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 Folliculitis in the Rheumatoid Arthritis Clinical Development Program

In the all baricitinib rheumatoid arthritis dataset, folliculitis was reported in 27 (0.7% [EAIR = 0.2]) patients. None were a serious adverse event or resulted in permanent discontinuation of baricitinib.

Incidence of Folliculitis

Treatment-Emergent Adverse Events

A TEAE is an adverse event that either occurred or worsened in severity after the first dose of study treatment and did not necessarily have a causal relationship to study treatment.1

7-Study Placebo-Controlled Dataset

Description

The 7-study pooled dataset included patients with RA randomized to BARI 4 mg (N=1142, PYE=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2 studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON, and RA-BALANCE). Patients could have been taking background MTX or other conventional DMARDs. Evaluation time periods included through

  • the 12-week placebo-controlled period in phase 2 studies

  • 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and

  • 24 weeks of assigned treatment or until rescue in phase 3 studies.2

Data from BARI 2 mg (N=479, PYE=185.8) were derived from 4 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).2

Incidence of Folliculitis

In this safety analysis, through 24 weeks of treatment, the TEAE of

  • folliculitis was reported in

    • 3 (0.3%) patients in the BARI 4 mg group,

    • 3 (0.6%) patients in the BARI 2 mg group, and

    • 0 patients in the placebo group.1

All Baricitinib Rheumatoid Arthritis Analysis Set

Description

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, and 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 September 1, 2019.3,4

Incidence of Folliculitis

In the All BARI RA analysis dataset through September 1, 2019, a TEAE of

  • folliculitis was reported in 27 (0.7%, [EAIR=0.2]) patients.1

Of these 27 TEAEs of folliculitis,

  • 0 were reported as serious adverse events

  • 4 resulted in temporary interruption of BARI, and

  • 0 resulted in permanent discontinuation of BARI.1

Information From the Label

Folliculitis is not listed as an adverse drug reaction in the BARI Summary of Product Characteristics.5

References

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

2. Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis over a median of 3 years of treatment: an updated integrated safety analysis. Lancet Rheumatol. 2020;2(6):E347-E357. https://doi.org/10.1016/S2665-9913(20)30032-1

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. https://ard.bmj.com/content/79/Suppl_1/642.1

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.

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

Glossary

BARI = baricitinib

DMARD = disease-modifying antirheumatic drug

EAIR = exposure-adjusted incidence rate

MTX = methotrexate

PYE = patient-years of exposure

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: September 01, 2020


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