Immunoglobulins in systemic sclerosis management. A large multicenter experience.

OBJECTIVE: To analyze the effectiveness and safety of intravenous immunoglobulin (IVIG) given in routine care to patients with systemic sclerosis (SSc). METHODS: A retrospective multicenter observational study was conducted in SSc patients treated with IVIG. We collected data on epidemiological parameters and clinical outcomes. Firstly, we assessed changes in organ manifestations during IVIG treatment. Secondly, we analyzed the frequency of adverse effects. The following parameters were collected from baseline to the last follow-up: the patient's weight, modified Rodnan Skin Score (mRSS), modified manual muscle strength scale (MRC), laboratory test(creatine kinase(CK), hemoglobin and protein levels), The University of California Los Angeles Scleroderma Clinical Trials Consortium gastrointestinal tract 2.0 (UCLA GIT 2.0) questionnaire, pulmonary function tests, and echocardiography. RESULTS: Data were collected on 78 patients (82% females; 59% with diffuse SSc). Inflammatory idiopathic myopathy was the most frequent concomitant overlap disease (41%). The time since Raynaud's phenomenon and SSc onset were 8.8 ± 18 and 6.2 ± 6.7 years respectively. The most frequent IVIG indication was myositis (38/78), followed by gastrointestinal (27/78) and cutaneous (17/78) involvement. The median number of cycles given were 5. 54, 53 and 9 patients have been treated previously with glucocorticoids, synthetic disease-modifying antirheumatic drugs and biologic therapies respectively. After IVIG use we found significant improvements in muscular involvement (MRC ≥ 3/5 92% IVIG, p = 0.001 and CK levels from 1149 ± 2026 UI to 217 ± 224 UI, p = 0.02), mRSS (15 ± 12.4 to 13 ± 12.5, p = 0.015) and improvement in total score of UCLA GIT 2.0 (p = 0.05). None Anti-RNA polymerase III patients showed an adequate response in gastrointestinal involvement (0/7) in comparison with other antibodies (0 vs. 25, p = 0,039). Cardiorespiratory involvement remained stable. A total of 12 adverse events were reported with only one withdrawn due to serious adverse effect. CONCLUSIONS: this study suggest that IVIG may improve myositis, gastrointestinal and skin involvement in SSc patients treated in routine care and seems to have a good safety profile.

High prevalence of cardiovascular co-morbidities in patients with symptomatic knee or hand osteoarthritis.

OBJECTIVES: To evaluate the frequency of cardiovascular events (CVEs) and metabolic syndrome (MetS) in patients with symptomatic knee or hand osteoarthritis (OA). METHOD: A cross-sectional study conducted by rheumatologists in a primary care setting. Consecutive symptomatic patients with primary knee or hand OA were included and patients with soft tissue conditions served as the control group. Hypertension, diabetes mellitus, obesity, dyslipidaemia, and CVEs consisting of myocardial infarction, angina, or cerebrovascular disease were recorded. RESULTS: A total of 254 OA patients (184 with knee OA and 70 with hand OA) and 254 control patients were included. The frequency of obesity was higher in all OA groups and hypertension was more frequent in knee OA. MetS was significantly more frequent in patients with OA as a whole group and in knee or hand OA groups separately (p < 0.001, p = 0.002, and p = 0.007, respectively, vs. control group), with odds ratio (OR) 2.4, 95% confidence interval (CI) 1.26-4.55 in the OA group, OR 2.29, 95% CI 1.15-4.54 in the knee OA group, and OR 2.67, 95% CI 1.15-6.19 in the hand OA group. A higher prevalence of CVEs in the three OA groups was observed compared with the control group. CONCLUSIONS: A high frequency of MetS and CVEs was observed in OA patients in a primary care setting.

Sexual dysfunction in fibromyalgia patients.

OBJECTIVE: To investigate the prevalence of sexual dysfunction in female patients with fibromyalgia (FM), the impact of FM on sexual activity and the factors associated with sexual dysfunction in these patients. METHODS: Thirty-one consecutive women with FM were enrolled; two groups of 20 aged-matched healthy women and 26 patients with rheumatoid arthritis (RA) were used as controls. Demographic features were recorded in all patients. A cross-sectional analysis of pain (100-mm VAS scale), anxiety and depression (as determined by the STAI and Beck Depression Inventory scales, respectively) was performed. Sexual function was assessed by the Changes in Sexual Functioning Questionnaire (CSFQ). RESULTS: FM and RA patients showed a significantly higher rate of sexual dysfunction compared to healthy controls. Sexual dysfunction was more frequent among FM patients (97%) than in RA patients (84%) but without statistical differences. A univariate analysis showed that age (p=0.0002), marital (p=0.036) and work status (p=0.048), pain intensity (p=0.007), level of anxiety (p=0.002), level of depression (p=0.0005), were significantly associated with sexual dysfunction in FM. However, only the intensity of depression was associated with the sexual dysfunction in patients with FM in the multivariate analysis (p=0.012). CONCLUSIONS: Sexual function was very frequently and severely affected in patients with FM and this impairment appeared to be particularly associated with the degree of depression. The recognition of this dysfunction and its inclusion for the multidisciplinary management of FM may contribute to improve quality of life of these patients.

Colecalciferol o calcidiol. ¿Qué metabolito utilizar en el déficit de Vitamina D? / Calciol or cholecalciferol. What metabolite should be used in vitamin D deficit?

