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INTRODUCTION: Biological therapies used for the treatment of inflammatory bowel disease (IBD) have shown to be effective and safe, although these results were obtained from studies involving mostly a young population, who are generally included in clinical trials. The aim of our study was to determine the efficacy and safety of the different biological treatments in the elderly population. METHODS: Multicenter study was carried out in the GETECCU group. Patients diagnosed with IBD and aged over 65 years at the time of initiating biological therapy (infliximab, adalimumab, golimumab, ustekinumab or vedolizumab) were retrospectively included. Among the patients included, clinical response was assessed after drug induction (12 weeks of treatment) and at 52 weeks. Patients' colonoscopy data in week 52 were assessment, where available. Regarding complications, development of oncological events during follow-up and infectious processes occurring during biological treatment were collected (excluding bowel infection by cytomegalovirus). RESULTS: A total of 1090 patients were included. After induction, at approximately 12-14 weeks of treatment, 419 patients (39.6%) were in clinical remission, 502 patients (47.4%) had responded without remission and 137 patients (12.9%) had no response. At 52 weeks of treatment 442 patients (57.1%) had achieved clinical remission, 249 patients had responded without remission (32.2%) and 53 patients had no response to the treatment (6.8%). Before 52 weeks, 129 patients (14.8%) had discontinued treatment due to inefficacy, this being significantly higher (p<0.0001) for Golimumab - 9 patients (37.5%) - compared to the other biological treatments analyzed. With respect to tumor development, an oncological event was observed in 74 patients (6.9%): 30 patients (8%) on infliximab, 23 (7.14%) on adalimumab, 3 (11.1%) on golimumab, 10 (6.4%) on ustekinumab, and 8 (3.8%) on vedolizumab. The incidence was significantly lower (p=0.04) for the vedolizumab group compared to other treatments. As regards infections, these occurred in 160 patients during treatment (14.9%), with no differences between the different biologicals used (p=0.61): 61 patients (19.4%) on infliximab, 39 (12.5%) on adalimumab, 5 (17.8%) on golimumab, 22 (14.1%) on ustekinumab, and 34 (16.5%) on vedolizumab. CONCLUSIONS: Biological drug therapies have response rates in elderly patients similar to those described in the general population, Golimumab was the drug that was discontinued most frequently due to inefficacy. In our experience, tumor development was more frequent in patients who used anti-TNF therapies compared to other targets, although its incidence was generally low and that this is in line with younger patients based on previous literature.
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AIMS: The aim of the study is to evaluate the clinical and biochemical response of inflammatory bowel disease patients treated with vedolizumab, 16 weeks after transitioning from intravenous (iv) to subcutaneous (sc). METHODS: An observational, prospective, single-center cohort study was performed. Patients with inflammatory bowel disease and maintenance treatment with vedolizumab, stable for at least 4 months, were offered to switch to sc formulation. At the same time of treatment administration a blood test was performed, with vedolizumab levels and fecal calprotectin. RESULTS: Forty-three patients were included, 12 of them (27.9%) chose to transition to sc formulation. All included patients remained in remission during follow-up. At week 16 no significant differences were found in terms of calprotectin levels in patients on iv treatment (mean 146.6±SD 45.9) vs. sc (159.26±53.9) (p=0.9). Vedolizumab serum levels at week 16 were higher in the sc group (22,364.3±5141.6) vs. iv (11,425.9±1514.2) (p=0.009). At week 16, 9 (75%) of the patients in the sc group were highly satisfied with the medication and 11 (91.7%) considered it easy to administer. Four patients (12.9%) in the iv group and 2 (16.6%) in the sc group presented mild adverse effects. The 2 cases (100%) of the sc group the adverse event was local inflammation at the injection site. CONCLUSION: In our experience, vedolizumab sc is a convenient alternative to iv administration. Vedolizumab serum levels in patients who transitioned to sc were higher than iv formulation.
