Real‐World Experience of Adalimumab Therapy for Patients with Ulcerative Colitis: A Single Tertiary Medical Center Experience in Central Taiwan

Abstract Background Ustekinumab has been recently approved for the treatment of moderately to severely active ulcerative colitis (UC). The registry trials for ustekinumab in UC demonstrated efficacy and safety, but data on real-world outcomes are limited. We describe the effectiveness and safety of ustekinumab in patients with UC from 2 US tertiary inflammatory bowel disease centers. Methods Patients with moderately to severely active UC treated with ustekinumab at NYU Langone Health (New York, New York) and University of Chicago Medical Center (Chicago, Illinois) between January 2016 and March 2020 were retrospectively included. The primary outcome was clinical remission at 3 and 12 months, defined as a partial Mayo score of ≤2, with a combined rectal bleeding and stool frequency subscore of ≤1. Results Sixty-six UC patients were included. Ninety-two percent of patients had prior exposure to biologics or tofacitinib. Forty-three percent and 45% of patients achieved clinical remission by 3 and 12 months, respectively. Anti-TNF nonresponse and endoscopic Mayo score of 3 were negative predictors of clinical remission. Thirty-three percent of those followed for a year achieved concurrent endoscopic and histologic healing, which was significantly associated with lower partial Mayo score (P < 0.01) and lower stool frequency (P = 0.02). Serious adverse events occurred in 4 (6%) patients (3 UC exacerbations, 1 vasculitis). Conclusions In this cohort of mostly biologic-refractory UC patients, treatment with ustekinumab achieved remission in nearly half of them at 12 months, and was associated with an overall favorable safety profile. These results are modestly better than the pivotal trials.

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Real‐world efficacy and safety of vedolizumab among patients with inflammatory bowel disease: A single tertiary medical center experience in Central Taiwan

Advances in Digestive Medicine ◽

10.1002/aid2.13188 ◽

2020 ◽

Author(s):

Yu‐Chiao Chiu ◽

Chia‐Chang Chen ◽

Chung‐Wang Ko ◽

Szu‐Chia Liao ◽

Hong‐Zen Yeh ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Real World ◽

Bowel Disease ◽

Medical Center ◽

Efficacy And Safety ◽

Inflammatory Bowel ◽

Central Taiwan

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Efficacy and Safety of Lenvatinib Therapy for Unresectable Hepatocellular Carcinoma in a Real-World Practice in Korea

Liver Cancer ◽

10.1159/000512239 ◽

2021 ◽

pp. 1-11

Author(s):

Myung Ji Goh ◽

Joo Hyun Oh ◽

Yewan Park ◽

Jihye Kim ◽

Wonseok Kang ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Prognostic Factors ◽

Disease Progression ◽

Real World ◽

Medical Center ◽

Objective Response ◽

Progression Free Survival ◽

Efficacy And Safety ◽

Eligibility Criteria ◽

Unresectable Hepatocellular Carcinoma

Background: Lenvatinib has been recently approved as a first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC) in Korea. We aimed to study the efficacy and safety of lenvatinib therapy in a real-world practice and to find prognostic factors related to survival and disease progression. Methods: A hospital-based retrospective study was conducted on 111 consecutive patients who had unresectable HCC and were treated with lenvatinib at Samsung Medical Center from October 2018 to March 2020. Efficacy was determined using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria in 111 patients who completed 1st tumor assessment. Safety was evaluated in 116 HCC patients including 5 patients who discontinued lenvatinib due to adverse events (AEs) before 1st tumor assessment using Common Terminology Criteria for AEs version 5.0. Results: A total of 111 patients with a median age of 59 years were analyzed during a median follow-up duration of 6.2 (4.4–9.0) months. The Kaplan-Meier estimate of overall survival was 10.5 months, and the median progression-free survival was 6.2 months. Based on mRECIST criteria, the objective response rate was 18.9% and disease control rate was 75.7%. AEs developed in 86/116 (74.1%) patients, and grade ≥3 AEs developed in 16/116 (13.8%) patients. Diarrhea, hand-foot skin rash, abdominal pain, hypertension, and anorexia were identified as the AEs with the highest frequencies of any grade. REFLECT eligibility criteria including tumor extent ≥50% liver occupation or inadequate bone marrow function and occurrence of anorexia were prognostic factors for survival, and occurrence of diarrhea was a favorable factor for disease progression. Conclusion: Lenvatinib therapy showed a favorable efficacy and safety in a real-world practice. The REFLECT eligibility criteria and specific AEs could be one of the prognostic markers.

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284 Real World Data of Sequencing Immune Checkpoint Inhibitors (ICI) after Initial ICI

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2020-sitc2020.0284 ◽

2020 ◽

Vol 8 (Suppl 3) ◽

pp. A310-A310

Author(s):

Krishna Gunturu ◽

Muhammad Awidi ◽

Rojer Ranjit ◽

Brendan Connell ◽

Rachel Carrasquillo ◽

...

