Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Olumiant® ▼ (baricitinib): Insidens av depression och suicidalitet i det kliniska utvecklingsprogrammet

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

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 integrated safety dataset included 3492 patients who received BARI at a variety of doses for a total of 7860 patient-years of exposure from 1 phase 1, 3 phase 2 and 5 phase 3 studies. The analysis covered all exposure time points including after rescue or changes in study treatment through 01 April 2017.1

In this analysis, there were

  • 4 (0.1%) events of suicidal ideation

  • 1 (<0.1%) suicide attempt in a patient with prior depression, and

  • no completed suicides.1

Information from the label

Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate.2

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.

Glossary

BARI = baricitinib

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.

Datum fӧr senaste ӧversyn 2017 M12 18


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