Preconception, pregnancy, and lactation in systemic lupus erythematosus patients / Preconcepción, embarazo y lactancia en pacientes con lupus eritematoso sistémico

ABSTRACT Systemic lupus erythematosus is a complex and chronic disease which impacts on the reproductive function of patients suffering this condition. This assertion is supported by the fact that lupus patients have a smaller family size in comparison to the general population as well as a higher risk of adverse pregnancy outcomes. While this disease per se does not affect fertility, there are several other factors affecting fertility such as age, drugs, disease activity, damage-related disease, and some comorbidities. Currently, there are several interventions to preserve fertility with very good outcomes, among them, cryopreservation or the use of gonadotropin releasing hormone agonists. It is recommended that lupus patients be in low disease activity or in remission for at least six months before conception and pregnancy. If the latter is achieved, multidisciplinary management is very important and recommended, but in particular, physicians must know how to differentiate between a lupus flare and pregnancy-related hypertension. The efficacy and safety of antimalarials throughout pregnancy has been demonstrated so its use must be continued and encouraged. Taking into account all the above, fertility and pregnancy in lupus patients must be an integral part of the management of this disease.

RESUMEN El lupus eritematoso sistémico es una enfermedad compleja y crónica que afecta la función reproductiva de los pacientes que la presentan, considerando que suelen tener un tamaño familiar reducido en comparación con la población general, así como un riesgo más alto de resultados adversos perinatales. Si bien esta enfermedad per se no afecta la fertilidad, existen otros factores que la alteran, como la edad, los fármacos, la actividad de la enfermedad, el dano relacionado con ella y algunas comorbilidades. En la actualidad, existen numerosas intervenciones para preservar la fertilidad, con muy buenos resultados, entre las cuales se encuentran la criopreservación o el uso de análogos de la hormona liberadora de gonadotropinas. Es recomendable que los pacientes lúpicos se encuentren en baja actividad de la enfermedad o en remisión por al menos seis meses antes de la concepción y el embarazo. Si esto se logra, el manejo multidisciplinario es muy importante y recomendado pero, sobre todo, los médicos deben saber cómo diferenciar entre reactivación de la enfermedad y enfermedad hipertensiva del embarazo. Se ha demostrado la eficacia y la seguridad de los antimaláricos a lo largo del embarazo, por lo cual su uso debe ser continuado y aconsejado. Teniendo en cuenta lo señalado en las líneas precedentes, la fertilidad y el embarazo en pacientes lúpicos deben ser parte del manejo integral de esta enfermedad.

Riesgo de fracturas en pacientes con enfermedades reumáticas en tratamiento con corticoides orales crónicos / Risk of fractures in patients with rheumatic diseases in treatment with chronic oral corticosteroids

