Persistence of Tofacitinib Treatment in Patients With Ulcerative Colitis Who Entered the Open-Label, Long-Term Extension Study, OCTAVE OPEN Without a Clinical Response

Introduction: Drug survival in open-label, long-term extension (OLE) studies may provide information on the long-term efficacy and tolerability of a therapy. Methods: We present data on the persistence of tofacitinib treatment in the OLE study for: (1) delayed responders: induction non-responders (pts who did not achieve a clinical response [CR] after 8 weeks [wks] induction treatment with tofacitinib 10 mg BID) who achieved a CR at Wk 8 (total of 16 wks induction) of the OLE study and continued to receive 10 mg BID;(2) retreatment responders: tofacitinib 10 mg BID induction responders who experienced treatment failure with PBO in OCTAVE Sustain and entered the OLE study and received 10 mg BID, and achieved a CR at Wk 8 of the OLE study;and (3) dose escalation responders: tofacitinib 10 mg BID induction responders who experienced treatment failure with 5 mg BID in OCTAVE Sustain and entered the OLE study and received 10 mg BID, and achieved a CR at Wk 8 of the OLE study (Figure 1). The calculations are based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there are no missing data due to COVID-19. 3CDAI < 150 4Average daily stool frequency (SF) ≤ 2.8 and not worse than baseline AND average daily abdominal pain (AP) score ≤ 1 and not worse than baseline 5Decrease in SES-CD > 50% from baseline (or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline), as scored by central readers.

Best Practice Guidance for Adult Infusion Centres during the COVID-19 Pandemic: Report from the COVID-19 International Organization for the Study of IBD [IOIBD] Task Force.

Infusion centres are a central part in the management of patients with inflammatory bowel disease [IBD] and could be a source of transmission of SARS-COV-2. Here we aimed to develop global guidance for best practices of infusion centres for IBD patients and to determine the impact of the COVID-19 pandemic on these centres. Under the auspices of the International Organization for the Study of Inflammatory Bowel Disease [IOIBD], a task force [TF] was formed, an online survey was developed to query infusion centre protocols during COVID-19, and recommendations were made, based on TF experience and opinion. Recommendations focus mainly on patients screening, infusion centres re-organization, personnel protection, and protocol modifications such as shortening infusion duration or replacing it with subcutaneous alternatives. Implementing these recommendations will hopefully reduce exposure of both IBD patients and care givers to SARS-COV-2 and improve the function and safety of infusion centres during the COVID-19 pandemic as well as potential future threats.

Expression of SARS-CoV-2 Entry Molecules ACE2 and TMPRSS2 in the Gut of Patients With IBD.

BACKGROUND: Patients with inflammatory bowel disease (IBD) have intestinal inflammation and are treated with immune-modulating medications. In the face of the coronavirus disease-19 pandemic, we do not know whether patients with IBD will be more susceptible to infection or disease. We hypothesized that the viral entry molecules angiotensin I converting enzyme 2 (ACE2) and transmembrane serine protease 2 (TMPRSS2) are expressed in the intestine. We further hypothesized that their expression could be affected by inflammation or medication usage. METHODS: We examined the expression of Ace2 and Tmprss2 by quantitative polymerase chain reacion in animal models of IBD. Publicly available data from organoids and mucosal biopsies from patients with IBD were examined for expression of ACE2 and TMPRSS2. We conducted RNA sequencing for CD11b-enriched cells and peripheral and lamina propria T-cells from well-annotated patient samples. RESULTS: ACE2 and TMPRSS2 were abundantly expressed in the ileum and colon and had high expression in intestinal epithelial cells. In animal models, inflammation led to downregulation of epithelial Ace2. Expression of ACE2 and TMPRSS2 was not increased in samples from patients with compared with those of control patients. In CD11b-enriched cells but not T-cells, the level of expression of ACE2 and TMPRSS2 in the mucosa was comparable to other functional mucosal genes and was not affected by inflammation. Anti-tumor necrosis factor drugs, vedolizumab, ustekinumab, and steroids were linked to significantly lower expression of ACE2 in CD11b-enriched cells. CONCLUSIONS: The viral entry molecules ACE2 and TMPRSS2 are expressed in the ileum and colon. Patients with IBD do not have higher expression during inflammation; medical therapy is associated with lower levels of ACE2. These data provide reassurance for patients with IBD.

Use of the Endoscopic Healing Index (EHI) for Monitoring of Disease Activity in Crohn’s Disease Patients in the COVID Era

<p>Management of Crohn’s disease (CD) during COVID-19 is challenging when colonoscopy is not feasible. This study describes a blood-based test that has been validated against colonoscopy in CD patients as an alternative even in patients with high inflammation from infections.</p>