Keyword(s):

Cell Death ◽

Programmed Cell Death ◽

Real World ◽

Immune Checkpoint ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Medical Center ◽

Clear Understanding ◽

Real World Data ◽

World Data

BackgroundICI revolutionized modern Oncology landscape and being utilized in metastatic to adjuvant and neo-adjuvant settings. As Oncologists, we are treating cancer patients with ICI every day, yet there is still a lot that is unknown about these drugs. We don’t have clear understanding of the efficacy and toxicity when sequencing one ICI for another. We conducted a retrospective review of real world data at Lahey Hospital and Medical Center to understand further and to pave path for prospective studies to understand this issue further to improve patient care.MethodsWe retrospectively reviewed Oncology patient charts who received ICI between January1, 2014 to December 18, 2018. Total 483 patients received ICI during this time frame and 22 of these patients received a second ICI either as monotherapy or in combination with other ICI or chemotherapy.ResultsA total of 22 patients received subsequent ICI after the initial ICI as showed in table 1. 15 of the 22 (68%) patients were transitioned from one ICI to another monotherapy. 11 of these patients were transitioned secondary to disease progression (73%), three had immune related adverse events and one was switched per standard of care. One patient had ICI re-challenge. Three patients had a transition from ICI monotherapy to combination ICI therapy. One patient went onto chemo-immunotherapy and 2 patients transitioned from combination ICI to chemo-immunotherapy.Abstract 284 Table 1Real world data of sequencing immune checkpoint inhibitors (ICI) after initial ICIConclusionsICI therapy is evolving and patients are being treated with multiple lines of ICI. In current practices, ICI is frequently being transitioned from cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death 1 (PD-1) or its ligand, programmed cell death ligand 1 (PD-L1) classes or combined with chemotherapy or targeted therapy. It would be prudent to explore the effects of sequencing these medications either as a monotherapy or in combination with other therapies to better serve our patients and to prevent financial toxicity.

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Superior treatment persistence with ustekinumab in Crohn’s disease and vedolizumab in ulcerative colitis compared with anti‐TNF biological agents: real‐world registry data from the Persistence Australian National IBD Cohort (PANIC) study

Alimentary Pharmacology & Therapeutics ◽

10.1111/apt.16436 ◽

2021 ◽

Author(s):

Yanna Ko ◽

Sudarshan Paramsothy ◽

Yunki Yau ◽

Rupert W. Leong

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Real World ◽

Biological Agents ◽

Registry Data ◽

Treatment Persistence

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Alcohol Hand Rub Significantly Reduces Overall Bacterial Bioburden on Stethoscopes in a Real-World Clinical Setting

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2020.620 ◽

2020 ◽

Vol 41 (S1) ◽

pp. s114-s115

Author(s):

Alexandra Johnson ◽

Bobby Warren ◽

Deverick John Anderson ◽

Melissa Johnson ◽

Isabella Gamez ◽

...

Keyword(s):

Real World ◽

Medical Center ◽

Academic Medical Center ◽

Randomized Study ◽

Healthcare Providers ◽

Clinical Workflow ◽

Provider Type ◽

Academic Medical ◽

Rn Students ◽

The Impact

Background: Stethoscopes are a known vector for microbial transmission; however, common strategies used to clean stethoscopes pose certain barriers that prevent routine cleaning after every use. We aimed to determine whether using readily available alcohol-based hand rub (ABHR) would effectively reduce bacterial bioburden on stethoscopes in a real-world setting. Methods: We performed a randomized study on inpatient wards of an academic medical center to assess the impact of using ABHR (AlcareExtra; ethyl alcohol, 80%) on the bacterial bioburden of stethoscopes. Stethoscopes were obtained from healthcare providers after routine use during an inpatient examination and were randomized to control (no intervention) or ABHR disinfection (2 pumps applied to tubing and bell or diaphragm by study personnel, then allowed to dry). Cultures of the tubing and bell or diaphragm were obtained with premoistened cellulose sponges. Sponges were combined with 1% Tween20-PBS and mixed in the Seward Stomacher. The homogenate was centrifuged and all but ~5 mL of the supernatant was discarded. Samples were plated on sheep’s blood agar and selective media for clinically important pathogens (CIPs) including S. aureus, Enterococcus spp, and gram-negative bacteria (GNB). CFU count was determined by counting the number of colonies on each plate and using dilution calculations to calculate the CFU of the original ~5 mL homogenate. Results: In total, 80 stethoscopes (40 disinfection, 40 control) were sampled from 46 physicians (MDs) and MD students (57.5%), 13 advanced practice providers (16.3%), and 21 nurses (RNs) and RN students (26.3%). The median CFU count was ~30-fold lower in the disinfection arm compared to control (106 [IQR, 50–381] vs 3,320 [986–4,834]; P < .0001). The effect was consistent across provider type, frequency of recent usual stethoscope cleaning, age, and status of pet ownership (Fig. 1). Overall, 26 of 80 (33%) of stethoscopes harbored CIP. The presence of CIP was lower but not significantly different for stethoscopes that underwent disinfection versus controls: S. aureus (25% vs 32.5%), Enterococcus (2.5% vs 10%), and GNB (2.5% vs 5%). Conclusions: Stethoscopes may serve as vectors for clean hands to become recontaminated immediately prior to performing patient care activities. Using ABHR to clean stethoscopes after every use is a practical and effective strategy to reduce overall bacterial contamination that can be easily incorporated into clinical workflow. Larger studies are needed to determine the efficacy of ABHR at removing CIP from stethoscopes as stethoscopes in both arms were frequently contaminated with CIP. Prior cleaning of stethoscopes on the study day did not seem to impact contamination rates, suggesting the impact of alcohol foam disinfection is short-lived and may need to be repeated frequently (ie, after each use).Funding: NoneDisclosures: NoneDisclosures: NoneFunding: None

