To review the efficacy and safety of rituximab in vasculitic neuropathy (VN) METHODS: A literature search was performed on Medline and Embase up until 2017. It included terms related to ..."vasculitis","vasculitic neuropathy" and "Rituximab". Research was carried out by two reviewers. The main outcome was rituximab efficacy.
Of an initial selection of 702 articles, 5 remained with a level of evidence between 1+ and 3 and variable recommendation degree. In the only clinical trial included, rituximab was superior to conventional therapy for cryoglobulinemic vasculitis with VN showing an increase in drug retention rate (64.3% vs. 3.5%; P<.001)and with a lower rate of serious adverse effects (.12 vs. .48). Cohort studies of patients with cryoglobulinemic vasculitis showed improvement and complete/partial remission of VN. In a series of 5 cases of refractory EGPA suffering from VN, 60% and 20% of patients achieved complete and partial remission respectively.
Rituximab seems an effective and safe treatment for VN in the context of cryoglobulinemic vasculitis. Evidence for specific efficacy in VN in the context of other types of vasculitis is lacking.
Background Plasma concentrations of lipoprotein (a) (Lp(a)), a lipoprotein with atherogenic and thrombogenic properties, have a strong genetic basis, although high concentrations of Lp(a) have also ...been reported in the context of inflammation, as in rheumatoid arthritis (RA). Few studies evaluate the impact of biologic therapies (BT) on Lp(a) in RA, taking into account that with these new therapies a better control of inflammation is achieved. Objective The aim of the study was to evaluate the plasma concentrations of Lp(a) in Spanish RA patients on BT attending rheumatology outpatient clinics. Methods Baseline analysis of the CARdiovascular in rheuMAtology project, a 10-year prospective study, evaluating the risk of cardiovascular events in RA and other forms of inflammatory arthritis. RA patients were classified according to treatment: no biologic, anti-tumor necrosis factor, anti-interleukin-6 receptor tocilizumab (TCZ), and other biologic (rituximab or abatacept). A model of linear multivariate regression was built in which the dependent variable was Lp(a) concentration and the explanatory variable was BT. The model was adjusted for confounding factors. Results Seven hundred and seventy-five RA patients were analyzed. Plasma concentrations of total cholesterol and triglyceride were significantly higher in TCZ-treated patients. Nevertheless, no significant difference in the atherogenic index between TCZ-treated patients and patients without BT was found. After adjusting for confounding factors, patients with BT had lower concentrations of Lp(a) than those without BT; however, only TCZ-treated patients achieved statistically significant differences (β: −0.303, 95% confidence interval: −0.558 to −0.047; P = .02). Conclusions RA patients treated with TCZ show lower plasma concentrations of Lp(a) compared with patients without BT.
This study aimed at determining socio-demographic and clinical factors of primary Sjögren syndrome (pSS) associated with osteoporosis (OP) and fragility fracture. SJOGRENSER is a cross-sectional ...study of patients with pSS, classified according to American European consensus criteria developed in 33 Spanish rheumatology departments. Epidemiological, clinical, serological and treatment data were collected and a descriptive analysis was conducted. Bivariate and multivariate analyses were performed using a binomial logistic regression to study the factors associated with OP and fragility fracture in pSS. 437 patients were included (95% women, with a median age of 58.6 years). 300 women were menopausal (76.4%). Prevalence of OP was 18.5% in men (
N
= 21) this measured 19%. A total of 37 fragility fractures were recorded. In the multivariate analysis, there was an association between OP and age: in the 51–64 age range (menopausal women), the OR measured 9.993 (95% CI 2301–43,399,
p
= 0.002); In the age > 64 years group, OR was 20.610 (4.679–90.774,
p
< 0.001); between OP and disease duration, OR was 1.046 (1.008–1085,
p
= 0.017); past treatment with corticosteroids, OR 2.548 (1.271–5.105,
p
= 0.008). Similarly, an association was found between fragility fractures and age: in the 51–64 age group, OR measured 5.068 (1.117–22,995,
p
= 0.035), age > 64 years, OR was 7.674 (1.675–35,151,
p
< 0.009); disease duration, OR 1.049 (CI 1.003–1097,
p
< 0.036) and the ESSDAI index, OR 1.080 (1.029–1134,
p
= 0.002). Patients with pSS can develop osteoporosis and fragility fractures over the course of the disease. Age, corticosteroids treatment and disease duration were associated with the development of OP. Disease duration and ESSDAI were associated with the development of fractures in patients with pSS.
To describe whether rheumatic inflammatory diseases (RID) are associated with a higher risk of hospitalization and/or mortality from COVID-19 and identify the factors associated with hospitalization ...and mortality in RID and COVID-19 in different Hospitals in Andalusia.
Design: Multicentre observational case-COntrol study. Patients: RID and COVID-19 from different centres in Andalusia. Controls: patients without RIS matched by sex, age and CRP-COVID.
Protocol A list of patients with PCR for COVID-19 was requested from the microbiology service from March 14 to April 14, 2020. The patients who had RID were identified and then consecutively a paired control for each case.
