- |||||||||| Tavneos (avacopan) / Amgen
Review, Journal: Evaluating Avacopan in the Treatment of ANCA-Associated Vasculitis: Design, Development and Positioning of Therapy. (Pubmed Central) - Jan 13, 2025
Combining preclinical studies, clinical trials, and real-world evidence helps to provide a better position of avacopan for the management of AAV in routine clinical practice, taking advantage of the GC-sparing effects of avacopan as a possible solution for the current challenge of reducing GC-toxicity in AAV patients. Furthermore, we delineate current knowledge gaps and future research areas that need to be addressed.
- |||||||||| Tavneos (avacopan) / Amgen
Review, Journal: Complement as a major mediator of ANCA vasculitis and a target for precision therapy. (Pubmed Central) - Jan 3, 2025
While complement activation is undoubtedly involved in ANCA vasculitis pathogenesis, less clear is whether measuring complement activation markers can reliably assess disease activity, predict those who will benefit from complement-targeting therapy, or identify patients in stable remission and able to stop therapy. Better understanding the clinical implications of complement activation will shed more light on the utility of complement inhibition and facilitate precision medicine in ANCA vasculitis.
- |||||||||| Review, Journal: Update on treatment of ANCA-associated vasculitis (Pubmed Central) - Dec 3, 2024
Better understanding the clinical implications of complement activation will shed more light on the utility of complement inhibition and facilitate precision medicine in ANCA vasculitis. Rituximab (RTX) is used for remission induction and maintenance in organ-threatening and non-organ-threatening granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)...The dosing of GC for remission induction in GPA and MPA is now lower than was previously used and additionally, avacopan is approved as a
- |||||||||| Tavneos (avacopan) / Amgen
Journal: C5aR expression in kidney tubules, macrophages and fibrosis. (Pubmed Central) - Nov 28, 2024
C5a activity was C5aR dependent, as demonstrated by reversal with the C5aR inhibitor avacopan. Collectively, these results suggest that myeloid C5aR may induce excessive inflammation in the kidney via immune cell recruitment, extracellular matrix destruction, and remodeling, resulting in fibrotic tissue deposition.
- |||||||||| Tavneos (avacopan) / Amgen
Review, Journal: Role of Avacopan on Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis. (Pubmed Central) - Nov 27, 2024
Avacopan, a novel C5a receptor inhibitor, represents a promising therapeutic option for vasculitis with renal involvement. This article provides a comprehensive review of the role of complement in the pathogenesis of vasculitis with renal involvement and the role of avacopan for its treatment, taking into account recent updates to both the EULAR and KDIGO guidelines and published experience of avacopan use in real clinical settings.
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Treatment of ANCA-Associated Glomerulonephritis in a Patient with Bacteremia and Vertebral Osteomyelitis: A Challenging Clinical Dilemma () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5325;
Despite treatment with Rituximab and high-dose corticosteroids, he developed Enterobacter Cloacae bacteremia and vertebral osteomyelitis...The treatment of ANCA-associated small vessel vasculitis and glomerulonephritis primarily involves high-dose corticosteroids and cyclophosphamide...Lower dose steroid regimens and new agents like Avacopan may offer safer alternatives without compromising efficacy...7/30/20237/29/20236/12/2023Na134135138K4.24.44.3Cl10099105CO2222224Anion Gap12149BUN545636Creatinine6.155.911.62eGFR9944Calcium8.48.18.5Phosphorus 4.94.5. .
- |||||||||| Tavneos (avacopan) / Amgen
Avacopan as Adjuvant Therapy for ANCA-Associated Vasculitis: A Case Report () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5319;
Standard treatment for ANCA vasculitis often includes high-dose steroids, rituximab, or cyclophosphamide...The patient received 60 mg prednisone and 1 g Rituximab...Despite the lack of case reports on avacopan as adjuvant therapy for partial responders to standard ANCA vasculitis treatment, our patient's positive outcome highlights its potential benefit. To date, the patient's kidney function remains stable, emphasizing avacopan's role in vasculitis management.
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Decoding the Kidney Conundrum: Dive into the Glomerulonephritis Mystery! () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5310;
Immune complex deposition in ANCA-associated vasculitis (AAV) GN is atypical, as AAV is typically "pauci-immune." Recent studies classify AAV/GN into "pauci-immune" (PI) and "immune complex" (IC) groups, with IC deposits potentially exacerbating ANCA effects and role of complement activation causing worsened proteinuria. Early recognition is crucial for preserving renal function, with rituximab and avacopan showing promise in treatment..
