Can the Dose of Belimumab be Reduced in Patients with Systemic Lupus Erythematosus?

OBJECTIVES: The aims of this study were to investigate the prevalence of dose reduction in patients with SLE treated with belimumab (BEL) in Spain, analyze treatment modalities, and determine impact on control of disease activity. METHODS: Retrospective longitudinal and multicentre study of SLE patients treated with BEL. Data on disease activity, treatments and outcomes were recorded before and after reduction (6-12 months), and they were compared. RESULTS: A total of 324 patients were included. The dose was reduced in 29 patients (8.9%). The dosing interval was increased in 9 patients receiving subcutaneous BEL and in 6 patients receiving intravenous BEL. The dose per administration was reduced in 16 patients.Pre-reduction status was remission (2021 DORIS) in 15/26 patients (57.7%) and LLDAS in 23/26 patients (88.5%). After reduction, 2/24 patients (8.3%) and 3/22 patients (13.6%) lost remission at 6 months and 12 months, respectively (not statistically significant [NS]). As for LLDAS, 2/23 patients (8.7%) and 2/21 patients (9.5%) lost their status at 6 and 12 months, respectively (NS). Significantly fewer patients were taking glucocorticoids (GCs) at their 12-month visit, although the median dose of GCs was higher at the 12-month visit (5 [0.62-8.75] vs 2.5 [0-5] at baseline). CONCLUSION: Doses of BEL can be reduced with no relevant changes in disease activity-at least in the short term-in a significant percentage of patients, and most maintain the reduced dose. However, increased clinical or serologic activity may be observed in some patients. Consequently, tighter post-reduction follow-up is advisable.

Health-related quality of life in patients with systemic lupus erythematosus: a Spanish study based on patient reports.

INTRODUCTION AND OBJECTIVES: Systemic lupus erythematosus (SLE) is a disease that significantly affects the quality of life and welfare of patients. SLE patients can be classified into multimorbidity levels using Clinical Risk Groups (CRGs) to help to incorporate predictive models of health needs. The goal of this study was to correlate CRGs with health-related quality of life (HR-QoL) and costs in SLE patients. METHODS: A questionnaire was administered to SLE patients in four hospital centers of the Valencian Community (Spain) between October 2015 and March 2016. The factors studied included HR-QoL (EQ-5D-5L and VAS), disease activity (SLAI/SELENA), damage (SLICC/ACR), and severity (IGK). RESULTS: The patients (N = 190, 92.06% female, age (mean ± SD) 47.23 ± 13.43 years) were sorted according to health status in nine CRGs. We found that most SLE patients (> 70%) were in CRGs 5 and 6. The main HR-QoL issues in these patients were related to mobility, ability to perform usual activities, and pain/discomfort. The scores (mean ± SD) for EQ-5D-5L and VAS were 0.74 ± 0.25 and 65.67 ± 23.52, respectively. We found that the age of the patients negatively affected their HR-QoL (r = - 0.266). SLE direct costs per patient increased with each CRG group, representing 71.92% of the total costs, while indirect costs were highly variable. The average cost per patient with SLE amounted to €8432.85 (year 2014). CONCLUSIONS: Patients' quality of life is related with age, disease activity, damage, and severity. Age was the parameter which most affects HR-QoL. Most costs of SLE are concentrated in two CRGs in which the HR-QoL deteriorates sharply.

