Real-Life Effectiveness and Safety of Baricitinib as Adjunctive to Standard-of-Care Treatment in Hospitalized Patients With Severe Coronavirus Disease 2019

Abstract Background Therapeutic options for hospitalized patients with severe coronavirus disease 2019 (sCOVID-19) are limited. Preliminary data have shown promising results with baricitinib, but real-life experience is lacking. We assessed the safety and effectiveness of add-on baricitinib to standard-of-care (SOC) including dexamethasone in hospitalized patients with sCOVID-19. Methods This study is a 2-center, observational, retrospective cohort study of patients with sCOVID-19, comparing outcomes and serious events between patients treated with SOC versus those treated with SOC and baricitinib combination. Results We included 369 patients with sCOVID-19 (males 66.1%; mean age 65.2 years; median symptom duration 6 days). The SOC was administered in 47.7% and combination in 52.3%. Patients treated with the combination reached the composite outcome (intensive care unit [ICU] admission or death) less frequently compared with SOC (22.3% vs 36.9%, P = .002). Mortality rate was lower with the combination in the total cohort (14.7% vs 26.6%, P = .005), and ICU admission was lower in patients with severe acute respiratory distress syndrome (29.7% vs 44.8%, P = .03). By multivariable analysis, age (odds ratio [OR] = 1.82, 95% confidence interval [CI] = 1.36–2.44, per 10-year increase), partial pressure of oxygen/fraction of inspired oxygen ratio (OR = 0.60, 95% CI = .52–0.68, per 10 units increase), and use of high-flow nasal cannula (OR = 0.34; 95% CI, .16–0.74) were associated with the composite outcome, whereas baricitinib use was marginally not associated with the composite outcome (OR = 0.52; 95% CI, .26–1.03). However, baricitinib use was found to be significant after inverse-probability weighted regression (OR = 0.93; 95% CI, .87–0.99). No difference in serious events was noted between treatment groups. Conclusions In real-life settings, addition of baricitinib to SOC in patients hospitalized with sCOVID-19 is associated with decreased mortality without concerning safety signals.

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Association of Proteinuria and Hematuria with Acute Kidney Injury and Mortality in Hospitalized Patients with COVID-19

Kidney & Blood Pressure Research ◽

10.1159/000511946 ◽

2020 ◽

Vol 45 (6) ◽

pp. 1018-1032

Author(s):

Imran Chaudhri ◽

Richard Moffitt ◽

Erin Taub ◽

Raji R. Annadi ◽

Minh Hoai ◽

...

Keyword(s):

Acute Kidney Injury ◽

Invasive Mechanical Ventilation ◽

Multivariable Analysis ◽

Kidney Injury ◽

Hospitalized Patients ◽

Hospital Death ◽

Study Cohort ◽

Icu Admission ◽

Risk Of Death ◽

Increased Risk

Introduction: Acute kidney injury (AKI) is strongly associated with poor outcomes in hospitalized patients with coronavirus disease 2019 (COVID-19), but data on the association of proteinuria and hematuria are limited to non-US populations. In addition, admission and in-hospital measures for kidney abnormalities have not been studied separately. Methods: This retrospective cohort study aimed to analyze these associations in 321 patients sequentially admitted between March 7, 2020 and April 1, 2020 at Stony Brook University Medical Center, New York. We investigated the association of proteinuria, hematuria, and AKI with outcomes of inflammation, intensive care unit (ICU) admission, invasive mechanical ventilation (IMV), and in-hospital death. We used ANOVA, t test, χ2 test, and Fisher’s exact test for bivariate analyses and logistic regression for multivariable analysis. Results: Three hundred patients met the inclusion criteria for the study cohort. Multivariable analysis demonstrated that admission proteinuria was significantly associated with risk of in-hospital AKI (OR 4.71, 95% CI 1.28–17.38), while admission hematuria was associated with ICU admission (OR 4.56, 95% CI 1.12–18.64), IMV (OR 8.79, 95% CI 2.08–37.00), and death (OR 18.03, 95% CI 2.84–114.57). During hospitalization, de novo proteinuria was significantly associated with increased risk of death (OR 8.94, 95% CI 1.19–114.4, p = 0.04). In-hospital AKI increased (OR 27.14, 95% CI 4.44–240.17) while recovery from in-hospital AKI decreased the risk of death (OR 0.001, 95% CI 0.001–0.06). Conclusion: Proteinuria and hematuria both at the time of admission and during hospitalization are associated with adverse clinical outcomes in hospitalized patients with COVID-19.