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Granulomatosis with Polyangiitis: Role of Nephrologist in Management of a Rare Systemic Disease () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5266;
Early recognition is crucial for preserving renal function, with rituximab and avacopan showing promise in treatment.. She received another cycle of pulse-dose steroids and two doses of cyclophosphamide, with improvement in eye and nasal symptoms...Continued immunosuppression with rituximab for 18
- |||||||||| Tavneos (avacopan) / Amgen
Avacopan beyond the 52-Week Treatment Course (Room 6D, Convention Center) - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4829;
Rituximab was used alongside AVP for remission maintenance in majority of patients. Infection complications were the most observed adverse effects.
- |||||||||| Tavneos (avacopan) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date: A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD) (clinicaltrials.gov) - Oct 3, 2024
P1, N=13, Active, not recruiting,
The primary end point for the study was not met; other clinical effects of avacopan to improve certain key kidney function parameters and slow disease progression were variable and require further evaluation. Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Oct 2024 | Trial primary completion date: Jan 2025 --> Oct 2024
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Journal: Crinkle-Cut Coronary Arteries in a Patient With Granulomatosis With Polyangiitis. (Pubmed Central) - Oct 3, 2024
Cardiac involvement in GPA is often subclinical and if clinically significant has been rarely reported, even less so as an initial presentation. We describe the case of a 44-year-old man who presented with what appeared to be inferior ST-segment elevation myocardial infarction and was found to have small vessel vasculitis of the coronary arteries with associated myocarditis as a presenting manifestation of GPA, which was ultimately treated with steroids, rituximab, and avacopan.
- |||||||||| Tavneos (avacopan) / Amgen
Journal, Real-world evidence, Real-world: The real-world use and effectiveness of avacopan in routine practice for the treatment of ANCA vasculitis. First experiences in Spain. (Pubmed Central) - Oct 3, 2024
We describe the case of a 44-year-old man who presented with what appeared to be inferior ST-segment elevation myocardial infarction and was found to have small vessel vasculitis of the coronary arteries with associated myocarditis as a presenting manifestation of GPA, which was ultimately treated with steroids, rituximab, and avacopan. The combination of avacopan in clinical practice presents a good safety profile and provides added value by contributing to the control of AAV activity, increase GFR, and removal of steroids.
- |||||||||| Tavneos (avacopan) / Amgen
From Lice to the Heart and Kidneys (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4261;
Here we present a case of Bartonella-associated dual-positive myeloperoxidase (MPO) and PR3 renal-limited ANCA vasculitisCase Description: A 55-year-old male with a history of stage 3 chronic kidney disease, heart failure with preserved ejection fraction (HFpEF), severe mitral regurgitation (MR), Hepatitis B on entecavir, and Hepatitis C presented with shortness of breath, lower extremity edema, and abdominal distention...Tissue confirmed Bartonella endocarditis and he was started on doxycycline and rifampin...Treatment with immunosuppression began within days of starting antimicrobial therapy and resulted in early signs of renal recovery nearing discharge. Early initiation of Avacopan therapy (post completion of rifampin to avoid its inducing effects) can be utilized to expedite a prednisone taper in patients with underlying infectious complications or need for adequate wound-healing 10x magnification of PAS stain showing diffuse cellular crescents
- |||||||||| Tavneos (avacopan) / Amgen
Case Series of Avacopan in Dual-Positive Anti-glomerular Basement Membrane (GBM) and ANCA Disease (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4257;
Treatment include steroids, plasma exchange(PLEX) & cyclophosphamide(CYC)...She was treated with CYC, rituximab & PLEX...One patient was managed without steroids, a rare approach in the management of anti-GBM disease & all maintained independent renal function. We suggest Avacopan should be considered in the management of patients with dual positive antibodies
- |||||||||| Tavneos (avacopan) / Amgen
Use of Avacopan outside the ADVOCATE Inclusion Criteria (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4227;
This small case series demonstrate successful use of Avacopan outside ADVOCATE inclusion criteria. Further real-life data is likely to support use of Avacopan for a wider and more severe presentations of AAV.
- |||||||||| Tavneos (avacopan) / Amgen
Characteristics and Treatment Patterns before Initiation of Avacopan in the United States (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4225;
Among initial users of avacopan in the US, most had kidney (including ESKD and dialysis) and pulmonary involvement, and used GCs in the year before starting avacopan. Future studies will assess outcomes following treatment with avacopan in a real-world setting.
