Unveiling the Link Between Antiphospholipid Antibodies and Cognitive Dysfunction in the Almenara Lupus Cohort.

OBJECTIVE: Cognitive dysfunction is a prevalent manifestation of systemic lupus erythematosus (SLE). There is evidence for the role of antiphospholipid (aPL) antibodies on its etiopathogenesis. Our objective was to identify the association between aPL antibodies and cognitive dysfunction in SLE patients. METHODS: This cross-sectional study included 135 patients evaluated from March 2015 to October 2017 at one center. Cognitive deficit was measured using the NEUROPSI test. Disease activity and damage were ascertained using the SLEDAI-2K (SLE Disease Activity Index 2000) and the SDI (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index), respectively; aPL antibodies were measured by enzyme-linked immunosorbent assay. The association between cognitive dysfunction and aPL antibodies was evaluated using univariable and multivariable linear regression models adjusted for age, sex, education, socioeconomic status, disease duration, SLEDAI-2K, SDI, mean current dose of prednisone, time of exposure to glucocorticoids, and drug use (immunosuppressants, hydroxychloroquine, aspirin, and warfarin). RESULTS: One hundred thirty-one patients (97.1%) were women; their mean (SD) age was 46.6 (12.5) years; 59 patients (43.7%) had positivity for at least 1 aPL antibody. IgM anticardiolipin (aCL) was positive in 24.5%, IgG in 13.5%, IgM aß2GP1 in 16.8%, IgG anti-ß2 glycoprotein in 24.6%, and the lupus anticoagulant in 5.3%. Ninety patients (66.7%) had some cognitive dysfunction. In the univariable analysis, a significant correlation between the NEUROPSI score and IgM aCL antibodies was found (B = -20.87 [SE, 3.2]; p < 0.001), which remained significant in the multivariable model (B = -13.89 [SE, 3.14]; p < 0.001). CONCLUSIONS: IgM aCL antibodies are associated with cognitive dysfunction in patients with SLE. Larger and longitudinal studies are needed to assess the impact of these findings.

Metabolic syndrome predicts new damage in systemic lupus erythematosus patients: Data from the Almenara Lupus Cohort.

OBJECTIVES: This study aims to determine whether the MetS predicts damage accrual in SLE patients. METHODS: This longitudinal study was conducted in a cohort of consecutive SLE patients seen since 2012 at one single Peruvian institution. Patients had a baseline visit and then follow-up visits every 6 months. Patients with ≥ 2 visits were included. Evaluations included interview, medical records review, physical examination, and laboratory tests. Damage accrual was ascertained with the SLICC/ACR damage index (SDI) and disease activity with the SLEDAI-2K. Univariable and multivariable Cox-regression survival models were carried out to determine the risk of developing new damage. The multivariable model was adjusted for age at diagnosis; disease duration; socioeconomic status; SLEDAI; baseline SDI; the Charlson Comorbidity Index; daily dose; and time of exposure of prednisone (PDN), antimalarials, and immunosuppressive drugs. RESULTS: Two hundred and forty-nine patients were evaluated; 232 of them were women (93.2%). Their mean (SD) age at diagnosis was 35.8 (13.1) years; nearly all patients were Mestizo. Disease duration was 7.4 (6.6) years. The SLEDAI-2K was 5.2 (4.3) and the SDI, 0.9 (1.3). One hundred and eight patients (43.4%) had MetS at baseline. During follow-up, 116 (46.6%) patients accrued at least one new point in the SDI damage index. In multivariable analyses, the presence of MetS was a predictor of the development of new damage (HR: 1.54 (1.05-2.26); p < 0.029). CONCLUSIONS: The presence of MetS predicts the development of new damage in SLE patients, despite other well-known risk factors for such occurrence.

Relationship between care model and disease activity states and health-related quality of life in systemic lupus erythematosus patients.

