scholarly journals AB0386 RITUXIMAB IN LUPUS NEPHRITIS. REAL CLINICAL PRACTICE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1493.2-1493
Author(s):  
C. Ramos Giráldez ◽  
M. L. Velloso Feijoo ◽  
S. Rodríguez Montero ◽  
J. L. Marenco
Keyword(s):  
Renal Function ◽  
Clinical Practice ◽  
Lupus Nephritis ◽  
Adverse Events ◽  
Serum Creatinine ◽  
Standard Treatment ◽  
Complete Response ◽  
Class Iii ◽  
Initial Values ◽  
Real Clinical Practice

Background:Lupus nephritis (LN) is a potentially life-threatening complication of systemic lupus erythematosus (SLE). Standard treatment of this entity includes glucocorticoids (GC) and immunosuppressants such as cyclophosphamide (CF), with remission rates between 20 and 70%. Given its pathogenesis, the anti-CD20 antibody rituximab (RTX) may be useful, although the information available in the scientific literature remains controversial.Objectives:To evaluate the effectiveness and safety of RTX in NL refractory to conventional treatment, under real clinical practice conditions.Methods:Retrospective descriptive observational study, which included consecutive patients attended in a Rheumatology Unit who met SLICC 2012 criteria for SLE, with renal involvement, and who had received RTX for NL refractory to standard treatment. We collected different epidemiological, clinical (including other manifestations of SLE as well as previous treatments), analytical, RTX-related and adverse event variables. In all cases, renal function prior to the initiation of RTX was determined, as well as the degree of proteinuria and sediment alterations. The therapeutic response was evaluated considering partial response if they presented reduction of proteinuria in >50% compared to initial and stabilization of renal function (± 25%) or improvement of serum creatinine with respect to initial values; and complete response if they presented levels of serum creatinine <1.2mg/dL (or decrease to initial values or ± 15% of the basal value in those with creatinine ≥1,2 mg/dL), proteinuria ≤0,5 g/24h and inactive sediment. A quantitative descriptive analysis has been carried out with the statistical program IBM SPSS 24.0 for Windows.Results:Thirteen patients (11 women and 2 men) were included, with a mean age of 32.3 years and a mean follow-up time from the start of RTX of 11.09 years. Class IV NL was the most frequent (46.15%), followed by Class III NL (38.46%). Class V NL represented 7.69% and another 7.69% the combination of Class III+V. Renal failure was present in 46.2% of patients at the beginning of RTX, 84.6% hematuria and all patients presented proteinuria, of which 76.9% were confirmed to have nephrotic range and 84.6% showed hypoalbuminemia. With regard to previous treatments, all cases had received high-dose of GC and at least one immunosuppressant: 92.3% had failed to CF, a similar percentage had received azathioprine and 46.2% had failed to mycophenolate. After treatment with RTX, partial or complete response was achieved in 84.61%, infections were identified in 46.15% of patients and allergic reactions in 15.38%; most adverse events were mild and all cases developed favorably.Conclusion:RTX treatment is effective in SLE and specifically in LN. More than 80% of patients in our study with refractory LN benefited from RTX treatment. Despite the not insignificant incidence of adverse events, most were mild and resolved without sequels or complications, so we can conclude that the safety of RTX is acceptable and should be considered as a treatment option for these patients according to the good risk-benefit profile.Disclosure of Interests:Consuelo Ramos Giráldez: None declared, Maria Luisa Velloso Feijoo: None declared, Sergio Rodríguez Montero: None declared, Jose Luis Marenco Speakers bureau: ABbvie, Pfzer, lilly

scholarly journals Bladder cancer. A retrospective analysis of the use of vinfluvin in real clinical practice

2021 ◽  
Vol 8 (2) ◽  
pp. 34-42
Author(s):  
A. S. Zhabina ◽  
A. I. Novikov ◽  
F. V. Moiseenko ◽  
N. M. Volkov ◽  
E. O. Stepanova ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Adverse Events ◽  
Medical Care ◽  
Urothelial Carcinoma ◽  
Response Duration ◽  
Complete Response ◽  
Metastatic Urothelial Carcinoma ◽  
Real Practice ◽  
Real Clinical Practice

