Tocilizumab in giant cell arteritis: differences between the GiACTA trial and a multicentre series of patients from the clinical practice.

OBJECTIVES: A potential point of concern among clinicians is whether results derived from the clinical trials can be reasonably applied or generalised to a definable group of patients seen in real world. It can be the case of the GiACTA study that is a phase III randomised controlled trial of tocilizumab (TCZ) in giant cell arteritis (GCA). To address this question, we compared the clinical features and the responses to TCZ from the GiACTA trial patients with those from a series of GCA seen in the daily clinical practice. METHODS: Comparative study of clinical features between patients from the GiACTA trial (overall n=251) and those from a multicentre series of real-world GCA patients undergoing TCZ therapy (n=134). The diagnosis of GCA in the GiACTA trial was established by the ACR modified criteria whereas in the series of real-world patients it was made by using the ACR criteria, a positive biopsy of temporal artery or the presence of imaging techniques consistent with large-vessel vasculitis in individuals who presented cranial symptoms of GCA. GiACTA trial patients received subcutaneous TCZ (162 mg every 1 or 2 weeks) whereas those from the clinical practice series were treated using standard IV dose (8 mg/kg/month) or subcutaneous (162 mg/week). RESULTS: Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial. Despite clinical differences, TCZ was equally effective in both GiACTA trial and clinical practice patients. However, serious infections were more commonly observed in GCA patients recruited from the clinical practice. CONCLUSIONS: Despite clinical differences with patients recruited in clinical trials, data from real-life patients confirm the efficacy of TCZ in GCA.

An exploratory study to determine whether infliximab modifies levels of rheumatoid factor and antibodies to cyclic citrullinated peptides in rheumatoid arthritis patients.

OBJECTIVES: The aim of this study was to investigate the relationship between serum infliximab (IFX) levels and changes of RF and ACPA levels in patients with rheumatoid arthritis (RA). METHODS: Enzyme-linked immunosorbent assays (ELISA) [Promonitor® IFX R1 (version 2) (Progenika Biopharma, Spain)] were used to measure drug levels and antidrug-antibodies (ADAb) in IFX RA-treated patients (n=19). Disease activity was assessed using DAS28. IgM rheumatoid factor (RF) and IgM, IgA and IgG anti-cyclic citrullinated peptide (ACPA) were determined through ELISA. RESULTS: A significant decrease in RF (p=0.01), ACPA IgG (p=0.007), IgM (p=0.01) and IgA (p=0.03) was observed in patients presenting adequate levels of serum IFX. No significant changes to RF or ACPA were observed in patients with undetectable IFX. CONCLUSIONS: Data from this study support the hypothesis that the anti-TNF antagonist IFX downregulates autoantibody levels in RA patients when IFX levels are detectable. Larger-scale studies need to be performed to establish RF and ACPA presence as therapeutic response predictive factors.

Frontotemporal dementia: clinical, neuropsychological, and neuroimaging description / Demencia frontotemporal: descripción clínica, neuropsicológica e imaginológica

Objetivo: To describe the relation between the clinical, neuropsychological, and brain imaging findings in a group of patients with fronto temporal dementia. Methods: A sample of 21 patients was collected, and their charts, cognitive profiles, and brain imagines were reviewed; all patients were evaluated as outpatients at the Hospital Psiquiátrico Universitario del Valle, in Cali, Colombia. Results: The mean age was 59.8 years old, the time elapsed between the beginning of the symptoms and the diagnosis was 2.7 years, the more frequent variant was the behavioral one, the main alteration at the magnetic resonance imaging was the frontotemporal atrophy, and the more frequent alteration on the brain SPECT was the frontotemporal hypo perfusion. On the cognitive evaluation the main finding was the normal scoring in praxis, which was related to a temporo parietal hypo perfusion at the brain SPECT (p <0.02). Mimnimental either CLOX were useful as screening tests.

Objetivo: Describir la relación entre los hallazgos clínicos, neuropsicológicos e imagenológicos en un grupo de pacientes con el diagnóstico de DFT. Métodos: Se revisaron las historias clínicas, pruebas cognitivas e imágenes cerebrales estructurales y de perfusión de 21 pacientes del Hospital Psiquiátrico Universitario del Valle, Cali, Colombia. Resultados: El promedio de edad fue de 59.8 años, el tiempo de evolución de la enfermedad fue de 2.7 años, la variante más frecuente fue la comportamental, la alteración más frecuente en la RMN fue la atrofia frontotemporal y en el SPECT fue la hipoperfusión frontotemporal. El hallazgo más importante fue el rendimiento normal del 61.9% de los pacientes en pruebas de praxis, la cual se relacionó con alteración en la perfusión temporo parietal en el SPECT (p <0.02). El minimental ni el clox sirvieron como pruebas de tamizaje.