Variables The main outcome variable was hospital admission and mortality from COVID-19.
Statistical analysis Bivariate followed by binary logistic regression models (DV: mortality/hospital admission).
One hundred and fifty-six patients were included, 78 with RID and COVID-19 and 78 without RID with COVID-19. The patients did not present characteristics of COVID-19 disease different from the general population, nor did they present higher hospital admission or mortality. The factor associated with mortality in patients with RID was advanced age (OR 95% CI, 1.1 1.0–1.2; P= .025), while the factors associated with hospitalization were advanced age (OR 95% CI, 1.1 1.0–1.1; P = .007) and hypertension (OR 95% CI, 3.9 1.5–6.7; P = .003).
Mortality and hospital admission due to COVID-19 do not seem to increase in RID. Advanced age was associated with mortality in RID and, in addition, HTN was associated with hospital admission.
Describir si las enfermedades inflamatorias reumáticas (EIR) se asocian con mayor riesgo de hospitalización y/o mortalidad por COVID-19 e identificar los factores asociados a la hospitalización y mortalidad en EIR y COVID-19 en diferentes hospitales de Andalucía.
Diseño: Estudio multicéntrico observacional de casos y controles. Pacientes Casos: EIR y COVID-19 de diferentes centros de Andalucía. Controles: pacientes sin EIR pareados por sexo, edad y PCR-COVID.
Protocolo Se solicitó al Servicio de Microbiología un listado de pacientes con PCR para COVID-19 desde 14 de marzo al 14 de abril de 2020. Se identificaron los pacientes que tuvieran EIR y luego consecutivamente un control pareado para cada caso.
Variables La variable de desenlace principal fue ingreso hospitalario y mortalidad por COVID-19.
Análisis estadístico Bivariante seguida de modelos de regresión logística binaria (variable dependiente: mortalidad/ingreso hospitalario).
Se incluyeron 156 pacientes con COVID-19, 78 con EIR y 78 sin EIR. Los pacientes con EIR no presentaron características de la enfermedad COVID-19 diferentes a la población general, tampoco mayor ingreso hospitalario ni mortalidad. El factor asociado con mortalidad en los pacientes con EIR fue edad (OR IC 95%, 1,1 1,0–1,2; p = 0,025), mientras que los factores asociados con ingreso hospitalario fueron edad (OR IC 95%, 1,1 1,1–1,2; p = 0,007) e hipertensión arterial (OR IC 95%, 3,9 1,5–6,7; p = 0,003).
La mortalidad y el ingreso hospitalario por COVID-19 no parecen aumentados en las EIR. La edad se asoció con mortalidad en EIR y, además, la hipertensión arterial se asoció con ingreso hospitalario.
To describe whether rheumatic inflammatory diseases (RID) are associated with a higher risk of hospitalization and/or mortality from COVID-19 and identify the factors associated with hospitalization ...and mortality in RID and COVID-19 in different Hospitals in Andalusia.
Design: Multicentre observational case-control study.
RID and COVID-19 from different centres in Andalusia.
patients without RIS matched by sex, age and CRP-COVID. Protocol A list of patients with PCR for COVID-19 was requested from the microbiology service from March 14 to April 14, 2020. The patients who had RID were identified and then consecutively a paired control for each case. Variables The main outcome variable was hospital admission and mortality from COVID-19. Statistical analysis Bivariate followed by binary logistic regression models (DV: mortality/hospital admission).
One hundred and fifty-six patients were included, 78 with RID and COVID-19 and 78 without RID with COVID-19. The patients did not present characteristics of COVID-19 disease different from the general population, nor did they present higher hospital admission or mortality. The factor associated with mortality in patients with RID was advanced age (OR 95% CI, 1.1 1.0-1.2; p = 0.025), while the factors associated with hospitalization were advanced age (OR 95% CI, 1.1 1.0-1.1; p = 0.007) and hypertension (OR 95% CI, 3.9 1.5-6.7; p = 0.003).
Mortality and hospital admission due to COVID-19 do not seem to increase in RID. Advanced age was associated with mortality in RID and, in addition, HTN was associated with hospital admission.
To evaluate the effectiveness and safety of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in clinical practice, establishing the optimized regimen and switching from intravenous (IV) ...to subcutaneous (SC) therapy.
Retrospective observational study. We included 53 RA patients treated with TCZ. The main outcome was TCZ effectiveness at week 24. Secondary outcome variables included effectiveness at week 52, therapeutic maintenance, physical function and safety. The effectiveness of optimization and the switch from IV to SC was evaluated at 3 and 6 months. The efficacy was measured with the Disease Activity Score. Paired t-tests or Wilcoxon were used to evaluate effectiveness and survival time using Kaplan-Meier.
The proportion of patients who achieved remission or low disease activity at weeks 24 and 52 was 75.5% and 87.3%, respectively. The mean retention time (95% confidence interval 95% CI was 81.7 months 76.6-86.7). Twenty-one of 53 patients (39.6%) optimized the TCZ dose and 35 patients switched from IV TCZ to SC, with no changes in effectiveness. The adverse event rate was 13.6 events/100 patient-years.