OBJECTIVE: To assess whether the care model (comprehensive vs regular) has any impact on the clinical outcomes of systemic lupus erythematosus patients. METHODS: Between August 2019 and January 2020, we evaluated SLE patients being cared for at two Peruvian hospitals to define the impact of care model on disease activity state and health-related quality of life (HRQoL). Disease activity was ascertained with the SLEDAI-2K and the Physician Global Assessment (PGA) which allows to define Lupus Low Disease Activity State (LLDAS) and Remission. HRQoL was measured with the LupusQoL. The association between care model and disease activity (Remission and LLDAS) state was examined using a binary logistic regression model. The association with HRQoL was examined with a linear regression model. All multivariable analyses were adjusted for possible confounders. RESULTS: 266 SLE patients were included, 227 from the comprehensive care model and 39 from the regular care model. The regular care model was associated with a lower probability of achieving remission (OR 0.381; CI: 95% 0.163-0.887) and LLDAS (OR 0.363; CI: 95% 0.157-0.835). Regular care was associated with a better HRQoL in two domains (pain and emotional health). We found no association between the care model and the other HRQoL domains. CONCLUSION: A comprehensive care model was associated with the probability of achieving remission and LLDAS but had no apparent impact on the patients' HRQoL.

Health-Related Quality of Life and fatigue are associated with a higher work productivity impairment in systemic lupus erythematosus patients: Data from the Almenara Lupus Cohort.

Objectives: This study aims to determine the factors associated with absenteeism, presenteeism, and overall work impairment in patients with systemic lupus erythematosus (SLE).Methods: A total of 133 consecutive working patients with SLE were assessed between October 2017 and December 2018, using a standardized data collection form. Sociodemographic, disease, and work-related variables were collected. Work productivity and activity impairment (WPAI) was assessed with the respective questionnaire; absenteeism and presenteeism due to overall health and symptoms during the past 7 days were scored. Linear regression models were performed to determine the factors associated with absenteeism, presenteeism, and overall work impairment. Potential factors included were age at diagnosis, gender, socioeconomic status, educational level, SLEDAI, SLICC/ACR damage index (SDI), FACIT-Fatigue, and the domains of the LupusQoLResults: The mean age at diagnosis was 32.2 years (11.8); 121 (91.7%) were female. Nearly all patients were Mestizo. The mean percent of time for absenteeism was 5.0 (12.9), it was 28.5 (26.4) for presenteeism, and it was 31.3 (27.2) for overall work impairment. In the multiple regression analysis, factors associated with absenteeism were disease duration (B = -0.34; SE = 0.12; p = 0.007), pain (B = -0.14; SE = 0.06; p = 0.046), intimate relationship (B = -0.07; SE = 0.03; p = 0.046), and emotional health (B = 0.16; SE = 0.06; p = 0.006); factors associated with presenteeism were physical health (B = -0.43; SE = 0.14; p = 0.002) and FACIT (B = -0.87; SE = 0.30; p = 0.005); and factors associated with overall work impairment were pain (B = -0.40; SE = 0.11; p = 0.001) and FACIT-Fatigue (B = -0.74; SE = 0.28; p = 0.010).Conclusion: A poor HRQoL and higher levels of fatigue were associated with a higher percentage of absenteeism, presenteeism, and overall work impairment in SLE patients.

Age at diagnosis and health-related quality of life are associated with fatigue in systemic lupus erythematosus patients: Data from the Almenara Lupus Cohort.

OBJECTIVE: To define the factors associated with fatigue in Mestizo patients with Systemic Lupus Erythematosus (SLE). METHODS: This is a cross-sectional study of SLE patients from a single center cohort. Visits were performed every six months. For these analyses, the first visit between October 2017 and December 2018 was included. Demographic and clinical characteristics as well as treatment were recorded at every visit. Fatigue was ascertained with the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-FT), Health-Related Quality of Life (HRQoL) with the LupusQoL, disease activity with the Systemic Lupus Erythematosus Disease Activity Index -2 K (SLEDAI-2K), and damage with the Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology damage index (SDI). Prednisone use was recorded as current daily dose. Immunosuppressive drugs and antimalarial use were recorded as current, past or never. Univariable and multivariable analyses were performed using linear regression models. For the multivariable analyses, model selection followed a backward elimination procedure. RESULTS: Two hundred and twenty-six patients were evaluated. The mean (SD) age at diagnosis was 35.6 (13.1) years, 211 (93.4%) were female; and disease duration was 11.0 (7.3) years. The mean SLEDAI and SDI were 2.4 (3.5) and 1.3 (1.5), respectively. The mean FACIT-FT was 33.1 (10.8). On the multivariable analysis, age at diagnosis and some domains of HRQoL (physical health, emotional health and fatigue) remained associated. CONCLUSIONS: Age at diagnosis is negatively associated with fatigue whereas HRQoL domains like physical health, emotional health and fatigue are positively associated with fatigue.

