- |||||||||| Empaveli (pegcetacoplan SC) / Apellis, SOBI
Review, Journal: Targeting complement in IgA nephropathy. (Pubmed Central) - Dec 6, 2023
Several ongoing trials are evaluating the efficacy of new agents against factor B (iptacopan, Ionis-FB-L), C3 (pegcetacoplan), factor D (vemircopan, pelecopan), C5 (ravulizumab, cemdisiran) and C5a receptor 1 (avacopan). In this study, we provide a comprehensive review of the role of complement in IgAN, including the emerging mechanisms of complement activation and the promising potential of complement inhibitors as a viable treatment option for IgAN.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal, Immunomodulating: The plethora of immunomodulatory drugs: opportunities for immune-mediated kidney diseases. (Pubmed Central) - Nov 13, 2023
This new understanding challenges the clinical investigator to translate new knowledge into novel therapies leading to better disease outcomes. This review highlights promising immunomodulatory therapies tested for immune-mediated kidney diseases as a primary indication, detail current clinical trials and discuss pathways that could be targeted in the future.
- |||||||||| Review, Journal: A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP). (Pubmed Central) - Nov 13, 2023
This review highlights promising immunomodulatory therapies tested for immune-mediated kidney diseases as a primary indication, detail current clinical trials and discuss pathways that could be targeted in the future. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka, Soliris (eculizumab) / AstraZeneca
Journal: Editorial: Role of complement activation in kidney diseases. (Pubmed Central) - Nov 6, 2023
Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab. No abstract available
- |||||||||| Tavneos (avacopan) / Amgen
Enrollment open: Avacostar - (PASS) (clinicaltrials.gov) - Sep 30, 2023
P=N/A, N=500, Recruiting,
On avacopan, the patient was able to discontinue mycophenolate mofetil (MMF) while maintaining remission. Not yet recruiting --> Recruiting
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka
Efficacy and Safety Experience with Avacopan Beyond 52 Weeks in the Early Access Program (EAP) (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2790;
These results suggest that continuation of avacopan beyond 52 weeks is generally well-tolerated in patients with GPA and MPA and may be effective in terms of disease control. Limitations of this program include low patient number, potential underreporting, and incomplete data.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka
Avacopan for the Treatment of ANCA-associated Vasculitis. Real World Experience in Spain (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2789;
Limitations of this program include low patient number, potential underreporting, and incomplete data. Avacopan, a selective antagonist of C5a receptor, has been approved for the treatment of adult patients with severe and active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in combination with rituximab (RTX) or cyclophosphamide (CF)...eGFR increased 6.1
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka
Safety and Efficacy of Avacopan in Patients 65 Years and Older with ANCA-Associated Vasculitis (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2788;
D. Jayne: AstraZeneca, 2, Aurinia, 4, Boehringer Ingelheim, 2, Chinook, 2, CSL Vifor, 2, Roche, 2; D. Geetha: Amgen, 2, Aurinia, 2, calliditas, 2, chemocentryx, 2, GlaxoSmithKlein(GSK), 2; C. Pagnoux: AstraZeneca, 1, 2, 6, GlaxoSmithKlein(GSK), 1, 6, Otsuka, 1, 2, 5, 6, Pfizer, 5, Roche, 2; S. Sattui: AstraZeneca, 5, Bristol Myers Squibb Foundation, 5, Rheumatology Research Foundation, 5, Sanofi, 2, 5; P. Merkel: AbbVie/Abbott, 5, Amgen, 2, 5, ArGenx, 2, AstraZeneca, 2, 5, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, Cabaletta, 2, CSL Behring, 2, Eicos, 5, Electra, 5, Genentech, 5, GlaxoSmithKlein(GSK), 2, 5, HiBio, 2, InflaRx, 2, 5, Janssen, 2, Jubilant, 2, Kyverna, 2, 11, MiroBio, 2, Neutrolis, 5, Novartis, 2, NS Pharma, 2, Q32, 2, Regeneron, 2, Sanofi, 2, Sparrow, 2, Takeda, 2, 5, UpToDate, 9, Visterra, 2.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka
Remission, Glucocorticoid Toxicity, Health-Related Quality of Life, and Safety Outcomes in Patients with Renal Involvement in the Phase 3 Trial of Avacopan for the Treatment of ANCA-Associated Vasculitis (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2787;