INTRODUCCIÓN: El tratamiento con glucocorticoides es necesario como puente de otros fármacos en el tratamiento de las enfermedades reumáticas. Evaluar el riesgo de fracturas en pacientes con enfermedades reumáticas en tratamiento crónico con glucocorticoides nos permite instaurar tratamiento a tiempo para prevenir esta complicación con alto impacto en la calidad de vida. OBJETIVO: Evaluar el riesgo de fracturas en pacientes con enfermedades reumáticas expuestos a uso crónico de corticoides orales en una clínica privada de Córdoba. MATERIAL Y MÉTODO: Estudio observacional, retrospectivo, de casos y controles, analítico. Se evaluaron los pacientes, mayores de 18 años, ambulatorios, con diagnóstico de enfermedades reumáticas en tratamiento con corticoides orales (dosis >5 mg de prednisona o equivalente) por al menos tres meses, mediante revisión de historias clínicas en Clínica Universitaria Reina Fabiola. Las características de la muestra de pacientes se reportaron con estadística descriptiva. Las variables asociadas a la presencia de fracturas se analizaron con regresión logística uní y multivariada, el nivel de significancia asignado fue p<0.05. El análisis estadístico se realizó mediante el programa SPSS1 22.0. RESULTADOS: La muestra estuvo conformada por un total de 110 pacientes, de los cuales 56 presentaban diagnóstico de enfermedades reumáticas y 55 controles. Los pacientes tenían una edad media (desviación estándar - DE) de 58.95 (14.51) años, de ellos en su mayoría fueron del sexo femenino 94 (85.5 %). Entre los pacientes con enfermedad reumática los diagnósticos fueron: artritis reumatoide 38 (35%), artritis seronegativas 7 (7%), lupus eritematoso sistémico 7 (7%), polimialgia reumática 2 (2%) y vasculitis 1 (0.9%). Cincuenta y seis pacientes recibieron terapia con corticoides, de los cuales 43 (39%) tenían una dosis media 2.5 -7.5 mg/día, 9 (8%) dosis alta > 7.5 mg/día y 4 (3.5%) una dosis baja menos de 2.5 mg/día. En cuanto al tiempo de tratamiento tuvieron una Me de 2.5 meses IRC 18 meses. La presencia de fracturas se encontró en 22 (20%) pacientes en el total de la muestra a los 18 meses. En el grupo de pacientes con corticoides orales y enfermedad reumática, la presencia de fracturas vertebrales fue de 9 (16%) y de fracturas no vertebrales de 8 (14.2%), mientras que en el grupo control hubo sólo 1 (1.8%) fractura vertebral y 4 (7.4%) no vertebrales. En relación a las variables asociadas a riesgo de fracturas en el análisis multivariado se encontró que tanto la edad 1.06 (IC 95%= 1.02-1.11), el tiempo de tratamiento con corticoides 1.02 (IC 95% 1.00-1.04) y la presencia de enfermedad reumática 1.85 (IC 95% 1.06-3.22) aumentan el riesgo relativo de fracturas. En cuanto a la presencia de fracturas vertebrales las variables asociadas al aumento del riesgo relativo fueron la edad 1.12 (IC 95% 1.03-1.20), la dosis de corticoides orales 5.84 (IC 95% 1.84-18.55) ), siendo las dosis altas las que mostraron diferencia significativas con un OR 6.58 (IC 95% 1.33-20.68) y el índice de masa corporal bajo 80.15 (IC 95% 3.18-216.63) y en las no vertebrales fueron la edad 1.03 (IC 95% 1.00-1.08) y el tiempo de tratamiento con corticoides 1.02 (IC 95% 1.00-1.04). CONCLUSIONES: La OP inducida por glucocorticoides es la causa más frecuente de OP secundaria, y se asocia a la presencia de fracturas hasta en un 30-50% de casos. El riesgo de fracturas depende de factores como edad, DMO previa, dosis diaria y acumulada de glucocorticoides y enfermedad subyacente. Nuestro estudio demuestra que la terapia crónica con glucocorticoides aumento el riesgo de fracturas con un OR 1.02, asociadas con el aumento de la edad OR 1.06 y la presencia de enfermedad reumática OR 1.85. Siendo las dosis altas mayores a 7.5 mg/día y el IMC bajo las variables independientes asociadas a riesgo de fractura vertebral.

INTRODUCTION: Glucocorticoid treatment is necessary as a bridge for other drugs in the treatment of rheumatic diseases. Assessing the risk of fractures in patients with rheumatic diseases in chronic glucocorticoid treatment allow us to establish treatment in time to prevent this complication with a high impact on the quality of life. OBJECTIVES: To evaluat the risk of fractures in patients with rheumatic diseases exposed to chronic use of oral corticosteroids in a private hospital in Córdoba. MATERIAL AND METHODS: Observational, retrospective, case-control study, analytical. Patients, over 18 years of age, outpatient, with a diagnosis of rheumatic diseases treated with oral corticosteroids (doses> 5 mg of prednisone or equivalent) for at least three months, will be evaluated by reviewing medical records at the Clínica Universitaria Reina Fabiola. The characteristics of the patient sample were reported with descriptive statistics. The variables associated with the presence of fractures were analyzed with uni and multivariate logistic regression, the level of significance assigned was p <0.05. Statistical analysis was performed using the SPSS1 22.0 program. RESULTS: The sample consisted of a total of 110 patients, of which 56 had a diagnosis of rheumatic diseases and 55 controls. The patients had a mean age (standard deviation - SD) of 58.95 (14.51) years, most of them female 94 (85.5%). Among the patients with rheumatic disease the diagnoses were: rheumatoid arthritis 38 (35%), seronegative arthritis 7 (7%), systemic lupus erythematosus 7 (7%), polymyalgia rheumatica 2 (2%) and vasculitis 1 (0.9%). Fifty-six patients received corticosteroid therapy, of which 43 (39%) had a medium dose 2.5 -7.5 mg / day, 9 (8%) high dose> 7.5 mg / day and 4 (3.5%) a lower dose less 2.5 mg / day. As for the treatment time, they had a 2.5-month IQR 18 months. The presence of fractures was found in 22 (20%) patients in the total sample at 18 months. In the group of patients with oral corticosteroids and rheumatic disease, the presence of vertebral fractures was 9 (16%) and non-vertebral fractures of 8 (14.2%), while in the control group there was only 1 (1.8%) fracture vertebral and 4 (7.4%) non-vertebral. Regarding the variables associated with fracture risk in the multivariate analysis, it was found that both age 1.06 (95% CI = 1.02-1.11), time of treatment with corticosteroids 1.02 (95% CI 1.00-1.04) and the presence of rheumatic disease 1.85 (95% CI 1.06-3.22) increase the relative risk of fractures. Regarding the presence of vertebral fractures, the variables associated with the increase in relative risk were age 1.12 (95% CI 1.03-1.20), the dose of oral corticosteroids 5.84 (95% CI 1.84-18.55), with high doses being that showed significant difference with an OR 6.58 (95% CI 1.33-20.68) and body mass index under 80.15 (95% CI 3.18-216.63) and in non-vertebral patients were age 1.03 (95% CI 1.00-1.08) and the time of treatment with corticosteroids 1.02 (95% CI 1.00-1.04). CONCLUSIONS: Glucocorticoid-induced OP is the most frequent cause of secondary OP, and is associated with the presence of fractures in up to 30-50% of cases. The risk of fractures depends on factors such as age, previous BMD, daily and cumulative dose of glucocorticoids and underlying disease. Our study demonstrates that chronic glucocorticoid therapy increases the risk of fractures with an OR 1.02, associated with increasing OR 1.06 age and the presence of OR 1.85 rheumatic disease. The high doses being greater than 7.5 mg / day and the BMI under the independent variables associated with the risk of vertebral fracture.

