- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Future directions of maintenance therapy in ANCA-associated vasculitis. (Pubmed Central) - Feb 24, 2023
The efficacy and safety of avacopan in Japanese patients with MPA or GPA were comparable to that observed in the overall ADVOCATE study population. No abstract available
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Arylboration for the synthesis of borylated N-heterocycles (Hall F-H (Indiana Convention Center)) - Feb 14, 2023 - Abstract #ACSSp2023ACS_SP_7630;
Additionally, the arylboration of endocyclic enecarbamates for the synthesis of borylated saturated N-heterocycles is disclosed. Both Cu/Pd and Ni-catalyzed arylboration reactions were developed to access borylated aza-cycles of ring sizes 4-7 that could be elaborated to biologically active compounds, such as an hNK1 antagonist and FDA-approved Avacopan.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Journal: Avacopan for the treatment of ANCA-associated vasculitis: an update. (Pubmed Central) - Dec 23, 2022
Based on the results of these studies, avacopan was approved in most countries since late 2021, as an adjunctive induction treatment for patients with AAV. Several newer questions now are pending answers, including as to how avacopan should be used in real-world practice, beyond how it was given in the original clinical trials.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Soliris (eculizumab) / AstraZeneca
Review, Journal: Role of complement activation in anti-neutrophil cytoplasmic antibody-associated glomerulonephritis. (Pubmed Central) - Dec 20, 2022
Thus, as therapeutic options targeting complement components are making rapid strides, the primary complement pathway involved in AAGN disease progression remains to be elucidated: this will directly impact the development of novel therapeutic strategies with high specificity and reduced side effects. This review summarizes and discusses the most recent evidence on the crucial roles of the complement system in the development of AAGN and possible therapeutic strategies that target complement components for disease management.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Journal: Avacopan for ANCA-associated vasculitis - information for prescribers. (Pubmed Central) - Dec 12, 2022
This review summarizes and discusses the most recent evidence on the crucial roles of the complement system in the development of AAGN and possible therapeutic strategies that target complement components for disease management. No abstract available
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Journal: AVACOPAN: A New Adjunctive Therapy for Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. (Pubmed Central) - Dec 6, 2022
Clinical trials prove that avacopan is an excellent adjunctive treatment option, although it is not approved for the primary treatment of ANCA-vasculitis at this time. Initial clinical trials show substantial promise for avacopan, but additional studies with a longer duration will be needed to test for its durability and safety.
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: Diagnosing and treating ANCA-associated vasculitis: an updated review for clinical practice. (Pubmed Central) - Nov 1, 2022
In addition, regimens with less glucocorticoids are equally effective and safer in inducing remission compared with conventional regimens, and avacopan is an effective glucocorticoid-sparing option...ANCA and other biomarkers can be helpful in association with clinical assessment to guide diagnosis and treatment decisions. Patients should be frequently evaluated during follow-up for possible disease relapses or treatment-related morbidity, and for monitoring damage accrual, especially metabolic and cardiovascular damage.
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
Integrated Safety of Avacopan in ANCA-Associated Vasculitis (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_3093;
ACR Open Rheumatol 2020;2:662. Exposure-Adjusted Adverse Event Rates by Treatment Group
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
Kidney C5aR Is Expressed in Resident Macrophages, Tubular Epithelial Cells, and in Association With Fibrosis (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_3031;
The antibody-specific differences in C5aR detection may be due to cell-dependent post-translational modification, since expression of C5aR detected by both antibodies was confirmed by ISH. C5aR expression in the kidney is consistent with its role in inflammation and tissue remodeling, and suggests the hypothesis that treatment with avacopan may reduce inflammation-driven fibrosis in disease.
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Practice Patterns of Induction Therapy in Severe ANCA-Associated Vasculitis: An International Physician Survey (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_2360;
In light of new data on plasma exchange (PLEX) and glucocorticoid (GC) use, as well as recent approval of avacopan (AVP), various medical societies have updated their AAV management guidelines...Pulse methylprednisolone (MeP) was used by 94%, reduced dose GC by 70%, PLEX by 38%, rituximab (RTX) by 92%, cyclophosphamide (CYC) by 89%, and AVP by 12%...Conclusion Our survey highlights significant differences in AAV induction therapy practices based on specialty, practice setting, and AAV patient volume. Additionally, one third of physicians continue to use standard GC.