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Vascular toxicities of endocrine therapy in early-stage breast cancer: Encouraging observations in a nontrial setting.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.27_suppl.68 ◽

2012 ◽

Vol 30 (27_suppl) ◽

pp. 68-68

Author(s):

Susan Faye Dent ◽

Freya L. Crawley ◽

Nadine A. Graham ◽

Michelle M. Campbell

Keyword(s):

Breast Cancer ◽

Endocrine Therapy ◽

Life Experience ◽

Early Stage ◽

Real Life ◽

Standard Of Care ◽

T Test ◽

Early Stage Breast Cancer ◽

Cancer Center ◽

Increased Risk

68 Background: Endocrine therapy (ET) is the standard of care for postmenopausal (PM) women with early stage breast cancer (EBC). Studies suggest higher risk of vascular toxicities (VT) on aromatase inhibitor (AI) therapy. We report incidence/discontinuation rates of VTs in a cardiac clinic. Methods: PM women with hormone receptor positive EBC treated with ET (tamoxifen (T) ± AI) at Ottawa Hospital Cancer Center 01/99-2/06. Data included: demographics, vascular co-morbidities (VCM), ET, duration, VTs. Results: 626 pts, median age 59 years (r: 30-92), median follow-up 98 months (m), stage: I (196 pts), II (341 pts) III (89 pts) EBC. Majority (52.5%) pts had VCM at ET initiation; hypertension (HTN) (36%), hyperlipidemia (HYLP) (17%), coronary disease (12%), thrombosis (9%), angina (6%) TIA (6%). Treatment discontinued due to VT 3x more with T vs. AI. Most common VTs: edema, arrhythmias (ARR), cardiovascular (CVS) event, and HYLP. With Letrozole and T, previous VCM significantly increased risk of developing VT (chi-square: P=0.022 and 0.009). Time to develop VT shortest for T and exemestane. Previous VCM did not affect this interval. Longer exposure to T correlated with higher VT rate (t-test: p=0.046) not seen with AIs. Exposure to multiple AIs associated with higher VT rate (t-test: p=0.009). Conclusions: This cohort study reports similar VT rates with AI therapy as reported in the literature. T was associated with higher discontinuation rates (10.5%) due to VTs compared to AIs (2.8-3.3%). Longer duration of AI therapy was not associated with increased risk of VTs. These encouraging results reflect the real-life experience of women exposed to ET. [Table: see text]

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Real-life use of remdesivir in hospitalized patients with COVID-19

Revista Española de Quimioterapia ◽

10.37201/req/018.2021 ◽

2021 ◽

Author(s):

Carolina Garcia-Vidal ◽

Fernanda Meira ◽

Alberto Cózar-Llistó ◽

Gerard Dueñas ◽

Pedro Puerta-Alcalde ◽

...

Keyword(s):

Intensive Care Unit ◽

Mechanical Ventilation ◽

Intensive Care ◽

Mortality Rate ◽

Intensive Care Unit Admission ◽

Life Experience ◽

Real Life ◽

Descriptive Study ◽

Hospitalized Patients ◽

Good Safety Profile

Objective. Controversial results on remdesivir efficacy have been reported. We aimed to report our real-life experience with the use of remdesivir from its availability in Spain. Methods. We performed a descriptive study of all patients admitted for ≥48 hours with confirmed COVID-19 who received remdesivir between the 1st of July and the 30th of September 2020. Results. A total of 123 patients out of 242 admitted with COVID-19 at our hospital (50.8%) received remdesivir. Median age was 58 years, 61% were males and 56.9 % received at least one anti-inflammatory treatment. No adverse events requiring remdesivir discontinuation were reported. The need of intensive care unit admission, mechanical ventilation and 30-days mortality were 19.5%, 7.3% and 4.1%, respectively. Conclusion. In our real-life experience, the use of remdesivir in hospitalized patients with COVID-19 was associated with a low mortality rate and good safety profile.