Prevalencia de dislipemia y riesgo cardiovascular elevado en pacientes con artritis reumatoide / Prevalence of dyslipidemia and elevated cardiovascular risk in patients with rheumatoid arthritis

Los objetivos del estudio fueron comparar la frecuencia de riesgo cardiovascular (CV) elevado y dislipemia (DLP) en pacientes con artritis reumatoide (AR) y en controles, identificar variables de la enfermedad asociadas a DLP y estimar el porcentaje de pacientes con AR medicados para DLP. Estudio de corte transversal que incluyó 409 pacientes con AR y 624 controles. El riesgo CV se determinó con las clasificaciones NCEP y SCORE modificados por European League Against Rheumatism (EULAR). Para DLP se utilizó la definición de Adult Treatment Panel III (ATP III). La frecuencia de riesgo CV elevado fue similar en pacientes con AR y controles excepto cuando fue definida por NCEP-EULAR (7% vs. 2%; p = 0.00002). La DLP fue encontrada en el 43% de los pacientes con AR y en el 47% de los controles (p = 0.15). Los pacientes con AR y DLP tuvieron más manifestaciones extra-articulares (36% vs. 24%; p = 0.01) y mayor velocidad de sedimentación globular (VSG) (21 (13-35) vs. 18 (10-30) mm; p = 0.003). El tratamiento recibido para DLP varió según la definición utilizada (11% a 32%). Se encontró mayor riesgo CV en los pacientes con AR solo cuando se definió por NCEP- EULAR. Los pacientes con AR y DLP tuvieron mayor VSG y manifestaciones extra-articulares. La mayoría de los pacientes con AR y DLP no estaban recibiendo tratamiento hipolipemiante.

The objectives of this study were to compare the frequency of dyslipidemia (DLP) and the elevated cardiovascular risk between rheumatoid arthritis (RA) patients and a control group, to identify disease-related factors associated with the presence of DLP and to estimate the frequency of RA patients receiving treatment for DLP. This is a cross sectional study that included 409 RA patients and 624 controls. Cardiovascular (CV) risk was determined using the Framingham score, National Cholesterol Education Program (NCEP) and the Systematic Coronary Risk Evaluation (SCORE) adapted versions according to the European League Against Rheumatism (EULAR) guidelines. DLP was defined according to the Adult Treatment Panel III (ATPIII). The frequency of CV risk was similar in RA patients and controls, except when NCEP-EULAR adapted version for RA was applied (7% vs. 2%; p = 0.00002). A 43% of patients and 47% of controls had DLP (p = 0.15). RA patients with DLP tended to have extra-articular manifestations more frequently (36% vs. 24%; p = 0.01) and higher erythrocyte sedimentation rate (ESR) (21 [13-35] vs. 18 [10-30] mm; p = 0.003). RA patients treated for DLP varied between 11% and 32% according to the definition used. Patients with RA showed an elevated CV risk only when the NCEP-EULAR definition was used. Among RA patients, those with higher ESR and the presence of extra-articular manifestations were more likely to show DLP. The vast majority of patients were not receiving treatment for DLP.

