Search

Supplemental material, sj-docx-2-tag-10.1177_17562848231153560 for Effectiveness and safety of ustekinumab in bio-naïve Crohn’s disease patients: a multicentre observational retrospective study by Valdés Delgado Teresa, Olmedo Martín Rául, Iborra Marisa, Herrera de Guisé Claudia, Fuentes-Valenzuela Esteban, Melcarne Luigi, Martín-Rodríguez Mª Mar, Kolle Casso Lilyan, De Castro Parga Luisa, Ponferrada Díaz Ángel, Vicente Lidón Raquel, Manceñido Marcos Noemí, Velayos Jiménez Benito, Lázaro Sáez Marta, López Cauce Beatriz, Mesonero Gismero Francisco, Gilabert Álvarez Pau and Argüelles-Arias Federico in Therapeutic Advances in Gastroenterology

Supplemental material, sj-docx-3-tag-10.1177_17562848231153560 for Effectiveness and safety of ustekinumab in bio-naïve Crohn’s disease patients: a multicentre observational retrospective study by Valdés Delgado Teresa, Olmedo Martín Rául, Iborra Marisa, Herrera de Guisé Claudia, Fuentes-Valenzuela Esteban, Melcarne Luigi, Martín-Rodríguez Mª Mar, Kolle Casso Lilyan, De Castro Parga Luisa, Ponferrada Díaz Ángel, Vicente Lidón Raquel, Manceñido Marcos Noemí, Velayos Jiménez Benito, Lázaro Sáez Marta, López Cauce Beatriz, Mesonero Gismero Francisco, Gilabert Álvarez Pau and Argüelles-Arias Federico in Therapeutic Advances in Gastroenterology

The incidence of extramammary Paget's disease (EMPD) is very low. It is very important to distinguish between primary Paget's disease and secondary to another process. An 85-year-old man consulted for the presence of an erythematous plaque located in the anal and gluteal area, confirming Paget cells in the biopsy.

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.

INTRODUCTION The primary goal of this study was to compare gastrointestinal symptom reduction in patients on bismuth-containing quadruple eradication therapy supplemented with Lactobacillus reuteri strains (DSM 17938 and ATCC PTA 6475) or placebo. MATERIALS AND METHODS This was randomized, double-blind, parallel-arm, placebo-controlled clinical trial. Patients received first-line an eradication regimen based on bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride (three-in-one capsules), and omeprazole 40 mg twice a day for ten days, plus a probiotic or placebo tablet for 30 days. During follow-up gastrointestinal symptoms were assessed using an evaluation scale (GSRS), and adverse events were collected at 0, 14, 28, and 56 days. RESULTS A total of 80 patients were included from February 2018 to May 2019 at a single site. Eradication therapy was effective for 85% of patients, with no differences between treatment arms. In the group receiving the probiotic, abdominal pain decreased in 42% of patients, compared with 19% in the control group (OR: 0.27; CI, 0.13-0.58; p < 0.001), and abdominal distension decreased in 25% versus 17% in the control group (OR: 0.24; IC, 0.19-0.84; p < 0.001); Conclusions: Treatment with L. reuteri only reduced abdominal pain and distension. Further studies are needed to establish the role of probiotics as adjuvant therapy in H. pylori eradication.

Background Ustekinumab is a monoclonal antibody that inhibits interleukins (IL)- 12 and -23 and it is approved for the treatment of Crohn's disease (CD) and more recently also ulcerative colitis (UC). Our aim was to evaluate the effectiveness and safety of Ustekinumab, as well as to identify possible predictive factors of response in a real-life setting. Methods Observational, retrospective, and multicenter study carried out in 4 hospitals in Andalusia. Adult patients with a confirmed diagnosis of CD treated with Ustekinumab from 2017 to 2019 were included. Clinical response was analyzed at 3, 6, and 12 months of treatment. Clinical disease activity was assessed with the Harvey Bradshaw index (HBI) and the Crohn's Disease Activity Index (CDAI), and the biochemical response was assessed with analytical parameters such as CRP and ESR. One-year ustekinumab drug-survival was analyzed. Results 98 patients were analyzed (mean age 43 and 52% men). 56% had failed to ≥2 previous biologicals therapies. At 3 months, 69% of the patients were in response and 40.8% in remission. At 6 months, 56% were in clinical remission. At 12 months, 73.7% in clinical response and 60.5% in remission. Corticosteroid-free remission was 32.4%, 44%, 47.4% at 3, 6, and 12 months, respectively. The cumulative survival at one year of treatment with ustekinumab was 85.3%. Biochemical parameters, such as CRP and ESR showed a statistically significant decrease between baseline and control levels at 3, 6, and 12 months. A lower HBI at baseline and female sex were predictors of corticosteroid-free clinical remission in a univariate analysis. In the multivariate analysis, no variables were found as predictors of corticosteroid-free clinical remission Conclusion: Ustekinumab therapy is safe and useful inducing a clinical response in more than 50% of patients including patients who have failed other biological therapies.

Primary follicular lymphomas (FL) of the gastrointestinal (GI) tract are very rare and constitute < 4 % of all non-Hodgkin's lymphomas at this location. We report our experience with primary FL of the GI tract.

Ischemic gastritis is an extremely rare entity due to the rich gastric vascularization. The case we are going to present could be the ideal setting to suspect it.

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.

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.

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.