Evidence map›Paper›PMID 29463520›Full record

ReviewAnnals of the rheumatic diseases2018

Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies.

Peter C Taylor, Joel M Kremer, Paul Emery, Steven H Zuckerman, Giacomo Ruotolo, Jinglin Zhong, Lei Chen, Sarah Witt, Chadi Saifan, Monika Kurzawa and 7 more

8 registry-linked trialsOpen access · hybridAbstract readReview
In one paragraph

Review in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 3% 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.

NCT00902486 phase2completednot on this map

A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics

TypeinterventionalSponsorIncyte CorporationRan2009 to 2010Enrolled127ConditionsRheumatoid ArthritisArmsINCB028050, Placebo
NCT01185353 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2010 to 2014Enrolled301ConditionsArthritis, RheumatoidArmsLY3009104, Placebo, Methotrexate
NCT01469013 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2011 to 2013Enrolled145ConditionsArthritis, RheumatoidArmsPlacebo, Baricitinib, Methotrexate
NCT01710358 phase3completednot on this map

A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2015Enrolled1,307ConditionsRheumatoid ArthritisArmsAdalimumab, Baricitinib, Methotrexate, Adalimumab Placebo, Baricitinib Placebo
NCT01711359 phase3completednot on this map

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2015Enrolled588ConditionsRheumatoid ArthritisArmsBaricitinib, Methotrexate, Baricitinib Placebo, MTX Placebo, Folic Acid
NCT01721044 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

TypeinterventionalSponsorEli Lilly and CompanyRan2013 to 2014Enrolled527ConditionsRheumatoid ArthritisArmsPlacebo, Baricitinib, cDMARD
NCT01721057 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2014Enrolled684ConditionsRheumatoid ArthritisArmsPlacebo, Baricitinib, cDMARD
NCT01885078 phase3completednot on this map

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis

TypeinterventionalSponsorEli Lilly and CompanyRan2013 to 2020Enrolled2,877ConditionsRheumatoid ArthritisArmsBaricitinib, Placebo
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Topical ruxolitinib ± oral baricitinib in the treatment of active non-segmental vitiligo: A retrospective analysis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. [Effectiveness of tofacitinib combined with iguratimod in the treatment of difficult-to-treat moderate-to-severe rheumatoid arthritis].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2023
    Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review
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

17 authors at 7 institutions in 2 countries.

Peter C TaylorBotnar Research Centre, Nuffield Department ofOrthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Joel M KremerCenter for Rheumatology, Albany Medical College, Albany, New York, USA.
Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Steven H ZuckermanEli Lilly and Company, Indianapolis, Indiana, USA.
Giacomo RuotoloEli Lilly and Company, Indianapolis, Indiana, USA.
Jinglin ZhongIQVIA, Morrisville, North Carolina, USA.
Lei ChenEli Lilly and Company, Indianapolis, Indiana, USA.
Sarah WittEli Lilly and Company, Indianapolis, Indiana, USA.
Chadi SaifanEli Lilly and Company, Indianapolis, Indiana, USA.
Monika KurzawaEli Lilly and Company, Indianapolis, Indiana, USA.
James D OtvosLaboratory Corporation of America Holdings (LabCorp), Morrisville, North Carolina, USA.
Margery A ConnellyLaboratory Corporation of America Holdings (LabCorp), Morrisville, North Carolina, USA.
William L MaciasEli Lilly and Company, Indianapolis, Indiana, USA.
Douglas E SchlichtingEli Lilly and Company, Indianapolis, Indiana, USA.
Terence P RooneyEli Lilly and Company, Indianapolis, Indiana, USA.
Stephanie de BonoEli Lilly and Company, Indianapolis, Indiana, USA.
Iain B McInnesInstitute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Eli Lilly (United States) · USLabCorp (United States) · USCenter for Rheumatology · USIQVIA (United States) · USUniversity of Glasgow · GBUniversity of Leeds · GBUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesLipid profiles are altered by active disease in patients with rheumatoid arthritis (RA) and may be further modified by treatment with Janus kinase inhibitors and other disease-modifying antirheumatic drugs.

methodsLipid data were analysed from phase II and III studies of 4 mg (n=997) and 2 mg (n=479) oral baricitinib administered once daily in patients with moderate-to-severe active RA. Lipoprotein particle size and number and GlycA were evaluated with nuclear magnetic resonance in one phase III study. The effect of statin therapy on lipid levels was evaluated in patients on statins at baseline and in patients who initiated statins during the study.

resultsTreatment with baricitinib was associated with increased levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides, but no significant change in LDL-C:HDL-C ratio. Lipid levels plateaued after 12 weeks of treatment. Baricitinib treatment increased large LDL and decreased small, dense LDL particle numbers and GlycA. Lipid changes from baseline were not significantly different between baseline statin users and non-users. In patients who initiated statin therapy during the study, LDL-C, triglycerides (baricitinib 4 mg only) and apolipoprotein B decreased to pre-baricitinib levels; HDL-C and apolipoprotein A-I levels remained elevated.

conclusionsBaricitinib was associated with increased LDL-C, HDL-C and triglyceride levels, but did not alter the LDL-C:HDL-C ratio. Evaluation of cardiovascular event rates during long-term treatment is warranted to further characterise these findings and their possible clinical implications. TRIAL REGISTRATION NUMBER: NCT00902486, NCT01469013, NCT01185353, NCT01721044, NCT01721057, NCT01711359, NCT01710358, NCT01885078.

Indexed as

Administration, OralAdultAgedAntirheumatic AgentsArthritis, RheumatoidAzetidinesCholesterol, HDLCholesterol, LDLClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLipid MetabolismAntirheumatic AgentsAzetidinesbaricitinibCholesterol, HDLCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsPurinesPyrazolesSulfonamidesDMARDs (biologics)lipidsrheumatoid arthritis

Identifiers

PMID29463520
PMCPMC6029633
OpenAlexW2789004799

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 2 more above

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 Socratic graph.