Vaccination and Associated Adverse Events in Dogs Previously Treated for Primary Immune-Mediated Hemolytic Anemia

2019 ◽  
Vol 55 (1) ◽  
pp. 29-34 ◽  
Author(s):  
Alaina Moon ◽  
Julia Veir
Keyword(s):  
Adverse Events ◽  
Hemolytic Anemia ◽  
Rabies Vaccine ◽  
Initial Diagnosis ◽  
Canine Distemper ◽  
Time Period ◽  
Immune Mediated ◽  
Secondary Objective ◽  
Previously Treated ◽  
The Relationship

ABSTRACT This study described the rate of vaccine reactions in a population of dogs receiving vaccines after diagnosis of primary immune-mediated hemolytic anemia (IMHA). A secondary objective was to describe the time elapsed between vaccination and initial diagnosis of IMHA. A medical record search identified cases meeting criteria for primary IMHA. Owners and referring veterinarians were surveyed regarding vaccination of the dog following diagnosis. Referring veterinarians were surveyed regarding vaccination prior to diagnosis of IMHA. A completed survey was returned in 44 cases. Twenty-two dogs received vaccinations after diagnosis, and 22 dogs did not. The median time elapsed between vaccination and initial diagnosis was 280 days. No dog was vaccinated within 30 days of diagnosis. Two of the following possible reactions were noted out of 22 dogs vaccinated: vomiting and urticarial eruption in a dog administered a rabies and canine distemper vaccine, and recurrent anemia in a dog administered a rabies vaccine. The rate of vaccine reactions was higher than previously reported, although the time period evaluated was longer than in previous studies. The relationship between initial vaccination and development of IMHA, and between vaccination and vaccine reaction, in this population is uncertain and may reflect coincidence or differences in susceptibility.

An FDA analysis of the association between adverse events and outcome in patients with urothelial cancer receiving a programmed death protein 1 or programmed death ligand 1 (anti-PD-1/L1) antibody.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4549-4549
Author(s):  
Chana Weinstock ◽  
Virginia Ellen Maher ◽  
Laura L. Fernandes ◽  
Shenghui Tang ◽  
Sundeep Agrawal ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Urothelial Cancer ◽  
Locally Advanced ◽  
Study Drug ◽  
Drug Approval ◽  
Systemic Corticosteroids ◽  
Immune Mediated ◽  
Programmed Death ◽  
The Relationship

4549 Background: To assess the relationship between tumor response rate, overall survival, and the development of related adverse events of special interest (AESIs) or related immune-mediated adverse events (imAEs) in patients with urothelial cancer treated with anti-PD-1/L1 antibodies. Methods: We examined seven trials that led to drug approval and which included 1747 patients with metastatic or locally advanced urothelial cancer treated with an anti-PD-1/L1 antibody. Five trials enrolled patients who had received prior platinum-based therapy and two enrolled patients who were cisplatin-ineligible. The datasets were searched for AESIs, related AESIs, imAEs, and related imAEs. The relationship to study drug was determined by the Investigator. Immune-mediated adverse events were defined as AESIs treated with topical or systemic corticosteroids. Results: In these exploratory analyses, a related AESI was reported in 64% of responding patients and in 34% of patients who did not respond to the anti-PD-1/L1 antibody while a related imAE occurred in 28% and 12% of patients who did and did not respond to study drug, respectively. In a responder analysis, an increase in overall survival was seen in patients with related AESIs compared to those with no related AESI [hazard ratio (HR) 0.42; 95% CI: 0.37, 0.49]. Fifty-seven percent of responding patients with a related AESI reported a related AESI prior to documentation of response. Conclusions: Patients who responded to treatment with an anti-PD-1/L1 antibody were more likely to report a related AESI or related imAE. This relationship did not appear to be due to the increased duration of exposure in responding patients. Systemic corticosteroid use did not appear to affect the duration of response.

