Voclosporin (lupus nephritis) ' Benefit assessment according to '35a Social Code Book V 1 Translation of Sections I 1 to I 6 of the dossier assessment Voclosporin (Lupusnephritis) – Nutzenbewertung gemäß § 35a SGB V. Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Voclosporin (lupus nephritis) Benefit assessment according to §35a SGB V1 EXTRACT Project: A23-16 Version: 1.0 Status: 30 May 2023 Extract of dossier assessment A23-16 Version 1.0 Voclosporin ( lupus nephritis) 30 May 2023 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Voclosporin (lupus
Belimumab (Benlysta) in lupus nephritis Register online | Log in | My PrescrireISSUE CONTENTSTOPICSABOUT PRESCRIREOFFERSenglish.prescrire.org > Spotlight > 100 most recent > Belimumab (Benlysta°) in lupus nephritisSpotlightEvery month, the subjects in Prescrire’s Spotlight.100 most recent : 1 | 10 | 20 | 30 | 40 | 50 | 60 | 70 | 80 | 90Spotlight100 most recentArchivesBelimumab (Benlysta °) in lupus nephritis Marketing Authorisations Belimumab, a monoclonal antibody directed against a protein called BLyS (B lymphocyte stimulator), was initially authorised in the European Union for subcutaneous or intravenous use in systemic lupus erythematosus. It has now also been authorised for use in active lupus nephritis.Its evaluation in this situation is based on a single double-blind randomised
Advice - Reimburse voclosporin (Lupkynis) for the treatment of rare kidney inflammation (lupus nephritis) Go to contentYou are here:HomePublicationsAdvice - Reimburse voclosporin (Lupkynis®) for the treatment of rare kidney inflammation (lupus nephritis)Search within English part of National Health Care InstituteOpen search boxAdvice - Reimburse voclosporin (Lupkynis®) for the treatment of rare kidney inflammation (lupus nephritis)The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse voclosporin (Lupkynis®) from the basic health care package. This medicinal product can be used in certain patients with rare kidney inflammation. If the Minister adopts our advice, voclosporin will be entered into the Medicine Reimbursement System (GVS). Only
Voclosporin (Lupkynis) - lupus nephritis 1 Published 09 October 2023 1 SMC2570 voclosporin soft capsule (Lupkynis®) Otsuka Pharmaceutical (UK) Ltd 08 September 2023 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission voclosporin (Lupkynis®) is accepted for use within NHSScotland. Indication under review: in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis. Addition of voclosporin to mycophenolate mofetil significantly
Voclosporin (Lupkynis) - To treat lupus nephritis Drug Approval Package: LUPKYNIS * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products
Belimumab (Benlysta) - lupus nephritis Published 11 April 2022 4 March 2022 ADVICE: in the absence of a submission from the holder of the marketing authorisation belimumab (Benlysta®) is not recommended for use within NHSScotland. Indication under review: In combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. The holder
Acute tubulointerstitial nephritis (ATIN) including drug-induced, tubulointerstitial nephritis and uveitis (TINU), ANCA-associated vasculitis (AAV), kidney- limited sarcoidosis, and hemolysis: a case series from Syria. This study aimed to detail acute tubulointerstitial nephritis (ATIN) patients, from relevant clinical manifestations to outcomes. We reviewed ATIN patients between 2018 and 2022 , and thrombocytopenia. Also, mesalamine and allopurinol induced gradual kidney failure a few months after the drug initiation. A patient with Tubulointerstitial nephritis and uveitis (TINU) syndrome showed refractory uveitis presenting during glucocorticoids (GCs) tapering, which resolved quickly with azathioprine (AZA) when not responding to GCs reescalation. Among the rarest cases, ATIN induced by a kidney-limited
Identification and validation of key autophagy-related genes in lupus nephritis by bioinformatics and machine learning. Lupus nephritis (LN) is one of the most frequent and serious organic manifestations of systemic lupus erythematosus (SLE). Autophagy, a new form of programmed cell death, has been implicated in a variety of renal diseases, but the relationship between autophagy and LN remains
Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. Obinutuzumab, a humanized type II anti-CD20 monoclonal antibody, provided significantly better renal responses than placebo in a phase 2 trial involving patients with lupus nephritis receiving standard therapy. In a phase 3, randomized, controlled trial, we assigned adults with biopsy-proven active lupus nephritis in a 1:1 ratio . Among adults with active lupus nephritis, obinutuzumab plus standard therapy was more efficacious than standard therapy alone in providing a complete renal response. (Funded by F. Hoffmann-La Roche; REGENCY ClinicalTrials.gov number, NCT04221477.).