Prevalencia de dislipemia y riesgo cardiovascular elevado en pacientes con artritis reumatoide / Prevalence of dyslipidemia and elevated cardiovascular risk in patients with rheumatoid arthritis

Los objetivos del estudio fueron comparar la frecuencia de riesgo cardiovascular (CV) elevado y dislipemia (DLP) en pacientes con artritis reumatoide (AR) y en controles, identificar variables de la enfermedad asociadas a DLP y estimar el porcentaje de pacientes con AR medicados para DLP. Estudio de corte transversal que incluyó 409 pacientes con AR y 624 controles. El riesgo CV se determinó con las clasificaciones NCEP y SCORE modificados por European League Against Rheumatism (EULAR). Para DLP se utilizó la definición de Adult Treatment Panel III (ATP III). La frecuencia de riesgo CV elevado fue similar en pacientes con AR y controles excepto cuando fue definida por NCEP-EULAR (7% vs. 2%; p = 0.00002). La DLP fue encontrada en el 43% de los pacientes con AR y en el 47% de los controles (p = 0.15). Los pacientes con AR y DLP tuvieron más manifestaciones extra-articulares (36% vs. 24%; p = 0.01) y mayor velocidad de sedimentación globular (VSG) (21 (13-35) vs. 18 (10-30) mm; p = 0.003). El tratamiento recibido para DLP varió según la definición utilizada (11% a 32%). Se encontró mayor riesgo CV en los pacientes con AR solo cuando se definió por NCEP- EULAR. Los pacientes con AR y DLP tuvieron mayor VSG y manifestaciones extra-articulares. La mayoría de los pacientes con AR y DLP no estaban recibiendo tratamiento hipolipemiante.(AU)

The objectives of this study were to compare the frequency of dyslipidemia (DLP) and the elevated cardiovascular risk between rheumatoid arthritis (RA) patients and a control group, to identify disease-related factors associated with the presence of DLP and to estimate the frequency of RA patients receiving treatment for DLP. This is a cross sectional study that included 409 RA patients and 624 controls. Cardiovascular (CV) risk was determined using the Framingham score, National Cholesterol Education Program (NCEP) and the Systematic Coronary Risk Evaluation (SCORE) adapted versions according to the European League Against Rheumatism (EULAR) guidelines. DLP was defined according to the Adult Treatment Panel III (ATPIII). The frequency of CV risk was similar in RA patients and controls, except when NCEP-EULAR adapted version for RA was applied (7% vs. 2%; p = 0.00002). A 43% of patients and 47% of controls had DLP (p = 0.15). RA patients with DLP tended to have extra-articular manifestations more frequently (36% vs. 24%; p = 0.01) and higher erythrocyte sedimentation rate (ESR) (21 [13-35] vs. 18 [10-30] mm; p = 0.003). RA patients treated for DLP varied between 11% and 32% according to the definition used. Patients with RA showed an elevated CV risk only when the NCEP-EULAR definition was used. Among RA patients, those with higher ESR and the presence of extra-articular manifestations were more likely to show DLP. The vast majority of patients were not receiving treatment for DLP.(AU)

[Prevalence of dyslipidemia and elevated cardiovascular risk in patients with rheumatoid arthritis]. / Prevalencia de dislipemia y riesgo cardiovascular elevado en pacientes con artritis reumatoide.

The objectives of this study were to compare the frequency of dyslipidemia (DLP) and the elevated cardiovascular risk between rheumatoid arthritis (RA) patients and a control group, to identify disease-related factors associated with the presence of DLP and to estimate the frequency of RA patients receiving treatment for DLP. This is a cross sectional study that included 409 RA patients and 624 controls. Cardiovascular (CV) risk was determined using the Framingham score, National Cholesterol Education Program (NCEP) and the Systematic Coronary Risk Evaluation (SCORE) adapted versions according to the European League Against Rheumatism (EULAR) guidelines. DLP was defined according to the Adult Treatment Panel III (ATPIII). The frequency of CV risk was similar in RA patients and controls, except when NCEP-EULAR adapted version for RA was applied (7% vs. 2%; p = 0.00002). A 43% of patients and 47% of controls had DLP (p = 0.15). RA patients with DLP tended to have extra-articular manifestations more frequently (36% vs. 24%; p = 0.01) and higher erythrocyte sedimentation rate (ESR) (21 [13-35] vs. 18 [10-30] mm; p = 0.003). RA patients treated for DLP varied between 11% and 32% according to the definition used. Patients with RA showed an elevated CV risk only when the NCEP-EULAR definition was used. Among RA patients, those with higher ESR and the presence of extra-articular manifestations were more likely to show DLP. The vast majority of patients were not receiving treatment for DLP.

