Intravenous ustekinumab maintenance treatment in patients with loss of response to subcutaneous dosing.

Background: Ustekinumab (UST) is indicated for the treatment of Crohn's disease (CD) and Ulcerative Colitis (UC). Despite having shown clinical effectiveness in the real world, some patients may lose response over time or need a higher dose to achieve it. In this context, UST intravenous (IV) maintenance has been proposed. Objectives: The primary endpoint of our study was to evaluate the efficacy and safety of maintenance IV UST treatment in Inflammatory Bowel Disease (IBD) patients who present with partial response or loss of response to subcutaneous (SC) UST. Design: We performed a monocentric observational retrospective study including patients with active IBD on maintenance treatment with IV UST. Methods: The clinical response and remission was analyzed at week 12, defined as either Harvey-Bradshaw Index ⩽ 4 for CD or partial Mayo Score ⩽ 2 for UC. The reduction of objective markers of disease activity, fecal calprotectin, and C-reactive protein was evaluated. Moreover, UST trough levels were measured pre- and post-UST IV maintenance and any adverse events were assessed. Results: We included 23 patients. Clinical remission at week 12 was achieved by 43.5% of the patients. The proportion of patients in clinical response after 12 weeks on UST IV maintenance was 82.6%. After a median follow-up of 9.3 months all patients remained on IV UST maintenance. No adverse events were recorded in any patient for the duration of the study. Conclusions: IV UST maintenance treatment was able to recapture response in most of the patients who had lost response to SC maintenance.

Severe outbreak of ulcerative colitis and cerebral neoplasia. Difficult management in COVID time.

A 61-year-old male diabetic patient, diagnosed with ulcerative colitis (UC) 30 years ago, currently under treatment with mesalazine is presented. He was admitted to the emergency department due to a severe outbreak of UC, with 15 depositions daily, rectal bleeding and poor general condition. A brain CT-scan was carried out in the emergency department due to a sudden self-limited aphasia. A left frontal lesion of 45x38 mms with a prominent perilesional edema and with a displacement of the midline was reported. This was believed to be a meningioma (figure 1A). Urgent neurosurgery was not performed, prioritizing the severe flare-up UC. Based on this, full-dose metilprednisolone was administered.

GIST. Duodenopancreatectomía. Tumor neuroendocrino no funcionante.

Zollinger Ellison syndrome is an unusual entity. This termn is used to describe the clinical manifestations of a gastrin-synthesizing neoplasm. Gastrinomas occur mainly in the duodenum and pancreas. Primary gastrinomas are rarely found in other intra-abdominal sites, such as the ovary, bile ducts, spleen or kidney, or even more unusual in extra-abdominal locations. Several studies provide strong evidence that gastrinomas can also occur in the lymph nodes. However, the existence of primary lymph node gastrinomas is controversial.

Switch to subcutaneous infliximab during the SARS-CoV-2 pandemic: preliminary results.

A new subcutaneous formulation of the infliximab biosimilar CT-P13 has recently been developed for the treatment of inflammatory bowel disease (IBD), providing response rates similar to intravenous treatment. The use of this new formulation was requested, in an effort to limit patient attendance at intravenous infusion centers and to maintain biological treatment during the COVID-19 pandemic. The objective of this observational, retrospective and descriptive study was to assess CT-P13 efficacy and safety after switching from intravenous to a subcutaneous formulation in patients with IBD receiving maintenance therapy. This article shows preliminary results after six months of follow-up.

Comparison of the Mayo Endoscopy Score and the Ulcerative Colitis Endoscopy Index of Severity and the Ulcerative Colitis Colonoscopy Index of Severity.

