Evidence map›Paper›PMID 25776953›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2015

Outcomes of nonsevere relapses in antineutrophil cytoplasmic antibody-associated vasculitis treated with glucocorticoids.

E M Miloslavsky, U Specks, P A Merkel, P Seo, R Spiera, C A Langford, G S Hoffman, C G M Kallenberg, E W St Clair, N K Tchao and 9 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2015. 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 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
5.5field-weighted citation impact, top 4% 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

27 citing papers in PubMed, 53 citations in OpenAlex.

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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

19 authors at 13 institutions in 2 countries.

E M MiloslavskyMassachusetts General Hospital, Boston.
U SpecksMayo Clinic, Rochester, Minnesota.
P A MerkelUniversity of Pennsylvania, Philadelphia.
P SeoJohns Hopkins University, Baltimore, Maryland.
R SpieraHospital for Special Surgery, New York, New York.
C A LangfordCleveland Clinic Foundation, Cleveland, Ohio.
G S HoffmanCleveland Clinic Foundation, Cleveland, Ohio.
C G M KallenbergUniversity of Groningen and University Medical Center, Groningen, The Netherlands.
E W St ClairDuke University Medical Center, Durham, North Carolina.
N K TchaoImmune Tolerance Network, South San Francisco, California.
L DingNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland.
D IkléRho, Chapel Hill, North Carolina.
M VillarealRho, Chapel Hill, North Carolina.
N LimImmune Tolerance Network, Bethesda, Maryland.
P BrunettaGenentech, South San Francisco, California.
F C FervenzaMayo Clinic, Rochester, Minnesota.
P A MonachBoston University and Boston Medical Center, Boston, Massachusetts.
J H StoneMassachusetts General Hospital, Boston.
Rituximab in ANCA-Associated Vasculitis-Immune Tolerance Network Research Group
Cleveland Clinic · USImmune Tolerance Network · USMayo Clinic · USRho (United States) · USBoston Medical Center · USDuke Medical Center · USHarvard University Press · USHospital for Special Surgery · USJohns Hopkins University · USMassachusetts General Hospital · USNational Institute of Allergy and Infectious Diseases · USPhiladelphia University · USUniversity Medical Center Groningen · NL

Funding

Institute for Clinical and Translational Research (UL1)UL1RR025005 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$75.8M
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
The importance of the IgG4 glycome in IgG4-related disease(s)U19AI110495 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI Ramnik J Xavier · 2014 to 2026
$7.9M
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 TR000439NCATS NIH HHS UL1-TR-000439NCRR NIH HHS 1-UL1-RR-024150-01NCRR NIH HHS M01 RR000533NCRR NIH HHS M01-RR-00533NCRR NIH HHS UL1 RR024150NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1-RR-025005NCRR NIH HHS UL1 RR025771NCRR NIH HHS UL1-RR-025771NIAID NIH HHS N01 AI015416NIAID NIH HHS N01-AI-15416NIAID NIH HHS U19 AI110495NIAMS NIH HHS K23 AR052820NIAMS NIH HHS K23-AR-052820NIAMS NIH HHS K24 AR002224NIAMS NIH HHS K24-AR-02224NIAMS NIH HHS K24 AR049185NIAMS NIH HHS K24-AR-049185
6 · The paper itself

Abstract

objectiveNonsevere relapses are more common than severe relapses in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), but their clinical course and treatment outcomes remain largely unexamined. We undertook this study to analyze the outcomes of patients with nonsevere relapses in the Rituximab in ANCA-Associated Vasculitis (RAVE) trial who were treated with prednisone according to a prespecified protocol.

methodsRAVE was a randomized, double-blind, placebo-controlled trial comparing rituximab (RTX) to cyclophosphamide (CYC) followed by azathioprine (AZA) for induction of remission. Patients who experienced nonsevere relapses between months 1 and 18 were treated with a prednisone increase without a concomitant change in their nonglucocorticoid immunosuppressants, followed by a taper.

resultsForty-four patients with a first nonsevere relapse were analyzed. In comparison to the 71 patients who maintained relapse-free remission over 18 months, these patients were more likely to have proteinase 3-ANCAs, diagnoses of granulomatosis with polyangiitis (Wegener's), and a history of relapsing disease at baseline. A prednisone increase led to remission in 35 patients (80%). However, only 13 patients (30%) were able to maintain second remissions through the followup period (mean 12.5 months); 31 patients (70%) had a second disease relapse, 14 of them with severe disease. The mean time to second relapse was 9.4 months (4.7 months in the group treated with RTX versus 13.7 months in the group treated with CYC/AZA; P < 0.01). Patients who experienced nonsevere relapses received more glucocorticoids than those who maintained remission (6.7 grams versus 3.8 grams; P < 0.01).

conclusionTreatment of nonsevere relapses in AAV with an increase in glucocorticoids is effective in restoring temporary remission in the majority of patients, but recurrent relapses within a relatively short interval remain common. Alternative treatment approaches are needed for this important subset of patients.

Indexed as

Antibodies, Monoclonal, Murine-DerivedAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAutoantibodiesAzathioprineCyclophosphamideDouble-Blind MethodFemaleGlucocorticoidsGranulomatosis with PolyangiitisHumansImmunosuppressive AgentsMaintenance ChemotherapyMaleMicroscopic PolyangiitisMyeloblastinPeroxidaseAntibodies, Monoclonal, Murine-DerivedAutoantibodiesAzathioprineCyclophosphamideGlucocorticoidsImmunosuppressive AgentsMyeloblastinPeroxidasePrednisoneRituximab

Identifiers

PMID25776953
PMCPMC5956529
OpenAlexW2137080874

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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.