D. Geetha: Amgen, 2, Aurinia, 2, calliditas, 2, chemocentryx, 2, GlaxoSmithKlein(GSK), 2; F. Cortazar: Amgen, 2, 6, Aurinia, 2, 6, Calliditas, 6, Travere, 2, Valenza Bio, 2; A. Bruchfeld: Amgen, 2, AstraZeneca, 2, 12, Investigator fees, Bayer, 2, ChemoCentryx, 1, 12, Investigator fees, CSL Vifor, 2, 12, Investigator fees, Fresenius, 2, 12, Investigator fees, Merck/MSD, 2, 12, Investigator fees; a. Karras: AstraZeneca, 6, GlaxoSmithKlein(GSK), 4, Novartis, 2, Pfizer, 6; P. Merkel: AbbVie/Abbott, 5, Amgen, 2, 5, ArGenx, 2, AstraZeneca, 2, 5, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, Cabaletta, 2, CSL Behring, 2, Eicos, 5, Electra, 5, Genentech, 5, GlaxoSmithKlein(GSK), 2, 5, HiBio, 2, InflaRx, 2, 5, Janssen, 2, Jubilant, 2, Kyverna, 2, 11, MiroBio, 2, Neutrolis, 5, Novartis, 2, NS Pharma, 2, Q32, 2, Regeneron, 2, Sanofi, 2, Sparrow, 2, Takeda, 2, 5, UpToDate, 9, Visterra, 2; D. Jayne: AstraZeneca, 2, Aurinia, 4, Boehringer Ingelheim, 2, Chinook, 2, CSL Vifor, 2, Roche, 2.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Efficacy and Safety of Avacopan in Patients with ANCA-Associated Vasculitis Receiving Rituximab in a Phase 3 Trial (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2785;
Compared to the prednisone group, patients in the avacopan group had numerical improvements in remission at week 26, relapse rate, eGFR, albuminuria, and less GC toxicity. There was no increase in serious TEAEs in patients treated with avacopan.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Avacopan in ANCA-associated Vasculitis Received Intensified Induction Therapy with Cyclophosphamide Plus Rituximab (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2783;
Avacopan appears to favor steroid tapering in severe courses of AAV on combined therapy with cyclophosphamide plus rituximab. However, due to the small number of cases and the retrospective evaluation, the results have to be confirmed by studies with larger number of cases.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka
Change in Albuminuria in Patients with ANCA-Associated Vasculitis Treated with Avacopan (Ballroom 20D; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1759;
The rapid reduction in UACR seen in patients with AAV receiving avacopan suggests more rapid control of glomerular inflammation which may have contributed to the observed subsequent improvement in eGFR. D.
- |||||||||| Journal: Complement inhibitors in pediatric kidney diseases: new therapeutic opportunities. (Pubmed Central) - Sep 21, 2023
Many of these molecules have been shown to be effective in reducing proteinuria and stabilizing kidney function in different complement-mediated kidney diseases. Thanks to their efficacy and target specificity, these novel drugs may radically improve the outcome of complement-mediated kidney diseases, contributing to an improvement in our understanding of their underlying pathophysiology.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical guideline, Japanese regulatory, Journal: Clinical practice guidelines of (Pubmed Central) - Aug 21, 2023
No abstract available The recommendations have been updated based on patient preference, certainty of evidence, benefit and risk balance, and cost.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: Systematic literature review informing the 2022 update of the EULAR recommendations for the management of ANCA-associated vasculitis (AAV): part 1-treatment of granulomatosis with polyangiitis and microscopic polyangiitis. (Pubmed Central) - Jul 26, 2023
The recommendations have been updated based on patient preference, certainty of evidence, benefit and risk balance, and cost. This SLR provides current evidence to inform the 2022 update of the EULAR recommendations for the management of AAV.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka, Soliris (eculizumab) / AstraZeneca
Journal: C5a-licensed phagocytes drive sterilizing immunity during systemic fungal infection. (Pubmed Central) - Jun 26, 2023
Lower serum C5a concentrations or a C5 polymorphism that decreases leukocyte C5 expression correlated independently with poor patient outcomes. Thus, local, phagocyte-derived C5 production licenses phagocyte antimicrobial function and confers innate protection during systemic fungal infection.
