Olumiant® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant® ▼(baricitinib): Incidence of Rheumatoid Nodules in the Rheumatoid Arthritis Clinical Development Program

The effect of baricitinib on rheumatoid nodules was not evaluated in the rheumatoid arthritis clinical development program.

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 preexisting 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 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 2019.3,4

In the All BARI RA analysis, 14 patients (0.4%; EAIR=0.1) 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 8.4 years: an updated integrated safety analysis [abstract]. Ann Rheum Dis. 2020;79(suppl 1):638. http://scientific.sparx-ip.net/archiveeular/?c=a&view=4&item=2020FRI0123

4. 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.

Glossary

BARI = baricitinib

EAIR = exposure-adjusted incidence rate

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.

Date of Last Review: June 01, 2020

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