Background and study aims: Endoscopy plays an essential role in managing patients with ulcerative colitis (UC), as it allows us to visualize and assess the severity of the disease. As such assessments are not always objective, different scores have been devised to standardize the findings. The main aim of this study was to assess the interobserver variability between the Mayo Endoscopy Score (MES), Ulcerative Colitis Endoscopy Index of Severity (UCEIS) and Ulcerative Colitis Colonoscopy Index of Severity (UCCIS) analyzing the severity of the endoscopic lesions in patients with ulcerative colitis. Patients and methods: This was a single-cohort observational study in which a colonoscopy was carried out on patients with UC, as normal clinical practice, and a video was recorded. The results from the video were classified according to the MES, UCEIS and UCCIS by three endoscopic specialists independently, and they were compared to each other. The Mayo Endoscopy Score (MES) was used to assess the clinical situation of the patient. The therapeutic impact was analyzed after colonoscopy was carried out. Results: Sixty-seven patients were included in the study. The average age was 51 (SD ±â€Š16.7) and the average MES was 3.07 (SD ±â€Š2.54). The weighted Kappa index between endoscopists A and B for the MES was 0.8; between A and C 0.52; and between B and C 0.49. The intraclass correlation coefficient for UCEIS was 0.92 among the three endoscopists (CI 95 %: 0.83-0.96) and 0.96 for UCCIS among the three endoscopists (CI 95 % 0.94-0.97). A change in treatment for 34.3 % of the patients was implemented on seeing the results of the colonoscopy. Conclusions: There was an adequate, but not perfect, correlation between the different endoscopists for MES, UCEIS, UCCIS. This was higher with the last two scores. Thus, there is still some subjectivity to be minimized through special training, on assessing the seriousness of the endoscopic lesions in patients with UC.

An extremely uncommon complication of acute pancreatitis: spontaneous pancreatic cutaneous fistula.

We report the case of a 67-year-old male who was referred to our hospital due to severe abdominal pain and fever. His past medical history included a total gastrectomy surgery for stomach cancer. Abdominal examination showed intense pain on deep palpation in the epigastric region. Laboratory test revealed elevated C-reactive protein (235 mg/l) and amylase (1,789 U/l). Computerized tomography reported a pancreatic collection with the presence of air bubbles inside and areas of necrotic pancreatic parenchyma.

Views of patients with inflammatory bowel disease during the COVID-19 pandemic: ACCU survey results.

INTRODUCTION AND OBJECTIVES: the SARS-COV-2 pandemic has forced a substantial change in the care of patients with digestive pathologies, especially for inflammatory bowel disease (IBD) patients taking immunosuppessive medications. In this regard, some national and international guidelines have indicated the standards to be taken into account. However, few studies have evaluated how patients have dealt with this infection. Therefore, this study was performed with the aim to determine how the SARS-COV-2 pandemic has affected our IBD patients. MATERIAL AND METHODS: an online survey was performed among the members (295) of the Association of Crohn's Disease and Ulcerative Colitis (ACCU), which consisted of 19 questions. Finally, it was completed by 168 patients. RESULTS: fifty-eight per cent of cases were female, 63.7 % had Crohn's disease (CD) and 53 % received biologic therapy. Five per cent were infected by SARS-CoV-2 and were male. The main concern of the patients was the fear of acquiring the infection (80.9 %). More than 90 % continued their treatments and half of the patients worked from home during the pandemic period. CONCLUSIONS: the perspective of the patients is necessary to achieve an adequate management and evolution of the disease. More studies are needed to assess the impact that exceptional situations, such as the COVID-19 pandemic, may have on IBD patients in order to improve adherence and control of the disease.

Índice de Mayo Endoscópico e Índice de Severidad Endoscópica de la Colitis Ulcerosa: ¿son igual de válidos? / No disponible