Minimum effective dosages of anti-TNF in rheumatoid arthritis: a cross-sectional study.

AIMS: To evaluate the modified dosages of anti-TNF in controlling disease activity in rheumatoid arthritis (RA) measured by DAS28-ESR. PATIENTS AND METHODS: Cross-sectional study: RA patients treated with etanercept (ETN), adalimumab (ADA) or infliximab (IFX), at standard or modified doses. MAIN VARIABLES: dosage, concomitant disease modifying drugs (DMARDs), DAS28-ESR. RESULTS: 195 RA patients included (79% women, mean age 58.1 years): ETN=81, ADA=56, IFX=58. Mean disease duration and time to first biological treatment was higher in IFX group (P=.01). Patients distribution by dosage: standard: ETN (72.8%), ADA (69.6%), IFX (27.6%); escalated: IFX (69%), ADA (5.4%), ETN (0%); reduced: ETN (27.1%), ADA (25%), IFX (3.4%). Concomitant DMARDs use was lower in ETN (58.2%) than ADA (66.07%) and IFX (79.31%). Higher proportion of responders (DAS28 ≤3.2) in ADA (65.3%) and ETN (61.7%) than IFX (48.3%). CONCLUSIONS: RA clinical control can be preserved with modified anti-TNF dosages. Controlled prospective studies should be performed to define when therapy can be tailored and for which patients.

Anti-TNF treatments in rheumatoid arthritis: economic impact of dosage modification.

Rheumatoid arthritis (RA) is a chronic systemic disease that leads to increases in health system economic burden through direct and indirect costs, including chronic treatment, reduced productivity and premature mortality. Anti-TNF agents have represented a major advance in the treatment of RA. The most commonly used (adalimumab, etanercept and infliximab) have demonstrated their cost-effectiveness at label doses. However, physicians may need to adapt the treatment by increasing the dose when a drug is not effective enough or by reducing it when there is a sustained effectiveness. In a cross-sectional study conducted in our hospital in which information from RA patients treated with anti-TNF drugs under conventional and modified doses were collected, the authors analyzed the costs of the medication in order to estimate the mean patient-year cost, the annual costs related to clinical efficacy and the cost per responder patient to anti-TNF treatment when dosage modification is undertaken in daily clinical practice.

Precision of a commercial hartmann-shack aberrometer: limits of total wavefront laser vision correction.

PURPOSE: To assess the intrasession and intersession precision of higher-order aberrations (HOAs) measured using a commercial Hartmann-Shack wavefront sensor (Zywave; Bausch & Lomb) in refractive surgery candidates. DESIGN: Prospective, experimental study of a device. METHODS: To analyze intrasession repeatability, 1 experienced examiner measured 30 healthy eyes 5 times successively. To study intersession reproducibility, the same clinician obtained measurements from another 30 eyes in 2 consecutive sessions at the same time of day 1 week apart. RESULTS: For intrasession repeatability, excellent intraclass correlation coefficients (ICCs) were obtained for total ocular aberrations, total HOAs, and second-order terms (ICC, > 0.94). The ICCs for third-order terms also were high (ICCs, > 0.87); however, fourth-order ICCs varied from 0.71 to 0.90 (Z(4)(0) = 0.90); and fifth-order ICCs were less than 0.85. For intersession reproducibility, only total ocular aberrations, total ocular HOAs, second-order terms, Z(4)(0), Z(3)(1), and Z(3-)(3) had ICCs of 0.90 or more. Bland-Altman analysis showed that the limits of agreement (were clinically too wide for most higher-order Zernike terms, especially for the third-order terms (> 0.21 µm). CONCLUSIONS: Total ocular aberrations, total HOAs, and second-order terms can be measured reliably by Zywave aberrometry without anatomic recognition. Third-order terms and Z(4)(0) are repeatable, but not as reproducible between visits. Fourth-order terms, except for Z(4)(0), and fifth-order terms are not sufficiently reliable for clinical decision making or treatment. Because the variability of Zywave can be a major limitation of a truly successful wavefront-guided excimer laser procedure, surgeons should consider treating HOA magnitudes that are more than the intrasession repeatability values (2.77 × S(w)) as those presented in this study.

