Evidence map›Paper›PMID 34615636›Full record

Trial reportAnnals of the rheumatic diseases2022

B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial.

Richard A Furie, Gustavo Aroca, Matthew D Cascino, Jay P Garg, Brad H Rovin, Analia Alvarez, Hilda Fragoso-Loyo, Elizabeth Zuta-Santillan, Thomas Schindler, Paul Brunetta and 3 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02550652 (A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis), which is not on this map. Cited by 222 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
222citing papers in PubMed, 9 pooled it
64.3field-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.

NCT02550652 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

TypeinterventionalSponsorHoffmann-La RocheRan2015 to 2023Enrolled126ConditionsLupus NephritisArmsMycophenolate Mofetil/Mycophenolic Acid, Obinutuzumab, Placebo, Methylprednisolone, Prednisone
3 · Its place in the literature

Who cites it

222 citing papers in PubMed, 9 syntheses or guidelines pooled it, 406 citations in OpenAlex.

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162 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

13 authors at 7 institutions in 7 countries.

Richard A FurieDivision of Rheumatology, Northwell Health, Great Neck, New York, USA RFurie@northwell.edu.
Gustavo ArocaUniversidad Simón Bolívar and Clínica de la Costa, Barranquilla, Colombia.
Matthew D CascinoGenentech Inc, South San Francisco, California, USA.
Jay P GargGenentech Inc, South San Francisco, California, USA.
Brad H RovinDivision of Nephrology, Department of Medicine, The Ohio State University, Columbus, Ohio, USA.
Analia AlvarezCEMIC, Buenos Aires, Argentina.
Hilda Fragoso-LoyoDepartment of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Elizabeth Zuta-SantillanInstituto de Ginecología y Reproducción, Lima, Peru.
Thomas SchindlerF. Hoffmann-La Roche AG, Basel, Switzerland.
Paul BrunettaGenentech Inc, South San Francisco, California, USA.
Cary M LooneyGenentech Inc, South San Francisco, California, USA.
Imran HassanHoffmann-La Roche Ltd, Mississauga, Ontario, Canada.
Ana MalvarOrganización Médica de Investigación, Buenos Aires, Argentina.
Roche (Switzerland) · CHCentro de Educación Médica e Investigaciones Clínicas Norberto Quirno · ARCentro de Infertilidad y Reproducción Humana · ESInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXNorthwell Health · USThe Ohio State University · USUniversidad Simón Bolívar · CO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveRandomised trials of type I anti-CD20 antibodies rituximab and ocrelizumab failed to show benefit in proliferative lupus nephritis (LN). We compared obinutuzumab, a humanised type II anti-CD20 monoclonal antibody that induces potent B-cell depletion, with placebo for the treatment of LN in combination with standard therapies.

methodsPatients with LN receiving mycophenolate and corticosteroids were randomised to obinutuzumab 1000 mg or placebo on day 1 and weeks 2, 24 and 26, and followed through week 104. The primary endpoint was complete renal response (CRR) at week 52. Exploratory analyses through week 104 were conducted. The prespecified alpha level was 0.2.

resultsA total of 125 patients were randomised and received blinded infusions. Achievement of CRR was greater with obinutuzumab at week 52 (primary endpoint, 22 (35%) vs 14 (23%) with placebo; percentage difference, 12% (95% CI -3.4% to 28%), p=0.115) and at week 104 (26 (41%) vs 14 (23%); percentage difference, 19% (95% CI 2.7% to 35%), p=0.026). Improvements in other renal response measures, serologies, estimated glomerular filtration rate and proteinuria were greater with obinutuzumab. Obinutuzumab was not associated with increases in serious adverse events, serious infections or deaths. Non-serious infusion-related reactions occurred more frequently with obinutuzumab.

conclusionsImproved renal responses through week 104 were observed in patients with LN who received obinutuzumab plus standard therapies compared with standard therapies alone. Obinutuzumab was well tolerated and no new safety signals were identified. TRIAL REGISTRATION NUMBER: NCT02550652.

Indexed as

Adrenal Cortex HormonesAdultAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB-LymphocytesDouble-Blind MethodDrug Therapy, CombinationEnzyme InhibitorsFemaleGlomerular Filtration RateHumansLupus NephritisMaleMycophenolic AcidPlacebosTreatment OutcomeAdrenal Cortex HormonesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalEnzyme InhibitorsMycophenolic AcidobinutuzumabPlaceboslupus erythematosuslupus nephritisrituximabsystemic

Identifiers

PMID34615636
PMCPMC8762029
OpenAlexW3202510981

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.