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M1708 Infliximab in Hospitalized Patients with Acute Severe Ulcerative Colitis: Real Life Experience

Gastroenterology ◽

10.1016/s0016-5085(08)61878-8 ◽

2008 ◽

Vol 134 (4) ◽

pp. A-402

Author(s):

Kenneth Atkinson ◽

Robert M. Penner ◽

David Pearson ◽

Brian Bressler ◽

Nawal S. ALNahdi ◽

...

Keyword(s):

Ulcerative Colitis ◽

Life Experience ◽

Real Life ◽

Hospitalized Patients ◽

Severe Ulcerative Colitis

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The Use of Infliximab for Treatment of Hospitalized Patients with Acute Severe Ulcerative Colitis

Canadian Journal of Gastroenterology ◽

10.1155/2008/749547 ◽

2008 ◽

Vol 22 (11) ◽

pp. 937-940 ◽

Cited By ~ 25

Author(s):

B Bressler ◽

JK Law ◽

N Al Nahdi Sheraisher ◽

K Atkinson ◽

MF Byrne ◽

...

Keyword(s):

Ulcerative Colitis ◽

Life Experience ◽

Rescue Therapy ◽

Real Life ◽

Case Series ◽

Hospitalized Patients ◽

Severe Ulcerative Colitis ◽

Duration Of Disease ◽

Intravenous Steroids ◽

Steroid Refractory

BACKGROUND/AIM: The use of infliximab in severe ulcerative colitis (UC) is established; however, its role in severe acute UC requires clarification. The present multicentre case series evaluated infliximab in hospitalized patients with steroid-refractory severe UC.METHODS: Patients from six hospitals were retrospectively evaluated. Data collection included demographics, duration of disease and previous treatments. The primary end point was response to in-hospital infliximab; defined as discharge without colectomy.RESULTS: Twenty-one patients (median age 26 years) were admitted between May 2006 and May 2008 with severe UC requiring intravenous steroids and given infliximab (median time to infusion eight days). Sixteen (76%) patients were discharged home without colectomy; three of these underwent colectomy at a later date. Of the remaining 13 patients (62%), all but two did not require further courses of steroids; six patients had infliximab as a bridge to azathioprine and seven patients were maintained on regular infliximab. Five patients required in-hospital colectomy after the initial infliximab.CONCLUSIONS: In this real-life experience of infliximab in patients with steroid-refractory severe UC, infliximab appears to be a viable rescue therapy. The majority of patients were discharged without surgery and 62% maintained response either as a bridge to azathioprine or maintenance infliximab.

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How I manage frontline transplant-ineligible multiple myeloma

Hematology Reports ◽

10.4081/hr.2020.8956 ◽

2020 ◽

Vol 12 (s1) ◽

Author(s):

Daniele Derudas ◽

Francesca Capraro ◽

Giovanni Martinelli ◽

Claudio Cerchione

Keyword(s):

Multiple Myeloma ◽

Plasma Cells ◽

Life Experience ◽

Hematological Malignancy ◽

Real Life ◽

Standard Of Care ◽

Newly Diagnosed ◽

Safety And Efficacy ◽

Frailty Status ◽

Careful Assessment

The Multiple Myeloma (MM) is a plasma cells hematological malignancy with a median age of 69 years at diagnosis. The autologous stem cell transplantation is the standard of care for this disease but less than half of newly diagnosed patients are assessed for this treatment due to comorbidities or complications of disease. The management of transplant ineligible MM patients is based on the balance safety and efficacy of the new available regimen and a careful assessment of the frailty status is mandatory to define the goals. In this review we discuss of the clinical dilemmas in the management and define how to manage them based on the evidence from clinical trials and “real life” experience.

