Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study

BACKGROUND: A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. METHODS: Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm. RESULTS: The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. CONCLUSION: The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.Journal ArticleMulticenter StudyResearch Support, Non-U.S. Gov'tinfo:eu-repo/semantics/publishe

Treatment of neuromyelitis optica: state-of-the-art and emerging therapies.

Neuromyelitis optica (NMO) is an autoimmune disease of the CNS that is characterized by inflammatory demyelinating lesions in the spinal cord and optic nerve, potentially leading to paralysis and blindness. NMO can usually be distinguished from multiple sclerosis (MS) on the basis of seropositivity for IgG antibodies against the astrocytic water channel aquaporin-4 (AQP4). Differentiation from MS is crucial, because some MS treatments can exacerbate NMO. NMO pathogenesis involves AQP4-IgG antibody binding to astrocytic AQP4, which causes complement-dependent cytotoxicity and secondary inflammation with granulocyte and macrophage infiltration, blood-brain barrier disruption and oligodendrocyte injury. Current NMO treatments include general immunosuppressive agents, B-cell depletion, and plasma exchange. Therapeutic strategies targeting complement proteins, the IL-6 receptor, neutrophils, eosinophils and CD19--all initially developed for other indications--are under clinical evaluation for repurposing for NMO. Therapies in the preclinical phase include AQP4-blocking antibodies and AQP4-IgG enzymatic inactivation. Additional, albeit currently theoretical, treatment options include reduction of AQP4 expression, disruption of AQP4 orthogonal arrays, enhancement of complement inhibitor expression, restoration of the blood-brain barrier, and induction of immune tolerance. Despite the many therapeutic options in NMO, no controlled clinical trials in patients with this condition have been conducted to date

Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease

BACKGROUND Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin-12 and inter-leukin-23, was evaluated as an intravenous induction therapy in two populations with moderately to severely active Crohn’s disease. Ustekinumab was also evaluated as subcutaneous maintenance therapy. METHODS We randomly assigned patients to receive a single intravenous dose of ustekinumab (either 130 mg or approximately 6 mg per kilogram of body weight) or placebo in two induction trials. The UNITI-1 trial included 741 patients who met the criteria for primary or secondary nonresponse to tumor necrosis factor (TNF) antagonists or had unacceptable side effects. The UNITI-2 trial included 628 patients in whom conventional therapy failed or unacceptable side effects occurred. Patients who completed these induction trials then participated in IM-UNITI, in which the 397 patients who had a response to ustekinumab were randomly assigned to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 8 weeks or every 12 weeks) or placebo. The primary end point for the induction trials was a clinical response at week 6 (defined as a decrease from baseline in the Crohn’s Disease Activity Index [CDAI] score of ≥100 points or a CDAI score <150). The primary end point for the maintenance trial was remission at week 44 (CDAI score <150). RESULTS The rates of response at week 6 among patients receiving intravenous ustekinumab at a dose of either 130 mg or approximately 6 mg per kilogram were significantly higher than the rates among patients receiving placebo (in UNITI-1, 34.3%, 33.7%, and 21.5%, respectively, with P≤0.003 for both comparisons with placebo; in UNITI-2, 51.7%, 55.5%, and 28.7%, respectively, with P<0.001 for both doses). In the groups receiving maintenance doses of ustekinumab every 8 weeks or every 12 weeks, 53.1% and 48.8%, respectively, were in remission at week 44, as compared with 35.9% of those receiving placebo (P = 0.005 and P = 0.04, respectively). Within each trial, adverse-event rates were similar among treatment groups. CONCLUSIONS Among patients with moderately to severely active Crohn’s disease, those receiving intravenous ustekinumab had a significantly higher rate of response than did those receiving placebo. Subcutaneous ustekinumab maintained remission in patients who had a clinical response to induction therapy. (Funded by Janssen Research and Development; ClinicalTrials.gov numbers, NCT01369329, NCT01369342, and NCT01369355.