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A 62-year-old woman, originally from Peru, with rheumatoid arthritis under treatment with anti-tumor necrosis factor (anti-TNF) therapy, was admitted due to constitutional syndrome and suspicion of neoplasia. Computed tomography (CT) scan revealed involvement of three segments of the colon, ascites, and likely peritoneal implants. Ascitic fluid analysis showed elevated adenosine deaminase (ADA) levels and lymphocytosis. The patient presented with hematemesis and hematochezia with hemodynamic instability. Upper gastrointestinal endoscopy identified an extensive ulcer in the middle esophagus with a granular base, elevated and defined edges, indeterminate for malignancy and without blood residues. Colonoscopy also revealed multiple extensive ulcers in the transverse colon, with whitish bases and thickened and necrotic-looking surrounding mucosal edges. Histology showed granulomas and yeast-like fungal structures with methenamine silver staining in both tissues, consistent with disseminated histoplasmosis. Antifungal treatment was initiated with good clinical evolution.
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BACKGROUND: Limited data are available on the outcome of inflammatory bowel disease (IBD) in patients with solid organ transplantation (SOT). We describe the natural history of pre-existing IBD and de novo IBD after SOT. METHODS: This was a retrospective, multicenter study that included patients with pre-existing IBD at the time of SOT and patients with de novo IBD after SOT. The primary outcome was IBD progression, defined by escalation of medical treatment, surgical therapy, or hospitalization due to refractory IBD. Risk factors were identified using multivariate Cox proportional hazard analysis. RESULTS: A total of 177 patients (106 pre-existing IBD and 71 de novo IBD) were included. Most patients with pre-existing IBD (92.5%) were in remission before SOT. During follow-up, 32% of patients with pre-existing IBD had disease progression, with a median time between SOT and IBD progression of 2.2 (interquartile range, 1.3-4.6) years. In the de novo cohort, 55% of patients had disease progression with a median time to flare of 1.9 (interquartile range, 0.8-3.9) years after diagnosis. In the pre-existing IBD cohort, active IBD at the time of SOT (hazard ratio, 1.80; 95% confidence interval, 1.14-2.84; Pâ =â .012) and the presence of extraintestinal manifestations (hazard ratio, 3.10; 95% confidence interval, 1.47-6.54; Pâ =â .003) were predictive factors for IBD progression. CONCLUSIONS: One-third of patients with pre-existing IBD and about half of patients with de novo IBD have disease progression after SOT. Active IBD at the time of SOT and the presence of extraintestinal manifestations were identified as risk factors for IBD progression.
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BACKGROUND: The role of ustekinumab (UST) and vedolizumab (VDZ) in the extraintestinal joint manifestations of inflammatory bowel disease (IBD) remain unclear, and most existing studies are retrospective. The aim of this prospective study was to analyze the incidence of new-onset joint disease or the worsening of pre-existing IBD-associated joint disease in patients treated with UST and VDZ. METHODS: The study population comprised IBD patients with previous spondyloarthritis (SpA) or new-onset arthropathy undergoing treatment with VDZ or UST. RESULTS: Eighty patients were referred to rheumatology because of previous SpA or onset of symptoms. Most patients (90%) were anti-TNF experienced. Two patients with previous SpA (2/22; 9%) experienced a flare-up (one with UST and one with VDZ), and two patients with VDZ developed SpA during follow-up (2/58; 3%). Only one of these four patients did not have gastrointestinal symptoms, and VDZ was discontinued because of joint symptoms. The other three patients had concomitant intestinal activity, and treatment was not discontinued. CONCLUSION: Our experience shows that treatment with UST and VDZ did not worsen joint disease in patients with SpA. Most remained stable or improved. In addition, poor control of IBD in patients with joint flare-ups could be the main cause of worsening SpA.
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BACKGROUND: The rates of clinical and biochemical responses in Crohn's disease (CD) patients treated with intravenous (IV) ustekinumab (UST) intensification are scarcely described. METHODS: Patients with diagnosis of CD who were under intensified IV ustekinumab treatment (130 mg every 4 weeks) were retrospectively included, evaluating the clinical and biochemical response 12 weeks after the change in treatment regimen (switch from SC to IV), as well as the serum levels of the drug. RESULTS: Twenty-seven patients, all of whom had transitioned to intensified intravenous ustekinumab treatment due to a secondary loss of response to the drug, were included in the retrospective analysis. At the baseline visit, prior to changing IV UST, differences in levels were observed between intensified and non-intensified patients (7216 vs. 2842 ng/mL, p = 0.00005). However, no significant differences were found between these two groups 12 weeks after IV intensification (7949 vs. 7937 ng/mL; p = 0.99). In patients with previous intensified UST SC, a decrease in fecal calprotectin was observed 12 weeks after starting IV intensification, going from a mean of 1463 ug/g to 751 ug/g, although the differences were not significant (p = 0.14). CONCLUSION: In our experience, intensifying treatment with IV UST leads to clinical and biochemical improvements in CD patients with a secondary loss of response to SC maintenance with this drug, and an increase in drug levels was observed 12 weeks after IV UST intensification.