Checkpoint inhibitor (CPI) experienced patients (pts) from COSMUS-1: A clinical observational study of talimogene laherparepvec (T-VEC) in United States practice.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 142-142 ◽  
Author(s):  
Matthew Perez ◽  
Thomas Amatruda ◽  
Robert Martin Conry ◽  
Charlotte Eielson Ariyan ◽  
Anupam M. Desai ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Real World Data ◽  
Clinicopathologic Characteristics ◽  
Immune Mediated ◽  
Group A ◽  
Previously Treated ◽  
Group B

142 Background: T-VEC, a modified oncolytic herpes virus, is an intralesional therapy for unresectable advanced melanoma. COSMUS-1, a recently presented observational chart review study from 7 US academic sites, described metastatic melanoma treatment (tx) patterns and safety of T-VEC in the real-world setting (Perez et al, SMR 2018). In this analysis, we evaluated T-VEC use in pts after prior CPI use or with CPI from COSMUS-1. Methods: Of 76 pts treated with T-VEC (first dose 27Nov2015-15Dec2016), 33 pts had received pembrolizumab, nivolumab and/or ipilimumab (ie, CPI) prior to or with T-VEC and were analyzed for demographics, clinicopathologic characteristics, outcomes, and adverse events. Two groups were identified: Group A, CPI then T-VEC only and Group B, CPI with T-VEC. Results: There were 21 pts in A and 12 pts in B; in B, all received TVEC + CPI with (1) prior CPI, n = 5, (2) prior CPI and additional CPI after combination, n = 1, (3) as combination only, n = 4, or (4) as combination followed by CPI only, n = 2. In A and B, respectively, mean age was 72 yrs and 63 yrs; 12 (57%) and 9 (75%) were men; 17 (81%) and 9 (75%) had ECOG 0-1,10 (48%) and 4 (33%) had Stage IIIB-IVM1a, and 11 (52%) and 7 (58%) had Stage IVM1b/c. Two pts (both in B) remained on T-VEC by study end. 21 (100%) pts in A and 10 (83%) pts in B discontinued T-VEC (most common, respectively: 10 pts and 3 pts due to disease progression, 4 pts and 2 pts due to physician decision). 2 pts had no injectable lesions left (in A) and 1 pt (in A) had pathologic complete response (CR). Adverse events of interest were reported in 7 pts (33%) in A and 6 pts (50%) in B; most common events in A and B, respectively, were immune-mediated events (n = 3 and 6) which included flu-like symptoms (fever, chills, rigor; n = 2 and 5) and injection site complications (n = 5 and 2). No herpetic infections were reported in pts. Conclusions: These real-world data suggest that T-VEC is well tolerated and can be administered in pts previously treated with a CPI, both those who switched to T-VEC or those where T-VEC was added on. One pt achieved a pathologic CR.

Immune-mediated hemolytic anemia: 70 cases (1988-1996)

1999 ◽  
Vol 35 (5) ◽  
pp. 384-391 ◽  
Author(s):  
ME Reimer ◽  
GC Troy ◽  
LD Warnick
Keyword(s):  
Treatment Group ◽  
Mortality Rate ◽  
Hemolytic Anemia ◽  
Median Survival ◽  
Mortality Rates ◽  
Survival Times ◽  
Treatment Regimens ◽  
Time Period ◽  
Immune Mediated ◽  
Overall Mortality

Survival times and mortality rates in dogs with idiopathic immune-mediated hemolytic anemia (IMHA) have been infrequently reported in the literature. This study evaluates survival and mortality in a large group of dogs with IMHA. The association of age, sex, and breed with IMHA was evaluated by comparing affected dogs to control dogs admitted to the hospital during the same time period. Treatment regimens were reviewed to determine the effects of different agents upon survival of dogs with IMHA during hospitalization and after discharge. Median survival times for each treatment group were 57 days (prednisone), 28 days (prednisone, cyclophosphamide), 974 days (prednisone, azathioprine), 15 days (prednisone, cyclophosphamide, azathioprine), and one day (no treatment). Overall mortality rate in the population of dogs studied was 70%. Twenty-nine (41.4%) dogs either died or were euthanized while hospitalized. Forty-one (59%) dogs were discharged from the hospital. Of the dogs discharged, 10 died within the first month, another five died within three months, and another five died within a year of discharge due to assumed complications of therapy or relapses of IMHA.