Purpose of the study. There is the generalized analysis of administration of vinflunine in real clinical practice in St.Petersburg Clinical Scientific and Practical Center of Specialized medical Care (oncological).Materials and methods. This analysis gathered 27 patients with urothelial carcinoma treated using this medicine in St.Petersburg Clinical Scientific and Practical Center of Specialized medical Care (oncological). We assessed efficacy, safety profile of vinflunine in this subset of patients.Results. Clinical efficacy of vinflunine (complete response + partial response + stable disease) was 51,86 %, one patient demonstrated complete response. Median of response duration accounts for 3,4 months. Adverse events were observed in 28,4 %, most of them were 1-2 grades. 2 patients stopped therapy due to adverse events.Conclusion. In our analysis vinflunine was more effective than in randomized clinical trial and other studies from real practice in Europe. Thus, confirm expediency to administer of vinflunine for metastatic urothelial carcinoma.

Serum uric acid as a predictor for nephritis in Egyptian patients with systemic lupus erythematosus

Lupus ◽  
2020 ◽  
pp. 096120332097904
Author(s):  
Eman Ahmed Hafez ◽  
Sameh Abd El-mottleb Hassan ◽  
Mohammed Abdel Monem Teama ◽  
Fatma Mohammed Badr
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Renal Function ◽  
Uric Acid ◽  
Lupus Nephritis ◽  
Serum Creatinine ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Systemic Lupus ◽  
Group 2 ◽  
Group 1

Objective Lupus nephritis (LN) is closely associated with hyperuricemia, and uric acid is considered a risk factor for renal involvement in systemic lupus erythematosus (SLE). This study aimed to examine the association between serum uric acid (SUA) level and LN development and progression in SLE patients with normal renal function. Methods A total of 60 SLE patients with normal renal function from Ain Shams University Hospital were selected and assigned to group 1 (30 patients with LN) and group 2 (30 patients without LN). All patients were subjected to history taking, clinical examination, disease activity assessment based on SLE disease activity index (SLEDAI) and renal SLEDAI (SLEDAI-R) scores, and laboratory investigations, including as SUA, complete blood count, blood urea nitrogen (BUN), serum creatinine, creatinine clearance, urine analysis, protein/creatinine ratio, 24-h urinary protein excretion, Antinuclear antibodies (ANA), anti-dsDNA antibody, and serum complement (C3, C4). Results Disease duration, SLEDAI score, and SUA level were higher in group 1 than in group 2 (p < 0.001). SUA level was positively correlated with SLEDAI and SLEDAI-R scores, proteinuria, urinary casts, renal biopsy class, disease activity and chronicity indices, BUN level, and serum creatinine level but was negatively correlated with creatinine clearance (p < 0.05). SUA was a predictor of LN development in SLE patients (sensitivity, 83.3%; specificity, 70%). Conclusion SUA is associated with the development of lupus nephritis in patients with normal kidney function also SUA in-dependently correlated with disease activity and chronicity in LN.

MO661COMPARISON OF CLINICAL EFFICACY OF CENTRIFUGAL-MEMBRANOUS DOUBLE FILTRATION PLASMAPHERESIS AND MEMBRANOUS DOUBLE FILTRATION PLASMAPHERESIS ON SEVERE LUPUS NEPHRITIS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Jianhua Dong ◽  
Li Huang ◽  
Chuan Li ◽  
Ling Kong ◽  
Lixuan Huang ◽  
...  
Keyword(s):  
Lupus Nephritis ◽  
Adverse Events ◽  
Blood Cell ◽  
Serum Creatinine ◽  
Clinical Efficacy ◽  
Vascular Access ◽  
Double Filtration Plasmapheresis ◽  
Severe Lupus Nephritis ◽  
Double Filtration

