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Background: Severe cases of lymphopenia have been reported during siponimod clinical trials, which may negatively impact its benefit/risk profile. Objective: We aimed to evaluate the incidence of lymphopenia following the initiation of siponimod treatment in clinical practice. The secondary objectives included the analysis of factors predisposing to and the clinical relevance of lymphopenia events. Methods: In this multicenter retrospective cohort study, information collected from the medical records of 129 patients with MS from 15 tertiary hospitals in Spain who initiated treatment with Siponimod were followed-up for at least 3 months, including at least one lymphocyte count evaluation per patient. Results: Of the 129 patients, 121 (93.6%) reported lymphopenia events, including 110 (85.3%) with grade ≤ 3 and 11 (8.5%) with grade 4 lymphopenia, higher than those reported in the pivotal clinical trial (73.3% and 3.3% for grade ≤ 3 and grade 4 lymphopenia, respectively). The study included an unexpectedly high proportion of male subjects (72.9%), which might have led to an underestimation of the actual magnitude of the risk. Conclusions: In this study, the incidence and severity of lymphopenia after starting siponimod treatment were higher than those reported in previous clinical trials. Therefore, our results reinforce the need for the closer monitoring of novel MS drugs in clinical practice, as well as larger and longer follow-up studies to properly characterize this risk. [ABSTRACT FROM AUTHOR]

Background: Since the first confirmed case of severe acute respiratory syndrome coronavirus 2 in Spain in January 2020, the susceptibility of patients with rheumatic disease has remained unclear. In this report, we will describe the main features of coronavirus disease 2019 (COVID-19) that occurred in rheumatic patients with inflammatory disorders and try to identify features associated with severe disease. Methods: We included all rheumatic patients with immune-mediated diseases followed at 6 centers belonging to the public healthcare system in the Basque Country (Spain) and diagnosed with COVID-19 from March 1, 2020, to May 31, 2020. Results: In total, 131 patients were included in this study. The most frequent rheumatic disease was rheumatoid arthritis (46.6%), and the main comorbidities were arterial hypertension (45%). Forty-seven percent were taking glucocorticoids (GC) (62 patients), 61.8% were under treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARD), and 25 patients (19.1%) were receiving targeted therapies (TT). Thirty-eight percent of patients required hospital admission, 2.3% required transfer to intensive care uni, and the rate of mortality was 9.2%. Associated factors in univariate analysis for a bad outcome were older age, use of GC, obesity, previous cardiovascular disease, and lymphopenia. Use of GC and lymphopenia remained within the multivariate model. Conclusion: The frequency of COVID-19 seems to be similar in rheumatic patients as in the general population. Advanced age, obesity, heart disease, glucocorticoids, and low levels of lymphocytes were more common among the patients with a bad outcome. Neither exposure to csDMARD nor TT was associated with severe cases. [ABSTRACT FROM AUTHOR]

Purpose: Dimethyl fumarate (DMF) is an oral formulation approved for the treatment of moderate-to-severe psoriasis in adult patients requiring systemic therapy. Here, we describe our clinical experience with DMF for moderate-to-severe psoriasis in Spain. Patients and Methods: This is a retrospective study including 30 adult patients with moderate-to-severe psoriasis under treatment with DMF between September 2018 and January 2020. Patients were treated with DMF as per its Summary of Product Characteristics and the median duration of treatment was 15 weeks (4– 55 weeks). Psoriasis Area and Severity Index (PASI) and body surface area (BSA) severity scales were evaluated from baseline to week 36 and adverse events (AEs) developed during treatment were described. Results: The efficacy of DMF was assessed at week 8 and at week 36 (n = 5), both PASI and BSA were 0. At week 24, median PASI showed a decrease in both the last observation carried forward (LOCF; n = 23) and the observed cases (OC) (n = 10): from 10 to 6 and from 10 to 1.5, respectively. Median BSA also showed a decrease from 19 to 10 in LOCF and from 17 to 3 in OC. The most frequent AEs were diarrhoea (40.0%), flushing (13.3%) and lymphopenia (3.3%). In 47.1% patients, AEs have been solved by adjusting the DMF dose. Treatment discontinuation rate due to AEs was 43.3%. Conclusion: Our clinical experience indicates that DMF could be an effective and safe treatment for moderate-to-severe psoriasis in adult patients. [ABSTRACT FROM AUTHOR]

