Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Interstitiell lungsjukdom

Interstitiell lungsjukdom (ILD) har rapporterats i kliniska studier av reumatoid artrit (RA) med baricitinib.

Interstitial Lung Disease in Patients With 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

Information from the Label

Interstitial lung disease is not listed among the adverse events listed in the summary of product characteristics.5

Interstitial Lung Disease in the Baricitinib 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

  • data through 13 February 2018, and

  • 10,127 PYE.6,7

Incidence of Interstitial Lung Disease in the All BARI RA Dataset

In the All BARI RA dataset, the MedDRA preferred term, ILD, was reported as a TEAE in 15 patients treated with BARI (0.4%; 0.1 EAIR); an EAIR of 0.1 per 100 PYE for patients treated with baricitinib is consistent with the background rate of ILD in patients with RA.8

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

Of the 15 reported TEAEs of ILD, 9 patients had events that led to temporary interruption, permanent discontinuation or were classified as SAE Table 1.8

Table 1. Incidence of Interstitial Lung Disease in the All BARI RA Safety Dataset8

 

TEAE
n (EAIR)

Treatment Interruption
n (EAIR)

Permanent Study Discontinuation
n (EAIR)

SAE
n (EAIR)

All BARI RA (N=3770)

15 (0.1)

1 (0.01)

6 (0.06)

4 (0.04)

Abbreviations: BARI = baricitinib; EAIR = exposure-adjusted incidence rate; N = number of patients in the safety analysis dataset; n = number of patients in the specified category; 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

Only 1 patient of the 9 who had events that led to temporary interruption, permanent discontinuation, or were classified as SAEs had a past medical history of ILD. This patient experienced an event >100 days after starting BARI.8

Confounding Variables

Seven patients of the 9 who had events that led to temporary interruption, permanent discontinuation, or were classified as SAEs were taking methotrexate concomitantly. Additionally, 2 of the patients reported smoking cigarettes.8

Resolution of Event

Seven patients of the 11 who had events that led to temporary interruption, permanent discontinuation, or were classified as SAEs were hospitalized due to ILD, which was 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.

One SAE was medically significant, the event of moderate severity ILD was ongoing at the time of discontinuation from the study.8

References

1. Brito 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

2. Hyldgaard C, Hilberg O, 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

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

4. Zamora-Legoff JA, Krause ML, 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

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

6. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Ann Rheum Dis. 2019;78(2):308-309. http://dx.doi.org/10.1136/annrheumdis-2019-eular.691

7. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Presented as an oral presentation at: European League Against Rheumatism (EULAR) Annual Meeting; June 12-15, 2019; Madrid, Spain.

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

Glossary

BARI = baricitinib

EAIR = exposure-adjusted incidence rate

ILD = interstitial lung disease

MedDRA = Medical Dictionary for Regulatory Activities

PYE = patient-years of exposure

RA = rheumatoid arthritis

SAE = serious adverse event

TEAE = treatment-emergent adverse event

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M08 09

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