Olumiant® (Baricitinib)

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Baricitinib: Incidence of Depression and Suicidality in the Rheumatoid Arthritis Clinical Development Program

Depression and suicidality are not listed in the baricitinib (BARI) approved prescribing information as adverse drug reactions (Data on file).

Assessment of Depression and Suicidality in the RA Clinical Development Program

In the BARI RA clinical trial program, the Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-SR16) instrument was used to assess the presence and severity of depressive symptoms, including suicidal ideation.1

Safety Analyses Results

6-Study Placebo Controlled BARI 4 mg Dataset

The 6 study dataset included patients with RA who were randomized to BARI 4 mg (N=997) or placebo (N=1070) from 3 phase 2 studies and 3 phase 3 studies through 24 weeks of assigned treatment or until rescue.1

In this analysis, compared to placebo, BARI 4 mg

  • had a significantly greater improvement in the QIDS-SR16 total score at week 12 (least squares mean change p<.05), and

  • was not significantly different in the proportion of patients with worsening in QIDS-SR16 from baseline through week 24, in both

    • total score, BARI 4mg 15.7% vs placebo 18.2%, and

    • suicidal ideation score, BARI 4mg 5.4% vs placebo 4.8%.1

4-Study BARI 4 mg and BARI 2 mg Dataset

Through 24 weeks, in a safety analysis dataset that included BARI 2 mg (n=455), BARI 4 mg (n=455) and placebo (n=502) treatment groups, there was no statistically significant difference in the proportion of patients worsening in QIDS-SR16 total score between

  • BARI 2 mg and BARI 4 mg, and

  • BARI 2 mg and placebo.1

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 2019.2,3

In this analysis, there were

  • 5 (0.1%) events of suicidal ideation

  • 2 (0.1%) suicide attempts, and

  • no completed suicides.1

Reference

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 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

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. Poster presented at: European League Against Rheumatism Virtual Congress; June 3-6, 2020.

Glossary

BARI = baricitinib

PYE = patient-years of exposure

QIDS-SR16 = Quick Inventory of Depressive Symptomatology Self-Rated

RA = rheumatoid arthritis

Fecha de la última revisión: 2020 M06 09


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