- |||||||||| Tavneos (avacopan) / Amgen
Antineutrophil Cytoplasmic Autoantibody Levels in Patients in the Avacopan Phase 3 Trial (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4223;
The addition of avacopan to RTX or CYC for treatment of GPA or MPA does not appear to impact ANCA levels. The lack of correlation between ANCA levels and outcome of treatment in the ADVOCATE trial suggests that ANCA levels are an unreliable marker of treatment response.
- |||||||||| Tavneos (avacopan) / Amgen
Baseline Characteristics of the First Patients in AvacoStar, a Real-World Study of Avacopan in ANCA-Associated Vasculitis (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4222;
P
Funding: Commercial Support - Vifor Fresenius Medical Care Renal Pharma AG Background: Avacopan, an oral, selective C5a receptor antagonist, was approved by the EMA in January 2022 for the treatment of adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), in combination with rituximab or cyclophosphamide. AvacoStar baseline characteristics are currently similar between groups and consistent with clinical practice, suggesting study outcomes may yield generalizable insights on safety and use patterns of avacopan.
- |||||||||| Tavneos (avacopan) / Amgen
General, Nervous System, Eye, and Skin Involvement in the Phase 3 Trial of Avacopan for the Treatment of ANCA-Associated Vasculitis (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4221;
AvacoStar baseline characteristics are currently similar between groups and consistent with clinical practice, suggesting study outcomes may yield generalizable insights on safety and use patterns of avacopan. In the ADVOCATE trial, treatment with either avacopan or a prednisone taper was associated with the reversal of nearly all active general, nervous system, mucous membranes/eyes, and skin manifestations of GPA or MPA.
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Two Cases of Recurrence Immediately after Living Donor Kidney Transplantation for ANCA-Associated Vasculitis (AAV) (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1810;
After administration of avacopan, creatinine remained at 1.5-1.7 mg/dl.[Case 2] A 23-year-old woman diagnosed with AAV 18 months ago, was treated with steroid pulse therapy and rituximab, but kidney biopsy showed devastated glomeruli and fibrous crescents, and hemodialysis was introduced...She was diagnosed to have recurrent AAV and was treated with steroid pulse, plasma exchange, cyclophosphamide pulse, and abacopan...Among cases presenting with RPGN, relapse is reported to be more common in ANCA-positive cases than in non-positive cases. The fact that AAV recurred immediately after administration of rituximab, also used in KT, suggests that the MPO-ANCA-producing cells may have already changed from B cells to plasma cells.
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
Triad of Troubles: Rare Confluence of Three Glomerular Diseases (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1745;
Treatment of multiple co-existing glomerulopathies is not well described, and our medical decision making was to attempt to apply occam's razor to treatment, using a single treatment strategy that would treat all the co-existing glomerulopathies. This case demonstrates a wide range of medical decision making, highlighting its educational merit.
- |||||||||| Tavneos (avacopan) / Amgen, Rituxan (rituximab) / Roche
A Case of Membranous Nephropathy Secondary to ANCA-Associated Vasculitis (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1730;
Avacopan in combination with rituximab and early dose reduction of prednisolone resulted in resolution of P-ANCA, improvement of renal dysfunction, and resolution of proteinuria in this patient. Steroid-sparing therapy with avacopan and rituximab may be effective in secondary MN due to ANCA.
- |||||||||| TPOXX (tecovirimat) / SIGA Technologies
Journal: Supervised screening of Tecovirimat-like compounds as potential inhibitors for the monkeypox virus E8L protein. (Pubmed Central) - Sep 12, 2024
As a result, we have shortlisted five drugs named ABX-1431, Alflutinib, Avacopan, Caspitant, and Darapalib that effectively engage the MPXV surface binding protein. Furthermore, the affinity of the proposed drugs is relatively higher than the Tecovirimat by having higher docking scores, establishing more hydrogen and hydrophobic bonds, engaging key residues in the target's structure, and exhibiting stable molecular dynamics.Communicated by Ramaswamy H. Sarma.
- |||||||||| Tavneos (avacopan) / Amgen
Journal: A case of rapid avacopan-induced liver injury in pediatric granulomatosis with polyangiitis. (Pubmed Central) - Aug 27, 2024
Discontinuation of rituximab and avacopan resulted in improved liver function; no change in the Birmingham Vasculitis Activity Score during liver function test abnormalities was observed. Avacopan-associated abnormalities in liver function tests suggest that drug-induced liver injury may occur rapidly in children, and appropriate dosing strategies should be reconsidered.
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