Aceclofenac vs paracetamol in the management of symptomatic osteoarthritis of the knee: a double-blind 6-week randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and tolerability of aceclofenac, 200 mg/day, and paracetamol, 3000 mg/day, in the treatment of osteoarthritis (OA) of the knee. METHODS: This was a double-blind, parallel-group, multicentre clinical trial involving patients with symptomatic OA of the knee, conducted in Spain. Patients were randomly allocated to aceclofenac 100 mg twice daily (n=82) or paracetamol 1000 mg three times daily (n=86). Patients were assessed at baseline and 6 weeks. Primary efficacy measures were severity of pain (visual analogue scale, VAS), Lequesne OA knee index, and patient's and physician's global assessment of disease activity. Severity of knee pain at rest or walking, stiffness, knee swelling and tenderness, and assessment of health-related quality of life (Health Assessment Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index, and Short Form 36) were included as secondary endpoints. RESULTS: Both treatment groups showed significant improvement compared with their baseline values in the four primary endpoints. Mean between-treatment differences favoured aceclofenac over paracetamol on pain (VAS, 7.64 mm [95% confidence interval (CI), 0.44-14.85 mm]), Lequesne OA index (1.41 [95% CI, 0.45-2.36]), and patient's (0.33 [95% CI, 0.06-0.61]) and physician's (0.23 [95% CI, 0.01-0.47]) global assessments. Adverse events were similar for both drugs (paracetamol, 29% patients vs aceclofenac, 32%; P=0.71). Four patients withdrew in each group due to adverse events. Patients tended to prefer aceclofenac to paracetamol (P=0.001), and more treated with paracetamol withdrew from the study due to lack of efficacy (n=8 vs n=1, P=0.035, for paracetamol and aceclofenac, respectively). CONCLUSION: At 6 weeks, patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with aceclofenac than paracetamol with no difference in tolerability.

Terapias hormonales, fertilidad y embarazo en el síndrome Antifosfolipídico / Hormone therapy, fertility and pregnancy in antiphospholipid syndrome

Debido al riesgo trombótico, y a sus implicaciones en la fertilidad, el síndrome antifosfolipídico (SAF) conlleva consideraciones particulares respecto a cualquier tipo de terapia hormonal y a la gestación. En el presente artículo, se procede a revisar ampliamente todos estos aspectos. Se desglosa lo referente a anticoncepción, terapia hormonal sustitutiva y moduladores selectivos de los receptores de estrógenos en el SAF. Se revisa la fertilización in vitro/transferencia embrionaria y la inducción ovárica en estas pacientes. Por último, se detallan las posibles complicaciones fetales y maternas durante la gestación, y basándose en la bibliografía, se indica una posible guía para el manejo del embarazo en mujeres con SAF(AU)

Antiphospholipid syndrome (APS) carries a risk of thrombosis and infertility. Consequently the use of any type of hormone therapy and pregnancy in APS requires special considerations. The present article provides a broad review of all these issues. The use of contraception, hormone replacement therapy and selective estrogen receptor modulators in APS are described. In vitro fertilization/embryo transfer and ovarian induction in these patients are reviewed. Lastly, the possible fetal and maternal complications that can occur during pregnancy are described and, based on the literature, recommendations for the management of pregnancy inwomen with APS are provided(AU)

[Hormone therapy, fertility and pregnancy in antiphospholipid syndrome]. / Terapias hormonales, fertilidad y embarazo en el síndrome antifosfolipídico.

Antiphospholipid syndrome (APS) carries a risk of thrombosis and infertility. Consequently the use of any type of hormone therapy and pregnancy in APS requires special considerations. The present article provides a broad review of all these issues. The use of contraception, hormone replacement therapy and selective estrogen receptor modulators in APS are described. In vitro fertilization/embryo transfer and ovarian induction in these patients are reviewed. Lastly, the possible fetal and maternal complications that can occur during pregnancy are described and, based on the literature, recommendations for the management of pregnancy in women with APS are provided.

Upper gastrointestinal and overall tolerability of alendronate once weekly in patients with osteoporosis: results of a randomized, double-blind, placebo-controlled study.