Immune mediated destruction of platelets in dogs with heat stroke: A prospective study

2009 ◽  
Vol 37 (05) ◽  
pp. 314-318 ◽  
Author(s):  
L. Keller ◽  
K. Meichner ◽  
S. Unterer ◽  
K. Hartmann ◽  
I. Zenker
Keyword(s):  
Heat Stroke ◽  
Treatment Protocol ◽  
Severe Thrombocytopenia ◽  
Prospective Evaluation ◽  
Antiplatelet Antibodies ◽  
Time Period ◽  
Immune Mediated ◽  
Standardized Treatment ◽  
A Prospective Study ◽  
Risk For Bleeding

Summary Objective: Severe thrombocytopenia is a common sequelae to heat stroke in dogs. So far it has been hypothezised that it is due to disseminated intravascular coagulation. We hypothezised that it is due to immune mediated destruction via antiplatelet antibodies. Material and methods: Prospective evaluation of dogs with heat stroke from May 2005 to August 2008. Dogs that developed severe thrombocytopenia within 5 days of admission were included in the study. All dogs were treated with a standardized treatment protocol. In addition, they received either immunoglobulins or prednisolone. Results: Six dogs were presented with heat stroke during that time period. Four developed a severe thrombocytopenia. All four dogs tested positive for antiplatelet antibodies and did not have elevated D-Dimers at that time. Platelet count in three dogs recovered fully, one dog was euthanized due to liver and renal failure. Conclusion: In those cases thrombocytopenia was due to immune mediated destruction not due to DIC. Clinical rele-vance: Due to the severity of the thrombocytopenia and the high risk for bleeding in those patients, immunosuppressive therapy in addition to DIC prophylaxis should be discussed.

Burn-In Acceleration Considerations in 130nm and 90nm Products

2005 ◽  
Author(s):  
Nobuyuki Wakai ◽  
Yuji Kobira ◽  
Takashi Setoya ◽  
Tamotsu Oishi ◽  
Shinichi Yamasaki
Keyword(s):  
Failure Analysis ◽  
Shape Parameter ◽  
Defect Density ◽  
Failure Mechanisms ◽  
Effective Procedure ◽  
Time Period ◽  
Related Defect ◽  
The Relationship

Abstract An effective procedure to determine the Burn-In acceleration factors for 130nm and 90 nm processes are discussed in this paper. The relationship among yield, defect density, and reliability, is well known and well documented for defect mechanisms. In particular, it is important to determine the suitable acceleration factors for temperature and voltage to estimate the exact Burn- In conditions needed to screen these defects. The approach in this paper is found to be useful for recent Cu-processes which are difficult to control from a defectivity standpoint. Performing an evaluation with test vehicles of 130nm and 90nm technology, the following acceleration factors were obtained, Ea>0.9ev and β (Beta)>-5.85. In addition, it was determined that a lower defect density gave a lower Weibull shape parameter. As a result of failure analysis, it is found that the main failures in these technologies were caused by particles, and their Weibull shape parameter “m” was changed depending of the related defect density. These factors can be applied for an immature time period where the process and products have failure mechanisms dominated by defects. Thus, an effective Burn-In is possible with classification from the standpoint of defect density, even from a period of technology immaturity.

scholarly journals A Review of Immune-Mediated Adverse Events in Melanoma

2019 ◽  
Vol 7 (2) ◽  
pp. 101-120 ◽  
Author(s):  
Lucy Boyce Kennedy ◽  
April K. S. Salama
Keyword(s):  
Adverse Events ◽  
Immune Mediated