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Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers Withdrawal Is Associated with Higher Mortality in Hospitalized Patients with COVID-19

Journal of Clinical Medicine ◽

10.3390/jcm10122642 ◽

2021 ◽

Vol 10 (12) ◽

pp. 2642

Author(s):

Emilia Roy-Vallejo ◽

Aquilino Sánchez Purificación ◽

José Torres Peña ◽

Beatriz Sánchez Moreno ◽

Francisco Arnalich ◽

...

Keyword(s):

Mechanical Ventilation ◽

Angiotensin Converting Enzyme ◽

Angiotensin Receptor Blockers ◽

Invasive Mechanical Ventilation ◽

Hospitalized Patients ◽

Angiotensin Ii Receptor Blocker ◽

Composite Outcome ◽

Converting Enzyme ◽

Icu Admission ◽

All Cause Mortality

Our main aim was to describe the effect on the severity of ACEI (angiotensin-converting enzyme inhibitor) and ARB (angiotensin II receptor blocker) during COVID-19 hospitalization. A retrospective, observational, multicenter study evaluating hospitalized patients with COVID-19 treated with ACEI/ARB. The primary endpoint was the incidence of the composite outcome of prognosis (IMV (invasive mechanical ventilation), NIMV (non-invasive mechanical ventilation), ICU admission (intensive care unit), and/or all-cause mortality). We evaluated both outcomes in patients whose treatment with ACEI/ARB was continued or withdrawn. Between February and June 2020, 11,205 patients were included, mean age 67 years (SD = 16.3) and 43.1% female; 2162 patients received ACEI/ARB treatment. ACEI/ARB treatment showed lower all-cause mortality (p < 0.0001). Hypertensive patients in the ACEI/ARB group had better results in IMV, ICU admission, and the composite outcome of prognosis (p < 0.0001 for all). No differences were found in the incidence of major adverse cardiovascular events. Patients previously treated with ACEI/ARB continuing treatment during hospitalization had a lower incidence of the composite outcome of prognosis than those whose treatment was withdrawn (RR 0.67, 95%CI 0.63–0.76). ARB was associated with better survival than ACEI (HR 0.77, 95%CI 0.62–0.96). ACEI/ARB treatment during COVID-19 hospitalization was associated with protection on mortality. The benefits were greater in hypertensive, those who continued treatment, and those taking ARB.

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P560 Clinical outcomes of vedolizumab maintenance treatment for Korean patients with inflammatory bowel disease who failed anti-TNF therapy: A KASID prospective multicenter cohort study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.681 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S523-S524

Author(s):

K Oh ◽

J Kim ◽

N Kim ◽

H Yoon ◽

K M Lee ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Adverse Events ◽

Clinical Remission ◽

Maintenance Treatment ◽

Multivariable Analysis ◽

Real Life ◽

Life Effectiveness ◽

The Real ◽

Korean Patients

Abstract Background We investigated the real-life effectiveness and safety of vedolizumab maintenance treatment among Korean patients with Crohn’s disease (CD) or ulcerative colitis (UC) who previously failed anti-tumour necrosis factor (anti-TNF) therapy. Methods Adult patients with CD or UC who have previously failed anti-TNF therapy and received vedolizumab were prospectively enrolled from 16 hospitals in Korea. The primary outcome was clinical remission at week 54. Clinical remission was defined as a Crohn’s disease activity index (CDAI) <150 and a partial Mayo score ≤2 with a combined rectal bleeding and stool frequency subscore ≤1. We also analyzed factors associated with clinical remission at week 54. Results Between August 2017 to July 2020, a total of 165 patients (81 with CD and 84 with UC) received vedolizumab therapy, of whom 154 patients (93.3%) (75 with CD and 79 with UC) received vedolizumab maintenance therapy (Table 1). Clinical remission and response rates at week 54 were 22.2% and 24.1% among patients with CD and 41.4% and 45.7% among patients with UC, respectively (Figure 1A and 1B). Among 70 patients with UC with baseline Mayo endoscopic subscore ≥2, endoscopic remission (Mayo endoscopic subscore ≤1) at week 54 was observed in 19 patients (27.1%). Out of 50 patients with CD with ulcers in baseline endoscopy, 2 patients (4%) showed a disappearance of ulcers at week 54 (Figure 1C). In the multivariable analysis, age at baseline (adjusted odds ration [aOR] 1.065, 95% confidence interval [CI] 1.003–1.131, P=0.041) and Mayo endoscopic subscore at baseline (aOR 0.141, 95% CI 0.026–0.746, P=0.021) were significantly associated with clinical remission at week 54 among patients with UC (Table 2). No factors were found to be associated with clinical remission at week 54 among patients with CD. Among patients who experienced one or more adverse events (n=134, 81.2%), serious adverse events occurred in 82 patients (49.7%) (Table 3). Disease exacerbation was the most common adverse events (n=89, 53.9%). Conclusion The real-life effectiveness of vedolizumab maintenance treatment for Korean patients with UC who failed anti-TNF therapy was generally similar with the outcomes reported from the previous Western studies. A substantial proportion of patients with CD experienced a loss of response during the first year of treatment. Less severe disease at baseline was associated with clinical remission at 1 year of vedolizumab therapy among patients with UC.

