Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): lungfibros

Pulmonell fibros har rapporterats i kliniska studier av reumatoid artrit (RA) med baricitinib.

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 2019.1,2

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.3

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 Table 1).3

Table 1. Incidence of Interstitial Lung Disease in the All BARI RA Safety Dataset3

 

TEAE
n (EAIR)

Treatment Interruption
n (EAIR)

Permanent Study Discontinuation
n (EAIR)

SAE
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.3

Confounding Variables

Ten patients were taking methotrexate concomitantly. Additionally, 2 of the patients reported smoking cigarettes.3

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.3

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

  • ILD

  • acute respiratory failure, and

  • lung infection.3

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.3

Information from the Label

Interstitial lung disease is not listed among the adverse events listed in the summary of product characteristics.4

References

1. Genovese 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 [abstract]. Ann Rheum Dis. 2020;79(suppl 1):638. https://ard.bmj.com/content/79/Suppl_1/642.1

2. Genovese 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.

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

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

Glossary

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

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 2020 M07 20


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