Discrepant Perception of Lupus Disease Activity: A Comparison Between Patients' and Physicians' Disease Activity Scores.

OBJECTIVE: The aim of this study was to compare patient and physician (MD) assessment of disease activity in systemic lupus erythematosus patients. METHODS: This cross-sectional study was conducted between August 2016 and December 2017 at 2 Peruvian hospitals. One group assessed disease activity using a visual analog scale (VAS, 0-100 mm) and the other one using a numerical rating scale (NRS, 0-4), before and after their MD's visit. MDs assessed it with the Mexican Systemic Lupus Erythematosus Disease Activity (Mex-SLEDAI) (0-32) and with the SLICC/ACR Damage Index (SDI) for damage. Health-related quality of life was ascertained with the LupusQoL. Visual analog scale and NRS were compared using the Wilcoxon signed-rank test and the correlation between disease activity as assessed by the patient and the Mex-SLEDAI, SDI, and LupusQoL with the Spearman rank correlation. RESULTS: Two hundred forty patients were included; mean (SD) age at diagnosis was 34.9 (12.9) years; most patients were Mestizo. Disease duration was 10.1 (7.0) years. The Mex-SLEDAI was 1.9 (2.7) and the SDI 1.2 (1.5). Disease activity as assessed by the patient, either by VAS or NRS, did not correlate with the Mex-SLEDAI or the SDI. In contrast, patient assessment of disease activity, by VAS or NRS, significantly correlated with several components of the LupusQoL (physical health, pain, planning, emotional health, and fatigue). CONCLUSIONS: Physician's and patient's assessments of disease activity are discrepant; overall, patients score higher than their MDs. Patients score how they perceive the disease is affecting them, rather than disease activity per se. The VAS could be more useful than the NRS as a measurement of disease activity.

Factors associated with health-related quality of life in Peruvian patients with systemic lupus erythematosus.

Objective In this paper, we aim to define factors associated with health-related quality of life (HRQoL) in Mestizo patients with systemic lupus erythematosus (SLE). Methods We evaluated patients with SLE from Peru's two largest hospitals between October 2012 and July 2015 to ascertain HRQoL. Using a standard protocol, we incorporated demographic characteristics, clinical manifestations and treatment in our analysis. HRQoL was measured with the LupusQoL, disease activity was ascertained with the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and damage was appraised with the Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) damage index (SDI). The associations between the LupusQoL and these variables were examined using linear regression models. Model selection was based on backward elimination. Results A total of 277 patients fit the inclusion criterion. Of these, 254 (91.7%) were female, the median (interquartile range, IQR) age at diagnosis was 41.5 (33.8-51.8) years, disease duration was 6.5 (2.7-11.3) years. The HRQoL domains most affected were the following: burden to others, fatigue, and intimate relationships. Through multivariate analysis, we determined that older age at diagnosis, higher disease activity, damage, and immunosuppressive drug use were negatively associated with HRQoL. Further, we found that higher socioeconomic status, disease duration, and antimalarial use were positively associated with HRQoL. Conclusion Age at diagnosis, disease activity, damage, and use of immunosuppressive drugs were negatively associated with HRQoL; high socioeconomic status, disease duration, and use of antimalarials were positively associated with HRQoL.