Prevalencia de dislipemia y riesgo cardiovascular elevado en pacientes con artritis reumatoide. / [Prevalence of dyslipidemia and elevated cardiovascular risk in patients with rheumatoid arthritis].

The objectives of this study were to compare the frequency of dyslipidemia (DLP) and the elevated cardiovascular risk between rheumatoid arthritis (RA) patients and a control group, to identify disease-related factors associated with the presence of DLP and to estimate the frequency of RA patients receiving treatment for DLP. This is a cross sectional study that included 409 RA patients and 624 controls. Cardiovascular (CV) risk was determined using the Framingham score, National Cholesterol Education Program (NCEP) and the Systematic Coronary Risk Evaluation (SCORE) adapted versions according to the European League Against Rheumatism (EULAR) guidelines. DLP was defined according to the Adult Treatment Panel III (ATPIII). The frequency of CV risk was similar in RA patients and controls, except when NCEP-EULAR adapted version for RA was applied (7

vs. 2

; p = 0.00002). A 43

of patients and 47

of controls had DLP (p = 0.15). RA patients with DLP tended to have extra-articular manifestations more frequently (36

vs. 24

; p = 0.01) and higher erythrocyte sedimentation rate (ESR) (21 [13-35] vs. 18 [10-30] mm; p = 0.003). RA patients treated for DLP varied between 11

and 32

according to the definition used. Patients with RA showed an elevated CV risk only when the NCEP-EULAR definition was used. Among RA patients, those with higher ESR and the presence of extra-articular manifestations were more likely to show DLP. The vast majority of patients were not receiving treatment for DLP.

Systemic lupus erythematosus in a multiethnic US cohort (LUMINA): LXI. Value of C-reactive protein as a marker of disease activity and damage.

OBJECTIVE: To determine whether C-reactive protein (CRP) measured by a high sensitivity (hs) assay is a surrogate marker of disease activity and damage in systemic lupus erythematosus (SLE). METHODS: Five hundred eighty-eight patients with SLE participating in a multiethnic cohort (Hispanic, African American, and Caucasian) were studied. Disease activity was measured with the Systemic Lupus Activity Measure-Revised (SLAM-R) and damage with the Systemic Lupus International Collaborating Clinics (SLICC) Damage Index (SDI). hs-CRP was measured by immunometric assay. Disease activity and hs-CRP were measured at enrollment and damage accrual at last visit. The association of hs-CRP with the SLAM-R and SDI was examined by univariable (Pearson's correlation) and multivariable (linear regression) analyses. The association of hs-CRP and each individual domain of the SLAM-R and SDI was examined by Spearman's correlation. RESULTS: hs-CRP was associated with the SLAM-R in the univariable (r = 0.35, p < 0.001) and multivariable (t = 7.11, coefficient beta = 0.27, p < 0.001) analyses. It also correlated with the constitutional, eye, pulmonary, gastrointestinal, neuromotor, and laboratory domains of the SLAM-R. hs-CRP was associated with the SDI (r = 0.12, p = 0.004) in the univariable analysis but not in the multivariable analysis. When the individual domains of the SDI were analyzed, hs-CRP correlated with the renal, pulmonary, cardiovascular, musculoskeletal, and diabetes domains. CONCLUSIONS: hs-CRP was associated with disease activity but not with overall damage accrual; however, it correlated with specific domains of the damage index. hs-CRP may be useful to monitor the course of the disease and predict its intermediate outcome, but longitudinal studies with serial hs-CRP measurements are necessary to define its clinical value.

Rate and causes of infliximab discontinuation in patients with rheumatoid arthritis in a private clinical practice.

