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.

Differences in clinical manifestations and increased severity of systemic lupus erythematosus between two groups of Hispanics: European Caucasians versus Latin American mestizos (data from the RELESSER registry).

BACKGROUND: Systemic lupus erythematosus (SLE) is regarded as a prototype autoimmune disease because it can serve as a means for studying differences between ethnic minorities and sex. Traditionally, all Hispanics have been bracketed within the same ethnic group, but there are differences between Hispanics from Spain and those from Latin America, not to mention other Spanish-speaking populations. OBJECTIVES: This study aimed to determine the demographic and clinical characteristics, severity, activity, damage, mortality and co-morbidity of SLE in Hispanics belonging to the two ethnic groups resident in Spain, and to identify any differences. METHODS: This was an observational, multi-centre, retrospective study. The demographic and clinical variables of patients with SLE from 45 rheumatology units were collected. The study was conducted in accordance with Good Clinical Practice guidelines. Hispanic patients from the registry were divided into two groups: Spaniards or European Caucasians (EC) and Latin American mestizos (LAM). Comparative univariate and multivariate statistical analyses were carried out. RESULTS: A total of 3490 SLE patients were included, 90% of whom were female; 3305 (92%) EC and 185 (5%) LAM. LAM patients experienced their first lupus symptoms four years earlier than EC patients and were diagnosed and included in the registry younger, and their SLE was of a shorter duration. The time in months from the first SLE symptoms to diagnosis was longer in EC patients, as were the follow-up periods. LAM patients exhibited higher prevalence rates of myositis, haemolytic anaemia and nephritis, but there were no differences in histological type or serositis. Anti-Sm, anti-Ro and anti-RNP antibodies were more frequently found in LAM patients. LAM patients also had higher levels of disease activity, severity and hospital admissions. However, there were no differences in damage index, mortality or co-morbidity index. In the multivariate analysis, after adjusting for confounders, in several models the odds ratio (95% confidence interval) for a Katz severity index >3 in LAM patients was 1.45 (1.038-2.026; p = 0.02). This difference did not extend to activity levels (i.e. SLEDAI >3; 0.98 (0.30-1.66)). CONCLUSION: SLE in Hispanic EC patients showed clinical differences compared to Hispanic LAM patients. The latter more frequently suffered nephritis and higher severity indices. This study shows that where lupus is concerned, not all Hispanics are equal.

Atypical Ulcerated Lesions in a Patient With Cogan Syndrome / Lesiones ulcerativas atípicas en un paciente con síndrome de Cogan

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Validity of the ankylosing spondylitis disease activity score (ASDAS) in patients with early spondyloarthritis from the Esperanza programme.

OBJECTIVES: To evaluate the validity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in early spondyloarthritis (SpA) in comparison with conventional clinical measures of disease activity. METHODS: Six hundred and seventy-six incident cases of early SpA from the Esperanza programme were included. Patients were categorised into high and low disease activity states based on patient and physician global assessment scores and on the physician's decision to start treatment with a disease-modifying antirheumatic drug or tumour necrosis factor blocker. The discriminant ability of ASDAS-C-reactive protein (CRP) and ASDAS-erythrocyte sedimentation rate (ESR) was tested using standardised mean differences between patients with high and low disease activity. Convergent validity was tested by Pearson correlation between ASDAS versions and other measures of disease activity. RESULTS: ASDAS-ESR and ASDAS-CRP showed good correlation with BASDAI (r=0.79 and 0.74, respectively). Both indices correlated well with the patient global assessment (r=0.70 in both indices) and moderately with the physician global score (r=0.46 and 0.47, respectively). CRP and ESR showed poor correlation with patient- and physician-derived measures. ASDAS performed similarly across the global SpA sample, ankylosing spondylitis (AS), non-radiographic axial SpA and peripheral SpA. CONCLUSIONS: ASDAS performed as a valid activity score even being slightly better than the Bath Ankylosing Spondylitis Disease Activity Index in its ability to discriminate between high and low disease activity in early SpA. ASDAS performed similarly in AS, early forms of SpA, non-radiographic axial SpA and peripheral SpA.