Circulating naive and memory CD4+ T cells and metabolic syndrome in patients with systemic lupus erythematosus: data from a primarily Mestizo population.

OBJECTIVE: The aim of this study was to determine whether the proportions of naive and memory CD4(+) T cell are independently associated with the metabolic syndrome (MetS) in patients with SLE. METHODS: This cross-sectional study was conducted in SLE patients seen at our rheumatology department between September 2013 and April 2014. CD4(+) T cell subpopulations were examined by flow cytometry. The association of MetS and CD4(+) T cell subpopulations was examined by Mann-Whitney U-test and by multivariable analysis, adjusting for all possible confounding variables. RESULTS: One hundred and seventeen patients were evaluated. Their mean age was 44.6 years (S.D. 12.6), 109 (93.2%) were female and all patients were Mestizo (mixed Caucasian and Amerindian ancestry). Fifty-two patients (44.4%) presented with MetS. Disease duration was 7.6 years (S.D. 6.8). The percentage of naive CD4(+) T cells was 25.0 (S.D. 12.7) and memory CD4(+) T cells was 66.7 (S.D. 13.2) and the memory:naive CD4(+) T cell ratio was 4.3 (S.D. 5.6). In multivariable analysis, the percentage of naive CD4(+) T cells was negatively associated with the presence of MetS [odds ratio (OR) 0.959 (95% CI 0.923, 0.997), P = 0.033], whereas the percentage of memory CD4(+)T cells and the memory:naive CD4(+) T cell ratio were positively associated with its presence [OR 1.040 (95% CI 1.003, 1.078), P = 0.031 and OR 1.238 (95% CI 1.041, 1.472), P = 0.016, respectively]. CONCLUSION: In the SLE patients studied, a lower percentage of naive CD4(+) T cells, a higher percentage of memory CD4(+) T cells and the memory:naive CD4(+) T cell ratio were independently associated with the presence of MetS. This association could reflect the impact of immunosenescence among SLE patients with cardiovascular morbidity.

A better self-efficacy is predictive of better health-related quality of life (HRQoL) in patients with systemic lupus erythematosus: data from the Almenara Lupus Cohort.

OBJECTIVE: To determine the possible predictive value of self-efficacy on health-related quality of life (HRQoL) in patients with SLE. METHODS: Patients with SLE from the Almenara Lupus Cohort were included. Self-efficacy was ascertained with the six domains from the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing chronic conditions. For PROMIS domains, a score of 50 is the average for a clinical population (people with a chronic condition), a higher score indicates that the respondent has greater self-efficacy. HRQoL was ascertained with the physical and mental component summary (PCS and MCS) measures of the Short-Form 36 (SF-36). Generalised estimating equations were performed, using as outcome the PCS or MCS in the subsequent visit, and the self-efficacy domain in the previous visit; multivariable models were adjusted for possible confounders. The confounders were measured in the same visit as the self-efficacy domain. RESULTS: Two-hundred and nine patients for a total of 564 visits were included; 194 (92.8%) patients were women and mean age at diagnosis was 36.4 (14.0) years. In the multivariable models, a better PCS was predicted by a better self-efficacy for managing symptoms, managing medications and treatments and managing social interactions and general self-efficacy; a better MCS was predicted by a better self-efficacy for managing daily activities, managing symptoms, managing medications and treatments and managing social interactions. CONCLUSION: A better self-efficacy is predictive of subsequent better HRQoL, even after adjustment for possible confounders. These results should encourage clinicians to develop strategies to improve self-efficacy in patients with SLE.

LLDAS (lupus low disease activity state) and/or remission are associated with less damage accrual in patients with systemic lupus erythematosus from a primarily Mestizo population: data from the Almenara Lupus Cohort.