OBJECTIVES: To describe the rate of infliximab discontinuation and the causes of this event in a population of rheumatoid arthritis patients. PATIENTS AND METHODS: Rheumatoid arthritis patients from an out-patient private center treated with infliximab (at least 2 consecutive doses) were retrospectively studied. The infliximab discontinuation rate was examined by the Kaplan-Meier survival method. Variables associated with infliximab discontinuation were analyzed by univariable and multivariable Cox proportional hazards regression analyses. RESULTS: Seventy-seven patients treated with infliximab between August 2000 and December 2006 were identified; of them, 33 (43%) discontinued this drug. The cumulative discontinuation rate was of 23%, 35%, and 43% at 12, 24, and 36 months, respectively. Causes of discontinuation were drug-related adverse reactions (41%), financial constraints (15%), lack of efficacy (12%), and others (32%). Variables independently associated with infliximab discontinuation were the number of tender joints on an average during infliximab treatment [hazard ratio (HR) = 1.17, 95% confidence interval (CI) 1.05-1.31; P = 0.005] and the occurrence of any adverse reaction attributed to infliximab (HR = 2.86, 95% CI 1.37-7.19; P = 0.026), whereas having full pharmacy coverage for infliximab (HR = 0.32, 95% CI 0.13-0.79, P = 0.014) was protective. CONCLUSION: Forty-three percent of patients discontinued infliximab at 3 years; most of them because of adverse reactions and financial constraints. Rheumatologists should be aware that those patients with more active disease were also at higher risk of discontinuing infliximab.

Lack of correlation between satisfaction and knowledge in clinical trials participants: a pilot study.

OBJECTIVES: To address participants' knowledge of informed consent and to explore whether knowledge level is related to clinical trial satisfaction. METHODS: One hundred and fourteen patients enrolled in three ongoing randomized controlled trials of osteoarthritis and rheumatoid arthritis were asked to complete a mailed form. The survey was related to aspects of the informed consent process: quality of information given during the informed consent process, participants' self perception of knowledge, objective evaluation of participants' knowledge and participants' overall trial satisfaction. These four aspects were categorized as high, intermediate or low. Correlation between participants' knowledge and satisfaction was measured using the Spearman's Rho test and variables associated with knowledge by standard univariable analyses. A p value< or =0.05 was considered significant. RESULTS: One hundred and five participants answered the questionnaire. The quality of information given during the informed consent process was rated as being high by 81% participants, intermediate by 15.2% and low by 3.8%. Fifty-one percent of the participants believed they had a good level of knowledge, but, objective evaluation qualified as high in only 14.3% of them. Overall trial satisfaction was high in 95% of the participants. No significant correlation was found between knowledge and satisfaction (r=0.16; p=0.086). Age was negatively associated with a higher level of knowledge (48 vs. 58 years old, p=0.008). CONCLUSIONS: We found a lack of correlation between satisfaction and knowledge in clinical trials participants. During a randomized controlled trial the investigator should consider encouraging activities to improve not only participants' satisfaction, but also their level of knowledge.

[Use of infliximab in patients of a rheumatologic center]. / Uso de infliximab en pacientes de un centro reumatológico.

The objective of this study was to obtain post-marketing information about the use of infliximab in an ambulatory setting. We studied--retrospectively and prospectively--the case records of patients with rheumatoid arthritis (n=37), psoriatic arthritis (n=5), mixed connective tissue disease (n=1), and ankylosing spondylitis (n=2) who received infliximab (3 mg/kg) from August 2000 to January 2003. Descriptive values were given as percentage, mean or median, and standard deviation or interquartile range. Wilcoxon test was used for paired analysis of pre/post doses of corticosteroids, non-steroidal anti-inflammatory drugs, and methotrexate therapy. A p value < or = 0.05 was considered significant. Forty-five patients were included. A total of 207 infusions were administered. In 4 patients the treatment was permanently discontinued due to severe back pain during the infusion (2 cases) and serious anaphylactic reactions (2 cases). Other adverse reactions occurring during infusions were mild and successfully managed with standard treatment. A case of staphylococcal septic arthritis resolved with standard antibiotic treatment. No patient had evidence of active tuberculosis. One patient with rheumatoid arthritis and chronic renal insufficiency, received treatment with infliximab 1.9 mg/kg, every 30 days, with no changes in renal function. Due to improvement of symptoms, 14/39 (35.9%) patients could decrease the doses of corticosteroids, 15/43 (34.8%) decreased the doses of antiinflammatory drugs and 12/34 (35.3%) decreased methotrexate dosage. Although some questions remain to be elucidated, this case series shows the drug safety profile, the possibility to reduce concomitant drug doses, as well as individual approaches for situations where there are not yet guidelines available, so that rheumatologists have to make decisions based on clinical needs.