OBJECTIVE: To compare the upper gastrointestinal (GI) and overall tolerability profiles of alendronate 70 mg once weekly with placebo. RESEARCH DESIGN AND METHODS: This 12-week international, multi-center, randomized, double-blind, placebo-controlled trial included 449 postmenopausal women and men with osteoporosis at 44 sites in 19 countries in Europe, the Americas, Africa, and Asia-Pacific. Subjects were randomized to alendronate 70 mg once weekly or matching placebo in a 1:1 ratio. MAIN OUTCOME MEASURES: The safety and tolerability of weekly alendronate and placebo were captured as clinical and laboratory adverse events. The primary endpoint was upper GI tolerability based on the incidence of upper GI tract adverse events. Secondary endpoints included the percentage of subjects who discontinued therapy due to a drug-related upper GI adverse event. Change from baseline in bone turnover as measured by the urinary N-telopeptide-collagen crosslinks corrected for creatinine (NTx/Cr) was assessed at 12 weeks as an indicator of efficacy. RESULTS: The percentages of subjects reporting an upper GI tract adverse event in the alendronate 70 mg once weekly group (9.8%) and the placebo group (9.4%) were similar. The risk difference between the two treatment groups (alendronate minus placebo) was 0.4% [95% confidence interval (CI), -5.1%, 5.9%]. Percentages of subjects who discontinued due to a drug-related upper GI adverse event were also similar (alendronate 2.7%; placebo 2.2%; risk difference 0.4%, 95% CI, -2.4, 3.3). The overall tolerability profile of alendronate 70 mg once weekly, as measured by the percentage 8.0% (95% CI, 1.4%, 15.0%) increase in the of subjects reporting any adverse event, was similar to that of placebo (risk difference 2.1%, 95% CI -6.9, 11.0). There was a significant 43.3% (95% CI, -47.9%, -38.3%) decrease from baseline in urinary NTx/Cr in the alendronate group compared with an placebo group at Week 12. CONCLUSION: Alendronate 70 mg administered once weekly to women and men with osteoporosis has an upper GI and overall tolerability profile similar to that of placebo.

Estado actual de los hospitales de día de reumatología en España / Current status of rheumatology day hospitals in Spain

El objetivo esencial del hospital de día (HD) es ofrecer una asistencia sanitaria especializada y técnicamente cualificada, en régimen ambulatorio, y evitar la estancia hospitalaria en régimen de internado. Objetivo: Describir el estado actual de los HD de reumatología en nuestro país y analizar los problemas más frecuentes derivados de la instauración de este tipo de infraestructuras, así como las medidas adoptadas para subsanarlos. Resultados: Existen 24 centros en España con HD autogestionado. Las artropatías inflamatorias son las patologías que más frecuentemente reciben atención en HD. Infliximab es el fármaco administrado con más frecuencia (100 por ciento), seguido de ciclofosfamida (52 por ciento), pamidronato (48 por ciento) y esteroides intravenosos (26 por ciento). Los problemas más comunes observados son la saturación de pacientes y, en algunas ocasiones, una falta de comunicación entre el responsable del HD y el médico habitual del paciente. Conclusiones: El HD es una estructura cada vez más necesaria en las unidades de reumatología debido a la aparición de nuevas terapias que precisan administración intravenosa. Las ventajas que ofrece son la reducción del número de visitas del paciente, la optimización de recursos y un mejor control sobre los efectos secundarios (AU)

Bursitis: análisis clínico de 52 casos / Bursitis: clinical analysis of 52 patients

Estudio retrospectivo longitudinal que evalúa las características clínicas de los pacientes diagnosticados de bursitis durante un año en una sección de reumatología de un hospital terciario, comparándolos con resultados previos de la bibliografía. Se incluyó a 52 pacientes, diagnosticados todos de bursitis según criterios clínicos y ecográficos. De ellos, 19 pacientes (36,5 por ciento) presentaban bursitis superficial, y 33 (63,5 por ciento) bursitis profunda. La mayoría de las bursitis superficiales ocurrieron en varones (84,2 por ciento), con una media de 49,2 años de edad. En cambio, las bursitis profundas se dieron predominantemente en mujeres (78,8 por ciento) con una edad media de 53,8 años. Entre los factores predisponentes para las bursitis superficiales encontramos diferentes profesiones (albañil, fontanero, carpintero y ama de casa), frente a las profundas, en que los pacientes eran predominantemente sedentarios (el 100 por ciento de las bursitis glúteas). Las radiografías simples fueron normales, excepto en un 18,8 por ciento de las bursitis superficiales, en las que se observó un aumento de partes blandas. El diagnóstico clínico fue confirmado ecográficamente en todos los casos. Se obtuvo líquido de las bursas en 17 de las bursitis superficiales (89,4 por ciento), y en todos ellos se practicó examen en fresco y cultivo. En ningún caso se observaron cristales. El cultivo fue positivo en 8 pacientes (47 por ciento), y Staphylococcus aureus fue el germen aislado con más frecuencia (75 por ciento). Otros microorganismos aislados fueron: Streptoccus piogenes y Staphylococcus epidermidis. Sólo en cinco (15,1 por ciento) de las bursitis profundas se obtuvo líquido bursal: el cultivo fue negativo en todos los casos, detectándose la presencia de cristales de hidroxiapatita en un caso. El tratamiento más empleado en las bursitis superficiales consistió en la administración de antibióticos (89,5 por ciento); en cambio, en las bursitis profundas, predominó el uso de la infiltración local de esteroides (57,5 por ciento).Conclusiones: Las diferencias etiológicas encontradas entre las bursitis superficiales y las profundas pueden ser de utilidad a la hora de escoger el tratamiento correcto desde el inicio (AU)