OBJECTIVE: To determine if achieving lupus low disease activity state (LLDAS) or remission prevents damage accrual in a primarily Mestizo population. METHODS: Patients with SLE from a single-centre cohort with at least two visits occurring every 6 months were included. The definitions used were the following: for remission, the 2021 Definition Of Remission In SLE; and for LLDAS, the Asia Pacific Lupus Collaboration. Damage accrual was ascertained with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Univariable and three multivariable interval-censored survival regression models were done: (1) remission versus not on remission; (2) LLDAS/remission versus active; and (3) remission and LLDAS (not on remission) versus active. Three similar multivariable models were also examined considering the duration on each state. Possible confounders included in these analyses were gender, age at diagnosis, socioeconomic status, educational level, disease duration, antimalarial use and SDI at baseline. RESULTS: Two hundred and eighty-one patients were included. Eighty-three patients (29.5%) showed increased SDI during the follow-up. In the analyses of remission, being on remission predicted a lower probability of damage (HR=0.456; 95% CI 0.256 to 0.826; p=0.010). In the analyses of LLDAS/remission, being on LLDAS/remission predicted a lower damage (HR=0.503; 95% CI 0.260 to 0.975; p=0.042). When both states were considered, remission but not LLDAS (not on remission) predicted a lower probability of damage (HR=0.423; 95% CI 0.212 to 0.846; p=0.015 and HR=0.878; 95% CI 0.369 to 2.087; p=0.768, respectively). When the duration of these states was taken into account, remission, LLDAS/remission and LLDAS not on remission were associated with a lower probability of damage accrual. CONCLUSIONS: LLDAS and/or remission were associated with a lower probability of damage accrual.

Severe flares are associated with a poorer health-related quality of life (HRQoL) in patients with SLE: data from the Almenara Lupus Cohort.

BACKGROUND: Flares in patients with SLE, regardless of their severity, have been associated with damage accrual. However, their impact on health-related quality of life (HRQoL) has not been fully evaluated. In fact, disease activity is only minimally associated with HRQoL. OBJECTIVE: To determine the association between flares and HRQoL. METHODS: Patients from the Almenara Lupus Cohort were included. Visits occurring between December 2015 and February 2020 were evaluated. Flares were defined as an increase on the SLE Disease Activity Index 2000 (SLEDAI-2K) of at least 4 points; severe flares were those with a final SLEDAI-2K ≥12 and mild-moderate flares all the others. HRQoL was measured using the LupusQoL. Univariable and multivariable generalised estimating regression equations were performed, adjusting for possible confounders. Confounders were determined at one visit, whereas the outcome was determined on the subsequent visit; flares were determined based on the variation of the SLEDAI-2K between these visits. RESULTS: Two hundred and seventy-seven patients were included; 256 (92.4%) were female, mean age at diagnosis was 36.0 (SD: 13.3) years and mean disease duration at baseline was 9.1 (SD: 7.1) years. Patients had mean of 4.8 (SD: 1.9) visits and a mean follow-up of 2.7 (1.1) years. Out of 1098 visits, 115 (10.5%) flares were defined, 17 were severe and 98 mild-moderate. After adjustment for possible confounders, only severe flares were associated with a poorer HRQoL in planning, pain, emotional health and fatigue. CONCLUSIONS: Severe flares, but not mild-moderate, flares are associated with poorer HRQoL.

Serum uric acid is associated with damage in patients with systemic lupus erythematosus.

Introduction: Serum uric acid levels have been reported as predictors of cardiovascular, pulmonary, neurological and renal morbidity in patients with SLE. However, their role in cumulative global damage in these patients has not yet been determined. Objective: To determine whether serum uric acid levels are associated with new damage in patients with SLE. Methods: This is a longitudinal study of patients with SLE from the Almenara Lupus Cohort, which began in 2012. At each visit, demographic and clinical characteristics were evaluated, such as activity (Systemic Lupus Erythematosus Disease Activity Index-2K or SLEDAI-2K) and cumulative damage (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index or SDI). Treatment (glucocorticoids, immunosuppressive drugs and antimalarials) was also recorded. Univariable and multivariable Cox regression models were used to determine the impact of serum uric acid levels on the risk of new damage. Results: We evaluated 237 patients, with a mean age (SD) at diagnosis of 35.9 (13.1) years; 220 patients (92.8%) were women, and the duration of the disease was 7.3 (6.6) years. The mean SLEDAI-2K and SDI scores were 5.1 (4.2) and 0.9 (1.3), respectively. Serum uric acid level was 4.5 (1.4) mg/dL. Follow-up time was 3.1 (1.3) years, and 112 (47.3%) patients accrued damage during follow-up. In univariable and multivariable analyses, serum uric acid levels were associated with new damage (HR=1.141 (95% CI 1.016 to 1.282), p=0.026; HR=1.189 (95% CI 1.025 to 1.378), p=0.022, respectively). Conclusion: Higher serum uric acid levels are associated with global damage in patients with SLE.

