Evidence map›Paper›PMID 34184191›Full record

ArticleRheumatology and therapy2021

Baricitinib and the Risk of Incident Interstitial Lung Disease: A Descriptive Clinical Case Report from Clinical Trials.

Carlo Salvarani, Marco Sebastiani, Philippe Dieude, Miriam Garcia, Walter Deberdt, Veronica Rogai, Inmaculada de la Torre, José Inciarte-Mundo, Alejandro Balsa

Open access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 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
2.8field-weighted citation impact, top 9% 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.

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, 25 citations in OpenAlex.

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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

9 authors at 6 institutions in 4 countries.

Carlo SalvaraniRheumatology Unit, Azienda USL-IRCCS di Reggio Emilia and Università di Modena e Reggio Emilia, Viale Risorgimento, 80, 42123, Modena, Reggio Emilia, Italy. carlo.salvarani@unimore.it.
Marco SebastianiRheumatology Unit, Department of Surgery, Medicine, Dentistry and Morphological Sciences with Transplant Surgery, Oncology and Regenerative Medicine Relevance, University of Modena and Reggio Emilia, Modena, Italy.
Philippe DieudeDepartment of Rheumatology, DMU Locomotion, INSERM UMR1152, Hôpital Bichat-Claude Bernard, APHP, Université de Paris, Paris, France.
Miriam GarciaEli Lilly and Company, Indianapolis, IN, USA.
Walter DeberdtEli Lilly and Company, Indianapolis, IN, USA.
Veronica RogaiEli Lilly and Company, Indianapolis, IN, USA.
Inmaculada de la TorreEli Lilly and Company, Indianapolis, IN, USA.
José Inciarte-MundoRheumatology Department, Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain.
Alejandro BalsaRheumatology Department, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.
Eli Lilly (United States) · USHospital Clínic de Barcelona · ESHospital La Paz Institute for Health Research · ESIstituti di Ricovero e Cura a Carattere Scientifico · ITUniversité Paris Cité · FRUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesInterstitial lung disease (ILD) occurs in up to 30% of patients with rheumatoid arthritis (RA), resulting in increased morbidity and death in the absence of proven therapies. The aim of this study is to estimate the number of incident ILD cases reported through development studies with baricitinib in patients with RA.

methodsEstimates were based on 3770 patients with RA from eight randomized clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension study on baricitinib for which ILD was not an exclusion criterion with 12,358 patient-years of exposure (PYE).

resultsTwenty-one non-infectious cases of ILD were reported with an exposure-adjusted incidence rate (EAIR) of 0.17 per 100 PYE. Of the 21 cases, six were reported as serious and 15 as non-serious resulting in an incidence rate of 0.05 per 100 PYE and 0.12 per 100 PYE, respectively. There were also 11 cases caused by an infectious agent: seven serious (IR: 0.06 per 100 PYE) and four non-serious cases (IR: 0.03 per 100 PYE).

conclusionsThe findings of this analysis in patients with RA treated with baricitinib are consistent with a low risk to develop non-infectious ILD during baricitinib treatment, similar to that observed with other Janus kinase inhibitors.

Indexed as

BaricitinibInterstitial lung diseaseRheumatoid arthritis

Identifiers

PMID34184191
PMCPMC8380601
OpenAlexW3173844848

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.