Olumiant® (Baricitinib)

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Baricitinib: Effects on Hepatic Analytes in the Rheumatoid Arthritis Clinical Development Program

ncreases in ALT and AST were observed in rheumatoid arthritis patients treated with baricitinib.

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Warnings and Precautions Related to Liver Enzyme Elevations

Increases in ALT and AST were observed in RA patients treated with BARI. If increases in ALT or AST are observed and drug-induced liver injury is suspected, BARI should be interrupted until diagnosis is excluded.1

No cases meeting Hy’s Law criteria were reported in patients receiving BARI treatment.2

Hepatic Analyte Elevations With Baricitinib Use

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

  • 10,127 total PYE
  • median exposure of 3.1 years
  • maximimum exposure of 6.9 years, and  
  • data through 13 February 2018.3,4

The proportion of patients who had an elevated ALT value of

  • ≥3X ULN was 4.3%
  • ≥5X ULN was 1.3%, and
  • ≥10X ULN was 0.3%.1

The proportion of patients who had an elevated 

  • AST value of ≥3X ULN was 2.5%
  • total bilirubin ≥2X ULN was 0.1%, and
  • ALP ≥1.5X ULN was 6.0%.1

7-Study Placebo-Controlled Dataset

The 7-study pooled dataset included patients with RA randomized to BARI 4 mg (N=1142, PYE=471.8) or placebo (N=1215, PYE=450.8) from 3 phase 2 studies and 4 phase 3 studies (RA-BEAM, RA-BUILD, RA-BEACON and RA-BALANCE). Patients in the placebo group could have been taking background MTX or other conventional DMARDs. Evaluation time periods included through

  • the 12-week placebo-controlled period in phase 2 studies
  • 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and
  • 24 weeks of assigned treatment or until rescue in phase 3 studies.3

Data from BARI 2 mg (N=479, PYE=185.8) is derived from 4 of these studies in which both BARI 2 mg and BARI 4 mg were options during randomization (2 phase 2 studies as well as RA-BUILD and RA-BEACON).3

ALT ≥3X ULN

The proportion of patients who experience an ALT value ≥3X ULN was

  • 1.5% in the BARI 4-mg group
  • 1.5% in the BARI 2 mg group, and
  • 1.2% in the placebo group.1,2

AST ≥3X ULN

The proportion of patients who experience an AST value ≥3X ULN was

  • 1.1% in the BARI 4-mg group
  • 1.3% in the BARI 2-mg group, and
  • 1.1% in the placebo group.1

Total Bilirubin ≥2X ULN

The proportion of patients who experience a total bilirubin value ≥2X ULN was

  • 0% in the BARI 4-mg group
  • 0% in the BARI 2-mg group, and
  • 0.1% in the placebo group.1

ALP ≥1.5X ULN

The proportion of patients who experience an ALP value ≥1.5X ULN was

  • 4.9% in the BARI 4-mg group
  • 2.5% in the BARI 2-mg group, and
  • 4.9% in the placebo group.1

References

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

2Smolen 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

3Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis over a median of 3 years of treatment: an updated integrated safety analysis. Lancet Rheumatol. 2020;2(6):E347-E357. https://doi.org/10.1016/S2665-9913(20)30032-1

4Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 7 years: an updated integrated safety analysis. Presented as an oral presentation at: European League Against Rheumatism (EULAR) Annual Meeting; June 12-15, 2019; Madrid, Spain.

Glossary

ALP = alkaline phosphate

ALT = alanine aminotransferase

AST = aspartate aminotransferase

BARI = baricitinib

DMARD = disease-modifying antirheumatic drug

MTX = methotrexate

PYE = patient-years of exposure

RA = rheumatoid arthritis

ULN = upper limit of normal

Fecha de la última revisión: 2020 M06 08


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