Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® (baricitinib): venösa tromboembolismhändelser i det kliniska utvecklingsprogrammet

Depression och suicidalitet anges inte i produktresumén som biverkningar för baricitinib.

SE_cFAQ_BAR143A_DEPRESSION_SUICIDALITY_TEAE_RA
SE_cFAQ_BAR143A_DEPRESSION_SUICIDALITY_TEAE_RA
en-GB

Assessment of Depression and Suicidality

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

References

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

2Genovese 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. Ann Rheum Dis. 2020;79(suppl 1):638. European League Against Rheumatism abstract FRI0123. https://ard.bmj.com/content/79/Suppl_1/642.1

3Genovese 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

Datum fӧr senaste ӧversyn June 09, 2020


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