Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial.

Multiple myeloma (MM) patients typically receive several lines of combination therapy and first-line treatment commonly includes lenalidomide. As patients age, they become less tolerant to treatment, requiring convenient/tolerable/lenalidomide-free options. Carfilzomib and/or bortezomib-exposed/intolerant, lenalidomide-refractory MM patients with ≥2 prior lines of therapy were randomized 3:2 to ixazomib-dexamethasone (ixa-dex) (n = 73) or pomalidomide-dexamethasone (pom-dex) (n = 49) until progression/toxicity. Median progression-free survival (mPFS) was 7.1 vs 4.8 months with ixa-dex vs pom-dex (HR 0.847, 95% CI 0.535-1.341, P = 0.477; median follow-up: 15.3 vs 17.3 months); there was no statistically significant difference between arms. In patients with 2 and ≥3 prior lines of therapy, respectively, mPFS was 11.0 vs 5.7 months (HR 1.083, 95% CI 0.547-2.144) and 5.7 vs 3.7 months (HR 0.686, 95% CI 0.368-1.279). Among ixa-dex vs pom-dex patients, 69% vs 81% had Grade ≥3 treatment-emergent adverse events (TEAEs), 51% vs 53% had serious TEAEs, 39% vs 36% had TEAEs leading to drug discontinuation, 44% vs 32% had TEAEs leading to dose reduction, and 13% vs 13% died on study. Quality of life was similar between arms and maintained during treatment. Ixa-dex represents an important lenalidomide-free, oral option for this heavily pretreated, lenalidomide-refractory, proteasome inhibitor-exposed population.Trial registration: ClinicalTrials.gov number, NCT03170882.

The impact of COVID-19 on patients with asthma: A Big Data analysis

BackgroundFrom the onset of the COVID-19 pandemic, an association between the severity of COVID-19 and the presence of certain medical chronic conditions has been suggested. However, unlike influenza and other viruses, the burden of the disease in patients with asthma has been less evident. ObjectiveThis study aims at a better understanding of the burden of COVID-19 in patients with asthma and the impact of asthma, its related comorbidities, and treatment on the prognosis of COVID-19. MethodsWe analyzed clinical data from patients with asthma from January 1st to May 10th, 2020 using big data analytics and artificial intelligence through the SAVANA Manager(R) clinical platform. ResultsOut of 71,192 patients with asthma, 1,006 (1.41%) suffered from COVID-19. Compared to asthmatic individuals without COVID-19, patients with asthma and COVID-19 were significantly older (55 vs. 42 years), predominantly female (66% vs. 59%), had higher prevalence of hypertension, dyslipidemias, diabetes, and obesity, and smoked more frequently. Contrarily, allergy-related factors such as rhinitis and eczema were less frequent in asthmatic patients with COVID-19 (P < .001). Higher prevalence of hypertension, dyslipidemia, diabetes, and obesity was also confirmed in those patients with asthma and COVID-19 who required hospital admission. The percentage of individuals using inhaled corticosteroids (ICS) was lower in patients who required hospitalization due to COVID-19, as compared to non-hospitalized patients (48.3% vs. 61.5%; OR: 0.58: 95% CI 0.44 - 0.77). During the study period, 865 (1.21%) patients with asthma were being treated with biologics. Although these patients showed increased severity and more comorbidities at the ear, nose, and throat (ENT) level, their hospital admission rates due to COVID-19 were relatively low (0.23%). COVID-19 increased inpatient mortality in asthmatic patients (2.29% vs 0.54%; OR 2.29: 95% CI 4.35 - 6.66). ConclusionOur results indicate that the number of COVID-19 cases in patients with asthma has been low, although higher than the observed in the general population. Patients with asthma and COVID-19 were older and were at increased risk due to comorbidity-related factors. ICS and biologics are generally safe and may be associated with a protective effect against severe COVID-19 infection.

Updating of normal levels of copper, zinc and selenium in serum of pregnant women.

Selenium, copper and zinc status is important in pregnant women. The aim of this study was to establish updated normal ranges for these elements in serum of pregnant women from the Spanish region of Aragon, and to study variation in levels with respect to gestational period and maternal age. The study group consisted of 159 pregnant women who did not suffer from serious pathologies. These samples were classified into four gestational-period groups. Zn and Cu determinations were obtained by flame atomic absorption spectroscopy in a Perkin-Elmer 1100B apparatus, and Se was determined by electrothermal atomic absorption spectrometry with Zeeman correction, in a Perkin-Elmer 4110 ZL apparatus. The concentrations of Cu, Zn and Se averaged 73.61+/-43.67 microg/dL, 65.37+/-12.87 microg/dL and 99.59+/-21.74 microg/L, respectively. The Cu/Zn ratio increased from first trimester to the third trimester (2.07-3.49). There was no significant correlation between Zn and Se levels, but a significant correlation was found between Cu and Se levels (p<0.05) and between Cu and Zn levels (p<0.001). Serum Zn and Se levels decreased over gestation, while serum Cu concentrations increased; in all cases the variation occurred mostly in the first 3 or 4 months, with mean levels then remaining fairly stable until the end of pregnancy. Maternal age did not influence levels of any of the three metals.

[Socioeconomic factors and utilization of public family practice facilities in Madrid]. / Factores socioeconómicos y frecuentación en las consultas de medicina de familia de la red sanitaria pública madrileña.

OBJECTIVES: To describe the possible association between demographic, social and economic characteristics of health areas in the autonomous community of Madrid and utilization of public family practice facilities. METHODS: An ecological study was carried out using health areas as the unit of analysis. The information sources were official data on population statistics and the reports of the National Institute of Health for 1996 and 2001. Indicators were income, mean household size, unemployment rate, the percentage of housewives, and the percentage of individuals with university education. The association between these indicators and utilization of public family practice facilities was analyzed using the Spearman correlation coefficient. A multivariate linear regression model was also fitted. RESULTS: The consultation rate in public family practice facilities in Madrid was directly associated with the percentage of housewives (r = 0.44), income (r = -0,697), and the percentage of individuals with university education (r = -0.72). In the multivariate linear regression model, 77% of the varian-ce in utilization was explained by income (48%), the percentage of housewives (19%), and average household size (9%). CONCLUSIONS: The results show the relationship between social and economic factors and utilization of public family practice facilities and suggest the advisability of including demographic and socioeconomic factors in primary care planning.