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Manifestations of renal system involvement in hospitalized patients with COVID-19 in Saudi Arabia

PLoS ONE ◽

10.1371/journal.pone.0253036 ◽

2021 ◽

Vol 16 (7) ◽

pp. e0253036

Author(s):

Khaled S. Allemailem ◽

Ahmad Almatroudi ◽

Amjad Ali Khan ◽

Arshad H. Rahmani ◽

Ibrahim S. Almarshad ◽

...

Keyword(s):

Acute Kidney Injury ◽

Saudi Arabia ◽

Demographic Data ◽

Multivariable Analysis ◽

Laboratory Data ◽

Kidney Injury ◽

Hospitalized Patients ◽

System Involvement ◽

Icu Admission ◽

Renal System

Background Although COVID-19 is an acute disease that usually resolves rapidly in most cases, the disease can be fatal and has a mortality rate of about 1% to 56%. Alveolar injury and respiratory failure are the main causes of death in patients with COVID 19. In addition, the effect of the disease on other organs is not fully understood. Renal system affection has been reported in patients with COVID 19 and is associated with a higher rate of diverse outcomes, including mortality. Therefore, in the present work, we reported the clinical characteristics and laboratory data of hospitalized patients with COVID-19 and analyzed the manifestations that indicated renal system involvement and their impact on clinical outcomes. Materials and methods This was an observational retrospective study conducted at King Fahd Specialist Hospital, Buraydah, Saudi Arabia. All patients with COVID-19 who were admitted to this Hospital from April to December 2020 were included in the study. The patients’ findings at presentation were recorded. Demographic data and laboratory results (hematuria, proteinuria, urinary sediment cast and pus cell presence, and kidney function tests) were retrieved from electronic patient records. Results One hundred and ninety-three patients with confirmed COVID 19 were included in the study. Dipstick examinations of all urine samples showed proteinuria and hematuria in 53.9% and 22.3% of patients, respectively, whereas microscopic examination revealed the presence of pus and brown muddy granular casts in 33.7% and 12.4% of samples, respectively. Acute kidney injury was reported in 23.3% of patients. A multivariable analysis demonstrated that hematuria was associated with acute kidney injury (AKI) (OR, 2.4; 95% CI, 1.2–4.9; P = 0.001), ICU admission (OR, 3.789; 95% CI, 1.913–7.505; P = 0.003), and mortality (OR, 8.084; 95% CI, 3.756–17.397; P = 0.002). Conversely, proteinuria was less significantly associated with the risk of AKI (OR, 1.56; 95% CI, 1.91–7.50; P = 0.003), ICU admission (OR, 2.493; 95% CI, 1.25–4.72; P = 0.001), and mortality (OR, 2.764; 95% CI, 1.368–5.121; P = 0.003). Patients with AKI had a higher probability for mortality than did those without AKI (OR, 14.208; 95% CI, 6.434–31.375; P = 0.003). Conclusion The manifestations of the involvement of the renal system are not uncommon in COVID-19. These manifestations included proteinuria, hematuria, and AKI and were usually associated with a poor prognosis, including high incidences of both ICU admission and mortality.

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