TY - JOUR
T1 - Baricitinib and the Risk of Incident Interstitial Lung Disease
T2 - A Descriptive Clinical Case Report from Clinical Trials
AU - Salvarani, Carlo
AU - Sebastiani, Marco
AU - Dieude, Philippe
AU - Garcia, Miriam
AU - Deberdt, Walter
AU - Rogai, Veronica
AU - de la Torre, Inmaculada
AU - Inciarte-Mundo, José
AU - Balsa, Alejandro
N1 - Funding Information:
We thank the participants of the study. The study and Rapid service Fee were funded by Eli Lilly and Company. The authors would like to thank Adam Clooney, PhD, employee of Eli Lilly, for writing and editorial assistance. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Miriam Garcia, Veronica Rogai, Inmaculada de la Torre: concept, study design, results interpretation and drafting the manuscript Walter Deberdt, Carlo Salvarani, Alejandro Balsa: study design, results interpretation and drafting the manuscript Marco Sebastiani, Philippe Dieude, Jos? Inciarte-Mundo: concept, results interpretation and drafting the manuscript. Carlo Salvarani: Consultant: Eli Lilly, BMS, Roche, Pfizer, Novartis. Miriam Garcia, Veronica Rogai and Walter Deberdt are employees of Eli Lilly and Company. Inmaculada de la Torre: is an employee and stakeholder of Eli Lilly and Company. Alejandro Balsa: received speaker grants and honoraria from AbbVie, BMS, Pfizer, Gilead, Galapagos, Roche, Sanofi, UCB, Amgen, Sandoz and Novartis. Philippe Dieude: Consultant: BMS, Pfizer, Roche, Chugai, MEDAC, Eli Lilly, Sanofi-Genzyme, Janssen, Boehringer Ingelheim; Unrestricted grant: BMS, Pfizer, Roche, Chugai. Jos? Inciarte-Mundo: received fees from Pfizer, AbbVie, Roche, UCB, Lilly, BMS and MSD for research grant, consultation and/or speaker. JI was an Eli and Lilly Company employee from 2017 to 2019. Marco Sebastiani has nothing to disclose. This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. All data generated or analyzed during this study are included in this published article/as supplementary information files.
Funding Information:
The study and Rapid service Fee were funded by Eli Lilly and Company.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/9
Y1 - 2021/9
N2 - Objectives: Interstitial 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. Methods: Estimates 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). Results: Twenty-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). Conclusions: The 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.
AB - Objectives: Interstitial 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. Methods: Estimates 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). Results: Twenty-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). Conclusions: The 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.
KW - Baricitinib
KW - Interstitial lung disease
KW - Rheumatoid arthritis
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U2 - 10.1007/s40744-021-00332-w
DO - 10.1007/s40744-021-00332-w
M3 - Article
AN - SCOPUS:85113264928
VL - 8
SP - 1435
EP - 1441
JO - Rheumatology and Therapy
JF - Rheumatology and Therapy
SN - 2198-6576
IS - 3
ER -