INTRODUCCIÓN: la endoscopia tiene un papel fundamental en el manejo de los pacientes con colitis ulcerosa (CU), ya que permite la visualización y evaluación de la gravedad de la enfermedad. No obstante, dicha evaluación no es siempre algo objetivo, por lo que se han desarrollado diferentes escalas que pretenden homogeneizar los hallazgos. Objetico: el objetivo del estudio fue evaluar la variabilidad interobservador entre el Índice de Mayo Endoscópico (IME) y el Índice de Severidad Endoscópica de la Colitis Ulcerosa (UCEIS), al analizar la gravedad de las lesiones endoscópicas en pacientes con CU. El objetivo secundario fue analizar si la preparación catártica afectaba al grado de concordancia entre los endoscopistas. MATERIAL Y MÉTODOS: se trata de un estudio observacional comparativo de una única cohorte a la cual se realiza una colonoscopia bajo guía de práctica clínica habitual a pacientes con CU y se estadifica según el IME y el UCEIS por tres endoscopistas expertos. Para valorar el grado de correlación interobservador se utilizaron el índice de Kappa para el IME y el coeficiente de correlación intraclase para el UCEIS. Se incluyeron 67 pacientes, con edad media de 51 años (DE ± 16,7) e índice de Mayo clínico medio de 3,07 (DE ± 2,54). RESULTADOS: el índice de Kappa ponderado entre los endoscopistas A y B para el IME fue de 0,8; entre el A y el C, de 0,52; y entre el B y el C, de 0,49. Para el UCEIS, el coeficiente de correlación intraclase fue del 0,922 entre los tres endoscopistas (IC 95 %: 0,832-0,959). Se encontró una mejor correlación interobservador cuando la preparación catártica era ≥ 8 según la escala de Boston. CONCLUSIÓN: existe, por tanto, una superior correlación entre los diferentes endoscopistas para el UCEIS que para el IME, por lo que debería ser considerado como el mejor índice a utilizar en la práctica clínica. Una buena preparación catártica es importante para mejorar la correlación interobservador

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Index of the Mayo Endoscopy and Ulcerative Colitis Endoscopy Index of Severity: are they equally valid?

INTRODUCTION: endoscopy plays an essential role in the management of patients with ulcerative colitis (UC), as it allows us to visualize and assess the severity of the disease. Different scores have been devised to standardize the findings because such assessments are not always objective. AIMS: the aim of this study was to assess the interobserver variability between the Index of Mayo Endoscopy (IME) and the Ulcerative Colitis Endoscopy Index of Severity (UCEIS), analyzing the severity of the endoscopic lesions in patients with UC. The secondary aim was to analyze if the cathartic preparation affected the degree of concordance amongst the endoscopists. MATERIAL AND METHODS: this was a single-cohort observational, comparative study in which a colonoscopy was performed in patients with UC, as the normal clinical practice. The results were classified according to the IME and the UCEIS by three endoscopic specialists. In order to assess the degree of interobserver correlation, the Kappa index for IME was used and the intraclass correlation coefficient was used for UCEIS. RESULTS: sixty-seven patients were included in the study. The average age was 51 (SD ± 16.7) and the average Mayo Clinic index was 3.07 (SD ± 2.54). The weighted Kappa index between endoscopists A and B for the IME was 0.8, 0.52 between A and C and 0.49 between B and C. The intraclass correlation coefficient for UCEIS was 0.922 between the three endoscopists (95 % CI: 0.832-0.959). A better interobserver correlation was found when the cathartic preparation was ≥ 8 based on the Boston Scale. CONCLUSIONS: there was a higher correlation between the different endoscopists for the UCEIS than for the IME. Thus, this should be considered to be the best index to use in the clinical practice. A good cleansing preparation is important to improve the interobserver correlation.

Cut-off ranges of infliximab serum levels in Crohn's disease in the clinical practice

INTRODUCTION: between 30 % and 40 % of patients treated with infliximab lose response during maintenance. Therapeutic drug monitoring could be used to optimize management in these situations. However, infliximab serum levels are not well defined. The aim of this study was to determine the cut-off range of infliximab serum levels in Crohn's disease patients in remission in the clinical practice. METHODS: an observational retrospective study was performed from 2016 to 2017. Patients were included with established Crohn's disease, who had been on a maintenance dose schedule of infliximab. Infliximab levels and antibodies to infliximab were measured at least twice in all patients, after induction and after six months of treatment. Clinical remission was defined as ≤ 4 using the Harvey-Bradshaw index. Cluster analysis was used to analyze the results. RESULTS: one hundred and five Crohn's disease patients were included in the study; 57.1 % were male with a mean age of 39 years (SD ± 12.9). The median (range) time of the disease was eleven years (7-15) and the median (range) time of follow-up was 32 months (22-38). Patients who achieved remission had infliximab serum levels between 4.26-8.26 ug/ml versus 0.06-1.43 ug/ml in patients who did not achieve remission after induction. Infliximab serum levels were 2.84-7.75 ug/ml and 0.05-2.69 ug/ml in patients who achieved remission versus those who did not achieve remission after six months of treatment. Overall, 4.26-8.26 ug/ml was found to be the best cut-off range for remission. CONCLUSIONS: in our clinical practice, serum levels of infliximab in Crohn's disease patients should be higher than 4 ug/ml to achieve clinical remission