Tocilizumab appears to be effective and safe in RA in clinical practice. The optimized regimen appears to be effective in most patients in remission, even when they change from IV to SC.
To evaluate the effectiveness and safety of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in clinical practice, establishing the optimised regimen and switching from intravenous (IV) ...to subcutaneous (SC) therapy.
Retrospective observational study. We included 53 RA patients treated with TCZ. The main outcome was TCZ effectiveness at week 24. Secondary outcome variables included effectiveness at week 52, therapeutic maintenance, physical function and safety. The effectiveness of optimization and the switch from IV to SC was evaluated at 3 and 6 months. The efficacy was measured with the Disease Activity Score. Paired t-tests or Wilcoxon were used to evaluate effectiveness and survival time using Kaplan–Meier.
The proportion of patients who achieved remission or low disease activity at weeks 24 and 52 was 75.5% and 87.3%, respectively. The mean retention time (95% confidence interval 95% CI was 81.7 months 76.6–86.7). Twenty-one of 53 patients (39.6%) optimised the TCZ dose and 35 patients switched from IV TCZ to SC, with no changes in effectiveness. The adverse event rate was 13.6 events/100 patient-years.
Tocilizumab appears to be effective and safe in RA in clinical practice. The optimised regimen appears to be effective in most patients in remission, even when they change from IV to SC.
Evaluar la efectividad y la seguridad de tocilizumab (TCZ) en pacientes con artritis reumatoide (AR) en práctica clínica; la optimización de dosis y el cambio de formulación intravenosa (iv) a subcutánea (sc).
Estudio observacional retrospectivo. Se incluyó a 53 pacientes con AR tratados con TCZ. El desenlace principal fue efectividad de TCZ en la semana 24. Variables de desenlace secundarias incluyeron: efectividad en la semana 52, tiempo de retención del tratamiento, función física y seguridad. También se midió efectividad de la optimización de dosis y del cambio de formulación iv a sc a los 3 y 6 meses. La efectividad se midió con el índice de actividad según el Disease activity score-28. Se usó la prueba T pareada o prueba de rangos con signos de Wilcoxon para evaluar efectividad y el tiempo de supervivencia mediante curvas de Kaplan-Meier.
La proporción de pacientes que alcanzaron la remisión o baja actividad de la enfermedad en las semanas 24 y 52 fue del 75,5 y el 87,3%, respectivamente. La media de tiempo de retención (intervalo de confianza del 95% IC del 95%) fue de 81,7 meses (76,6-86,7). Veintiuno de 53 pacientes (39,6%) optimizaron la dosis de TCZ y 35 pacientes cambiaron a TCZ sc desde iv, sin cambios en resultados de efectividad. La tasa de efectos adversos fue 13,6 eventos/100 pacientes-año.
Tocilizumab parece efectivo y seguro en AR en práctica clínica. La reducción de dosis parece efectiva en la mayoría de los pacientes en remisión, incluso cuando cambian de iv a sc.
Objectives: To describe the characteristics and progression of interstitial lung disease in patients with associated systemic autoimmune disease (ILD-SAI) and to identify factors associated with ...progression and mortality. Patients and methods: We performed a multicenter, retrospective, observational study of patients with ILD-SAI followed between 2015 and 2020. We collected clinical data and performed pulmonary function testing and high-resolution computed tomography at diagnosis and at the final visit. The main outcome measure at the end of follow-up was forced vital capacity (FVC) >10% or diffusing capacity of the lungs for carbon monoxide >15% and radiological progression or death. Cox regression analysis was performed to identify factors associated with worsening of ILD. Results: We included 204 patients with ILD-SAI: 123 (60.3%) had rheumatoid arthritis (RA), 58 had (28.4%) systemic sclerosis, and 23 (11.3%) had inflammatory myopathy. After a median (IQR) period of 56 (29.8–93.3) months, lung disease had stabilized in 98 patients (48%), improved in 33 (16.1%), and worsened in 44 (21.5%). A total of 29 patients (14.2%) died. Progression and hospitalization were more frequent in patients with RA (p = 0.010). The multivariate analysis showed the independent predictors for worsening of ILD-SAI to be RA (HR, 1.9 95% CI, 1.3–2.7), usual interstitial pneumonia pattern (HR, 1.7 95% CI, 1.0–2.9), FVC (%) (HR, 2.3 95% CI, 1.4–3.9), and smoking (HR, 2.7 95%CI, 1.6–4.7). Conclusion: Disease stabilizes or improves after a median of 5 years in more than half of patients with ILD-SAI, although more than one-third die. Data on subgroups and risk factors could help us to predict poorer outcomes.
Currently, the measurement of bone remodeling biomarkers is an innovate proposal in clinical evaluation of patients with osteoporosis. Its use may identify patients at increased risk of fracture as ...well as monitoring therapeutic efficacy. Because they constitute a relatively inexpensive non-invasive measurement, its use should be widespread for serial and frequent measurements of bone turnover. However, their analytical and biological variability limits their clinical applicability.