Abstract Background and Aims The Study delves into the clinical efficacy and advantages of centrifugal double filtration plasmapheresis on severe lupus nephritis (LN) by comparing it with membranous double filtration plasmapheresis (DFPP). Method A retrospective analysis was performed on 56 patients who were diagnosed with severe LN and had received DFPP treatment from May 2016 and January 2020. Of them, 38 were given centrifugal DFPP and had their plasma centrifuged in a blood cell separator, and 18 were given membranous DFPP and had their plasma centrifuged in an MPS07 plasma separator. An EC20W plasma component separator was used as the secondary filter to reprocess the separated plasma of all of them. The two DFPPs were compared for differences in clinical efficacy, vascular access, dosage of anticoagulant, treatment cost and adverse events in patients with severe LN. Results Of the 56 severe LN patients (including 43 females and 13 males), the median of age of onset was 29 years old, the SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) was 18.6±6.0 points and the serum creatinine was 402(294,553) umol/L, and all patients had acute kidney injury and 51 of them (91.1%) required renal replacement therapy (RRT). A total of 142 DFPPs were performed, including 97 centrifugal DFPPs and 45 membranous DFPPs. After treatment and at Month 3 of follow-up visit, patients in both the centrifugal DFPP group and the membranous DFPP group had ANA, AdsDNA titer, quantitative urinary protein, urinary red blood cell count and serum creatinine significantly dropped and hemoglobin significantly increased over those before treatment, the differences in which between the two groups, however, were not statistically significant. The centrifugal DFPP group had a more significant drop in complements C3 and C4 after treatment. Comparison of the data before and after a single DFPP treatment showed that the membranous DFPP group had a more significantly longer prothrombin time, but there were no differences in partial prothrombin time, fibrinogen and platelet change between the two groups. At Month 3 of follow-up visit, 31 of the 51 RRT patients (60.8%) (including 34 given centrifugal DFPP and 17 given membranous DFPP) were released from dialysis, including 23 given centrifugal DFPP and 8 given membranous DFPP. In the membranous DFPP group, all patients had the vascular access built via the central venous catheter, while in the centrifugal DFPP group, 6 patients (15.8%) had the vascular access built by puncturing into the artery or vein. The dosage of the anticoagulant, the low molecular weight heparin, to the centrifugal DFPP group was significantly lower than that to the membranous DFPP group (1174±243 vs 4106±399IU, P&lt;0.001), and in the centrifugal DFPP group, 29 patients (76.3%) were given 4% citric acid alone for anti-coagulation. No blood coagulation occurred. In terms of treatment consumables, the membranous DFPP group had a significantly higher cost than the centrifugal DFPP group (RMB4340.2±237.0 vs 5677.0±0.0, P&lt;0.001). Two patients (4.4%) in the membranous DFPP group developed skin ectasis, epistaxis or aggravated alveolar hemorrhage after treatment, and four patients (4.1%) in the centrifugal DFPP group developed perioral numbness, numbness in distal extremities or tetany during treatment, which was alleviated after calcium supplementation. Conclusion Centrifugal DFPP differed little from membranous DFPP in clinical efficacy in severe LN patients, but had lower anti-coagulation requirements, cost less on treatment consumables, and caused no severe adverse events, so it can be used as an important means to treat severe LN.

scholarly journals Effect of Renamezin upon attenuation of renal function decline in pre-dialysis chronic kidney disease patients: 24-week prospective observational cohort study

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252186
Author(s):  
Hayne Cho Park ◽  
AJin Cho ◽  
Do Hyoung Kim ◽  
Kyu-sang Yun ◽  
Juhee Kim ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Renal Function ◽  
Cohort Study ◽  
Kidney Disease ◽  
Adverse Events ◽  
Serum Creatinine ◽  
Observational Cohort Study ◽  
Prospective Observational Cohort Study ◽  
Renal Function Decline ◽  
Observational Cohort