Antecedents and objectives:The coronavirus disease 2019 (COVID-19) has spread worldwide to be reported to date 3.446.072 cases in Spain which causes a very challenging situation for the Spanish Health Care System. This study aims to describe the adjustments, analytical and microbiological parameters of patients clinically diagnosed with SARSCoV-2 infection in the first weeks of the pandemic. Material and methods:A retrospective observational study. 180 patients have been included in the study since they were treated by our emergency unit for a period beginning on March 9 ending on April 24, 2020. They were clinically diagnosed with COVID-19. The study provides analysis on their demographic, analytical and microbiological data. Results: The average patient was 64 years old and 60.6 % were men. 86.1 % obtained a positive RT-PCR, 3.9 % a negative one. The 10 % left provided an inconclusive result. IgG antibodies were detected in 84.4 % and IgM antibodies in 85.6 %. 26.0 % of our patients suffered from lymphopenia and 13.6 % thrombocytopenia. 67.4 % and 77.3 % had respectively D-dimer and fibrinogen levels above the normal range. High serum levels of ALT (45.0 %), AST (30.5 %), LDH (71.9 %), C-reactive protein (74.5 %), and procalcitonin (11.9 %) were reported. High ferritin concentrations were found in 75.2 %. Conclusions: The alterations observed in the analytical parameters are the most common in cases of COVID-19. These high level rates have been considered prognostic markers of severity and mortality. [ABSTRACT FROM AUTHOR]

Summary: The role of lymphocytes and their main subsets as prognostic factors of death in SARS‐CoV‐2‐infected patients remains unclear, with no information obtained from patients outside China. We aimed to assess whether measuring lymphocyte subpopulations added clinical value to the total lymphocyte counting regarding mortality when they were simultaneously tested at hospital admission. Peripheral blood was analysed in 701 polymerase chain reaction (PCR)‐confirmed consecutive patients by lysed–no washed flow cytometry. Demographic and clinical features were registered in electronic medical records. Statistical analysis was performed after a 3‐month follow‐up. The 112 patients who died were older and had significantly higher frequencies of known co‐morbidities than survivor COVID‐19 patients. A significant reduction in total lymphocytes, CD3+, CD4+, CD8+ and CD19+ counts and CD3+ percentage was found in the group of deceased patients (P < 0·001), while the percentage of CD56+/CD16+ natural killer (NK) cells was significantly higher (P < 0·001). Multivariate logistic regression analysis showed a significantly increased risk of in‐hospital death associated to age [odds ratio (OR) = 2·36, 95% confidence interval (CI) = 1·9–3·0 P < 0·001]; CD4+ T counts ≤ 500 cells/μl, (OR = 2·79, 95% CI = 1·1–6·7, P = 0·021); CD8+ T counts ≤ 100 cells/μl, (OR = 1·98, 95% CI = 1·2–3·3) P = 0·009) and CD56+/CD16+ NK ≥ 30%, (OR = 1·97, 95% CI = 1·1–3·1, P = 0·002) at admission, independent of total lymphocyte numbers and co‐morbidities, with area under the curve 0·85 (95% CI = 0·81–0·88). Reduced counts of CD4+ and CD8+ T cells with proportional expansion of NK lymphocytes at admission were prognostic factors of death in this Spanish series. In COVID‐19 patients with normal levels of lymphocytes or mild lymphopenia, imbalanced lymphocyte subpopulations were early markers of in‐hospital mortality. [ABSTRACT FROM AUTHOR]

Introduction: COVID 19 is novel coronavirus which first struck the world 5 months ago and became pandemic in such a short time. China suffered first and then this virus spread to more than 180 countries. Primary organ involved is lungs and the commonest cause of fatality is respiratory failure1. Although, its new virus, related to two earlier deadly viruses e.g. SARS and MERS but has already caused tremendous morbidity and mortality in nations heavily affected by it. This short review highlights about lung involvement due to this virus and to make our healthcare professionals aware about what to expect by learning from the experience of the countries where it has already affected thousands of civilians. Methodology: This review article was written with systematic literature review with the help of data search machine like Pubmed, Scopus, Web of Sciences and google scholar. In this article observational study wand case reports were included. Most of the data were taken from China, Italy and Spain. Review Findings: COAVID 19 affects lung parenchyma in moderate to severe disease causing pneumonia which starts as unilateral lower lobe, commonly on right side, peripheral ground glass infiltrates and rapidly spreads to involve both lungs with bilateral, multifocal consolidations2. Pleural effusion and pericardial involvement may occur. In severe cases the disease progresses to Acute Respiratory Distress Syndrome accounting for >90% of mortality. Pathology of lungs showed diffuse alveolar damage with organization and fibrosis as disease progresses. Conclusions: COVID 19 a novel coronavirus which is presently a pandemic has affected the world in manner reminiscence of 1918 Spanish flu. Lung involvement as community acquired pneumonia is determinant of mortality, which spreads exponentially to develop sever respiratory failure. [ABSTRACT FROM AUTHOR]

