Evidence map›Paper›PMID 26992106›Full record

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

Cumulative Corticosteroid Dose Over Fifty-Two Weeks in Patients With Systemic Lupus Erythematosus: Pooled Analyses From the Phase III Belimumab Trials.

Ronald F van Vollenhoven, Michelle Petri, Daniel J Wallace, David A Roth, Charles T Molta, Anne E Hammer, Yongqiang Tang, April Thompson

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
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 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–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

26 citing papers in PubMed.

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  19. The Contribution of Drugs andInternational journal of rheumatology · 2019
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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.

Ronald F van VollenhovenAcademic Medical Center, Amsterdam, The Netherlands.
Michelle PetriJohns Hopkins University School of Medicine, Baltimore, Maryland.
Daniel J WallaceCedars-Sinai Medical Center and University of California, Los Angeles David Geffen School of Medicine, Los Angeles.
David A RothGlaxoSmithKline, Research Triangle Park, North Carolina.
Charles T MoltaGlaxoSmithKline, Philadelphia, Pennsylvania.
Anne E HammerGlaxoSmithKline, Research Triangle Park, North Carolina.
Yongqiang TangGlaxoSmithKline, Research Triangle Park, North Carolina.
April ThompsonGlaxoSmithKline, Research Triangle Park, North Carolina.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine the effects of treatment with belimumab on corticosteroid dose in patients with systemic lupus erythematosus (SLE) over 52 weeks in 2 randomized, controlled trials.

methodsData on patients who were taking corticosteroids at baseline in the Study of Belimumab in Subjects with SLE trials were pooled post hoc to compare patients who received belimumab 10 mg/kg plus standard therapy with those who received placebo plus standard therapy. The primary end point was cumulative change from baseline in corticosteroid dose (prednisone equivalent) through week 52. Further analyses specifically examined oral corticosteroid dose.

resultsAt baseline, 966 of 1,125 patients (86%) were receiving corticosteroids (478 belimumab 10 mg/kg and 488 placebo). Most were women (94%), their mean age was 37.1 years, mean Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index score was 9.8, and mean corticosteroid dosage was 12.5 mg/day. Over 52 weeks, there was a smaller increase in mean cumulative corticosteroid dose for the belimumab group than for the placebo group (531.2 mg versus 916.3 mg; P < 0.0001). Compared with placebo, the mean of all decreases in cumulative corticosteroid dose was higher with belimumab (P = 0.0165), and the mean of all increases was lower (P = 0.0005). More patients in the belimumab group had decreases in oral corticosteroid dose (38.5% versus 30.9%), and fewer had increases in dose (18.4% versus 30.7%), compared with placebo. Adverse events were comparable across groups.

conclusionOur findings show a significantly smaller increase in cumulative corticosteroid dose over 1 year, more patients with decreases in oral corticosteroid dose, and fewer patients with increases in oral corticosteroid dose in the belimumab group compared with the placebo group. These data suggest that belimumab may be steroid sparing.

Indexed as

Adrenal Cortex HormonesAdultAntibodies, Monoclonal, HumanizedFemaleHumansImmunosuppressive AgentsLupus Erythematosus, SystemicMaleTime FactorsAdrenal Cortex HormonesAntibodies, Monoclonal, HumanizedbelimumabImmunosuppressive Agents

Identifiers

PMID26992106
PMCPMC5129492

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Registered trials

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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.