Reflective practice applied in a clinical oncology research setting

Regular reflective practice group sessions, focusing on enhancing mindfulness, were piloted as part of a support programme for researchers in a clinical oncology setting. Methods: As a previous systematic review highlighted a wide variety of approaches and a lack of published evidence on the use of specific models for reflective practice in health care, a scoping review of existing literature describing reflective practice models preceded piloting the programme with the research team. The Mindful Attention Awareness Scale (MAAS) was used to assess the benefit for participants. Scores from the first and last session were analysed using a paired-sample t-test. Feedback from questionnaires was analysed using descriptive statistics (for Likert scales) and direct quotes from free text exemplified the experience. Results: Seven people participated. Six were female, all were research nurses except for one research allied health professional. The median age was 37 (range: 23–40 years). The average time since graduation was 10 years (range: 1.5–18 years). All researchers worked in a tertiary oncology setting. Although a total of 21 reflective practice sessions were facilitated, the median number of sessions attended was 9 (range: 2–21). The mean MAAS score improved from 57.83 to 62.83 (p=0.0146). The participants rated the experience and impact as positive. Conclusion: The results of the MAAS score indicate that mindfulness was enhanced by the sessions. The feedback from the participants highlighted the impact on their professional development. This is encouraging to support developing similar facilitated reflective practice programmes in different settings. </jats:p

Effectiveness and persistence of Vedolizumab in patients with inflammatory bowel disease : results from the Belgian REal-LIfe study with VEdolizumab (Be-RELIVE).

Vedolizumab (VDZ) is a gutselective integrin inhibitor used to treat Crohn's disease (CD) and ulcerative colitis (UC). This retrospective study assessed effectiveness and treatment persistence of VDZ in a Belgian reallife cohort of CD and UC patients. CD and UC patients from 15 Belgian centers, who started VDZ between 01/09/2015 and 31/06/2016 and attended ≥1 visit after the first VDZ infusion, were included. Data were collected before first infusion, at week (W)10, W14 (CD patients only), month (M)6 and last follow-up. Treatment response and remission rates (changes in disease activity scores) and treatment persistence (Kaplan-Meier analysis) were assessed. Of the 348 patients receiving at least one dose of VDZ, 325 (202 CD, 45 biologic-naïve; and 123 UC, 42 biologic-naïve) patients were included in data analyses. At M6, 87.6% (176/201) of CD and 86.1% (105/122) of UC patients were still on VDZ treatment, 75.6% (34/45) and 83.9% (26/31) achieved clinical response, and 66.7% (44/66) and 42.9% (15/35) were in remission. At M6 remission rates was significantly higher while response rates tended to be higher among biologic-naïve versus biologic-failure CD patients. VDZ offers an effective treatment option in real-life settings and treatment effectiveness appears higher in biologic-naïve versus biologic-failure CD patients. (Acta gastroenterol. belg., 2020, 83, 15-23)

Effectiveness and persistence of Vedolizumab in patients with inflammatory bowel disease : results from the Belgian REal-LIfe study with VEdolizumab (Be-RELIVE)

Background and study aims: Vedolizumab (VDZ) is a gutselective integrin inhibitor used to treat Crohn's disease (CD) and ulcerative colitis (UC). This retrospective study assessed effectiveness and treatment persistence of VDZ in a Belgian reallife cohort of CD and UC patients. Patients and methods: CD and UC patients from 15 Belgian centers, who started VDZ between 01/09/2015 and 31/06/2016 and attended ≥1 visit after the first VDZ infusion, were included. Data were collected before first infusion, at week (W)10, W14 (CD patients only), month (M)6 and last follow-up. Treatment response and remission rates (changes in disease activity scores) and treatment persistence (Kaplan-Meier analysis) were assessed. Results: Of the 348 patients receiving at least one dose of VDZ, 325 (202 CD, 45 biologic-naïve; and 123 UC, 42 biologic-naïve) patients were included in data analyses. At M6, 87.6% (176/201) of CD and 86.1% (105/122) of UC patients were still on VDZ treatment, 75.6% (34/45) and 83.9% (26/31) achieved clinical response, and 66.7% (44/66) and 42.9% (15/35) were in remission. At M6 remission rates was significantly higher while response rates tended to be higher among biologic-naïve versus biologic-failure CD patients. Conclusions: VDZ offers an effective treatment option in real-life settings and treatment effectiveness appears higher in biologic-naïve versus biologic-failure CD patients. (Acta gastroenterol. belg., 2020, 83, 15-23).status: publishe