Evidence map›Paper›PMID 37979959›Full record

Trial reportAnnals of the rheumatic diseases2024

Efficacy and safety of avacopan in patients with ANCA-associated vasculitis receiving rituximab in a randomised trial.

Duvuru Geetha, Anisha Dua, Huibin Yue, Jason Springer, Carlo Salvarani, David Jayne, Peter Merkel, ADVOCATE Study Group

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02994927 (A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
10.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02994927 phase3completednot on this map

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine

TypeinterventionalSponsorAmgenRan2017 to 2019Enrolled331ConditionsANCA-Associated VasculitisArmsAvacopan, Prednisone, Cyclophosphamide, Rituximab, Azathioprine
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 42 citations in OpenAlex.

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  20. Complement System Inhibitors in Nephrology: An Update-Narrative Review.International journal of molecular sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 3 countries.

Duvuru GeethaDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA dgeetha1@jhmi.edu.ORCID http://orcid.org/0000-0001-8353-5542
Anisha DuaDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.ORCID http://orcid.org/0000-0002-3508-9290
Huibin YueDepartment of Biostatistics, Amgen Inc, San Carlos, California, USA.
Jason SpringerDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID http://orcid.org/0000-0002-3903-6049
Carlo SalvaraniDepartment of Medical Specialties, Azienda Unità Sanitaria Locale-IRCCS, Reggio Emilia, Italy.ORCID http://orcid.org/0000-0001-5426-5133
David JayneDepartment of Medicine, University of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0002-1712-0637
Peter MerkelDepartment of Medicine, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID http://orcid.org/0000-0001-9284-7345
ADVOCATE Study Group
Johns Hopkins University · USNorthwestern University · USUniversity of Cambridge · GBUniversity of Modena and Reggio Emilia · ITUniversity of Pennsylvania · USVanderbilt University Medical Center · USAmgen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy and safety of avacopan in the subgroup of patients with antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis receiving background induction therapy with rituximab in the phase 3 ADVOCATE trial.

methodsKey efficacy outcomes were remission at week 26 and sustained remission at week 52. Additional outcomes included the Glucocorticoid Toxicity Index, estimated glomerular filtration rate, urinary albumin to creatinine ratio, health-related quality of life and safety.

resultsOf the 330 patients who received study medication, 214 (64.8%) received rituximab (once weekly for 4 weeks), with a mean age of 59.8 years; 163 (76.2%) had renal vasculitis and 125 (58.4%) were newly diagnosed. Remission at week 26 and sustained remission at week 52 were achieved by 83/107 (77.6%) and 76/107 (71.0%) patients in the avacopan group and 81/107 (75.7%) and 60/107 (56.1%) in the prednisone taper group, respectively. The relapse rate, recovery of renal function, speed of reduction in albuminuria and glucocorticoid toxicity favoured the avacopan group. Serious adverse events occurred in 34.6% and 39.3% of patients in the avacopan and prednisone taper groups, respectively.

conclusionsThese data suggest that in patients with ANCA-associated vasculitis receiving rituximab, efficacy of treatment with avacopan compared with a prednisone taper was similar at week 26 and greater at week 52, with a favourable safety profile. In addition, avacopan was associated with improved renal outcomes and lower glucocorticoid toxicity. These results demonstrate the efficacy and safety of avacopan in patients receiving background induction therapy with rituximab. TRIAL REGISTRATION NUMBER: NCT02994927.

Indexed as

Aniline CompoundsAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisImmunosuppressive AgentsNipecotic AcidsAntibodies, Antineutrophil CytoplasmicGlucocorticoidsHumansMiddle AgedPrednisoneQuality of LifeRemission InductionRituximabAniline CompoundsAntibodies, Antineutrophil CytoplasmicavacopanGlucocorticoidsImmunosuppressive AgentsNipecotic AcidsPrednisoneRituximabGlucocorticoidsGranulomatosis with polyangiitisRituximabSystemic vasculitis

Identifiers

PMID37979959
PMCPMC10850685
OpenAlexW4388792895

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.