Frecuencia de depresión en pacientes con epilepsia que consultan dos instituciones de tercer nivel en Cali, Colombia / Frequency of depression in patients with epilepsy treated at two health institutions in Cali, Colombia

Objetivos: Determinar la frecuencia de depresión en pacientes con epilepsia que consultaron dos instituciones de tercer nivel de Cali, Colombia, durante los meses de mayo y junio del 2009, usando el Inventario de Depresión de Beck (BDI) y el Inventario de Depresión en Pacientes con Trastornos Neurológicos para Epilepsia (NDDI-E). Así mismo, identificar las características sociodemográficas y clínicas de la población bajo estudio, determinar factores clínicos asociados al cuadro depresivo y describir el tratamiento farmacológico suministrado a los pacientes. Método: Estudio descriptivo transversal que involucró a 124 pacientes con epilepsia mayores de edad. A estos pacientes se les aplicó el BDI y el NDDI-E, además de un formato en el que se registraron los datos demográficos. Para el análisis de los datos se utilizó el paquete estadístico Epi Info versión 3.4.1. Resultados: Se encontró que, de acuerdo con el BDI, 57,3% (IC: 48,1%-66,1%) de los pacientes estaban deprimidos y, según la NDDI-E, 34,7% (IC: 26,4%-46,7%). Esta discrepancia se explica porque las dos escalas miden severidades diferentes de los síntomas depresivos. La mayor parte de los pacientes con depresión estaban en tratamiento farmacológico. Conclusiones: Se encontró una frecuencia de depresión del 57,3% con una intensidad variable, dependiendo del instrumento que se use para medirla...

Objective: To find the prevalence of depressive symptoms in outpatients with epilepsy treated at the Hospital Psiquiátrico Universitario del Valle (HDPUV) and the Liga Colombiana Contra la Epilepsia (LCCE) between May and June, 2009. Method: It is a descriptive crosssectional study which included 124 subjects over 18 years. Patients underwent Beck´s Depression Inventory (BDI) and the Neurological Disorders and Depression Inventory in Epilepsy (NDDI-E), as well as a format for demographic variables. Data analysis was made with Epi Info version 3.4.1. Results: It was found that according to the BDI, 57.3% (IC:48.1%-66.1%) of the patients were diagnosed with depression, whereas 34.7% of the patients had a diagnosis of severe depressive disorder when the NDDI-E was applied. The explanation to this discrepancy is based on the fact that the inventories measure the severity of depressive symptoms differently. Most of the patients were under pharmacologic treatment. Conclusions: Depressive symptoms have a high prevalence in patients with epilepsy (57.3%), with a varying severity of the symptoms depending on the instrument used for the diagnosis...

Estudio descriptivo de la prevalencia de depresión en pacientes con epilepsia que consultan el Hospital Psiquiátrico Universitario del Valle (HPUV) y la Liga contra la Epilepsia (LCE) en Cali, Colombia / Descriptive Study of the Prevalence of Depression in Patients with Epilepsy from the Hospital Departamental Psiquiátrico Universitario del Valle (HDPUV) and Liga Contra la Epilepsia (LCE) in Cali, Colombia

Objetivo: Determinar la prevalencia de síntomas depresivos en pacientes con epilepsia que consultaron dos centros terciarios en abril de 2004 (Hospital Departamental Psiquiátrico Universitario del Valle –HDPUV- y la Liga Contra la Epilepsia, capitulo Cali -LCE); establecer la prevalencia depresión registrada, en la población con epilepsia, en ambos, en el 2003. Métodos: Estudio descriptivo con 100 pacientes con epilepsia, mayores de 18 años de edad. Muestra recolectada durante abril 2004. Se aplicó Beck y Hamilton. Análisis de resultados con EPIINFO versión 3.2, 2004. Resultados: Prevalencia de depresión registrada en 2003 del 26.7porciento para el HPUV y 24.5porciento para la LCCE. En el estudio, el 59porciento de los pacientes estaban deprimidos. Hubo asociación entre frecuencia de convulsiones y depresión (X2 = 6.46, p = 0,003, < 0.05). Conclusiones: Los síntomas depresivos son frecuentes en pacientes con epilepsia, el subregistro es importante. Esto implica tardanza en el diagnóstico y tratamiento. El control de crisis podría predecir depresión en pacientes convulsionadores...

Objective: To find the prevalence of depressive symptoms in outpatients with epilepsy, treated at two tertiary care centres in April 2004 and describe the prevalence of depression registered in both institutions in 2003. Methods: Descriptive study with 100 subjects over 18 years old. Sample collected in April 2004. Patients completed the Beck Depression Inventory and the Hamilton Rating Scale for Depression. Data analysis with EPIINFO version 3.2, 2004. Results: Prevalence registered for depression was 27.6 at the HDPUV, and 24.5 at the LCE in 2003. In our study, 59% of patients had a diagnosis of depression. There was a statistical association between the frequency of seizures and depression (X2 = 6.46, P< 0.05). Conclusions: Depressive symptoms are frequent in patients with epilepsy. Under-recording is common, causing problems in diagnosis and treatment. Seizure control could predict depression in epileptic patients...