Renamezin® is a modified capsule-type oral spherical adsorptive carbon which lowers indoxyl sulfate levels in patients with advanced chronic kidney disease (CKD). This 24-week prospective observational cohort study was performed to evaluate the effect of Renamezin® upon attenuation of renal function decline. A total of 1,149 adult patients with baseline serum creatinine 2.0–5.0 mg/dL were enrolled from 22 tertiary hospital in Korea from April 2016 to September 2018. Among them, a total of 686 patients completed the study and were included in the intention-to-treat analysis. A total of 1,061 patients were included in the safety analysis. The mean age was 63.5 years and male patients were predominant (63.6%). Most of the patients (76.8%) demonstrated high compliance with study drug (6g per day). After 24 week of treatment, serum creatinine was increased from 2.86±0.72 mg/dL to 3.06±1.15 mg/dL (p<0.001), but estimated glomerular filtration rate was not changed significantly during observation period (22.3±6.8 mL/min/1.73m2 to 22.1±9.1 mL/min/1.73m2, p = 0.243). Patients with age over 65 years old and those under good systolic blood pressure control <130 mmHg were most likely to get benefit from Renamezin® treatment to preserve renal function. A total of 98 (9.2%) patients out of 1,061 safety population experienced 134 adverse events, of which gastrointestinal disorders were the most common. There were no serious treatment-related adverse events. Renamezin® can be used safely to attenuate renal function decline in moderately advanced CKD patients.

scholarly journals P0657CHANGES IN CREATININE MAY NO REFLECT MEASURED RENAL FUNCTION CHANGES IN PREDIALYSIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Escamilla Cabrera Beatriz ◽  
Nuria Victoria Sánchez Dorta ◽  
Natalia Negrã­n Mena ◽  
Sergio Luis-Lima ◽  
Federico Gonzalez Rinne ◽  
...  
Keyword(s):  
Renal Function ◽  
Clinical Practice ◽  
Nutritional Status ◽  
Serum Creatinine ◽  
Outpatient Clinic ◽  
Intestinal Secretion ◽  
Repeated Measurement ◽  
Clinical Evolution ◽  
Measured Gfr

Abstract Background and Aims Serum creatinine is the most used biomarker of renal function in clinical practice. However, the correlation between creatinine and measured GFR is poor with a variability as wide as 200%. The causes of this phenomena are not clear. Some studies observed tubular handling (reabsorption and secretion) as well as intestinal secretion of creatinine, and depends of nutritional status . Importantly, these changes increased with the loss of renal function, masking changes in the evolution of real renal function. However, scarce evidence is available about the reliability of creatinine in reflecting the changes of renal function over the time in predialysis patients, compared to measured GFR. This information is relevant in the setting of clinical decisions. Method Spanish unicenter study developed at the Hospital Universitario de Canarias (Tenerife). In the pre-dialysis outpatient clinic, subjects are followed with measured GFR (clearance of iohexol by DBS). Measured GFR is performed at baseline and repeated as suggested by the clinical evolution. For this study we included all patients with repeated determinations of creatinine and measured GFR. The changes of creatinine in terms of increase (&gt;10%), decrease (&lt;10%) and stability (±10%) were compared with the changes in measured GFR. Results 89 cases with repeated measurement of GFR and creatinine were evaluated. In 61 cases (68.53%) discrepancies between changes in creatinine and measured GFR were evident. Graphic 1 shows differents discordancing cases with 39 cases (43.8%) overestimation, 7 (7.8%) of infraestimation and 15 cases (24.7%) not change of mGFR with changes on Cr. Conclusion Changes in creatinine do not reflect real changes in real renal function in about 70% of the cases. Whenever possible, the measurement of GFR by whichever method available should be considered in the renal care and follow-up of these patients.

