Evidence map›Paper›PMID 30194275›Full record

Trial reportAnnals of the rheumatic diseases2019

Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study.

Tsutomu Takeuchi, Mark C Genovese, Boulos Haraoui, Zhanguo Li, Li Xie, Rena Klar, Ana Pinto-Correia, Susan Otawa, Pedro Lopez-Romero, Inmaculada de la Torre and 3 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 6 pooled it
–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

37 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  11. [Tapering of treatment with JAK inhibitors].Zeitschrift fur Rheumatologie · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Tsutomu TakeuchiDivision of Rheumatology, Keio University School of Medicine, Tokyo, Japan tsutake@z5.keio.jp.
Mark C GenoveseRheumatology, Stanford University Medical Center, Palo Alto, California, USA.
Boulos HaraouiDepartment of Medicine, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Zhanguo LiPeking University People's Hospital, Beijing, China.
Li XieEli Lilly & Company, Indianapolis, Indiana, USA.
Rena KlarIQVIA, Durham, North Carolina, USA.
Ana Pinto-CorreiaEli Lilly & Company, Indianapolis, Indiana, USA.
Susan OtawaEli Lilly & Company, Indianapolis, Indiana, USA.
Pedro Lopez-RomeroEli Lilly & Company, Indianapolis, Indiana, USA.
Inmaculada de la TorreEli Lilly & Company, Indianapolis, Indiana, USA.
William MaciasEli Lilly & Company, Indianapolis, Indiana, USA.
Terence P RooneyEli Lilly & Company, Indianapolis, Indiana, USA.
Josef S SmolenDivision of Rheumatology, Department of Internal Medicine 3, Medical University of Vienna, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study investigated the effects of dose step-down in patients with rheumatoid arthritis (RA) who achieved sustained disease control with baricitinib 4 mg once a day.

methodsPatients who completed a baricitinib phase 3 study could enter a long-term extension (LTE). In the LTE, patients who received baricitinib 4 mg for ≥15 months and maintained CDAI low disease activity (LDA) or remission (REM) were blindly randomised to continue 4 mg or taper to 2 mg. Patients could rescue (to 4 mg) if needed. Efficacy and safety were assessed through 48 weeks.

resultsPatients in both groups maintained LDA (80% 4 mg; 67% 2 mg) or REM (40% 4 mg; 33% 2 mg) over 48 weeks. However, dose reduction resulted in small, statistically significant increases in disease activity at 12, 24 and 48 weeks. Dose reduction also produced earlier and more frequent relapse (loss of step-down criteria) over 48 weeks compared with 4 mg maintenance (23% 4 mg vs 37% 2 mg, p=0.001). Rescue rates were 10% for baricitinib 4 mg and 18% for baricitinib 2 mg. Dose reduction was associated with a numerically lower rate of non-serious infections (30.6 for baricitinib 4 mg vs 24.9 for 2 mg). Rates of serious adverse events and adverse events leading to discontinuation were similar across groups.

conclusionsIn a large randomised, blinded phase 3 study, maintenance of RA control following induction of sustained LDA/REM with baricitinib 4 mg was greater with continued 4 mg than after taper to 2 mg. Nonetheless, most patients tapered to 2 mg could maintain LDA/REM or recapture with return to 4 mg if needed.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidAzetidinesDrug Therapy, CombinationFemaleHumansInduction ChemotherapyMaintenance ChemotherapyMaleMiddle AgedProspective StudiesPurinesPyrazolesSeverity of Illness IndexSingle-Blind MethodAntirheumatic AgentsAzetidinesbaricitinibPurinesPyrazolesSulfonamidesdisease activityDMARDs (biologic)DMARDs (synthetic)rheumatoid arthritis

Identifiers

PMID30194275
PMCPMC6352419

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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.