Preliminary evaluation of the safety and efficacy of standard intravenous immunoglobulins in pregnant women with primary cytomegalovirus infection.
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ABSTRACT:
SUBMITTER: Polilli E
PROVIDER: S-EPMC3535874 | biostudies-literature | 2012 Dec
REPOSITORIES: biostudies-literature
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Preliminary evaluation of the safety and efficacy of standard intravenous immunoglobulins in pregnant women with primary cytomegalovirus infection.
Polilli Ennio E Parruti Giustino G D'Arcangelo Francesca F Tracanna Elisa E Clerico Luigi L Savini Vincenzo V D'Antonio Francesco F Rosati Maurizio M Manzoli Lamberto L D'Antonio Domenico D Nigro Giovanni G
Clinical and vaccine immunology : CVI 20121024 12
Hyperimmune globulins were reported to prevent and treat fetal cytomegalovirus (CMV) infection during pregnancy. Here, we report that infusions of standard human intravenous immunoglobulin significantly increase CMV IgG titers and avidity indexes in pregnant women, paving the way to their use for passive transfer of maternal CMV humoral immunity to fetuses. Preliminary data on perinatal outcomes of the first 67 newborns are encouraging. ...[more]
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Project description:BackgroundFor most viral encephalitides, therapy is merely supportive. Intravenous immunoglobulins (IVIG) have been used as a prophylactic and therapeutic approach. We conduct a systematic review on the safety and efficacy of IVIG in viral encephalitis.MethodsWe conducted a systematic review assessing PubMed, Cochrane Database, Biosis Previews and the ClinicalTrials.gov website to identify all reports on patients with viral encephalitis treated with IVIG as of May 31, 2019. The main outcomes assessed were therapeutic efficacy and safety. For an increased homogeneity of the population, atypical viral infections were excluded, as were reports on prophylactic IVIG use, intrathecal application of immunoglobulins, or use of antibody-enriched IVIG-preparations. Data were extracted from published studies. Descriptive statistics were used.ResultsWe included a total of 44 studies (39 case reports). The case reports cover a total of 53 patients. Our search retrieved two prospective and three retrospective studies. These show heterogeneous results as to the efficacy of IVIG therapy. Only one study reports a significant association between IVIG-use and death (odds ratio 0.032; 95% confidence interval 0.0033-0.3024; p = 0.0027). None of the studies report significant differences in the number of serious adverse events.ConclusionData on the efficacy of IVIG-therapy is heterogeneous. While it seems generally safe, evident superiority compared to supportive treatment has not been demonstrated so far. Future trials should also investigate the optimal dosing and timing of IVIG and their benefit in the immunosuppressed.
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Project description:BackgroundSubstantial evidence indicates that perinatal mental disturbances are associated with the risk for negative maternal-newborn outcomes. A neuroendocrine brain-placenta interaction has been described to explain the association between prenatal stress-related disorders and placental abnormalities. Whether these mechanisms may affect the likelihood of mother-to-child transmission (MTCT) of infections has never been investigated.AimsTo evaluate the role of psychological factors in cytomegalovirus (CMV) MTCT in pregnant women with primary CMV infection.MethodA cohort of 276 pregnant women with primary CMV infection underwent assessment of (a) reactive psychopathological symptoms, such as current depressive symptoms and ongoing symptoms of post-traumatic stress disorder; and (b) stable personality traits, such as alexithymia and Type D (distressed) personality. Congenital infection was diagnosed by CMV DNA amplification from blood and/or urine and saliva from newborn at birth.ResultsThe occurrence of congenital CMV disease in the newborn was independently predicted by post-traumatic stress symptoms during pregnancy.ConclusionsOur findings suggest that psychological stress-related disturbances may weaken the physical and immunological barrier against the mother-to-fetus transmission of viruses.Declaration of interestWe declare that we have no conflicting interests to disclose.Copyright and usage© The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.
