Evidence map›Paper›PMID 23313811›Full record

Trial reportAnnals of the rheumatic diseases2014

Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study.

Daniel J Wallace, Kenneth Kalunian, Michelle A Petri, Vibeke Strand, Frederic A Houssiau, Marilyn Pike, Brian Kilgallen, Sabine Bongardt, Anna Barry, Lexy Kelley and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00624351 (A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus), which is not on this map. Cited by 128 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
128citing papers in PubMed, 8 pooled it
35.0field-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.

NCT00624351 phase2completednot on this map

A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

TypeinterventionalSponsorUCB PharmaRan2008 to 2009Enrolled227ConditionsSystemic Lupus ErythematosusArmsEpratuzumab, Placebo
3 · Its place in the literature

Who cites it

128 citing papers in PubMed, 8 syntheses or guidelines pooled it, 328 citations in OpenAlex.

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  6. Interventions for cutaneous disease in systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021
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68 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

11 authors at 9 institutions in 4 countries.

Daniel J WallaceDavid Geffen School of Medicine at UCLA, Cedars-Sinai Medical Center, UCLA, Los Angeles, California, USA.
Kenneth Kalunian
Michelle A Petri
Vibeke Strand
Frederic A Houssiau
Marilyn Pike
Brian Kilgallen
Sabine Bongardt
Anna Barry
Lexy Kelley
Caroline Gordon
UCB Pharma (United States) · USCliniques Universitaires Saint-Luc · BEJohns Hopkins Medicine · USMassachusetts General Hospital · USStanford University · USUCB Pharma (Germany) · DEUniversity of California, Los Angeles · USUniversity of California, San Diego · USWellcome Trust · GB

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
NCATS NIH HHS UL1 TR001079
6 · The paper itself

Abstract

objectiveTo identify a suitable dosing regimen of the CD22-targeted monoclonal antibody epratuzumab in adults with moderately to severely active systemic lupus erythematosus (SLE).

methodsA phase IIb, multicentre, randomised controlled study (NCT00624351) was conducted with 227 patients (37-39 per arm) receiving either: placebo, epratuzumab 200 mg cumulative dose (cd) (100 mg every other week (EOW)), 800 mg cd (400 mg EOW), 2400 mg cd (600 mg weekly), 2400 mg cd (1200 mg EOW), or 3600 mg cd (1800 mg EOW). The primary endpoint (not powered for significance) was the week 12 responder rate measured using a novel composite endpoint, the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA).

resultsProportion of responders was higher in all epratuzumab groups than with placebo (overall treatment effect test p=0.148). Exploratory pairwise analysis demonstrated clinical improvement in patients receiving a cd of 2400 mg epratuzumab (OR for 600 mg weekly vs placebo: 3.2 (95% CI 1.1 to 8.8), nominal p=0.03; OR for 1200 mg EOW vs placebo: 2.6 (0.9 to 7.1), nominal p=0.07). Post-hoc comparison of all 2400 mg cd patients versus placebo found an overall treatment effect (OR=2.9 (1.2 to 7.1), nominal p=0.02). Incidence of adverse events (AEs), serious AEs and infusion reactions was similar between epratuzumab and placebo groups, without decreases in immunoglobulin levels and only partial reduction in B-cell levels.

conclusionsTreatment with epratuzumab 2400 mg cd was well tolerated in patients with moderately to severely active SLE, and associated with improvements in disease activity. Phase III studies are ongoing.

Indexed as

Severity of Illness IndexAdultAntibodies, Monoclonal, HumanizedB-LymphocytesDouble-Blind MethodFemaleHumansImmunosuppressive AgentsLupus Erythematosus, SystemicMaleMiddle AgedPlacebosTreatment OutcomeAntibodies, Monoclonal, HumanizedepratuzumabImmunosuppressive AgentsPlacebosB cellsSystemic Lupus ErythematosusTreatment

Identifiers

PMID23313811
PMCPMC3888603
OpenAlexW2111416025

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.