Background: Dimethyl fumarate (DMF) tolerability and safety in multiple sclerosis (MS) has been analyzed in randomized clinical trials. Real-life studies are needed to assess possible harms of this therapy in a wider MS population. Objective: To evaluate DMF tolerability, safety and persistence in MS in a real-world setting. Methods: We conducted a multicenter prospective study of patients who started DMF, attended in 16 public hospitals of Spain. A specific database was elaborated to collect data on most frequent adverse events (AE). Regression models were used to analyze the effect of demographic and clinical characteristics on risk of AEs and DMF discontinuation. Results: We collected data of 886 patients (2681 patients/years-exposition) with median 39.5 (IQR 23, 51.5) months on DMF exposure; 25.3% were treatment naïve and 74.7% switched to DMF from other disease-modifying therapies. DMF was discontinued in 29.9% of patients, in 13.2% due to AEs and in 13.5% to inefficacy. AEs were experienced by 71.2%, being flushing the most frequent (44.1%), 5.4% developed grade III lymphopenia, without cases of grade IV. Females showed a higher risk of flushing and gastroenteric symptoms (OR 1.49, p = 0.011; OR 1.69, p = 0.001, respectively); lymphopenia was associated with older age (OR 1.04, p < 0.001), and a higher EDSS with lymphopenia (OR 1.10, p = 0.035) and DMF withdrawal (HR 1.43, p = 0.012). No safety problems were reported. Conclusions: Our findings confirm good tolerability and safety of DMF in real-world setting and suggest that women have an increased risk of AEs and higher baseline disability involves greater risk of drug discontinuation. [ABSTRACT FROM AUTHOR]

Background: The causal link between elevated systemic inflammation biomarkers and poor survival has been demonstrated in cancer patients. However, the evidence for this correlation in endometrial cancer (EC) is too weak to influence current criteria of risk assessment. Here, we examined the role of inflammatory indicators as a tool to identify EC patients at higher risk of death in a retrospective observational study. Methods: A total of 155 patients surgically diagnosed with EC stage I-III FIGO 2009 and treated with postoperative External Beam Radiotherapy (EBRT) ± brachytherapy and chemotherapy according to ESMO-ESTRO-ESGO recommendation for patients at high risk of recurrence at the Gustave Roussy Institut, France, and Hospital Clínic, Spain, between 2008 and 2017 were evaluated. The impact of pre-treatment Neutrophil-to-Lymphocyte Ratio (NLR ≥ 2.2), Monocyte-to-Lymphocyte Ratio (MLR ≥ 0.18), Systemic Immune-Inflammatory Index (SII ≥ 1100) and lymphopenia (<1.0×109/L) on overall survival (OS), cancer-specific survival and progression-free survival was evaluated. Subsequently, a cohort of 142 patients within high-advanced risk groups according to ESMO-ESGO-ESTRO classification was evaluated. Results: On univariate analysis, NLR (HR = 2.2, IC 95% 1.1–4.7), SII (HR = 2.2, IC 95% 1.1–4.6), MLR (HR = 5.0, IC 95% 1.1–20.8) and lymphopenia (HR = 3.8, IC 95% 1.6–9.0) were associated with decreased OS. On multivariate analysis, NLR, MLR, SII and lymphopenia proved to be independent unfavorable prognostic factors. Conclusions: lymphopenia and lymphocytes-related ratio are associated with poorer outcome in surgically staged I-III FIGO EC patients classified as high risk and treated with adjuvant EBRT and could be considered at cancer diagnosis. External validation in an independent cohort is required before implementation for patients' stratification. [ABSTRACT FROM AUTHOR]

Introduction: Given the wide heterogeneity of common variable immunodeficiency (CVID), several groups have proposed clinical and immunological classifications to better define follow-up and prognostic algorithms. The present study aims to validate recent clinical and laboratory algorithms, based on different combinations of CVID biomarkers, to provide more personalized treatment and follow-up strategies., Methods: We analysed clinical and immunological features of 80 patients with suspected or diagnosed CVID, in two reference centres of Portugal and Spain. Clinical manifestations were categorized into clinical phenotyping proposed by Chapel et al. [1] that included cytopenia; polyclonal lymphocytic infiltration; unexplained enteropathy; and no disease-related complications., Results: 76% of patients in our cohort entered one of the four categories of clinical phenotyping, without overlap (cytopenia; polyclonal lymphocytic infiltration; unexplained enteropathy; and no disease-related complications). The most prominent phenotype was "cytopenia" (40%) followed by "polyclonal lymphocytic infiltration" (19%). The remaining 24% patients of our cohort had overlap of 2 clinical phenotypes (cytopenia and unexplained enteropathy mainly). A delay of CVID diagnosis in more than 6 years presented 3.7-fold higher risk of developing lymphoproliferation and/or malignancy (p < 0.05), and was associated with increased CD8 + CD45RO  +  T-lymphocytes (p < 0.05). An association between decreased switched-memory B cells with lymphoproliferation and malignancy was observed (p < 0.03 and p < 0.05, respectively). CD4  +  T-lymphocytopenia correlated with autoimmune phenotype, with 30% prevalence (p < 0.05). HLA-DR7 expression was related to CVID onset in early life in our patients (13 vs 25 years), and DQ2.5 or DQ2.2 with unexplained enteropathy (p < 0.05)., Conclusions: The phenotypic and genetic study is crucial for an adequate clinical orientation of CVID patients. In these two independent cohorts of patients, classification based in clinical and laboratory algorithms, provides more personalized treatment and follow-up strategies., Competing Interests: Declaration of Competing Interest The authors declare no other competing financial interests., (Copyright © 2020 European Federation of Immunological Societies. Published by Elsevier B.V. All rights reserved.)