- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] Neutrophil and C5aR dynamics in hidradenitis suppurativa disease progression () - Feb 12, 2021 - Abstract #SID2021SID_691; Recently we demonstrated that avacopan, a specific C5aR inhibitor, significantly improved the Hidradenitis Suppurativa Clinical Response (HiSCR) vs. placebo (42.6% vs 22.2%, mean responder rate) in Hurley stage III patients in a phase 2 trial. Together, these findings implicate a critical role of C5aR in disease progression and warrant further development of avacopan for HS.
- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Adjunctive Treatment With Avacopan, an Oral C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. (Pubmed Central) - Nov 2, 2020 P2 Selective inhibitors of C5aR1 may have therapeutic potential in AIS. Avacopan in addition to SOC for ANCA-associated vasculitis was well tolerated, and at the higher study dose, it appeared to improve time to remission (ClinicalTrials.gov identifier NCT02222155).
- |||||||||| Tavneos (avacopan) / Amgen
Trial primary completion date: ACCOLADE: Controlled Trial Evaluating Avacopan in C3 Glomerulopathy (clinicaltrials.gov) - Oct 19, 2020 P2, N=88, Recruiting, Avacopan in addition to SOC for ANCA-associated vasculitis was well tolerated, and at the higher study dose, it appeared to improve time to remission (ClinicalTrials.gov identifier NCT02222155). Trial primary completion date: Sep 2020 --> Mar 2021
- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] Complement Activation and C5aR1 Elevation in Hidradenitis Suppurativa Patient Lesions () - Oct 17, 2020 - Abstract #SHSA2020SHSA_75; Avacopan, a potent and specific inhibitor of human C5aR1, is currently being evaluated in a phase 2 clinical trial for HS...Potential use of therapeutics that target complement pathway in HS Takeaway Message: Systemic dysregulation of complement and elevation of C5aR1 within lesions are observed in HS patients. These findings strengthen the rationale for clinical studies to assess the efficacy of a C5aR1 inhibitor in HS.
- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Complement C5a Receptor Inhibitor Avacopan Improves Renal Function in ANCA Vasculitis (Simulive) - Oct 11, 2020 - Abstract #KIDNEYWEEK2020KIDNEY_WEEK_3726; Avacopan led to faster falls in UACR and greater recovery in eGFR when compared to standard prednisone therapy. These findings have important implications for the long term health of AAV patients through better overall disease control, reduced prednisone exposure and reduced severity of chronic kidney disease.
- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] The Effect on Renal Function of the Complement C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis (Feed 8) - Oct 8, 2020 - Abstract #ACRARHP2020ACR_ARHP_1047; In addition to an improved sustained remission outcome, the avacopan group had greater improvement in renal function compared to standard prednisone therapy. These findings suggest the potential for better long-term outcomes with avacopan for patients with renal disease than current standard of care treatment and provide intriguing insights into subclinical renal disease activity in ANCA-associated vasculitis.
- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Modelling the Cost-Effectiveness of Avacopan in ANTI-Neutrophil Cytoplasmic Antibody Associated Vasculitis Patients- A Conceptual Approach () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_547; Patients experiencing events in the model compared to organ damage reported in Robson (2015) at 7.3 years were: 47.2% and 47.9% CV events, 16.0% and 14.1% bone disease; 33.9% and 31.7% renal disease (GFR<50 mL/min); 12.2% and 9.0% ESRD (GFR<15 mL/min); 11.9% and 8.5% ocular disease, respectively. CONCLUSIONS : The cost-effectiveness model appears to validate reasonably against other available clinical data sources and gives some confidence in populating with further data (treatment effect, QoL, costs), including from ADVOCATE trial and subsequent use for reimbursement processes.
- |||||||||| Tavneos (avacopan) / Amgen
Enrollment closed, Trial completion date: Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA) (clinicaltrials.gov) - Sep 28, 2020 P2, N=390, Active, not recruiting, CONCLUSIONS : The cost-effectiveness model appears to validate reasonably against other available clinical data sources and gives some confidence in populating with further data (treatment effect, QoL, costs), including from ADVOCATE trial and subsequent use for reimbursement processes. Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Jun 2021
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen, Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo
Clinical, Review, Journal: Interventions for renal vasculitis in adults. (Pubmed Central) - Jun 14, 2020 AZA, methotrexate and leflunomide were effective as maintenance therapy. Further studies are required to more clearly delineate the appropriate place of newer agents within an evidence-based therapeutic strategy.
- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
[VIRTUAL] Unmet needs in ANCA associated vasculitis - can they be met with a targeted therapy? (Valkenburg) - Jun 13, 2020 - Abstract #EULAR2020EULAR_4618; The presentation will finish with a description of the ADVOCATE study (Merkel 2018) which is comparing avacopan (a specific C5a receptor 1 antagonist) with glucocorticoids for achieving and maintaining remission. This randomised controlled trial included 331 ANCA associated vasculitis patients, many in Europe, and was completed in late 2019 offering potentially a new option for clinicians, targeted at the underlying causes of the disease.
- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx
Journal: Complement inhibition in ANCA vasculitis. (Pubmed Central) - May 9, 2020 Complement inhibition has the potential to contribute to remission induction protocols achieving a higher quality of remission as well as replacing steroids. Confirmation of safety, especially infective risk, and the potential to replace steroids depends on further studies and a role in relapse prevention needs to be explored.
- |||||||||| Tavneos (avacopan) / Amgen
Trial completion date, Trial primary completion date: ACCOLADE: Controlled Trial Evaluating Avacopan in C3 Glomerulopathy (clinicaltrials.gov) - Mar 9, 2020 P2, N=88, Recruiting, Confirmation of safety, especially infective risk, and the potential to replace steroids depends on further studies and a role in relapse prevention needs to be explored. Trial completion date: Dec 2020 --> May 2021 | Trial primary completion date: Dec 2019 --> Sep 2020
- |||||||||| avacopan (CCX168) / Kissei, Vifor, ChemoCentryx, Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo, azathioprine orodispersible / Generic mfg.
Clinical, P3 data, Journal: A randomized, double-blind, active-controlled, Phase 3 study to evaluate the safety and efficacy of avacopan, a C5a receptor inhibitor, in patients with ANCA-associated vasculitis treated concomitantly with rituximab or cyclophosphamide/ azathioprine. (Pubmed Central) - Feb 25, 2020 P3 A significant reduction in glucocorticoid-related toxicity was observed in the avacopan vs. prednisone arms. Results will be released irrespective of whether the findings are positive or negative.
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Rituxan (rituximab) / Roche, Biogen
Journal: Molecular targeted therapies for microscopic polyangiitis and granulomatosis with polyangiitis. (Pubmed Central) - Jan 21, 2020 Clinical trials and observational studies have established cyclophosphamide (CY) or rituximab plus glucocorticoid (GC) as standard remission induction therapies in patients with microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA)...Phase II clinical trials of avacopan (CCX168), an orally administered C5a receptor antagonist, have suggested a reduction in the dosage of concomitant GC or the replacement of GC in patients with MPA and GPA...A randomized clinical trial comparing tocilizumab and intravenous CY in combination with GC is currently in progress. Molecular targeted therapy is expected to transform the treatment strategy for MPA and GPA to allow GC-free or at least less GC-dependent forms of therapy.
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