Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis.

OBJECTIVES: Current options for patients with steroid-dependent, chronic-active ulcerative colitis (UC) with insufficient response/intolerance to immunosuppressants (ISs) and/or biologics are limited. The aim of this study was to assess the long-term outcome of granulocyte/monocyte adsorptive (GMA) apheresis (Adacolumn®) in this population. MATERIALS AND METHODS: Ninety five adults with steroid-dependent active UC and insufficient response/intolerance to IS and/or TNF inhibitors received 5-8 aphereses in a single induction series of ≤10 weeks. Endpoints included rates of remission (clinical activity index [CAI] ≤ 4) at weeks 24 and 48. RESULTS: Of 94 patients (ITT population), remission and response rates were 34.0% and 44.7% at week 24, and 33.0% and 39.4% at week 48. Among 30 patients with prior failure of IS and biologics, 33.3% and 20.0% were in remission at weeks 24 and 48. At both weeks, 19.2% of patients achieved steroid-free remission. Sustained remission or response occurred in 27.7% of patients at 48 weeks. The cumulative colectomy rate at week 96 was 23.4%. Safety was consistent with previous findings. CONCLUSIONS: This study confirms findings of the 12-week interim analysis and demonstrates that GMA apheresis provides a safe and beneficial long-term outcome for patients with chronic active UC resistant/intolerant to IS and/or TNF inhibitors.

Absence of a role for interleukin-13 in inflammatory bowel disease.

IL-13 has been implicated in the pathogenesis of ulcerative colitis (UC), and may have a role in animal models of gut fibrosis. We studied the involvement of IL-13 in inflammation and fibrosis in UC and Crohn's disease (CD). Intestinal biopsies and anti-CD3/CD28- or anti-CD2/CD28-stimulated lamina propria mononuclear cells from UC and CD patients and control subjects were cultured, and IL-13, IL-4, IL-5, IL-17A and IFN-γ production was measured. Mucosal IL-13-producing cells were characterised by flow cytometry. Gut explants from strictured CD, non-strictured CD and healthy donors were cultured ex vivo, and secreted IL-13, IL-1ß and collagen were measured. IL-13 production by mucosal explants and activated lamina propria mononuclear cells did not differ between CD, UC and control subjects, and was at least a log lower than IFN-γ and IL-17A. IL-13-producing cells, and in particular natural killer T cells, were uniformly low in all groups. IL-4 and IL-5 were undetectable in culture supernatants. Explants of CD strictures produced low amounts of IL-13, whereas IL-1ß and collagen were elevated. We could not confirm that UC or strictured CD are associated with elevated IL-13 production. These data suggest that an anti-IL-13 Ab would not be an appropriate therapeutic strategy in inflammatory bowel disease.

Treatment of COVID-19 Patients at a Medical College Hospital in Bangladesh.

BACKGROUND AND AIM: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has induced a sense of panic around the world as the disease is highly contagious and has been spreading in full swing during last 5 months causing millions of COVID-19 patients and hundreds of thousands of deaths. Bangladesh, a country of 170 million people, is not an exception regarding COVID-19; it has reported several thousand COVID-19 patients with several hundred of deaths. This observational study has been planned to assess the scope and limitation of management strategy against COVID-19 patients in a medical college hospital of Bangladesh with available drugs in a real-life situation. MATERIALS AND METHODS: All patients in this cohort (N: 33) were positive for SARS-CoV-2 by polymerase chain reaction (PCR) and they attended the hospital with variable presenting symptoms those ranged from cough and fever to respiratory distress and pneumonia. As per the protocol, the patients were regularly evaluated for several parameters of COVID-19-related pathology. Before discharge, they were checked for SARS-CoV-2 for 2 consecutive times. The management strategy included standard of care (SoC) and administration of hydroxychloroquine and azythromycin, available in Bangladesh. RESULTS: Out of total 33 patients, 1 patient died at day 4 day after admission. Two patients developed severe complications and were referred to tertiary hospital in Dhaka (2 and 3 days after admission), the capital of Bangladesh, where they recovered and were discharged from hospital after being SARS-CoV-2 negative. The rest 30 patients were discharged from the medical college hospital after being negative for SARS-CoV-2 in two subsequent assessments and improvement of their COVID-related symptoms. The average hospital stay of these patients was 14.5 days with a range of 10-24 days. CONCLUSION: It seems that most of the COVID-19 patients may be adequately managed by standard of care management with drug support. However, early diagnosis and hospitalization with adequate care may be important variables for better survival. These factors may be properly ensured if the patient burden remains at a palatable level in forthcoming days in Bangladesh. HOW TO CITE THIS ARTICLE: Bhuyan MAR, Al Mahtab M, Ashab E, et al. Treatment of COVID-19 Patients at a Medical College Hospital in Bangladesh. Euroasian J Hepato-Gastroenterol 2020;10(1):27-30.

Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results.

BACKGROUND AND AIMS: Patients with active, steroid-dependent ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologic therapies have limited treatment options. Adacolumn, a granulocyte/monocyte adsorptive apheresis device, has shown clinical benefit in these patients. This study aimed to provide additional clinical data regarding the safety and efficacy of Adacolumn in this patient subgroup. METHODS: This single-arm, open-label, multicentre trial [ART] was conducted at 18 centres across the UK, France, and Germany. Eligible patients were 18-75 years old with moderate-to-severe, steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics. Patients received ≥ 5 weekly apheresis sessions with Adacolumn. The primary endpoint was clinical remission rate [clinical activity index ≤ 4] at Week 12. RESULTS: In all, 86 patients were enrolled. At Week 12, 33/84 [39.3%] of patients in the intention-to-treat population achieved clinical remission, with 47/84 [56.0%] achieving a clinical response [clinical activity index reduction of ≥ 3]. Clinical remission was achieved in 30.0% of patients with previous immunosuppressant and biologic failure; steroid-free clinical remission and response were observed in 22.6% and 35.7% of these patients, respectively. Quality of life [Short Health Scale] significantly improved at Week 12 [p < 0.0001]. The majority of adverse events were of mild/moderate intensity. CONCLUSIONS: At Week 12, Adacolumn provided significant clinical benefit in a large cohort of steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment, with a favourable safety profile. These results are consistent with previous studies and support Adacolumn use in this difficult-to-treat patient subgroup.