- |||||||||| Tavneos (avacopan) / Amgen
New trial: Avacostar - (PASS) (clinicaltrials.gov) - Jun 9, 2023
P=N/A, N=500, Not yet recruiting,
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka
GLUCOCORTICOID-RELATED ADVERSE EFFECTS IN THE TREATMENT OF ANCA-ASSOCIATED VASCULITIS (Focussed Oral Room 2) - May 4, 2023 - Abstract #ERAEDTA2023ERA_EDTA_1859;
This study provides additional evidence about the incidence of treatment related harms in AAV to further promote importance of alternative reduced dose or even GC free treatment approaches. This may be relevant in detecting risk groups for whom upcoming GC-sparing treatment strategies such as avacopan are essential to reduce treatment-related harm.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka
CHANGE IN ALBUMINURIA IN PATIENTS WITH ANCA-ASSOCIATED VASCULITIS TREATED WITH AVACOPAN (Focussed Oral Room 9) - May 4, 2023 - Abstract #ERAEDTA2023ERA_EDTA_1750;
In the ADVOCATE trial, UACR, an important early indicator of improving kidney function, improved three times faster in the avacopan group compared to the prednisone taper group. The rapid reduction in UACR seen in patients with ANCA-associated vasculitis receiving avacopan suggests more rapid control of glomerular inflammation which may have contributed to the observed subsequent greater improvement in eGFR
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Otsuka
A NEW ADJUNCTIVE THERAPY WITH AVACOPAN FOR ANCA-ASSOCIATED VASCULITIS (Focussed Oral Room 5) - May 4, 2023 - Abstract #ERAEDTA2023ERA_EDTA_866;
Herein, we describe practice observations on the use of avacopan in patients with AAV. While further studies are needed to confirm the efficacy of avacopan because the number of cases treated with avacopan is still lacking, our findings suggest that avacopan was beneficial in AAV patients because of the absence of steroid dependence.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Nucala (mepolizumab) / GSK, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
ANCA Related Glomerulonephritis (Room 3) - Apr 15, 2023 - Abstract #KSN2023KSN_37;
Medications with less toxicity, such as a lower doses of rituximab, methotrexate, or azathioprine are used to maintain remission. Patients with non- severe disease, defined as not having organ-/life-threatening manifestations, are often treated with oral medications such as methotrexate or azathioprine along with glucocorticoids.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Review, Journal: Novel aspects in the pathophysiology and diagnosis of glomerular diseases. (Pubmed Central) - Apr 14, 2023
Novel therapeutic approaches aim to mitigate these changes more efficiently and rapidly. Several new agents, such as avacopan, an oral C5aR1 inhibitor, or imlifidase, that dissolves IgG within minutes, are more specifically reducing inflammatory cascades in the kidney and repeat tissue sampling might help to understand their impact on immune cell deposition and finally kidney function recovery and potential impact of immune complexes/deposits.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: Management of antineutrophil cytoplasmic antibody-associated vasculitis: a changing tide. (Pubmed Central) - Apr 5, 2023
AAV treatments have changed tremendously over the past decade with a drive towards targeted PLEX use, increased rituximab use and lower GC dosing. Striking a crucial balance between morbidity from relapses and toxicities from immunosuppression remains a challenging path to navigate.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen
Another Case of the Sniffles: Chronic Sinusitis and Recurrent Otitis Media in Granulomatosis With Polyangiitis (Walter E. Washington Convention Center, Area G, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_4715;
This case shows a unique presentation of GPA with solely progressive ENT complaints that eventually led to severe pulmonary and renal involvement. It was essential to recognize one of the hallmarks of life-threatening disease includes pulmonary involvement in addition to acute renal failure.
- |||||||||| Tavneos (avacopan) / Kissei, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Novel Onset GPA Vasculitis and the Adjunctive Agentavacopan to Limit Glucocorticoid Exposure (Walter E. Washington Convention Center, Area A, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_4577;
Standard induction and maintenance therapy for ANCAv includes prednisone plus Cyclophosphamide or Rituximab[6]...In addition to Cefuroxime, the patient immediately initiated induction therapy with high dose steroids and Rituximab, followed by Prednisone 60mg daily and Rituximab once weekly for 4 weeks...Our patient responded well to Avacopan, and rapidly weaned off steroids with an excellent clinical response. Glucocorticoids have played a pivotal role in ANCAv therapy, however toxic effects of prolonged exposure makes the novel drug Avacopan appealing for prescribers and patients[6,7,8].
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