Assessment of possible nephrotoxicity from iohexol in patients with normal and impaired renal function

1998 ◽  
Vol 39 (4) ◽  
pp. 362-367 ◽  
Author(s):  
S. Lundqvist ◽  
G. Holmberg ◽  
G. Jakobsson ◽  
F. Lithner ◽  
K. Skinningsrud ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Renal Function ◽  
Adverse Events ◽  
Serum Creatinine ◽  
Creatinine Clearance ◽  
Impaired Renal Function ◽  
Urine Protein ◽  
Urine Protein Excretion ◽  
Protein Excretion ◽  
Patients With Diabetes

Purpose: To evaluate the possible nephrotoxic effects of iohexol in patients with normal and impaired renal function. Material and Methods: A prospective urographic study using iohexol (50 ml, 300 mg I/ml) was performed in 100 patients, 63 with impaired renal function (IRF) and 37 with normal renal function (NRF). The group included 24 patients with diabetes mellitus, 17 of them with IRF. Renal function parameters and adverse events were recorded for one week after the urography. Results: There were no significant changes in serum creatinine, creatinine clearance, or β-2-microglobulin. The 24-h urine protein excretion showed a statistically significant increase in patients with NRF as well as in patients with IRF. Nine patients experienced adverse events but none of them required any treatment. Conclusion: Iohexol was tolerated well in patients with NRF and in patients with IRF without significant overall nephrotoxic effects. Some minor adverse events were recorded.

scholarly journals Explanatory histological findings for urinary protein and serum creatinine levels at renal biopsy in lupus nephritis: A cross-sectional study

2020 ◽  
Author(s):  
Eri Katsuyama ◽  
Yoshia Miyawaki ◽  
Ken-ei Sada ◽  
Yosuke Asano ◽  
Keigo Hayashi ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Lupus Nephritis ◽  
Serum Creatinine ◽  
Renal Biopsy ◽  
Multiple Regression Analysis ◽  
Multiple Regression ◽  
Urinary Protein ◽  
Fibrinoid Necrosis ◽  
Class Iii ◽  
The Mean

Abstract Background To evaluate histological active and chronic lesions associated with proteinuria and serum creatinine (SCr) level as common clinical endpoints in many clinical trials for lupus nephritis (LN). Methods One hundred and nineteen patients from 1990 to 2015 with LN class III, IV, and V, as defined by the International Society of Nephrology/Renal Pathology Society classification, were enrolled. Multiple regression analysis was performed to explore semiquantitative histological variables related to urinary protein and SCr levels. Results The mean age of enrolled patients was 45 years and 79% were female. The mean SCr level was 0.87 mg/dl and mean urinary protein was 3.00 g/gCr at the time of the renal biopsy. Class IV (71%) was the most common type, followed by class III (17%) and class V (13%). Multicollinearity was confirmed between monocellular infiltration (variance inflation factor [VIF] = 10.22) and interstitial fibrosis (VIF = 10.29) and between karyorrhexis (VIF = 4.14) and fibrinoid necrosis (VIF = 4.29). After excluding fibrinoid necrosis and monocellular infiltration because of multicollinearity, only urinary protein level was correlated with wire loop (β−coefficient [β]: 1.09 and confidence interval [CI]: 0.35 to 1.83), and SCr level was correlated with glomerular sclerosis (β: 1.08 and CI: 0.43 to 1.74) by multiple regression analysis. Conclusion As urinary protein and SCr levels could not reflect active lesions quantitatively, they might be difficult to be evaluated for response to induction remission treatments in patients with LN.

scholarly journals Effectiveness of inhaled corticosteroids and long-acting β-agonists combinations in real clinical practice: results of a multicenter cross-sectional study in Russian patients with asthma

2021 ◽  
Vol 31 (5) ◽  
pp. 613-626
Author(s):  
Vladimir V. Arkhipov ◽  
Zaurbek R. Aisanov ◽  
Sergey N. Avdeev
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Asthma Control ◽  
Inhalation Technique ◽  
Adherence To Treatment ◽  
Uncontrolled Asthma ◽  
Cross Sectional ◽  
Long Acting ◽  
Adherence To Therapy ◽  
Real Clinical Practice