Multicenter longitudinal study of B-lymphocyte depletion in refractory systemic lupus erythematosus: the LESIMAB study.

OBJECTIVE: This study aimed to investigate the effectiveness and safety of single and repeated courses of rituximab in patients with refractory lupus. METHODS: LESIMAB is a multicenter, retrospective, longitudinal study of lupus patients who have not responded to standard therapy and have been treated with rituximab. Response rates at six months and at follow-up were defined as efficacy outcomes. Complete response was defined as a SELENA-SLEDAI score ≤ two and a SELENA-SLEDAI Flare Index of zero. Partial response was defined as a reduction in the SELENA-SLEDAI score of ≥four points with no new or worsening of symptoms. Adverse events were collected. RESULTS: Seventy-three (62.9%) of 116 patients achieved a response at six months (complete in 22 and partial in 51). Ninety-seven (77.6%) of 128 patients achieved a response after a mean follow-up of 20.0 ± 15.2 months (complete in 50 and partial in 47). High baseline SLEDAI score, previous treatment with ≥100 mg/day prednisone, and no history of severe hematologic flare were associated with response after the first treatment course. The median time to response was 6.5 months (95% CI, 5.0-8.0). Thirty-seven patients (38.1%) relapsed after the first infusion. The flare was severe in seven cases and mild to moderate in 29 cases. Serious infection rate was 12.6/100 patient-years. A schedule of four weekly doses was associated with more serious infections. Six patients died: two of infection and four of lupus complications. CONCLUSION: Rituximab can be an effective treatment option for patients who have refractory lupus with severe or life-threatening disease with an acceptable tolerance profile.

Crisis hipertensivas en los servicios de urgencias hospitalarios. Estudio SUHCRIHTA / Hypertensive crises at the hospital Emergency Services. The SUHCRIHTA study

Objetivos: Conocer la prevalencia de la crisis hipertensiva (CH), las características clínicas de los enfermos, las cargas de trabajo y los modos de actuación en los SUH para, de acuerdo con los resultados, recomendar unas pautas de actuación en urgencias ante una CH. Métodos: Estudio prospectivo multicéntrico observacional, desarrollado en quince SUH, que atienden a un numero mayor de doscientas urgencias/día, cada uno de ellos durante cuatro días al mes y tres meses consecutivos, en los cuales se recogieron los datos de los pacientes atendidos con CH. Resultados: Se recogieron los datos de 694 pacientes con CH, lo que supone una prevalencia del 1,45 por ciento del total de urgencias, y de 0,01 por ciento de la población, presentándose como urgencias hipertensivas (UH) el 1,05 por ciento y como emergencias hipertensivas (EH) el 0,4 por ciento. La mayoría tenían más de 60 años, predominaban las mujeres, y tres cuartas partes tenían antecedentes de hipertensión arterial (HTA). Aun cuando el 75 por ciento de casos tiene antecedentes de HTA, sólo al 65 por ciento se le había prescrito tratamiento y un 17 por ciento lo había abandonado. Los motivos de consulta más frecuentes fueron cefalea (15 por ciento), dolor torácico (15 por ciento) y elevación de las cifras tensionales (12 por ciento). La angina fue la causa más frecuente para considerar la CH como EH. Al 52 por ciento de los enfermos se les hicieron más de 4 exploraciones complementarias (hemograma, bioquímica, ECG, Rx tórax) y la cuarta parte permanecieron en el SUH más de 6 horas. El grupo farmacológico más utilizado en el tratamiento ha sido los inhibidores de la enzima conversora de la angiotensina (IECAs), con una amplia dispersión de fármacos, tanto en el SUH como en las urgencias extrahospitalarias. Conclusiones: l.- Las CH representan el 1,45 por ciento de las urgencias atendidas en nuestros hospitales; el 27 por ciento de ellos corresponde a EH. 2.- Aunque existe una tendencia a realizar hemograma, bioquímica elemental y ECG en las CH, el resto de las exploraciones complementarias no se utilizan razonablemente. 3.- Existe una amplia dispersión en el tratamiento utilizado en las CH, tanto a nivel de la urgencia hospitalaria como extrahospitalaria. 4.- Parece necesario establecer unas pautas de actuación diagnóstica y terapéutica ante una CH (AU)