Serum uric acid levels contribute to new renal damage in systemic lupus erythematosus patients.

This study aims to determine whether uric acid levels contribute to new renal damage in systemic lupus erythematosus (SLE) patients. This prospective study was conducted in consecutive patients seen since 2012. Patients had a baseline visit and follow-up visits every 6 months. Patients with ≥2 visits were included; those with end-stage renal disease (regardless of dialysis or transplantation) were excluded. Renal damage was ascertained using the SLICC/ACR damage index (SDI). Univariable and multivariable Cox-regression models were performed to determine the risk of new renal damage. Uric acid was included as a continuous and dichotomous (per receiving operating characteristic curve) variable. Multivariable models were adjusted for age at diagnosis, disease duration, socioeconomic status, SLEDAI, SDI, serum creatinine, baseline use of prednisone, antimalarials, and immunosuppressive drugs. One hundred and eighty-six patients were evaluated; their mean (SD) age at diagnosis was 36.8 (13.7) years; nearly all patients were mestizo. Disease duration was 7.7 (6.8) years. Follow-up time was 2.3 (1.1) years. The SLEDAI was 5.2 (4.3) and the SDI 0.8 (1.1). Uric acid levels were 4.5 (1.3) mg/dl. During follow-up, 16 (8.6%) patients developed at least one new point in the renal domain of the SDI. In multivariable analyses, uric acid levels (continuous and dichotomous) at baseline predicted the development of new renal damage (HR 3.21 (1.39-7.42), p 0.006; HR 18.28 (2.80-119.48), p 0.002; respectively). Higher uric acid levels contribute to the development of new renal damage in SLE patients independent of other well-known risk factors for such occurrence.

Educational website incorporating rheumatoid arthritis patient needs for Latin American and Caribbean countries.

Health education is fundamental in the management of RA patients. This study explored patient needs for educational material appropriate for RA patients in our region through a website. This study includes seven focus groups and semi-structured interviews across 4 countries (Argentina, Chile, Colombia, and Mexico) with 71 RA patients. Transcripts were analyzed by anthropologists using qualitative analysis (QA), resulting in themes and subthemes to be developed. Five themes and over 50 subthemes of interest were identified by patients. Grouped into categories as follows: (1) knowing the disease, (2) living with arthritis, (3) treatment and therapies for RA, (4) psychosocial support, and (5) information for families. A response was written by the team in plain Spanish on patient subthemes of interest including additional areas that the team considered relevant. Three videos for YouTube were produced: on patient-doctor relationships, patients at work, and home and at the clinic. Illustrations in a comic book format on RA diagnosis were created. The educational site on RA of PANLAR can be found at htpp://artritisreumatoide.cl. This project accomplished a comprehensive list of RA patient interests, revealing the complex relationship between the information on the disease, the experience of a chronic disease, and the way in which patients approach, conceive, and manage their disease. We expect to gather information on how the website will be used in the future for patients and their families and maintain and improve the website as well as adapt its content to different socioeconomic realities.