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Cut-off ranges of infliximab serum levels in Crohn's disease in the clinical practice.

INTRODUCTION: between 30 % and 40 % of patients treated with infliximab lose response during maintenance. Therapeutic drug monitoring could be used to optimize management in these situations. However, infliximab serum levels are not well defined. The aim of this study was to determine the cut-off range of infliximab serum levels in Crohn's disease patients in remission in the clinical practice. METHODS: an observational retrospective study was performed from 2016 to 2017. Patients were included with established Crohn's disease, who had been on a maintenance dose schedule of infliximab. Infliximab levels and antibodies to infliximab were measured at least twice in all patients, after induction and after six months of treatment. Clinical remission was defined as ≤ 4 using the Harvey-Bradshaw index. Cluster analysis was used to analyze the results. RESULTS: one hundred and five Crohn's disease patients were included in the study; 57.1 % were male with a mean age of 39 years (SD ± 12.9). The median (range) time of the disease was eleven years (7-15) and the median (range) time of follow-up was 32 months (22-38). Patients who achieved remission had infliximab serum levels between 4.26-8.26 ug/ml versus 0.06-1.43 ug/ml in patients who did not achieve remission after induction. Infliximab serum levels were 2.84-7.75 ug/ml and 0.05-2.69 ug/ml in patients who achieved remission versus those who did not achieve remission after six months of treatment. Overall, 4.26-8.26 ug/ml was found to be the best cut-off range for remission. CONCLUSIONS: in our clinical practice, serum levels of infliximab in Crohn's disease patients should be higher than 4 ug/ml to achieve clinical remission.

Erythema Nodosum: As an Extraintestinal Manifestation or Complication in Ulcerative Colitis?

In our case, we want to highlight the importance of screening for opportunistic infectious diseases in these immunosuppressed patients. We present the case of an erythema nodosum triggered by reactivation of Herpes Simplex Virus (HSV) in a patient with ulcerative colitis.

Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data.

BACKGROUND: Several studies have reported positive efficacy outcomes for patients with inflammatory bowel disease treated with CT-P13, an infliximab biosimilar. Data from follow-up periods longer than 1 year are still scarce. Here, we assessed the long-term efficacy data, loss of response and safety after switching from infliximab to CT-P13 in patients with inflammatory bowel disease. METHODS: This was a prospective single-center observational study involving patients with moderate-to-severe Crohn's disease and ulcerative colitis switched from infliximab to CT-P13 treatment and reviewed up to 24 months. Efficacy and loss of response were measured using the Harvey-Bradshaw (HB) index and partial Mayo score for patients with Crohn's disease and ulcerative colitis respectively. C-reactive protein, infliximab drug levels, adverse events and antidrug antibodies were also monitored throughout the study. RESULTS: A total of 64 patients with Crohn's disease and 36 patients with ulcerative colitis were included. Most of them (72%) remained on CT-P13. Overall, 28% of patients discontinued the therapy due to loss of response, adverse events or long-lasting clinical remission. Remission at 18 and 24 months occurred in 69.9% and 68.5% of patients, respectively. Dose increase was performed in 22% of patients, with remission being reached in 60% of them. HB index, partial Mayo score, C-reactive protein and infliximab drug levels did not show significant changes. Serious adverse events were reported in 14% of patients. Overall, two patients developed low levels of antidrug antibodies. CONCLUSIONS: Most of the patients switching from original infliximab were maintained on CT-P13 at 2 years of follow up with a good profile of efficacy and safety.