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Olumiant ® ▼ (baricitinib)
Olumiant® ▼ (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.
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
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
median exposure of 4.2 years,
maximum exposure of 8.4 years, and
In this analysis, there were
5 (0.1%) events of suicidal ideation
2 (0.1%) suicide attempts, and
no completed suicides.1
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.
BARI = baricitinib
PYE = patient-years of exposure
QIDS-SR16 = Quick Inventory of Depressive Symptomatology Self-Rated
RA = rheumatoid arthritis
▼ 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 09, 2020