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AIM: Granulocyte and monocyte apheresis (GMA) is a potential therapeutic option when combined with various drugs for treatment of ulcerative colitis (UC). In this study, we analyze the efficacy and safety of GMA combined with vedolizumab (VDZ) during induction in patients with moderate-severe UC and incomplete response to steroids. PATIENTS AND METHODS: Single-center retrospective review of patients receiving GMA+VDZ. Data on the disease and previous treatments were collected. Clinical response was classified as no response, response without remission, and remission. Available data on biochemical and endoscopic response were included. Adverse events (AEs) were recorded. RESULTS: The study population comprised 6 patients with UC who had received GMA+VDZ during induction after failure of an anti-TNF agent. The median number of GMA sessions was 5 (IQR 4-5; 3-10). All the patients received VDZ 300mg iv at 0, 2, and 6 weeks, and 5 (83%) received an additional dose at week 10. During maintenance, all the patients continued VDZ iv every 8 weeks. The median follow-up was 57.6 months (IQR: 39-74). Four of the 6 patients achieved clinical remission after GMA+VDZ and continued in deep remission until the end of follow-up. A median, non-significant decrease of 1378µg/g (IQR: 924-5778µg/g) was observed for calprotectin and 42.2mg/l (IQR: 15.3-113.5) for CRP vs. baseline. No patient underwent colectomy. No treatment-related AEs were observed. CONCLUSIONS: GMA+VDZ during induction can be effective and safe in selected patients with moderate-severe UC and partial response to steroids.
Subject(s)
Antibodies, Monoclonal, Humanized , Colitis, Ulcerative , Gastrointestinal Agents , Granulocytes , Monocytes , Tertiary Care Centers , Humans , Colitis, Ulcerative/therapy , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/blood , Antibodies, Monoclonal, Humanized/therapeutic use , Retrospective Studies , Male , Female , Adult , Middle Aged , Gastrointestinal Agents/therapeutic use , Severity of Illness Index , Combined Modality Therapy , Remission Induction , Leukapheresis , Blood Component Removal/methods , Treatment OutcomeABSTRACT
It is widely acknowledged that inflammatory bowel disease (IBD) is associated with a high prevalence of sexual dysfunction (SD). However, there is a notable paucity of specific literature in this field. This lack of information impacts various aspects, including the understanding and comprehensive care of SD in the context of IBD. Furthermore, patients themselves express a lack of necessary attention in this area within the treatment of their disease, thus creating an unmet need in terms of their well-being. The aim of this position statement by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is to provide a review on the most relevant aspects and potential areas of improvement in the detection, assessment, and management of SD in patients with IBD and to integrate the approach to sexual health into our clinical practice. Recommendations are established based on available scientific evidence and expert opinion. The development of these recommendations by GETECCU has been carried out through a collaborative multidisciplinary approach involving gastroenterologists, gynecologists, urologists, surgeons, nurses, psychologists, sexologists, and, of course, patients with IBD.
