Evidence map›Paper›PMID 27110697›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2016

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Treatment With Sirukumab (CNTO 136) in Patients With Active Lupus Nephritis.

Brad H Rovin, Ronald F van Vollenhoven, Cynthia Aranow, Carrie Wagner, Robert Gordon, Yanli Zhuang, Stanley Belkowski, Benjamin Hsu

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  6. Immunosuppressive treatment for proliferative lupus nephritis.The Cochrane database of systematic reviews · 2018
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8 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

8 authors.

Brad H RovinOhio State University and Ohio State University Wexner Medical Center, Columbus.
Ronald F van VollenhovenAmsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands).
Cynthia AranowFeinstein Institute for Medical Research, Northwell Health, Manhasset, New York.
Carrie WagnerJanssen Research & Development, LLC, Spring House, Pennsylvania.
Robert GordonJanssen Research & Development, LLC, Spring House, Pennsylvania.
Yanli ZhuangJanssen Research & Development, LLC, Spring House, Pennsylvania.
Stanley BelkowskiJanssen Research & Development, LLC, Spring House, Pennsylvania.
Benjamin HsuJanssen Research & Development, San Carlos, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy and safety of sirukumab, an anti-interleukin-6 monoclonal antibody, for the treatment of patients with active lupus nephritis (LN).

methodsPatients with class III or class IV LN (as determined by renal biopsy within 14 months of randomization) who had persistent proteinuria (>0.5 gm/day) despite receiving immunosuppressive therapy and who were being treated with stable doses of a renin-angiotensin system blocker were randomized (5:1) to receive treatment with sirukumab at a dose of 10 mg/kg intravenously (n = 21) or placebo (n = 4) every 4 weeks through week 24. The primary end point was the percent reduction in proteinuria (measured as the protein-to-creatinine [P:C] ratio in a 12-hour urine collection) from baseline to week 24.

resultsTwenty-five patients were enrolled, of whom 19 (76.0%) completed treatment through week 24 and 6 (24.0%) discontinued the study agent early, with 5 of the 6 discontinuing due to adverse events. At week 24, the median percent change in proteinuria from baseline to week 24 in sirukumab-treated patients was 0.0% (95% confidence interval -61.8, 39.6). In contrast, the 4 placebo-treated patients showed an increase in proteinuria (median percent reduction -43.3%) at week 24. Of note, a subset of 5 sirukumab-treated patients had ≥50% improvement in their P:C ratio through week 28. In the sirukumab group, 47.6% of patients experienced ≥1 serious adverse event through week 40; most were infection-related. No deaths or malignancies occurred. No serious adverse events were observed in the 4 placebo-treated patients.

conclusionThis proof-of-concept study did not demonstrate the anticipated efficacy nor did it demonstrate an acceptable safety profile for sirukumab treatment in this population of patients with active LN receiving concomitant immunosuppressive treatment.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodFemaleHumansLupus NephritisMaleTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedsirukumab

Identifiers

PMID27110697
PMCPMC5129491

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.