Evidence map›Paper›PMID 33200220›Full record

Trial reportRheumatology (Oxford, England)2021

Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study.

Josef S Smolen, Li Xie, Bochao Jia, Peter C Taylor, Gerd Burmester, Yoshiya Tanaka, Ayesha Elias, Anabela Cardoso, Rob Ortmann, Chad Walls and 1 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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

9 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Article
  4. Article
  5. Review
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  7. Review
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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.

Josef S SmolenDivision of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
Li XieLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Bochao JiaLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Peter C TaylorNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-7766-6167
Gerd BurmesterCharité - University of Medicine Berlin, Berlin, Germany.
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Ayesha EliasLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Anabela CardosoLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Rob OrtmannLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Chad WallsLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Maxime DougadosCochin Hospital, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the long-term efficacy of once-daily baricitinib 4 mg in patients with active RA who were either naïve to DMARDs or who had inadequate response (IR) to MTX.

methodsAnalyses of data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naïve) and RA-BEAM (MTX-IR), and one ongoing long-term extension (LTE) study (RA-BEYOND) were performed (148 total weeks). At week 52, DMARD-naïve patients treated with MTX monotherapy or baricitinib 4 mg+MTX in RA-BEGIN were switched to open-label baricitinib 4 mg monotherapy; MTX-IR patients treated with adalimumab (+MTX) in RA-BEAM were switched to open-label baricitinib 4 mg (+MTX) in the LTE. Patients who received placebo (+MTX) were switched to baricitinib 4 mg (+MTX) at week 24. Low disease activity (LDA) [Simple Disease Activity Index (SDAI) ≤11], clinical remission (SDAI ≤ 3.3), and physical functioning [Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5] were assessed. Data were assessed using a non-responder imputation.

resultsAt week 148, SDAI LDA was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI ≤ 0.5 was reached in up to 48% of DMARD-naïve patients and 38% of MTX-IR patients initially treated with baricitinib. Over 148 weeks, 3.6% and 10.7% of MTX-IR patients discontinued across treatment groups due to lack of efficacy or due to adverse events, respectively; discontinuation rates were similar in the DMARD-naïve population.

conclusionTreatment with baricitinib 4 mg demonstrated efficacy for up to 3 years and was well tolerated.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidAzetidinesDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedPurinesPyrazolesSulfonamidesTreatment OutcomeAntirheumatic AgentsAzetidinesbaricitinibMethotrexatePurinesPyrazolesSulfonamidesbaricitinibclinical remissionlong-term efficacylow disease activityrheumatoid arthritis

Identifiers

PMID33200220
PMCPMC8121442

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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.