Subject(s)
Colitis, Ulcerative , Crohn Disease , Sexual Dysfunction, Physiological , Humans , Crohn Disease/complications , Crohn Disease/therapy , Colitis, Ulcerative/complications , Colitis, Ulcerative/therapy , Sexual Dysfunction, Physiological/etiology , Sexual Dysfunction, Physiological/therapy , Spain , Female , Male , Sexual Dysfunctions, Psychological/etiology , Sexual Dysfunctions, Psychological/therapy , Sexuality , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/therapy , Sexual HealthABSTRACT
OBJECTIVE: Ustekinumab was recently approved for the treatment of moderate-to-severe ulcerative colitis (UC). Although data from the UNIFI clinical trial are encouraging, real-world data assessing effectiveness and safety are scarce. The aim of this study was to assess the effectiveness, safety and pharmacokinetics of ustekinumab in a large cohort of refractory UC patients. METHODS: Multicenter observational study of UC patients who received ustekinumab for active disease. The Partial Mayo Score (PMS), endoscopic activity, C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at different time points. Demographic and clinical data, adverse events (AEs) and surgeries were documented. RESULTS: A total of 108 patients were analyzed from 4 referral Spanish hospitals. The clinical remission rates were 59%, 56.5%, 57% and 69% of patients at weeks 8, 16, 24 and 52, respectively. Normalization of FC was achieved in 39.6%, 41% and 51% at weeks 8, 24 and 52, respectively. CRP normalization was observed in 79%, 75% and 76.5% of patients at weeks 8, 24 and 52, respectively. Fewer previous anti-TNF agents and loss of response to anti-TNF were associated with clinical response and normalization of FC, respectively. AEs were observed in 5 patients, and 9 underwent colectomy. Ustekinumab persistence rates were 91%, 83% and 81% at 24, 48 and 96 weeks, respectively. CONCLUSIONS: Ustekinumab demonstrated, in the real-world setting, long-term effectiveness and a favorable safety profile in a cohort of refractory UC patients.
Subject(s)
Colitis, Ulcerative , Ustekinumab , Humans , Ustekinumab/therapeutic use , Colitis, Ulcerative/surgery , Tumor Necrosis Factor Inhibitors/therapeutic use , Treatment Outcome , Remission Induction , C-Reactive ProteinABSTRACT
Introducción: Las principales guías de práctica clínica recomiendan la realización de endoscopia dentro de las 24horas posteriores a la admisión en urgencias en pacientes con hemorragia digestiva alta no variceal. Sin embargo, es un margen de tiempo muy amplio y el papel de la endoscopia urgente (<6horas) es controvertido. Material y métodos: Estudio prospectivo observacional realizado en Hospital Universitario La Paz, donde son seleccionados todos los pacientes, desde el 1 de enero de 2015 hasta el 30 de abril de 2020, que acudieron a urgencias y fueron sometidos a endoscopia por sospecha de hemorragia digestiva alta. Se establecieron dos grupos de pacientes: endoscopia urgente (<6horas) y precoz (6-24horas). El objetivo primario del estudio fue la mortalidad a los 30días. Resultados: Un total de 1.096 pacientes fueron incluidos, de los cuales 682 fueron sometidos a endoscopia urgente. La mortalidad a los 30 días fue del 6% (5% vs 7,7%, p=0,064) y del resangrado fue del 9,6%. No hubo diferencias estadísticamente significativas en la mortalidad, resangrado, necesidad de tratamiento endoscópico, cirugía y/o embolización, pero sí en la necesidad de transfusión (57,5% vs 68,4%, p<0,001) y el número de concentrados de hematíes transfundidos (2,85±4,01 vs 3,51±4,09, p=0,008). Conclusión: La endoscopia urgente, en pacientes con hemorragia digestiva alta aguda, también el subgrupo de alto riesgo (GBS ≥ 12), no se asoció con una mortalidad menor a los 30 días que la endoscopia precoz. Sin embargo, en los pacientes con lesiones endoscópicas de alto riesgo (Forrest I-IIB), fue un predictor significativo de menor mortalidad. Por lo tanto, se requieren más estudios para la identificación correcta de pacientes, que se beneficien de esta actitud médica (endoscopia urgente). (AU)
