth (nâ=â2), stent migration (nâ=â1), and stent collapse (nâ=â1). CONCLUSIONS: In Crohn's disease, it is technically feasible to treat bowel strictures with biodegradable stents. However, we have stopped using biodegradable stents due to lack of clinical success and side effects such as mucosal overgrowth and stent collapse.
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Treatment of inflammatory bowel disease with anti-tumour necrosis factor (TNF)-alpha biopharmaceuticals is generally well tolerated, but increases the risk of infections due to globally induced suppression of the immune system. National and international guidelines recommend screening and vaccination for selected infectious agents prior to anti-TNF initiation as well as during ongoing anti-TNF therapy. This review focuses on current available recommendations and discusses physicians' and patients' barriers for adherence to guidelines.