Control metabólico de la diabetes mellitus en relación con la calidad de las historias clínicas / Metabolic control of diabetes mellitus in relation to the quality of clinical records

Objetivo. Se pretende averiguar si existe relación entre la calidad de la historia clínica (HC) de atención primaria y el control metabólico de pacientes con diabetes mellitus (DM). Diseño. Observacional, retrospectivo. Emplazamiento. Quince centros de salud del Área de Segovia. Pacientes. Un total de 315 pacientes diabéticos, seleccionados aleatoriamente entre los que tienen registro del tipo de DM, fecha y resultado de al menos una HbA1c y tratamiento en el momento de la última HbA1c. Resultados. Se mide la calidad de las HC por la media de registro, en los 13 meses anteriores a la última HbA1c, de los siguientes ítems: peso y talla, pulsos periféricos, sensibilidad, examen de los pies, creatinina, proteinuria, microalbuminuria, glucemias, fondo de ojo, ECG, consejo de dieta, tabaco y alcohol. Se recogen otras variables que pueden condicionar la HbA1c, patologías crónicas y patologías relacionadas con la DM. De los pacientes tratados con dieta o antidiabéticos orales (ADO), los de HC de calidad 49 por ciento presentan una HbA1c media de 7,40 por ciento, mientras los de HC de calidad 50 por ciento tienen una media de 6,94 por ciento (diferencia, 0,46; IC del 95 por ciento, 0,03-0,90; p = 0,038). Esta disminución no es atribuible a diferencias en edad, género, años de evolución o IMC. El riesgo de tener una HbA1c 7,5 por ciento es el doble en pacientes con HC de calidad 49 por ciento, que en los de HC de calidad 50 por ciento (OR, 2,06; IC del 95 por ciento, 1,14-3,72). En los tratados con insulina, no se ha demostrado asociación entre calidad de HC y HbA1c. Conclusiones. El seguimiento de las recomendaciones de actuación clínica se asocia a mejor control metabólico en diabéticos tratados con dieta-ADO. Esta asociación no se ha comprobado en los tratados con insulina (AU)

[Metabolic control of diabetes mellitus en relation to the quality of the medical records]. / Control metabólico de la diabetes mellitus en relación con la calidad de las historias clínicas.

OBJECTIVE: To investigate whether there is a relationship between the quality of the clinical history (CH) in primary care and metabolic control of patients with diabetes (DM). DESIGN: Retrospective and observational. SETTING: 15 health centres in the Segovia Area. PATIENTS: 315 diabetic patients, selected at random from among those with a record of the type of DM, date and outcome of at least one HbA1c and treatment at the time of the most recent HbA1c. RESULTS: The quality of the clinical histories was measured through the mean of recording of the following items in the 13 months previous to the most recent HbA1c: weight and height, peripheral pulses, sensitivity, foot examination, creatinine, proteinuria, microalbuminuria, glucaemia levels, back of eye, ECG, and diet, tobacco and alcohol counselling. Other variables that could condition the HbA1c, chronic pathologies and those related to DM, were gathered too. Of patients treated with diet or oral diabetic drugs, patients with a clinical history of < or = 49% quality had a mean HbA1c of 7.40%, whereas those with CH of > or = 50% quality had an average of 6.94% (0.46 difference; 95% CI, 0.03-0.90; p = 0.038). This drop was not attributable to age, gender, years of evolution or BMI differences. The risk of having an HbA1c > or = 7.5% is double in patients with a CH of < or = 49% quality than in those with CH of > or = 50% quality (OR = 2.06; 95% CI, 1.14-3.72). In insulin-treated patients, no association between CH quality and HbA1c was found. CONCLUSIONS: Follow-up of the recommendations for clinical action is associated with better metabolic control in diabetics treated with diet--oral diabetic drugs. This association was not found in insulin-treated patients.