2019 Update of the Joint European League Against Rheumatism and European Renal Association - European Dialysis and Transplant Association (EULAR/ER-EDTA) recommendations for the management of lupus nephritis 2019 Update of the Joint European League Against Rheumatism and European Renal Association–European Dialysis and Transplant Association (EULAR/ERA–EDTA) recommendations for the management of lupus nephritis ================================================================================================================================================================================================================== * Antonis Fanouriakis * Myrto Kostopoulou * Kim Cheema * Hans-Joachim Anders * Martin Aringer * Ingeborg Bajema * John Boletis * Eleni Frangou * Frederic A Houssiau * Jane
1.25(OH)2D3 decreases PCNA and mTOR expression and alleviates renal injury in Thy-1 nephritis rat model. This study investigated the role and mechanisms of 1.25(OH)2D3 in proliferative glomerulonephritis and its effect on the regulation of mesangial cells. Sixty male SD rats were randomly divided into four groups: control (CG), nephritis (NG), nephritis + 1.25(OH)2D3(NVG), and nephritis + 1.25
Mycophenolic acid trough level assessment in patients with lupus nephritis; does it make a difference? Mycophenolate Mofetil (MMF) has become one of the cornerstone treatments of lupus nephritis (LN). It is converted into mycophenolic acid (MPA), an active metabolite, that displays high inter- and intra-individual pharmacokinetic variability. However, the routine monitoring of MPA trough level
The association between fractalkine/CX3CR1 axis with IgA vasculitis and nephritis. The study investigated whether the fractalkine/CX3CR1 axis is associated with the presence and severity of IgA vasculitis (IgAV) and IgA vasculitis nephritis (IgAVN) in children. We included 59 children with IgAV, 42 children with IgAVN (including 18 children with kidney biopsy), 26 plasma controls and 8 kidney
Three years is the minimal effective duration of sustained clinical remission which prevents impaired kidney function and damage accrual in lupus nephritis. To assess the minimum effective duration of remission preventing damage accrual (Systemic Lupus International Collaborating Clinics damage index [SDI]) and impaired kidney function (IKF: estimated glomerular filtration rate of <60 mL/min /1.73 m for at least 3 months) in active lupus nephritis (LN). Patients with biopsy-proven LN followed up at least twice yearly were enrolled; clinical variables were collected regularly. Sustained clinical remission (sCR) was defined as estimated glomerular filtration rate of >60 mL/min/1.73 m, proteinuria of <0.5 g/24 h and clinical systemic lupus erythematosus disease activity index of 0
Mizoribine or Cyclophosphamide for Lupus Nephritis: A Randomized Clinical Trial. Lupus nephritis is typically treated with intravenous cyclophosphamide, which is associated with serious adverse effects. Oral mizoribine may be an alternative for induction therapy of lupus nephritis. However, large-scale, long-term, randomized clinical studies of mizoribine are lacking. To assess the efficacy and safety of oral mizoribine vs intravenous cyclophosphamide as induction therapy for Chinese patients with lupus nephritis. This prospective, multicenter, parallel-group, open-label, phase 3 randomized clinical trial recruited patients with class III, III+V, IV, IV+V, or V lupus nephritis aged 18 to 70 years from 40 centers in China. Inclusion criteria included 24-hour urinary protein level of 1.0 g
Panax notoginseng saponins in Steroid-Resistant Lupus Nephritis by Inhibiting Macrophage-Derived Exosome-Induced Injury in Glomerular Endothelial Cells via the Mitochondrial Autophagy-NLRP3 Pathway. Microangiopathy represents a critical pathological characteristic of lupus nephritis (LN), with steroid resistance (SR) frequently observed among patients. Panax notoginseng saponins (PNS) has demonstrated potential in mitigating P-glycoprotein (P-gp)-mediated SR and attenuating inflammatory damage in glomerular endothelial cells (GECs) through exosomal pathways, although the precise mechanisms underlying these effects have yet to be fully elucidated. This research examines the impact of PNS on microangiopathy in steroid-resistant lupus nephritis (SR LN) and explores its involvement
(68)Ga-FAPI-04 PET/CT Imaging for Assessing Renal Tubulointerstitial Fibrosis in Lupus Nephritis. The objective of this study was to evaluate the feasibility of using Ga-labeled fibroblast activation protein inhibitor-04 (Ga-FAPI-04) PET/CT imaging as a molecular tracer and noninvasive tool for assessing active renal tubulointerstitial fibrosis in patients with lupus nephritis (LN). The study