Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Förekomst av gastrointestinala perforationer i RA

Gastrointestinal perforation anges inte i produktresumén som en biverkning för baricitinib.

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

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

References

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.

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

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.

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

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

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 M05 27


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