Comportamiento de capacidades y mermas en la producción del Instituto Finlay de Vacunas en el año 2017 / Behavior of capacities and losses in the production of the Finlay Institute of Vaccines in the year 2017

El análisis de las mermas y las capacidades son fundamentales para la gestión empresarial, en cuanto permite conocer el grado de uso que se hace de cada uno de los recursos en la organización y optimizarlos. Ambos estudios constituyen una herramienta útil para incidir en los costos y mejorar la eficiencia de la empresa. En el presente trabajo se analizó el comportamiento de las capacidades y las mermas del año 2017 en el Instituto Finlay de Vacunas, teniendo en cuenta el plan de capacidades y de mermas certificados para ese año por BioCubaFarma (Organización Superior de Desarrollo Empresarial, a la que se subordinan los centros de la biotecnología en Cuba). Se realizó una evaluación del comportamiento de la utilización de las capacidades productivas por meses al cierre del 2017, teniendo como base la comparación entre el plan de producción por meses, lo real producido y la capacidad productiva mensual. Paralelamente se realizó un estudio comparativo entre la merma total de la empresa y la mensual real por vacunas con respecto al estándar de mermas establecido. Los resultados mostraron que al cierre del 2017 la utilización de las capacidades productivas fue de 78,9 por ciento; incidiendo negativamente en este aspecto roturas de la línea de llenado. Se obtuvo un 80 por ciento de cumplimiento del plan de producción, las mayores afectaciones ocurrieron en los meses de mayo, agosto y septiembre debido a roturas de los sistemas críticos, roturas de equipamiento y las afectaciones provocadas por el huracán Irma. Al cierre del año que se analiza, las mermas estuvieron por debajo de las mermas certificadas. Sin embargo, los meses de junio, julio agosto y diciembre mostraron un incremento de las mismas por encima de lo planificado. Las vacunas que mayores mermas aportaron fueron: vax-TET® con 13,7 por ciento, VA-DIFTET® con 13,0 por ciento y diTe-vax® con 11,3 por ciento, siendo la etapa de llenado la de mayor contribución de mermas. La vacuna vax-TET® fue la que sistemáticamente aportó mermas en la presentación unidosis(AU)

The analysis losses and capacities are fundamental for the managerial administration because allow to know the degree of use that is made of each resources in the organization and to optimize them. Both studies constitute an useful tool to impact in the cost and to improve the efficiency of the company. Presently work was analyzed the behavior of the capacities and losses at the Finlay Vaccine Institute in the year 2017, taking into account the plan of capacities and losses certified by BioCubaFarma for this year. An evaluation of the behavior of the use of productive capacities per months at the end of 2017 was carried out, having like base the comparison among the production plan per months, the real produced and the monthly productive capacity. Also a comparative study among the company total losses and the monthly real one for each vaccine with regard to the standard established was carried out. The results showed that in 2017 the use of productive capacities were 78.9 percent, impacting negatively in this aspect the constants breaks of the filled line. 80 percent was obtained for execution of production plan, with the biggest affectations in May, August and September due to breaks of critical systems; breaks of equipment and the affectations caused by the hurricane Irma. At the end of the analyzed year, the losses were below the certified one. However, the months of June, July August and December showed an increment above that planned. The vaccines that contribute with bigger losses were: vax-TET® with 13.7 percent, VA-DIFTET® with 13.0 percent and diTe-vax® with 11.3 percent, being the stage of filled of bigger losses contribution. The vaccine that systematically contributed with losses was vax-TET® vaccine, in the unidoses presentation(AU)

Evaluación preliminar y actualización de las mermas productivas para mejorar la rentabilidad del Instituto Finlay de Vacunas / Preliminary evaluation and updating of the productive losses to improve the profitability of Finlay

