Olumiant ® (baricitinib)

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Olumiant® (baricitinib): Lung Disease in the Rheumatoid Arthritis Clinical Development Program

Interstitial lung disease and pulmonary fibrosis with baricitinib treatment has been reported in the rheumatoid arthritis clinical development program.


Incidence of Interstitial Lung Disease in Rheumatoid Arthritis

Depending on the study population, the prevalence of clinically significant ILD among RA patients has been reported to range between 5% to 30% or higher.1-3

Interstitial lung disease is a relatively common extra-articular manifestation of RA with subclinical interstitial lung abnormalities detected in 30% to 50% of RA patients.1,2

In addition to being a relatively common complication of RA, ILD confers a higher risk of mortality.2-4

Interstitial Lung Disease and Pulmonary Fibrosis in the Rheumatoid Arthritis Clinical Development Program

Description of the All BARI RA Dataset

The All BARI RA analysis set included 3770 patients with RA who received BARI at a variety of doses from 1 phase 1, 3 phase 2, and 5 phase 3 studies (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with

  • 13,148 PYE,
  • median exposure of 4.2 years,
  • maximum exposure of 8.4 years, and
  • data through 01 September 2019.5,6

Incidence of Interstitial Lung Disease in the All BARI RA Dataset

In the All BARI RA dataset, the MedDRA PT, ILD, was reported as a TEAE in 17 patients treated with BARI (0.5%; 0.1 EAIR); an EAIR of 0.1 per 100 PYE for patients treated with BARI is consistent with the background rate of ILD in patients with RA.7

Interstitial Lung Disease Events Leading to Temporary Interruption, Permanent Discontinuation, or Considered Serious

Of the 17 reported TEAEs of ILD, 13 patients had events that led to temporary interruption, permanent discontinuation, or were classified as SAE (see Incidence of Interstitial Lung Disease in the All BARI RA Safety Dataset).7

Incidence of Interstitial Lung Disease in the All BARI RA Safety Dataset7


n (EAIR)

Treatment Interruption
n (EAIR)

Permanent Study Discontinuation
n (EAIR)

n (EAIR)

All BARI RA (N=3770)

17 (0.1)

1 (0.0)

9 (0.1)

6 (0.05)

Abbreviations: BARI = baricitinib; EAIR = exposure-adjusted incidence rate;  RA = rheumatoid arthritis; SAE = serious adverse event; TEAE = treatment emergent adverse event.

Exposure-adjusted incidence rates were calculated as the number of patients with an event per 100 patient-years of exposure time, with exposure not censored at time of event.

Past Medical History

Three patients had a past medical history of ILD. One patient experienced an event >100 days after starting BARI.7

Confounding Variables

Ten patients were taking methotrexate concomitantly. Additionally, 2 of the patients reported smoking cigarettes.7

Resolution of Event

For the 7 patients who were hospitalized for ILD the event was considered resolved after hospitalization. Five patients were treated with antibiotics for pneumonia based on imaging or presentation with fever. Three patients had worsening cases, which resolved after antibiotics or hospitalization.7

Three patients that reported ILD adverse events died after hospitalization due to

  • ILD
  • acute respiratory failure, and
  • lung infection.7

Incidence of Pulmonary Fibrosis in the All BARI RA Dataset

In the All BARI RA dataset, the MedDRA PT, pulmonary fibrosis, was reported as a TEAE in 5 patients treated with BARI (0.1%; 0 EAIR). None of these events was considered a SAE, and none of these events led to temporary or permanent discontinuation of study drug.7

Information from the Label

Interstitial lung disease is not listed among the adverse events listed in the summary of product characteristics.8


1Brito Y, Glassberg MK, Ascherman DP. Rheumatoid arthritis-associated interstitial lung disease: current concepts. Curr Rheumatol Rep. 2017;19(12):79. https://dx.doi.org/10.1007/s11926-017-0701-5

2Hyldgaard C, Hilberg O, Pedersen AB, et al. A population-based cohort study of rheumatoid arthritis-associated interstitial lung disease: comorbidity and mortality. Ann Rheum Dis. 2017;76(10):1700-1706. https://dx.doi.org/10.1136/annrheumdis-2017-211138

3Bongartz T, Nannini C, Medina-Velasquez YF, et al. Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study. Arthritis Rheum. 2010;62(6):1583-1591. https://dx.doi.org/10.1002/art.27405

4Zamora-Legoff JA, Krause ML, Crowson CS, et al. Patterns of interstitial lung disease and mortality in rheumatoid arthritis. Rheumatology (Oxford). 2017;56(3):344-350. https://dx.doi.org/10.1093/rheumatology/kew391

5Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis. Ann Rheum Dis. 2020;79(suppl 1):638. European League Against Rheumatism abstract FRI0123. https://ard.bmj.com/content/79/Suppl_1/642.1

6Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis. Poster presented at: European League Against Rheumatism Virtual Congress; June 3-6, 2020.

7Data on file, Eli Lilly and Company and/or one of its subsidiaries.

8Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.


BARI = baricitinib

EAIR = exposure-adjusted incidence rate

ILD = interstitial lung disease

MedDRA = Medical Dictionary for Regulatory Activities

PT = preferred term

PYE = patient-years of exposure

RA = rheumatoid arthritis

SAE = serious adverse event

TEAE = treatment-emergent adverse event

Date of Last Review: 20 July 2020

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