440 Activity and safety of camrelizumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced non-small-cell lung cancer

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A466-A466
Author(s):  
Guo Gui Sun ◽  
Jing Hao Jia ◽  
Peng Gao ◽  
Xue Min Yao ◽  
Ming Da Chen ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Large Sample Size ◽  
Small Cell Lung ◽  
Previously Treated ◽  
Line Chemotherapy

BackgroundEffective options are limited for patients with non–small-cell lung cancer (NSCLC) whose disease progresses after first-line chemotherapy. Camrelizumab is a potent anti-PD-1 monoclonal antibody and has shown promising activity in NSCLC. We assessed the activity and safety of camrelizumab for patients with previously treated, advanced NSCLC patients with negative oncogenic drivers.MethodsPatients who progressed during or following platinum-based doublet chemotherapy were enrolled. All patients received camrelizumab(200 mg)every 3 weeks or in combination with chemotherapy until loss of clinical benefit. The primary endpoint was objective response rate (ORR), other endpoints included disease control rate (DCR), progression-free survival (PFS) and safety.ResultsBetween Aug 5, 2019, and Jun 19, 2020, we enrolled 29 patients, 25 patients were available evaluated, ORR and DCR was 36% (9/25) and 92% (23/25), respectively. 25 of 29 patients were still receiving the treatment, the median PFS was not yet achieved. Compared with those without reactive cutaneous capillary endothelial proliferation (RCCEP), patients with RCCEP had higher ORR (60% vs. 28.6%). Treatment-related adverse events (AEs) occurred in 69.0% of patients (all Grade), and the most common were RCCEP (37.9%), pneumonitis (6.9%), and chest congestion (6.9%). Treatment-related grade 3 to 4 adverse events occurred in 10.3% of patients.ConclusionsIn patients with previously treated advanced NSCLC, camrelizumab demonstrated improved ORR and DCR, compared with historical data of the 2nd line chemotherapy, with a manageable safety profile. While patients with RCCEP derived greater benefit from camrelizumab. Further studies are needed in large sample size trials.

scholarly journals Association between CYP3A5 Polymorphism and Statin-Induced Adverse Events: A Systemic Review and Meta-Analysis

2021 ◽  
Vol 11 (7) ◽  
pp. 677
Author(s):  
Jeong Yee ◽  
Hamin Kim ◽  
Yunhee Heo ◽  
Ha-Young Yoon ◽  
Gonjin Song ◽  
...  
Keyword(s):  
Adverse Events ◽  
Web Of Science ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Systemic Review ◽  
Event Risk ◽  
Total Data ◽  
Lipophilic Statin ◽  
The Relationship ◽  
Review Manager

Purpose: Cytochrome P450 (CYP) is involved in the metabolism of statins; CYP3A5 is the main enzyme responsible for lipophilic statin metabolism. However, the evidence of the association between CYP3A5*3 polymorphism and the risk of statin-induced adverse events remains unclear. Therefore, this study aimed to perform a systematic review and meta-analysis to investigate the relationship between the CYP3A5*3 polymorphism and the risk of statin-induced adverse events. Methods: The PubMed, Web of Science, and EMBASE databases were searched for qualified studies published until August 2020. Observational studies that included the association between statin-induced adverse events and the CYP3A5*3 polymorphism were reviewed. The odds ratios (ORs) and 95% confidence intervals (CIs) were evaluated to assess the strength of the relationship. The Mantel–Haenszel method was used to provide the pooled ORs. Heterogeneity was estimated with I2 statistics and publication bias was determined by Begg’s and Egger’s test of the funnel plot. Data analysis was performed using Review Manager (version 5.4) and R Studio (version 3.6). Results: In total, data from 8 studies involving 1614 patients were included in this meta-analysis. The CYP3A5*3 polymorphism was found to be associated with the risk of statin-induced adverse events (*3/*3 vs. *1/*1 + *1/*3: OR = 1.40, 95% CI = 1.08–1.82). For myopathy, the pooled OR was 1.30 (95% CI: 0.96–1.75). The subgroup analysis of statin-induced myopathy revealed a trend, which did not achieve statistical significance. Conclusions: This meta-analysis demonstrated that the CYP3A5*3 polymorphism affected statin-induced adverse event risk. Therefore, CYP3A5 genotyping may be useful to predict statin toxicity.