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Project description:BackgroundCytomegalovirus (CMV) is the most frequent cause of congenital infection. The objective of this study was to evaluate predictive factors for CMV seronegativity in a cohort of pregnant women in Paris, France.MethodsPregnant women enrolled in a prospective cohort during the 2009 A/H1N1 pandemic were tested for CMV IgG antibodies. Variables collected were age, geographic origin, lifestyle, work characteristics, socioeconomic status, gravidity, parity and number of children at home. A multivariate logistic regression model was used to identify independent predictive factors for CMV seropositivity.ResultsAmong the 826 women enrolled, 389 (47.1%) were primiparous, and 552 (67.1%) had Metropolitan France as a geographic origin. Out of these, 355 (i.e. 57.0%, 95% confidence interval (CI): [53.6%-60.4%]) were CMV seropositive: 43.7% (95% CI:[39.5%-47.9%]) in those whose geographic origin was Metropolitan France and 84.1% in those with other origins (95% CI:[79.2%-88.3%]). Determinants associated with CMV seropositivity in a multivariate logistic regression model were: (i) geographic origin (p<0.001(compared with Metropolitan France, geographic origins of Africa adjusted odds ratio (aOR) 21.2, 95% CI:[9.7-46.5], French overseas departments and territories and other origin, aOR 7.5, 95% CI:[3.9-14.6], and Europe or Asia, aOR 2.2, 95% CI: [1.3-3.7]); and (ii) gravidity (p?=?0.019), (compared with gravidity?=?1, if gravidity?3, aOR?=?1.5, 95% CI: [1.1-2.2]; if gravidity?=?2, aOR?=?1.0, 95% CI: [0.7-1.4]). Work characteristics and socioeconomic status were not independently associated with CMV seropositivity.ConclusionsIn this cohort of pregnant women, a geographic origin of Metropolitan France and a low gravidity were predictive factors for CMV low seropositivity. Such women are therefore the likely target population for prevention of CMV infection during pregnancy in France.
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Project description:Background:The aim of this study was to investigate the efficacy and safety of anlotinib for patients with advanced non-small cell lung cancer (NSCLC) who progressed after standard regimens in real world situations and the preliminary analysis of an efficacy predictor. Methods:A total of 118 patients with advanced NSCLC who progressed after standard regimens were included in this retrospective study. Efficacy was evaluated and toxicity profile was recorded. Progression-free survival (PFS) and overall survival (OS) were assessed using Kaplan-Meier survival curve and multivariate analysis was adjusted using Cox regression analysis. Results:All of the 118 patients with NSCLC were available for evaluation of efficacy. Complete response (CR, 0 case), partial response (PR, 10 cases), stable disease (SD, 79 cases) and progressive disease (PD, 29 cases) were evaluated according to RECIST version 1.1. In consequence, objective response rate (ORR) was 8.47% and disease control rate (DCR) was 75.42%. The median PFS of the 118 patients with NSCLC was 4.3 months and the median OS was 10.3 months. The results of Cox regression analysis suggested that ECOG score was an independent factor for PFS. The toxicity profile indicated that hypertension and hand-foot syndrome were the most common adverse reactions. Additionally, the preliminary analysis of an efficacy predictor suggested that the PFS of patients with hypertension was superior to those without hypertension. Conclusion:Anlotinib is effective and safe for patients with advanced NSCLC who progressed after standard regimens in real world situations. Hypertension may be a biomarker for efficacy prediction.
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Project description:BackgroundIn the current study, we aimed to investigate the efficacy and safety of intravenous immunoglobulin (IVIg)-SN 10%, a new 10% IVIg formulation, in adult patients with severe primary immune thrombocytopenia (ITP; platelet count < 20 × 109/L).MethodsPatients diagnosed as primary ITP, aged 19 years old or more, and had a platelet count of < 20 × 109/L by screening complete blood cell count performed within 2 weeks of study commencement were eligible. Patients received IVIg-SN 10% at a dose of 1 g/kg/day for two consecutive days. Response was defined as the achievement of a platelet count of ≥ 50 × 109/L at day 8.ResultsOut of 81 eligible patients, 31 patients were newly diagnosed, 7 patients had persistent ITP, and 43 patients had chronic ITP. In intent-to-treat analysis, 61.3 patients (75.7%) achieved response and satisfied the pre-defined non-inferiority condition. Median time to response was 2 days and mean duration of maintaining response after the completion of IVIg therapy was 9.13 ± 8.40 days. Response rates were not found to be dependent on the phase of ITP or previous treatment for ITP. The drug was well tolerated and the frequency of mucocutaneous bleeding decreased during the study period.ConclusionIn summary, IVIg-SN 10% formulation was found to be safe and effective in adult ITP patients (Trial registry at ClinicalTrials.gov, NCT02063789).
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