Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): lungfibros

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

Pulmonary Fibrosis in the Baricitinib Clinical Development Program

Description of the All BARI RA Dataset

The All BARI RA integrated safety dataset included 3492 patients who received BARI at a variety of doses for 6636 total PYs of exposure from 1 phase 1, 3 phase 2 and 5 phase 3 studies. The analysis covered all exposure time points including after rescue or changes in study treatment through September 1, 2016.1

Incidence of Pulmonary Fibrosis in the All BARI RA Dataset

In the All BARI RA dataset, the MedDRA preferred term, pulmonary fibrosis, was reported as a TEAE in 3 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.2

References

1. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 5.5 years: an updated integrated safety analysis. Abstract presented at American College of Rheumatology (ACR/ARHP) Annual Meeting; November 3-8, 2017; San Diego, CA.

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

Glossary

BARI = baricitinib

EAIR = exposure-adjusted incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

PY(s) = patient year(s)

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 2017 M10 13

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