Evidence map›Paper›PMID 38258434›Full record

Trial reportRheumatology (Oxford, England)2024

Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis up to 6.5 years of treatment: results of a long-term study.

Roberto Caporali, Peter C Taylor, Daniel Aletaha, Raimon Sanmartí, Tsutomu Takeuchi, Daojun Mo, Ewa Haladyj, Natalia Bello, Liliana Zaremba-Pechmann, Ying Fang and 1 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
4.2field-weighted citation impact, top 6% 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.

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
NCT06768294 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Baricitinib in Calcium PyrophosphAte DePosiTion DIseaSe Trial - a Proof of Concept Phase II Clinical Trial

TypeinterventionalSponsorI.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioRan2025 to 2027Enrolled32ConditionsCalcium Pyrophosphate Deposition Disease, ChondrocalcinosisArmsBaricitinib 4 MG Oral Tablet, Methylprednisolone (Corticosteroid), Colchicine 1 MG Oral Tablet, Hydroxychloroquine 200 mg, Methotrexate + Folic Acid
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

  1. Observational
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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

11 authors at 8 institutions in 7 countries.

Roberto CaporaliDepartment of Clinical Sciences & Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, Università degli Studi di Milano and ASST Gaetano Pini CTO, Milano, Italy.ORCID 0000-0001-6331-8559
Peter C TaylorBotnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-7766-6167
Daniel AletahaDepartment of Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria.
Raimon SanmartíRheumatology Department, Hospital Clínic de Barcelona and IDIBAPS, Barcelona, Spain.
Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo and Saitama Medical University, Saitama, Japan.
Daojun MoEli Lilly and Company, Indianapolis, IN, USA.
Ewa HaladyjEli Lilly and Company, Indianapolis, IN, USA.
Natalia BelloEli Lilly and Company, Indianapolis, IN, USA.
Liliana Zaremba-PechmannHaaPACS GmbH, Schriesheim, Germany.
Ying FangEli Lilly and Company, Indianapolis, IN, USA.
Maxime DougadosRheumatology Department, Cochin Hospital, APHP, Paris and INSERM U-1153, CRESS Paris-Sorbonne, Paris, France.
Eli Lilly (United States) · USCarrier (United States) · USDélégation Paris 5 · FRHospital Clínic de Barcelona · ESKeio University · JPMedical University of Vienna · ATNuffield Orthopaedic Centre · GBUniversity of Milan · IT

Funding

AbbVieEli Lilly and Company
6 · The paper itself

Abstract

objectivesTo evaluate the long-term efficacy of once-daily baricitinib 4 mg or 2 mg in patients with active rheumatoid arthritis who had inadequate response (IR) to MTX, csDMARDs or bDMARDs.

methodsData from three completed phase III studies-RA-BEAM (MTX-IR), RA-BUILD (csDMARD-IR) and RA-BEACON (bDMARD-IR)-and one completed long-term extension study (RA-BEYOND) were analysed up to 6.5 years [340 weeks (RA-BEAM) and 336 weeks (RA-BUILD and RA-BEACON)]. Low disease activity (LDA) [Simplified Disease Activity Index (SDAI) ≤11], clinical remission (SDAI ≤3.3) and physical function [Health Assessment Questionnaire Disability Index (HAQ-DI) ≤0.5] were the main outcomes assessed. Completer and non-responder imputation (NRI) analyses were conducted on each population.

resultsAt week 340 or 336, LDA was achieved in 37%/83% of MTX-IR, 35%/83% of csDMARD-IR and 23%/73% of bDMARD-IR patients treated with baricitinib 4 mg, assessed by NRI/completer analyses, respectively. Remission was achieved in 20%/40% of MTX-IR, 13%/32% of csDMARD-IR and 9%/30% of bDMARD-IR patients treated with baricitinib 4 mg, assessed by NRI/completer analyses, respectively. HAQ-DI ≤0.5 was reached in 31%/51% of MTX-IR, 25%/46% of csDMARD-IR and 24%/38% of bDMARD-IR patients treated with baricitinib 4 mg, assessed by NRI/completer analyses, respectively.

conclusionTreatment with baricitinib 4 mg or 2 mg demonstrated efficacy up to 6.5 years with maintained LDA/remission results across SDAI, CDAI and DAS28-hsCRP consistent with previously reported data, and was well tolerated.

trial registrationUnited States National Library of Medicine clinical trials database www.clinicaltrials.gov; RA-BEYOND; NCT01885078.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAzetidinesPurinesPyrazolesSeverity of Illness IndexSulfonamidesAdultFemaleHumansMaleMethotrexateMiddle AgedRemission InductionTreatment OutcomeAntirheumatic AgentsAzetidinesbaricitinibMethotrexatePurinesPyrazolesSulfonamidesbaricitinibclinical remissionlong-term efficacylow disease activityrheumatoid arthritis

Identifiers

PMID38258434
PMCPMC11443035
OpenAlexW4391142811

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.