Asthma management approaches are improving yearly, but the problem of asthma control is still acute. Combinations of inhaled glucocorticosteroids (ICS) and long-acting β2-agonists (LABA) play a crucial role in asthma therapy, but their effectiveness in real practice can be insufficient, and asthma control level in the population remains low. Optimizing the use of these drugs, changing the usual therapy regimens, and implementing upgraded inhalers can improve adherence to treatment and inhalation technique, which affects the effectiveness of the therapy.The study aimed to describe the key characteristics of the patient population getting asthma treatment in real clinical practice and assess factors influencing asthma control, including adherence to therapy.Methods. A single-stage cross-sectional observational study in 124 primary health care centers in 22 cities of the Russian Federation included 3,214 patients > 18 years old, with a clinical diagnosis of asthma for at least 1 year, who were able to perform a spirometry test and fill out the ACQ-5 and TAI-12 questionnaires.Results. Assessment of asthma control with the ACQ-5 questionnaire showed that most patients had uncontrolled asthma (56%). Controlled and partially controlled asthma was diagnosed in 21 and 19% of patients, respectively. 4% of patients had severe uncontrolled asthma. The TAI questionnaire revealed low adherence to therapy in more than half of the patients (53.6%). The rate of patients with controlled asthma and the average annual frequency of exacerbations were significantly lower in subgroups of patients who received therapy with extrafine ICS/LABA and ICS/formoterol in single inhaler regimen, compared with controller therapy using fixed and free combinations of ICS and LABA.Conclusion. The main causes of insufficient asthma control are low adherence to treatment, inhalation errors, monotherapy with ICS, asthma with small airways dysfunction, and adverse events associated with ICS. Prescribing the combinations of ICS/LABA in the form of extra-fine aerosol and using it in the Maintenance and Reliever Therapy (MART) regimen can significantly increase asthma control, reduce the risk of adverse events, and increase patient adherence to treatment. A potential alternative to improve asthma control is administering ICS-LABA combinations once daily.

scholarly journals Mycophenolate Mofetil Therapy in Lupus Nephritis

1999 ◽  
Vol 10 (4) ◽  
pp. 833-839
Author(s):  
MARY ANNE DOOLEY ◽  
FERNANDO G. COSIO ◽  
PATRICK H. NACHMAN ◽  
MICHAEL E. FALKENHAIN ◽  
SUSAN L. HOGAN ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Mycophenolate Mofetil ◽  
Lupus Nephritis ◽  
Adverse Events ◽  
Serum Creatinine ◽  
Lupus Erythematosus ◽  
Transplant Rejection ◽  
Initial Therapy ◽  
Controlled Clinical Trials ◽  
The Mean

Abstract. Controlled clinical trials in renal transplantation have demonstrated that mycophenolate mofetil is well tolerated and has lower renal transplant rejection rates than azathioprine regimens. This study reports on the clinical experiences at two institutions with mycophenolate mofetil (MMF) for severe lupus nephritis. Twelve patients with relapsing or resistant nephritis previously treated with cyclophosphamide therapy and one patient who refused cyclophosphamide as initial therapy for diffuse proliferative nephritis but accepted MMF were included. During combined MMF/prednisone therapy, serum creatinine values remained normal or declined from elevated values: mean change in serum creatinine was -0.26 ± 0.46 μM/L, P = 0.039. Proteinuria significantly decreased: mean change in urine protein-to-creatinine ratios was -2.53 ± 3.76, P = 0.039. Decreased serum complement component C3 and elevated anti-double-stranded DNA antibody levels at baseline improved in some, but not all, patients. The mean initial dose of MMF was 0.92 g/d (range, 0.5 to 2 g/d). The mean duration of therapy was 12.9 mo (range, 3 to 24 mo). Adverse events included herpes simplex stomatitis associated with severe leukopenia (n = 1), asymptomatic leukopenia (n = 2), nausea/diarrhea (n = 2), thinning of scalp hair (n = 1), pancreatitis (n = 1), and pneumonia without leukopenia (n = 1). Recurrence of the pancreatitis led to discontinuation of MMF in this patient; all other adverse events resolved with dose reduction. It is concluded that MMF is well tolerated and has possible efficacy in controlling major renal manifestations of systemic lupus erythematosus. Controlled clinical trials are needed to define the role of MMF in the management of lupus nephritis.

Sign in / Sign up

Export Citation Format

Share Document