Factors associated with patients' loss to follow-up after finishing randomized clinical trial participation.

OBJECTIVES: To study patient's follow-up after finishing participation in randomized clinical trials (RCTs), and to identify factors associated with loss to follow-up (FU). PATIENTS AND METHODS: Medical charts of 212 rheumatoid arthritis (RA) and osteoarthritis (OA) patients from a rheumatological out-patient center were analyzed. Loss to FU was considered when patients did not return to their regular appointments within the first year after finishing their participation in an RCT assessing anti-cyclooxygenase-2 non-steroidal anti-inflammatory drugs (anti-COX-2 NSAIDs). Mann-Whitney U-test, chi2 test and Wilcoxon test were performed as appropriate. Logistic regression was performed to identify factors which might be related to loss to FU. A survey was conducted to obtain lost to FU patients' opinions. p values less than 0.05 were considered significant. RESULTS: The mean frequency of patients' visits in the year before enrollment in an RCT was 3.73 SD 2.06, and during the year after participation was 2.6 SD 1.96 (p<0.0001). Fifty patients (23.6%) did not return to their usual rheumatologic visit. On multivariate analysis, the number of daily tablets of study medication (odds ratio (OR)=2.64, 95% confidence interval (CI) 1.1 to 6.3) and the frequency of clinical visits (OR=0.56, 95% CI 0.37 to 0.85) were associated with loss to FU (p<0.008). Lost to FU patients' opinions did not support these findings. CONCLUSIONS: After participating in a RCT assessing anti-COX-2 NSAIDs, many patients return with less frequency, or do not return at all to their regular rheumatologic visit. Although a high number of tablets of the investigational drug and a low frequency of protocol visits may be contributors to patient loss to FU, investigators should consider that personal situations not related to the RCTs may also influence patients' return to consultation in the private setting.

Uso de infliximab en pacientes de un centro reumatológico. / [Use of infliximab in patients of a rheumatologic center]

The objective of this study was to obtain post-marketing information about the use of infliximab in an ambulatory setting. We studied--retrospectively and prospectively--the case records of patients with rheumatoid arthritis (n=37), psoriatic arthritis (n=5), mixed connective tissue disease (n=1), and ankylosing spondylitis (n=2) who received infliximab (3 mg/kg) from August 2000 to January 2003. Descriptive values were given as percentage, mean or median, and standard deviation or interquartile range. Wilcoxon test was used for paired analysis of pre/post doses of corticosteroids, non-steroidal anti-inflammatory drugs, and methotrexate therapy. A p value < or = 0.05 was considered significant. Forty-five patients were included. A total of 207 infusions were administered. In 4 patients the treatment was permanently discontinued due to severe back pain during the infusion (2 cases) and serious anaphylactic reactions (2 cases). Other adverse reactions occurring during infusions were mild and successfully managed with standard treatment. A case of staphylococcal septic arthritis resolved with standard antibiotic treatment. No patient had evidence of active tuberculosis. One patient with rheumatoid arthritis and chronic renal insufficiency, received treatment with infliximab 1.9 mg/kg, every 30 days, with no changes in renal function. Due to improvement of symptoms, 14/39 (35.9

) patients could decrease the doses of corticosteroids, 15/43 (34.8

) decreased the doses of antiinflammatory drugs and 12/34 (35.3

) decreased methotrexate dosage. Although some questions remain to be elucidated, this case series shows the drug safety profile, the possibility to reduce concomitant drug doses, as well as individual approaches for situations where there are not yet guidelines available, so that rheumatologists have to make decisions based on clinical needs.

Soft tissue metastases presenting as greater trochanteric pain syndrome.

Greater trochanteric pain syndrome includes a complex differential diagnosis. We report the case of a 71-year-old woman who consulted us because of pain in the lateral aspect of the hip. A diagnosis of greater trochanter bursitis was suggested, and she was treated with local injections of a mixture of corticosteroids plus anesthetic, but the condition did not improve. A pelvic MRI showed a high intensity signal in the gluteus medius and minimus and a subsequent biopsy revealed a metastasis of an adenocarcinoma of unknown origin. Although pain on the lateral aspect of the hip is often attributed to trochanteric bursitis, other diagnoses, including this rare finding of malignant disease, should be considered in the differential diagnosis of the greater trochanteric pain syndrome.

