Evidence map›Paper›PMID 26621483›Full record

Trial reportAnnals of the rheumatic diseases2016

Clinical outcomes of treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis based on ANCA type.

Sebastian Unizony, Miguel Villarreal, Eli M Miloslavsky, Na Lu, Peter A Merkel, Robert Spiera, Philip Seo, Carol A Langford, Gary S Hoffman, Cg M Kallenberg and 11 more

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

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00104299 (Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis), which is not on this map. Cited by 109 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 5 pooled it
10.0field-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.

NCT00104299 phase2 / phase3completednot on this map

Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2005 to 2010Enrolled197ConditionsVasculitis, Wegener's Granulomatosis, Microscopic PolyangiitisArmsRituximab plus cyclophosphamide placebo (rituximab group), Cyclophosphamide plus rituximab placebo (control group), Azathioprine, Methylprednisolone (or other glucocorticoid), Prednisone
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 5 syntheses or guidelines pooled it, 258 citations in OpenAlex.

  1. Pooled it
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  3. Interventions for renal vasculitis in adults.The Cochrane database of systematic reviews · 2020
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49 more citing papers are in PubMed but not listed here.

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

21 authors at 12 institutions in 2 countries.

Sebastian UnizonyMassachusetts General Hospital, Boston, Massachusetts, USA.
Miguel VillarrealRho, Chapel Hill, North Carolina, USA.
Eli M MiloslavskyMassachusetts General Hospital, Boston, Massachusetts, USA.
Na LuMassachusetts General Hospital, Boston, Massachusetts, USA.
Peter A MerkelUniversity of Pennsylvania School of Medicine, Philadelphia, USA.
Robert SpieraHospital for Special Surgery, New York, New York, USA.
Philip SeoJohns Hopkins University, Baltimore, Maryland, USA.
Carol A LangfordCleveland Clinic, Cleveland, Ohio, USA.
Gary S HoffmanCleveland Clinic, Cleveland, Ohio, USA.
Cg M KallenbergUniversity of Groningen and University Medical Center Groningen, Groningen, The Netherlands.
E William St ClairDuke University Medical Center, Durham, North Carolina, USA.
David IkleRho, Chapel Hill, North Carolina, USA.
Nadia K TchaoImmune Tolerance Network, San Francisco, California, USA.
Linna DingNational Institute of Allergy & Infectious Disease/Division of Allergy, Immunology, & Transplantation (NIAID/DAIT), Bethesda, Maryland, USA.
Paul BrunettaGenentech, South San Francisco, California, USA.
Hyon K ChoiMassachusetts General Hospital, Boston, Massachusetts, USA.
Paul A MonachBoston University School of Medicine, Boston, Massachusetts, USA.
Fernando FervenzaMayo Clinic, Rochester, Minnesota, USA.
John H StoneMassachusetts General Hospital, Boston, Massachusetts, USA.
Ulrich SpecksMayo Clinic, Rochester, Minnesota, USA.
RAVE-ITN Research Group
Massachusetts General Hospital · USCleveland Clinic · USMayo Clinic · USRho (United States) · USBoston University · USDuke Medical Center · USHospital for Special Surgery · USImmune Tolerance Network · USJohns Hopkins University · USNational Institute of Allergy and Infectious Diseases · USUniversity Medical Center Groningen · NLUniversity of Pennsylvania · US

Funding

Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
YOGA INDUCED CHANGES IN BRAIN GABA LEVELSM01RR000533 · NCRR · BOSTON UNIVERSITY MEDICAL CAMPUS · PI HOLICK, MICHAEL F. · 1985 to 2008
$19.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025771 · NCRR · BOSTON UNIVERSITY MEDICAL CAMPUS · PI CENTER, DAVID M. · 2008 to 2011
$17.6M
Development of an ANCA-Vasculitis Index of Damage (AVID)K23AR052820 · NIAMS · JOHNS HOPKINS UNIVERSITY · PI SEO, PHILIP · 2005 to 2009
$661k
Studies in Scleroderma and Cystic Fibrosis OsteoporosisK24AR002224 · NIAMS · BOSTON UNIVERSITY MEDICAL CAMPUS · PI MERKEL, PETER A · 2001 to 2005
$609k
Translational Research in Systemic VasculitisK24AR049185 · NIAMS · JOHNS HOPKINS UNIVERSITY · PI STONE, JOHN H · 2003 to 2006
$351k
IMMUNE TOLERANCE NETWORK-266015416-266015416N01AI015416 · NIAID · REGENTS OF THE UNIVERSITY OF C · PI BLUESTONE, JEFFREY A · 2002 to 2006
–
NCATS NIH HHS UL1 TR000439NCRR NIH HHS M01 RR000533NCRR NIH HHS UL1 RR024150NCRR NIH HHS UL1 RR025771NIAID NIH HHS N01 AI015416NIAID NIH HHS UM2 AI117870NIAMS NIH HHS K23 AR052820NIAMS NIH HHS K24 AR002224NIAMS NIH HHS K24 AR049185
6 · The paper itself

Abstract

objectiveTo evaluate whether the classification of patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) according to ANCA type (anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO) antibodies) predicts treatment response.

methodsTreatment responses were assessed among patients enrolled in the Rituximab in ANCA-associated Vasculitis trial according to both AAV diagnosis (granulomatosis with polyangiitis (GPA)/microscopic polyangiitis (MPA)) and ANCA type (PR3-AAV/MPO-AAV). Complete remission (CR) was defined as disease activity score of 0 and successful completion of the prednisone taper.

resultsPR3-AAV patients treated with rituximab (RTX) achieved CR at 6 months more frequently than did those randomised to cyclophosphamide (CYC)/azathioprine (AZA) (65% vs 48%; p=0.04). The OR for CR at 6 months among PR3-AAV patients treated with RTX as opposed to CYC/AZA was 2.11 (95% CI 1.04 to 4.30) in analyses adjusted for age, sex and new-onset versus relapsing disease at baseline. PR3-AAV patients with relapsing disease achieved CR more often following RTX treatment at 6 months (OR 3.57; 95% CI 1.43 to 8.93), 12 months (OR 4.32; 95% CI 1.53 to 12.15) and 18 months (OR 3.06; 95% CI 1.05 to 8.97). No association between treatment and CR was observed in the MPO-AAV patient subset or in groups divided according to AAV diagnosis.

conclusionsPatients with PR3-AAV respond better to RTX than to CYC/AZA. An ANCA type-based classification may guide immunosuppression in AAV. TRIAL REGISTRATION NUMBER: NCT00104299; post-results.

Indexed as

AdultAgedAntibodies, Antineutrophil CytoplasmicAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAzathioprineBiomarkersCyclophosphamideDouble-Blind MethodDrug Therapy, CombinationFemaleGranulomatosis with PolyangiitisHumansMaleMicroscopic PolyangiitisMiddle AgedMyeloblastinAntibodies, Antineutrophil CytoplasmicAzathioprineBiomarkersCyclophosphamideMyeloblastinPeroxidaseRituximabCyclophosphamideGranulomatosis with polyangiitisSystemic vasculitisTreatment

Identifiers

PMID26621483
PMCPMC4908815
OpenAlexW2266467924

What OpenQuestion holds

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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.