Introducción. La hipovitaminosis D es frecuente entre la población de nuestro país. El tratamiento sustitutivo del déficit de vitamina D se puede realizar con colecalciferol o con calcidiol, pero se desconoce si estos dos metabolitos tienen una eficacia equivalente. En este estudio nos propusimos como objetivos, en primer lugar valorar la eficacia de una pauta de calcidiol para corregir en un corto plazo el déficit de vitamina D y compensar el hiperparatiroidismo secundario en pacientes con hipovitaminosis D, y en segundo lugar comparar la eficacia de dos pautas, una con calcidiol y otra con colecalciferol para mantener normales los niveles séricos de vitamina D y mantener compensado el hiperparatiroidismo secundario en pacientes con niveles ya previamente normalizados de 25-OHD3. Pacientes y métodos. Estudio prospectivo con inclusión consecutiva de todos los individuos que presentaban déficit de vitamina D, procedentes de una consulta ambulatoria de reumatología. Al inicio, y durante un mes, se realizó un tratamiento con calcidiol (16.000 UI vía oral en dosis única semanal y durante 4 semanas) para normalizar niveles de 25-OHD3. Se realizaron determinaciones en sangre (calcio, fósforo, fosfatasa alcalina, 25-OHD3 y hormona paratiroidea intacta [PTHi]) y en orina (calciuria de 24 horas) al inicio y fin del tratamiento. Los pacientes que normalizaron niveles de 25-OHD3 se incluyeron en un protocolo prospectivo aleatorizado, para mantener niveles de 25-OHD3 (con 800 UI de colecalciferol y calcio 1 g mínimo /día, o calcidiol 16.000 UI/3 semanas y el mismo aporte de calcio a diario) durante un año. A los 3,6 y 12 meses se realizaron controles analíticos. Resultados. Se incluyeron en el estudio 129 pacientes con una edad media de 72,4 [10] años. El valor medio de 25-OHD3 basal fue de 16 [5] ng/ml y el de PTHi 76 [42]. El 52% de los pacientes presentaba hiperparatiroidismo secundario. Tras el tratamiento inicial se observó normalización de los niveles de 25-OHD3 en 124 casos (96%) e hiperparatiroidismo secundario en 15 pacientes (19%). Ambos tratamientos mantuvieron unos niveles séricos de 25-OHD3 en la normalidad, pero significativamente más elevados con calcidiol (p < 0,001 a los 3, 6 y 12 meses). En un porcentaje de pacientes el tratamiento fue insuficiente para mantener los niveles de 25-OHD3, sobre todo en el grupo de colecalciferol (19% frente a 4% a los 6 meses; p= 0,04, y 18% frente a 0% a los 12 meses; p= 0,006). Conclusiones. Una pauta de 16.000 UI semanales de calcidiol, durante 4 semanas, es sumamente útil para normalizar los niveles séricos de 25-OHD3 y de PTH en pacientes con déficit de vitamina D. Calcidiol y colecalciferol son metabolitos eficaces para mantener normalizados los niveles de 25-OHD3 y de PTHi

Introduction. Hypovitaminosis D is frequent among the population of our country. Vitamin D deficiency replacement treatment may be done with cholecalciferol or with calcidiol but it is not known if these two metabolites have an equivalent efficacy. In this study, we propose the following objectives: first, evaluate the efficacy of a calcidiol regimen to correct a vitamin D deficiency in the short-term and compensate the secondary hyperparathyroidism in patients with hypovitaminosis D, and second, compare the efficacy of the two regimes, one with calcidiol and the other with cholecalciferol, to maintain serum levels of vitamin D normal and maintain the secondary hyperparathyroidism compensated in patients with levels of 25-OHD3 that have already been normalized. Patients and methods. Prospective study with consecutive enrolment of all the patients with vitamin D deficiency of outpatient rheumotology clinic. At the onset, and for one month, patients recieved calcidiol (16.000 IU orally in a single weekly dose and for 4 weeks) to normalized levels of 25-OHD3. Serum (calcium, phosphorus, alkaline phosphatase, 25-OHD3 and PTHi), and in urine (24-hour calciuria) analysis were performed at the onset and after the completion of treatment. Patients who normalized levels of 25-OHD3 were enrolled in a randomized prospective protocol to maintain levels of 25-OHD3, (with 800 IU of cholecalciferol plus calcium 1 g minimum/day or calcidiol 16.000 IU /3 weeks and the same daily suplementation of calcium), for one year. Laboratory controls were conducted at 3, 6 and 12 months. Results. 129 patients with a mean age of 72.4 [10] years were included in the study. The mean value of baseline 25-OHD3 was 16 [5] ng/ml and PTHi 76 [42]. 52% of the patients had secondary hyperparathyroidism. After the initial treatment, normalization of 25-OHD3 levels was observed in 124 cases (96%) and secondary hyperparathyroidism in 15 patients (19%). Both treatments maintained serum levels of 25-OHD3 within the nomal range, but they were significantly more elevated with calcidiol (p < 0.001 at 3, 6 and 12 months). Treatment was ineffective to maintain 25-OHD3 levels in some patients, mainly, in the cholecalciferol group (19% vs 4% at 6 months, p = 0.04, and 18% vs 0% at 12 months, p = 0.006). Conclusions. A regimen of 16.000 IU weekly of calcidiol for 4 weeks is very useful to normalize serum levels of 25-OHD3 and of PTH in patients with vitamin D deficiency. Both calcidiol and cholecalciferol are effective to maintain normalized levels of 25-OHD3 and PTHi