scholarly journals Autoimmune Hemolytic Anemia as a Complication of Congenital Anemias. A Case Series and Review of the Literature

2021 ◽  
Vol 10 (15) ◽  
pp. 3439
Author(s):  
Irene Motta ◽  
Juri Giannotta ◽  
Marta Ferraresi ◽  
Kordelia Barbullushi ◽  
Nicoletta Revelli ◽  
...  
Keyword(s):  
Hemolytic Anemia ◽  
Autoimmune Hemolytic Anemia ◽  
Case Series ◽  
Intravenous Immunoglobulins ◽  
Point Of View ◽  
First Line ◽  
Human Erythropoietin ◽  
Immune Mediated ◽  
Hemolytic Crisis ◽  
Life Threatening

Congenital anemias may be complicated by immune-mediated hemolytic crisis. Alloantibodies are usually seen in chronically transfused patients, and autoantibodies have also been described, although they are rarely associated with overt autoimmune hemolytic anemia (AIHA), a serious and potentially life-threatening complication. Given the lack of data on the AIHA diagnosis and management in congenital anemias, we retrospectively evaluated all clinically relevant AIHA cases occurring at a referral center for AIHA, hemoglobinopathies, and chronic hemolytic anemias, focusing on clinical management and outcome. In our cohort, AIHA had a prevalence of 1% (14/1410 patients). The majority were warm AIHA. Possible triggers were recent transfusion, infection, pregnancy, and surgery. All the patients received steroid therapy as the first line, and about 25% required further treatment, including rituximab, azathioprine, intravenous immunoglobulins, and cyclophosphamide. Transfusion support was required in 57% of the patients with non-transfusion-dependent anemia, and recombinant human erythropoietin was safely administered in one third of the patients. AIHA in congenital anemias may be challenging both from a diagnostic and a therapeutic point of view. A proper evaluation of hemolytic markers, bone marrow compensation, and assessment of the direct antiglobulin test is mandatory.

scholarly journals Longitudinal rates of hospital adverse events that contributed to death in Norway and Sweden from 2013 to 2018

2021 ◽  
pp. 251604352110261
Author(s):  
Ellen Tveter Deilkås ◽  
Marion Haugen ◽  
Madeleine Borgstedt Risberg ◽  
Hanne Narbuvold ◽  
Øystein Flesland ◽  
...  
Keyword(s):  
Adverse Events ◽  
Acute Care ◽  
Medical Records ◽  
Hospital Care ◽  
Hospital Admissions ◽  
Demographic Characteristics ◽  
Mutual Learning ◽  
Time Period ◽  
Relevant Context ◽  
Linear Trends

Objectives In this paper, we explore and compare types and longitudinal trends of hospital adverse events in Norway and Sweden in the years 2013–2018 with special reference to AEs that contributed to death. Design Acute care hospitals in both countries performed medical record reviews on randomly selected medical records from all eligible admissions. Analysis: Comparison between Norway and Sweden of linear trends from 2013–2018, and percentage rates of admissions with at least one AE according to types and severities. Setting Norway and Sweden have similar socio-economic and demographic characteristics, which constitutes a relevant context for cooperation, comparison and mutual learning. This setting has promoted the use of GTT to monitor national rates of AEs in hospital care in the two countries. Participants 53 367 medical records in Norway and 88 637 medical records in Sweden were reviewed. Results 13.2% of hospital admissions in Norway and 13.1% in Sweden were associated with an AE of all severities (E-I). 0.23% of hospital admissions in Norway and 0.26% in Sweden were associated with an AE that contributed to death (I). The differences between the two countries were not statistically significant. Conclusions There were no significant differences in overall rates (E-I) of AEs in Norway and Sweden, nor in rates of AEs that contributed to death (I). There was no significant change in AEs or fatal AEs in either country over the six-year time period.

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