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
Renal Recovery for Patients With Baseline eGFR ≤20 in Avacopan ADVOCATE Trial (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_1519;
Funding Commercial Support Background In the 330-patient ADVOCATE trial, where 81% of patients with ANCA-associated vasculitis had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 mL/min/1.73 m 2 with avacopan and 4.1 in the prednisone group (P=0.029) at Week 52 (Jayne et al...Results The mean age was similar to the overall study population (66 vs. 61 years), but with a higher proportion of newly diagnosed (88 vs. 69%), MPO+ (84 vs. 57%) and MPA patients (72 vs. 45%), and higher cyclophosphamide use (50 vs. 35%; Table)...NEJM 2021;384:599-609. eGFR Results
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical guideline, Japanese regulatory, Retrospective data, Review, Journal: Systematic review and meta-analysis for 2023 clinical practice guidelines of the Japan research committee of the ministry of health, labour, and welfare for intractable vasculitis for the management of ANCA-associated vasculitis. (Pubmed Central) - Sep 20, 2022
Here, we review three articles that describe these new trends in the management of ANCA vasculitis. This systematic review provided evidence required to develop the 2023 clinical practice guideline for the management of ANCA-associated vasculitis.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Glucocorticoid Use and Related Adverse Events in ADVOCATE Trial of Avacopan in ANCA-Associated Vasculitis (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2929;
Also, fewer patients taking avacopan received GCs for treatment of relapses, consistent with lower risk of relapse observed in this group (5). These findings are consistent with previous studies, supporting the clinical significance of the lower total prednisone-equivalent doses in the avacopan group, both for reduction of GC toxicity within the first year, but also for the likely reduction of longer term impacts of GC use not captured in this study.Table 1: Total Glucocorticoid Use (Cumulative, IV and Oral) by Treatment Group for the 52-Week Treatment Period Table 2: Incidence of Pre-Defined Adverse Events Possibly Related to Glucocorticoid Use by Organ System
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Safety of Avacopan in ANCA-Associated Vasculitis: Combined Data from Three Clinical Trials (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2928;
In the 3 randomized, double-blind trials, all groups received background cyclophosphamide followed by azathioprine, or rituximab; control groups received a full prednisone regimen (60 mg tapered to 0 over 20 weeks) plus placebo. In the context of avacopan’s demonstrated efficacy profile, these integrated safety results provide support for avacopan’s use in the treatment of patients with AAV.Table 1: Exposure-Adjusted Adverse Event Rates by Treatment Group Across Three Trials of Avacopan for the Treatment of ANCA-Associated Vasculitis
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
ANCA-Associated Vasculitis Treated with Avacopan versus a Standard Prednisone Taper: Glucocorticoid Toxicity Index Scores by Domain (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2927;
Moreover, these data demonstrate that the benefits were experienced across multiple domains of toxicity, emphasizing the value of a composite measure that quantifies GC toxicity directly, assessing both cumulative toxicity and aggregate change.Table 1. Glucocorticoid Toxicity Index (GTI) Cumulative Worsening Scores (CWS) and Aggregate Improvement Scores (AIS) for individual domains at weeks 13 and 26 by treatment group in the ADVOCATE study
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Recovery of Renal Function Among ANCA-Associated Vasculitis Patients with Baseline eGFR ≤20 in the Avacopan ADVOCATE Trial (Room 103) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2411;
The mean age in this low eGFR group of 50 patients was similar to the overall 330-patient population (66 vs. 61 years), but included a higher proportion of patients with newly diagnosed disease (88 vs. 69%), MPO+ (84 vs. 57%), and MPA (72 vs. 45%), and higher use of cyclophosphamide (50 vs. 35%).Individual eGFR data from all patients are shown in Figure 1. Among patients with baseline eGFR ≤20 mL/min/1.73 m2 in the ADVOCATE trial, eGFR improved more in the avacopan vs. control group.Figure 1: Change from Baseline in eGFR by Treatment Group over the Course of the 52-Week Treatment Period in the ADVOCATE trial of Avacopan for ANCA-associated Vasculitis in Patients with Baseline eGFR ≤20 mL/min/1.73 m2Table 1: Summary of Data on eGFR in the ADVOCATE trial of Avacopan for ANCA-associated Vasculitis in Patients with Baseline eGFR ≤20 mL/min/1.73 m2
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Nucala (mepolizumab) / GSK, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
A Systematic Literature Review Informing the 2022 Update of the EULAR Recommendations for the Management of ANCA-associated Vasculitis (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2064;
It summarizes randomized-controlled trials and meta-analyses covering remission induction treatment with cyclophosphamide, rituximab and mycophenolate, the role of plasma exchange, steroid sparing protocols including the use of avacopan, duration of remission maintenance treatment with conventional immunosuppressives and rituximab. This SLR identified recent developments affecting key areas of AAV management, that provide systematic evidence to inform the 2022 update of the EULAR recommendations for the management of AAV
