Olumiant® (Baricitinib)

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Baricitinib: Incidence of Gastrointestinal Perforations in the Rheumatoid Arthritis Clinical Development Program

Gastrointestinal (GI) perforation is not listed in the approved prescribing information as an adverse drug reaction for baricitinib in RA patients.

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Gastrointestinal Perforations in the Baricitinib Clinical Development Program

Gastrointestinal Perforations in Rheumatoid Arthritis Clinical Trials

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 2019.1,2

In the All BARI RA dataset, 6 patients treated with BARI had a confirmed GI perforation event occur after the randomized controlled period. The IR (95% CI) in the All BARI RA dataset was 0.04 (0.016-0.098).1,3

The cases of GI perforation included

  • perforated appendix in 2 patients
  • perforated diverticulum in 2 patients
  • intestinal perforation, and
  • upper GI tract perforation after knee surgery.3,4

Five of the patients were receiving background MTX, 4 of the patients were receiving background NSAIDs, and 4 patients were receiving concomitant prednisone.3,5

References

1Genovese 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. https://ard.bmj.com/content/79/Suppl_1/642.1

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. Poster presented at: European League Against Rheumatism Virtual Congress; June 3-6, 2020.

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Genovese 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

5Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 6 years: an updated integrated safety analysis. Poster presented at: Annual Meeting of the American College of Rheumatology (ACR); October 20-24, 2018; Chicago, IL.

Glossary

AD = atopic dermatitis

AE = adverse event

BARI = baricitinib

GI = gastrointestinal

IR = incidence rate

MTX = methotrexate

NSAID = nonsteroidal anti-inflammatory drug

PYE = patient-years of exposure

RA = rheumatoid arthritis

Fecha de la última revisión: 2020 M05 27


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