Se realizó una evaluación preliminar de las mermas productivas en varios escenarios de la Planta de Procesamiento Aséptico y de Envase del Instituto Finlay de Vacunas de La Habana, Cuba. La evaluación abarco las áreas de formulación, llenado, etiquetado y envase, durante el período 2011-2015, con el propósito de constituir una herramienta útil que incidiera sobre los costos de producción y mejorar la eficiencia de la empresa. Los resultados muestran que la etapa de formulación presenta mayor promedio de pérdidas por mermas (6,99 por ciento), principalmente aportadas por las vacunas DTP-vax® y VA-MENGOC-BC®; seguido de la etapa de llenado con un promedio de mermas de 4 por ciento. Las mermas para el resto de las etapas oscilaron entre 0,2 por ciento y 1,57 por ciento. El costo general de las mermas de este período fue de 8.949.871,79 pesos cubanos, aportado por las vacunas vax-SPIRAL®, vax-TyVi®, vax-TET® y VA-MENGOC-BC®. Se observó que, excepto para vax-TET-5® (presentación de 20 dosis), debido a problemas confrontados con el volumen de los bulbos, las mermas del año 2016 estuvieron por debajo del porcentaje establecido. Por último, se realizó un análisis de tendencia de las mermas totales y por presentación, en el período 2011 al 2016, mostrando que en el año 2015 se obtuvo la mayor cantidad de mermas de vacunas, con mayor incidencia en la presentación de 20 dosis(AU)

A preliminary evaluation of production losses was carried out in several scenarios of the Aseptic Processing and Packaging Plant of Finlay Vaccine Institute, Havana, Cuba. The evaluation covered the areas of formulation, filling, labeling and packaging, during the period 2011-2015, with the purpose of constituting a useful tool that would influence the production costs and improve the efficiency of the company. The results show that the formulation stage presents a higher average loss due to wastage (6.99 percent), mainly contributed by the vaccines DTP-vax® and VA-MENGOC-BC®; followed by the filling stage with an average loss of 4 percent. The losses for the rest of the stages ranged between 0.2 percent and 1.57 percent. The general cost of the losses of this period was 8,949,871.79 Cuban pesos, contributed by vax-SPIRAL®, vax-TyVi®, vax-TET® and VA-MENGOC-BC® vaccines. It was observed that, except for vax-TET-5)® (presentation of 20 doses), due to problems faced with the volume of the bulbs, the losses of the year 2016 were below the established percentage. Finally, a trend analysis was made of the total losses and by presentation, in the period 2011 to 2016, showing that in 2015 the highest quantity of vaccine losses was obtained, with a higher incidence in the presentation of 20 doses(AU)

Comparison of an interferon-gamma assay with tuberculin skin testing for detection of tuberculosis (TB) infection in patients with rheumatoid arthritis in a TB-endemic population.

OBJECTIVE: Tuberculosis (TB) in patients with rheumatoid arthritis (RA) undergoing treatment with anti-tumor necrosis factor (TNF) agents is commonly the result of reactivation of latent TB infection (LTBI); detection and treatment of LTBI is essential before treatment with anti-TNF agents. We reported previously that the tuberculin skin test (TST) is inaccurate for diagnosis of LTBI in patients with RA. Here, we compare the prevalence of LTBI in RA patients and matched controls according to positive TST and QuantiFeron-TB Gold In-Tube version (QFT) results and determine their agreement. METHODS: A cross-sectional study of 101 RA patients and 93 controls was conducted in Lima, Perú, where the prevalence of LTBI in the general population has been estimated to be 68%. Blood was drawn for QFT assay followed by TST using 2-TU of RT 23 purified protein derivative. TST was deemed positive at >or= 5 mm for RA patients and >or= 10 mm for controls. RESULTS: There were no significant differences between RA patients and controls for age, sex, bacillus Calmette-Guérin vaccination, or history of or contact with TB. 88% of patients had active RA disease and 2 (1.9%) patients had indeterminate QFT results. The number of subjects testing positive with the QuantiFeron assay was comparable between patients and controls (44.6% vs 59.1%, respectively), whereas the TST detected significantly less LTBI among RA patients (26.7%) than controls (65.6%). Thus, the rate of LTBI in RA patients represented 75% and 41% of the rate in their controls using QFT or TST, respectively (p = 0.008). Poor agreement between TST and QFT was seen in RA patients, but in controls, good agreement was observed between these tests. CONCLUSION: In a TB-endemic population, the QuantiFeron-TB Gold In-Tube assay seemed to be a more accurate test for detection of LTBI in RA patients compared with the TST, and may potentially improve the targeting of prophylactic therapy before treatment with anti-TNF agents.