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Tavneos (avacopan) / Kissei, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Induction Therapy Patterns for Severe ANCA-associated Vasculitis Differ Based on Physician Specialty, Expertise, and Practice Setting: An International Survey (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2049;
Considering reduced dose GC as a recent recommendation, our survey interestingly highlighted that the adoption of reduced dose GC was more common among physicians in nephrology, with greater patient volume, and in an academic setting. Despite this new recommendation, one third of physicians in the survey continue to use standard GC.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Safety of Avacopan in ANCA-Associated Vasculitis: Combined Data from Three Clinical Trials (Northern Liberties Stage) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1769;
In the 3 randomized, double-blind trials, all groups received background cyclophosphamide followed by azathioprine, or rituximab; control groups received a full prednisone regimen (60 mg tapered to 0 over 20 weeks) plus placebo. In the context of avacopan’s demonstrated efficacy profile, these integrated safety results provide support for avacopan’s use in the treatment of patients with AAV.Table 1: Exposure-Adjusted Adverse Event Rates by Treatment Group Across Three Trials of Avacopan for the Treatment of ANCA-Associated Vasculitis
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
ANCA-Associated Vasculitis Treated with Avacopan versus a Standard Prednisone Taper: Glucocorticoid Toxicity Index Scores by Domain (Northern Liberties Stage) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1768;
Moreover, these data demonstrate that the benefits were experienced across multiple domains of toxicity, emphasizing the value of a composite measure that quantifies GC toxicity directly, assessing both cumulative toxicity and aggregate change.Table 1. Glucocorticoid Toxicity Index (GTI) Cumulative Worsening Scores (CWS) and Aggregate Improvement Scores (AIS) for individual domains at weeks 13 and 26 by treatment group in the ADVOCATE study
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
SUCCESSFUL TREATMENT OF MICROSCOPIC POLYANGIITIS USING NOVEL STEROID-SPARING AGENT AVACOPAN (Convention Center Exhibit Hall: Rapid Area 4B) - Sep 11, 2022 - Abstract #CHEST2022CHEST_3277;
Glucocorticoid Toxicity Index (GTI) Cumulative Worsening Scores (CWS) and Aggregate Improvement Scores (AIS) for individual domains at weeks 13 and 26 by treatment group in the ADVOCATE study Our case report highlights that steroid sparing agents like Avacopan should be considered as a potentially safer alternative to high dose glucocorticoid therapy in patients with MPA.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Ultomiris IV (ravulizumab IV) / AstraZeneca, Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
250: Poster Tour: Rare and Orphan Diseases (In-person) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_255;
Avacopan in combination with cyclophosphamide and rituximab is a new cost-effective option for AAV patients in the NHS. Download the Rare and Orphan Diseases Poster Tour Guide Packet Posters featured in this tour: CO15: A Matching-Adjusted Indirect Comparison of Efgartigimod Versus Ravulizumab for Generalized Myasthenia Gravis EE382: Cost-Utility Analysis of Avacopan for the Treatment of Anca-Associated Vasculitis (AAV) Patients in the UK EE274: Orphan Drug Pricing Comparisons in Low-, Middle- and High-Income Countries EE147: Estimating the Causal Effect of Early Use of Erythropoietic Stimulating Agents in Intermediate-1 to Low-Risk MDS Patients: An Application of the Longitudinal Targeted Maximum Likelihood Estimation HPR17: Changing Landscape of Orphan Drug Reimbursement - Evidence From EU-4 and England SA73: Addressing Unmet Needs of Patients With Neuronopathic Gaucher Disease Type 2 and Type 3: Creation of the GARDIAN Patient Registry
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Updates in ANCA-associated vasculitis. (Pubmed Central) - Aug 24, 2022
However, the optimal dosing regimen and duration for maintenance remain to be better defined, at the individual patient level. Many changes have occurred in the standard of care for AAV over the past decades, and more are expected soon, including with use of avacopan, but also, likely, a few other agents under investigation or development.
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
Journal: C5a receptor antagonism coming of age for vascular pathology. (Pubmed Central) - Aug 22, 2022
The Food and Drug Administration recently approved the new drug avacopan for a relatively rare disease, anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis...Possible clinical risks and extension of therapeutic C5aR blockade are discussed. Therapeutic intervention on the blood-derived peptide C5a and on its G protein coupled receptor for specific forms of vascular injury contrasts with other current research approaches in vascular pathology, such as investigating the roles of cytokines and intracellular signaling.
- |||||||||| Tavneos (avacopan) / Kissei, Vifor, ChemoCentryx
Review, Journal: How the availability of anti-C5a agents could change the management of ANCA-associated Vasculitis. (Pubmed Central) - Aug 17, 2022
The results of the ADVOCATE trial opened new prospects for the treatment of AAV and also other immune-mediated diseases with renal involvement. The possible position of avacopan in a routine clinical setting and its possible indications in specific subsets of patients with AAV are extensively discussed.
|