Introduction: The main clinical practice guidelines recommend endoscopy within 24hours after admission to the Emergency Department in patients with non-variceal upper gastrointestinal bleeding. However, it is a wide time frame and the role of urgent endoscopy (<6hours) is controversial. Material and methods: Prospective observational study carried out at La Paz University Hospital, where all patients were selected, from January 1, 2015 to April 30, 2020, who attended the Emergency Room and underwent endoscopy for suspected upper gastrointestinal bleeding. Two groups of patients were established: urgent endoscopy (<6hours) and early endoscopy (6-24hours). The primary endpoint of the study was 30-day mortality. Results: A total of 1096 were included, of whom 682 underwent urgent endoscopy. Mortality at 30days was 6% (5% vs 7.7%, P=.064) and rebleeding was 9.6%. There were no statistically significant differences in mortality, rebleeding, need for endoscopic treatment, surgery and/or embolization, but there were differences in the necessity for transfusion(57.5% vs 68.4%, P<.001) and the number of concentrates of transfused red blood cells (2.85±4.01 vs 3.51±4.09, P=.008). Conclusion: Urgent endoscopy, in patients with acute upper gastrointestinal bleeding, as well as the high-risk subgroup (GBS ≥12), was not associated with lower 30-day mortality than early endoscopy. However, urgent endoscopy in patients with high-risk endoscopic lesions (ForrestI-IIB), was a significant predictor of lower mortality. Therefore, more studies are required for the correct identification of patients who benefit from this medical approach (urgent endoscopy). (AU)
Subject(s)
Humans , Male , Female , Middle Aged , Aged , Gastrointestinal Hemorrhage , Endoscopy/mortality , Endoscopy/methods , Prospective Studies , Cohort Studies , Endoscopy, GastrointestinalABSTRACT
INTRODUCTION: Intestinal failure is a rare pathology which requires knowledge and highly specialized multidisciplinary management. Crohn's disease (CD) being one of the most frequent causes in adults. MATERIAL AND METHODS: Survey format study carried out within the GETECCU group, included closed format questions about the diagnosis, management and current knowledge of intestinal failure in CD. RESULTS: Forty-nine doctors participated, belonging to different Spanish centers (19 cities). It was considered that a patient suffered from intestinal failure, in 67.3% (33/49 surveyed) when there was a disorder malabsorptive associated regardless of the intestinal length resected, with surgeries resective ileal repeated (40.8%, 20/49), the most frequent cause. It highlights frequent ignorance about the pathology (24.5%) did not know if there were patients in their center and also 40% did not know the pharmacological treatment. A total of 228 patients were registered for follow-up due to intestinal failure of any aetiology, 89 patients (39.5%) were identified with CD. Regarding the therapeutic management of patients with CD and intestinal failure (72.5%) were receiving total parenteral nutrition (NTP) and 24 patients (27%) with teduglutide. Regarding the response to the drug: 37.5% had no response to teduglutide, 37.5% partial response (reduce NTP) and 25% good response (withdrawal of home NTP). In questions related to knowledge about intestinal failure, it was considered limited (53.1%) or very limited (12.2%) by the surveyed. CONCLUSION: It is necessary to carry out a combined management of intestinal failure and CD in the context of a multidisciplinary approach.
Subject(s)
Crohn Disease , Intestinal Failure , Adult , Humans , Spain , Intestines , IleumABSTRACT
INTRODUCTION: The main clinical practice guidelines recommend endoscopy within 24hours after admission to the Emergency Department in patients with non-variceal upper gastrointestinal bleeding. However, it is a wide time frame and the role of urgent endoscopy (<6hours) is controversial. MATERIAL AND METHODS: Prospective observational study carried out at La Paz University Hospital, where all patients were selected, from January 1, 2015 to April 30, 2020, who attended the Emergency Room and underwent endoscopy for suspected upper gastrointestinal bleeding. Two groups of patients were established: urgent endoscopy (<6hours) and early endoscopy (6-24hours). The primary endpoint of the study was 30-day mortality. RESULTS: A total of 1096 were included, of whom 682 underwent urgent endoscopy. Mortality at 30days was 6% (5% vs 7.7%, P=.064) and rebleeding was 9.6%. There were no statistically significant differences in mortality, rebleeding, need for endoscopic treatment, surgery and/or embolization, but there were differences in the necessity for transfusion(57.5% vs 68.4%, P<.001) and the number of concentrates of transfused red blood cells (2.85±4.01 vs 3.51±4.09, P=.008). CONCLUSION: Urgent endoscopy, in patients with acute upper gastrointestinal bleeding, as well as the high-risk subgroup (GBS ≥12), was not associated with lower 30-day mortality than early endoscopy. However, urgent endoscopy in patients with high-risk endoscopic lesions (ForrestI-IIB), was a significant predictor of lower mortality. Therefore, more studies are required for the correct identification of patients who benefit from this medical approach (urgent endoscopy).