[Severe polyarthritis and tenosynovitis due to Streptococcus agalactiae in a patient with functional hyposplenia]. / Poliartritis y tenosinovitis grave por Streptococcus agalactiae en un paciente con hipoesplenia funcional.

Cases of arthritis caused by Streptococcus agalactiae are infrequent and in our knowledge there are no case reports of tenosynovitis caused by S. agalactiae. A 46-year-old woman presented with fever, polyarthralgia, myalgia, diarrhea and vomiting. She had a history of papillary thyroid carcinoma and functional hyposplenia. She was febrile, with arthritis in hands, wrists, elbows, right shoulder and left ankle joints, and presented tenosynovitis in both feet and left hand. Blood and right olecranon bursa sample cultures were positive for S. agalactiae. An ultrasound scan made at the musculus tibialis anterior of left foot revealed signs of tenosynovitis. She was treated with intravenous cefazolin for 20 days and oral cefuroxime for 12 days. The joint involvement completely subsided in 60 days. Streptococcus agalactiae can cause, infrequently, a polyarthritis and tenosynovitis syndrome similar to disseminated gonococcal infection.

Poliartritis y tenosinovitis grave por Streptococcus agalactiae en un paciente con hipoesplenia funcional / Severe polyarthritis and tenosynovitis due to Streptococcus agalactiae in a patient with functional hyposplenia

Cases of arthritis caused by Streptococcus agalactiae are infrequent and in our knowledge there are no case reports of tenosynovitis caused by S. agalactiae. A 46-year-old woman presented with fever, polyarthralgia, myalgia, diarrhea and vomiting. She had a history of papillary thyroid carcinoma and functional hyposplenia. She was febrile, with arthritis in hands, wrists, elbows, right shoulder and left ankle joints, and presented tenosynovitis in both feet and left hand. Blood and right olecranon bursa sample cultures were positive for S. agalactiae. An ultrasound scan made at the musculus tibialis anterior of left foot revealed signs of tenosynovitis. She was treated with intravenous cefazolin for 20 days and oral cefuroxime for 12 days. The joint involvement completely subsided in 60 days. Streptococcus agalactiae can cause, infrequently, a polyarthritis and tenosynovitis syndrome similar to disseminated gonococcal infection

Poliartritis y tenosinovitis grave por Streptococcus agalactiae en un paciente con hipoesplenia funcional. / [Severe polyarthritis and tenosynovitis due to Streptococcus agalactiae in a patient with functional hyposplenia]

Cases of arthritis caused by Streptococcus agalactiae are infrequent and in our knowledge there are no case reports of tenosynovitis caused by S. agalactiae. A 46-year-old woman presented with fever, polyarthralgia, myalgia, diarrhea and vomiting. She had a history of papillary thyroid carcinoma and functional hyposplenia. She was febrile, with arthritis in hands, wrists, elbows, right shoulder and left ankle joints, and presented tenosynovitis in both feet and left hand. Blood and right olecranon bursa sample cultures were positive for S. agalactiae. An ultrasound scan made at the musculus tibialis anterior of left foot revealed signs of tenosynovitis. She was treated with intravenous cefazolin for 20 days and oral cefuroxime for 12 days. The joint involvement completely subsided in 60 days. Streptococcus agalactiae can cause, infrequently, a polyarthritis and tenosynovitis syndrome similar to disseminated gonococcal infection.

Poliartritis y tenosinovitis grave por Streptococcus agalactiae en un paciente con hipoesplenia funcional / Severe polyarthritis and tenosynovitis due to Streptococcus agalactiae in a patient with functional hyposplenia

Cases of arthritis caused by Streptococcus agalactiae are infrequent and in our knowledge there are no case reports of tenosynovitis caused by S. agalactiae. A 46-year-old woman presented with fever, polyarthralgia, myalgia, diarrhea and vomiting. She had a history of papillary thyroid carcinoma and functional hyposplenia. She was febrile, with arthritis in hands, wrists, elbows, right shoulder and left ankle joints, and presented tenosynovitis in both feet and left hand. Blood and right olecranon bursa sample cultures were positive for S. agalactiae. An ultrasound scan made at the musculus tibialis anterior of left foot revealed signs of tenosynovitis. She was treated with intravenous cefazolin for 20 days and oral cefuroxime for 12 days. The joint involvement completely subsided in 60 days. Streptococcus agalactiae can cause, infrequently, a polyarthritis and tenosynovitis syndrome similar to disseminated gonococcal infection (AU)