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Olumiant ® ▼ (baricitinib)
Olumiant®▼ (baricitinib): Incidence of Gastrointestinal Perforations in the Rheumatoid Arthritis Clinical Development Program
Gastrointestinal (GI) perforation is not listed in the approved summary of product characteristics as an adverse drug reaction for baricitinib in RA patients.
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
median exposure of 4.2 years,
maximum exposure of 8.4 years, and
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
Information From the Label
Events of gastrointestinal perforation have been reported in clinical trials and from postmarketing sources.6
Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of gastrointestinal perforation.6
1. Genovese 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
2. Genovese 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.
4. Genovese 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
5. Genovese 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.
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
▼ 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.
Date of Last Review: May 27, 2020