Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Olumiant® ▼ (baricitinib): Insidens av reumatiska knutor i det kliniska fas 3-programmet

Effekten av baricitinib på reumatiska knutor har inte utvärderats i kliniska studier.

Baricitinib and Rheumatoid Nodules

Effect on Rheumatoid Nodules

An analysis of the effect of BARI treatment on rheumatoid nodules has not been conducted within the BARI clinical development program.1

Comorbid Rheumatoid Nodules

In the 4 phase 3 BARI clinical trials in patients with RA, 6 patients treated with BARI had a recorded pre-existing condition or historical diagnosis of rheumatoid nodules or rheumatoid nodule removal.1

Incidence of Rheumatoid Nodules

New or worsening of rheumatoid nodules is not an adverse event listed in the summary of product characteristics.2

The All BARI RA safety analysis dataset including 3770 patients who were treated with BARI in RA clinical studies representing 10,127 PYs of exposure.3

In the All BARI RA analysis with data through February 13, 2018, 14 patients (0.4%; EAIR, 0.1 per 100 PYs) had a reported TEAE of new or worsening rheumatoid nodules.1 Of the 14 events,

  • 1 was reported as a SAE

  • 1 led to temporary treatment interruption, and

  • 1 led to treatment discontinuation.1

The SAE was in an elderly patient diagnosed with RA more than 30 years prior to the event. The patient had bilateral rheumatoid nodules, one of which was infected and surgery for removal was elected by the patient. Baricitinib was temporarily interrupted and resumed once the infection resolved.1

References

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

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

3. 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

Glossary

BARI = baricitinib

EAIR = exposure-adjusted incidence rate

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 2019 M01 29


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