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P048 HISTORY OF CYTOMEGALOVIRUS COLITIS IS ASSOCIATED WITH POOR LONG-TERM OUTCOMES IN ADALIMUMAB THERAPY IN KOREAN PATIENTS WITH ULCERATIVE COLITIS: A HOSPITAL-BASED COHORT STUDY

Inflammatory Bowel Diseases ◽

10.1093/ibd/izy019.054 ◽

2018 ◽

Vol 24 (suppl_1) ◽

pp. S17-S17

Author(s):

Eun Hye Oh ◽

Eun Mi Song ◽

Sun-Ho Lee ◽

Kiju Chang ◽

Sung Wook Hwang ◽

...

Keyword(s):

Ulcerative Colitis ◽

Cohort Study ◽

Long Term Outcomes ◽

Korean Patients ◽

Cytomegalovirus Colitis ◽

Adalimumab Therapy ◽

History Of

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Automated computed tomography quantification of fibrosis predicts prognosis in combined pulmonary fibrosis and emphysema in a real-world setting: a single-centre, retrospective study

Respiratory Research ◽

10.1186/s12931-020-01545-3 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Masahiro Nemoto ◽

Yuichiro Nei ◽

Brian Bartholmai ◽

Kazuki Yoshida ◽

Hiroki Matsui ◽

...

Keyword(s):

Computed Tomography ◽

Retrospective Study ◽

Pulmonary Fibrosis ◽

Acute Exacerbation ◽

Real World ◽

Medical Center ◽

Pulmonary Function Tests ◽

Quantitative Computed Tomography ◽

Single Centre ◽

Real World Setting

Abstract Background Combined pulmonary fibrosis and emphysema (CPFE) is a heterogeneous clinico-radiological syndrome without a consensus definition. There are limited data on the relation between the amount of parenchymal fibrosis and prognosis. In this study, we assessed the prognostic implications of the extent of fibrosis assessed by an automated quantitative computed tomography (CT) technique and the radiological and functional change over time in patients with a broad spectrum of fibrotic interstitial lung diseases (ILDs) encountered in a real-world setting. Methods We conducted a single-centre, retrospective study of 228 consecutive patients with CPFE, encountered from 2007 to 2015 at Kameda Medical Center, Chiba, Japan. We investigated the prognostic value of automated CT fibrosis quantification and the subsequent course of CPFE. Results Among 228 patients with CPFE, 89 had fibrosis affecting < 5% of their lungs, 54 had 5 to < 10% fibrosis, and 85 had ≥ 10% fibrosis at the time of diagnosis. Lower volume of fibrosis correlated with lower rates of mortality and acute exacerbation (p < 0.001). In particular, among those with < 5% fibrosis, only 4.5% died and none experienced acute exacerbation during follow-up, whereas 57.6% and 29.4% of those with ≥ 10% fibrosis experienced death and acute exacerbation, respectively. Although, the ≥ 10% fibrosis group had the poorest overall survival as well as the highest incidence of acute exacerbation, the incidence of decline in pulmonary function tests, change per year in total lung volume, and progression of fibrosis on chest CT was highest in the 5 to < 10% fibrosis group. The Cox proportional hazard model for CPFE progression (defined by composite criteria of death, acute exacerbation, and decline in forced vital capacity or diffusing capacity) showed fibrosis proportion was a risk factor independent of age, sex, smoking pack-years, the Charlson Comorbidity Index, lung cancer, connective tissue disease, and idiopathic pulmonary fibrosis. Conclusions Less severe (< 5%) fibrosis at baseline was associated with disease stability and better prognosis compared to more severe fibrosis in CPFE occurring with fibrotic ILDs. Further studies including a validation cohort will be needed. Trial Registration Retrospectively registered.

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