Prevalence of Raynaud's phenomenon in general practice in the east of Spain.

Our aim was to establish the prevalence of Raynaud's phenomenon in a general practice in the east of Spain and compare our results with those of other studies performed in geographical areas with similar climatic characteristics. Two hundred and seventy-six subjects visiting their general practitioner for whatever reason were randomly selected from a particular area of the city of Valencia. Each was interviewed by their GP following the guidelines of a structured questionnaire to establish whether they had Raynaud's phenomenon or not. There were 205 women and 71 men. The mean age was 54.43, with a standard deviation of 18.22. Raynaud's phenomenon was present in nine subjects, two men and seven women, with a prevalence of 2.8% and 3.4%, respectively. Of the nine positives (mean age 60.56 years, standard deviation 16.38), two were diagnosed with hypertension and two with migraine. None of them usually took Raynaud's phenomenon-related drugs or performed physical exercise. No patient had a family history of Raynaud's phenomenon or had already been diagnosed with it. All the positive males were affected only by the pallor stage. This study shows lower prevalences than those of other studies performed in different geographical areas with similar climatic conditions.

[Radioisotopic synoviorthesis in rheumatoid arthritis. A study of 108 cases]. / La sinoviortesis radioisotópica en la artritis reumatoide. Estudio de 108 casos.

There are several therapeutic alternatives in the local treatment of rheumatoid arthritis (RA): intraarticular corticosteroids, chemical synoviorthesis, surgical synovectomy and synoviorthesis with radioisotopes. We present the results of an observational study on radioisotopic synoviorthesis carried out in the Valencian health care area from January 1989 to May 1997 which included 108 synoviortheses performed in 51 patients. This study aimed to assess the efficacy and safety of radiosynoviorthesis in the treatment of RA which had not responded to conventional treatment. Good and moderate results were obtained in 76.2% of the cases, there being significant differences in the efficacy of synoviorthesis in patients with and without advanced radiographic alterations. There were few side effects (3.7%). We conclude that radiosynoviortesis is a useful and safe therapeutic tool in RA that does not respond to conventional treatment, that it is more effective in large joints with little cartilaginous deterioration and that its repeated use does not decrease the expected therapeutic effect.

La sinoviortesis radioisotópica en la artritis reumatoide. Estudio de 108 casos / Radioisotopic synoviorthesis in rheumatoid arthritis. A study of 108 cases

En el tratamiento local de la artritis reumatoide (AR) existen diversas alternativas terapéuticas: los corticoides intraarticulares, la sinoviortesis química, la sinovectomía quirúrgica y la sinoviortesis con radioisótopos.Presentamos los resultados de un estudio observacional sobre la sinoviortesis radioisotópica realizado en un área sanitaria de Valencia desde enero de 1989 hasta mayo de 1997 que incluye 108 sinoviortesis realizadas en 51 pacientes. Los objetivos del estudio fueron valorar la eficacia y la seguridad de la radiosinoviortesis en el tratamiento de la AR que no había respondido al tratamiento convencional.Se obtuvieron resultados buenos y regulares en el 76,2 por ciento de los casos, observándose diferencias significativas en la eficacia de la sinoviortesis entre pacientes sin y con alteraciones radiográficas avanzadas. Los efectos secundarios fueron escasos (3,7 por ciento). Concluimos que la radiosinoviortesis es un instrumento terapéutico útil y seguro en la AR que no responde al tratamiento convencional, es más efectiva en articulaciones grandes con poco deterioro cartilaginoso y su aplicación repetida no disminuye el efecto terapéutico esperado. (AU)