Evidence map›Paper›PMID 30043749›Full record

Trial reportLancet (London, England)2018

Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial.

Daniel J Wallace, Richard A Furie, Yoshiya Tanaka, Kenneth C Kalunian, Marta Mosca, Michelle A Petri, Thomas Dörner, Mario H Cardiel, Ian N Bruce, Elisa Gomez and 7 more

Erratum issued Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02708095 (A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus), which is not on this map. Cited by 230 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
230citing papers in PubMed, 11 pooled it
53.6field-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.

NCT02708095 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2017Enrolled314ConditionsSystemic Lupus ErythematosusArmsBaricitinib, Placebo
3 · Its place in the literature

Who cites it

230 citing papers in PubMed, 11 syntheses or guidelines pooled it, 501 citations in OpenAlex.

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  8. Interventions for cutaneous disease in systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021
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170 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 5 countries.

Daniel J WallaceDivision of Rheumatology, Cedars-Sinai Medical Center, University of California at Los Angeles, Los Angeles, CA, USA. Electronic address: danielwallac@gmail.com.
Richard A FurieDivision of Rheumatology, Zucker School of Medicine at Hofstra, Northwell, New York, NY, USA.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Kenneth C KalunianDivision of Rheumatology, University of California at San Diego School of Medicine, La Jolla, CA, USA.
Marta MoscaDivision of Rheumatology, University of Pisa, Pisa, Italy.
Michelle A PetriDivision of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Thomas DörnerDivision of Rheumatology, Charite Universitätsmedizin Berlin, Berlin, Germany.
Mario H CardielCentro de Investigación Clínica de Morelia SC, Morelia, México.
Ian N BruceArthritis Research UK Centre for Epidemiology, Faculty of Biology, Medicine and Health, The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Elisa GomezEli Lilly and Company, Indianapolis, IN, USA.
Tara CarmackEli Lilly and Company, Indianapolis, IN, USA.
Amy M DeLozierEli Lilly and Company, Indianapolis, IN, USA.
Jonathan M JanesEli Lilly and Company, Indianapolis, IN, USA.
Matthew D LinnikLilly Biotechnology Center, San Diego, CA, USA.
Stephanie de BonoEli Lilly and Company, Indianapolis, IN, USA.
Maria E SilkEli Lilly and Company, Indianapolis, IN, USA.
Robert W HoffmanEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USCharité - Universitätsmedizin Berlin · DEHofstra University · USJohns Hopkins University · USUniversity of California, Los Angeles · USUniversity of California, San Diego · USUniversity of Manchester · GBUniversity of Occupational and Environmental Health Japan · JPUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus.

methodsIn this double-blind, multicentre, randomised, placebo-controlled, 24-week phase 2 study, patients were recruited from 78 centres in 11 countries. Eligible patients were aged 18 years or older, had a diagnosis of systemic lupus erythematosus, and had active disease involving skin or joints. We randomly assigned patients (1:1:1) to receive once-daily baricitinib 2 mg, baricitinib 4 mg, or placebo for 24 weeks. The primary endpoint was the proportion of patients achieving resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT02708095.

findingsBetween March 24, 2016, and April 27, 2017, 314 patients were randomly assigned to receive placebo (n=105), baricitinib 2 mg (n=105), or baricitinib 4 mg (n=104). At week 24, resolution of SLEDAI-2K arthritis or rash was achieved by 70 (67%) of 104 patients receiving baricitinib 4 mg (odds ratio [OR] vs placebo 1·8, 95% CI 1·0-3·3; p=0·0414) and 61 (58%) of 105 patients receiving baricitinib 2 mg (OR 1·3, 0·7-2·3; p=0·39). Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group. Serious adverse events were reported in ten (10%) patients receiving baricitinib 4 mg, 11 (10%) receiving baricitinib 2 mg, and five (5%) receiving placebo; no deaths were reported. Serious infections were reported in six (6%) patients with baricitinib 4 mg, two (2%) with baricitinib 2 mg, and one (1%) with placebo.

interpretationThe baricitinib 4 mg dose, but not the 2 mg dose, significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the foundation for future phase 3 trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for systemic lupus erythematosus.

fundingEli Lilly and Company.

Indexed as

Administration, OralAdultArthritisAzetidinesCholesterolCholesterol, HDLCreatine KinaseDose-Response Relationship, DrugDouble-Blind MethodExanthemaFemaleHumansInfectionsJanus Kinase InhibitorsLupus Erythematosus, SystemicMaleAzetidinesbaricitinibCholesterolCholesterol, HDLCreatine KinaseJanus Kinase InhibitorsPurinesPyrazolesSulfonamides

Identifiers

PMID30043749
OpenAlexW2883700530

What OpenQuestion holds

Textmetadata
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.