Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Förändringar i lymfocyter, neutrofiler och blodplättar

Nivåer av lymfocyter, neutrofiler och trombocyter var rutinmässigt övervakade under kliniska studier av baricitinib.

Warnings and Precautions Related to Lymphocytes and Neutrophils

It is recommended to avoid initiation or interrupt BARI treatment in patients with an

  • ALC <0.5 billion cells/L (500 cells/mm3), or

  • ANC <1.0 billion cells/L (1000 cells/mm3).1

Mean Changes in Lymphocytes and Neutrophils Over Time

The 5-study pooled dataset included patients with RA randomized to BARI 4 mg or placebo from 1 phase 2 study and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON and RA-BALANCE). Data includes a long-term extension study (RA-BEYOND) with data through 13 February 2018.2

BARI 2 mg data is pooled from 3 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (1 phase 2 study as well as RA-BUILD and RA-BEACON).2

Mean Lymphocyte Count Changes

Mean absolute lymphocyte count increased by 1 week after starting treatment with baricitinib, returned to baseline by week 24, and then remained stable through at least 104 weeks. For most patients, changes in lymphocyte count occurred within the normal reference range.1

As shown in Figure 1, mean lymphocyte counts increased within 4 weeks of initiation of BARI treatment, then stabilized and returned to baseline with prolonged administration.2-5

Figure 1. Time Course of Lymphocyte Levels in Patients From 5-Study Pooled Dataset2

Abbreviations: BARI = baricitinib; PBO = placebo; SE = standard error; yrs = years.
Notes: *109 cells/L

Mean Neutrophil Count Changes

As shown in Figure 2, mean neutrophil counts decreased within 4 weeks of initiation of BARI treatment, followed by stabilization and an increase to baseline after treatment discontinuation.2-5

Figure 2. Time Course of Neutrophil Levels in Patients From 5-Study Pooled Dataset2

Abbreviations: BARI = baricitinib; PBO = placebo; SE = standard error; yrs = years.
Notes: *109 cells/L

References

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

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

3. Kremer J, Huizinga TWJ, Chen L, et al. Analysis of neutrophils, lymphocytes, and platelets in pooled phase 2 and phase 3 studies of baricitinib for rheumatoid arthritis. Poster presented at: European League Against Rheumatism (EULAR) Annual Meeting; June 14-17, 2017; Madrid, Spain.

4. Eli Lilly and Company. Lilly FDA Advisory Committee Meeting NDA 207924 Briefing Document. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM605062.pdf. Accessed May 2, 2018a. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM605062.pdf

5. Smolen JS, Genovese MC, Takeuchi T, et al. Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment [published online September 15, 2018]. J Rheumatol. https://dx.doi.org/10.3899/jrheum.171361

Glossary

ALC = absolute lymphocyte count

ANC = absolute neutrophil count

BARI = baricitinib

RA = rheumatoid arthritis

SAE = serious adverse event

TEAE = treatment-emergent adverse event

VTE = venous thromboembolism

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 2020 M06 08


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