Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Förekomst av gastrointestinala perforationer

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

Gastrointestinal Perforations in the Baricitinib Clinical Development Program

All BARI RA Dataset

The All BARI RA integrated safety dataset includes 3770 patients who received BARI at a variety of doses for 10,127 total PYs of exposure from 1 phase 1, 3 phase 2, 5 phase 3 studies, and 1 phase 3 extension study. The analysis covered all exposure time points including after rescue or changes in study treatment through February 13, 2018.1

Through February 13, 2018, in the All BARI RA dataset 4 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 (0.011, 0.099).1,2

The cases of GI perforation included

  • perforated appendix

  • perforated diverticulum

  • upper gastrointestinal tract perforation after knee surgery, and

  • diverticulitis with perforation of the bowel.2,3

Three of the patients were receiving background methotrexate and NSAIDs, and 2 patients were receiving concomitant prednisone.3 None of the patients had a documented prior history of diverticulitis.2

4-Study Extended Dataset

The 4-study extended integrated safety dataset includes patients with RA from phase 2 and phase 3 studies and any further exposure for those patients in the phase 3 extension study, RA-BEYOND, who were randomized to BARI 4 mg (N=479) or BARI 2 mg (N=479). Evaluation time period included randomization through last available observation incorporating extension data through February 13, 2018 unless otherwise specified.1

Through February 13, 2018, in the 4-study extended dataset, there were

  • no reports of GI perforations with BARI at 2 mg, and

  • 1 event of GI perforation with BARI 4 mg (IR=0.1).1,2

Treatment-Emergent Adverse Events of Gastrointestinal Perforations

Gastrointestinal perforation is a serious but rare AE that has been observed in patients with RA.4,5 Known risk factors for GI perforation include

  • the use of glucocorticoids or NSAIDs

  • concomitant diverticulitis

  • increased age, and

  • higher levels of comorbidity.6

In a large claims database study of patients with RA, the observed GI perforation rate was 1.7 per 1000 PYs.6

Gastrointestinal perforation is a potential risk with certain RA therapies that interrupt interleukin-6 signaling including tocilizumab and tofacitinib.7,8

References

1. Genovese 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. Ann Rheum Dis. 2019;78(2):308-309. http://dx.doi.org/10.1136/annrheumdis-2019-eular.691

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

3. 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.

4. Curtis JR, Xie F, Chen L, et al. The incidence of gastrointestinal perforations among rheumatoid arthritis patients. Arthritis Rheumatol. 2011;63(2):346-351. http://dx.doi.org/10.1002/art.30107

5. Závada J, Lunt M, Davies R, et al; British Society for Rheumatology Biologics Register (BSRBR) Control Centre Consortium. The risk of gastrointestinal perforations in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the BSRBR-RA. Ann Rheum Dis. 2014;73(1):252-255. http://dx.doi.org/10.1136/annrheumdis-2012-203102

6. Curtis JR, Lanas A, John A, et al. Factors associated with gastrointestinal perforation in a cohort of patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64(12):1819-1828. http://dx.doi.org/10.1002/acr.21764

7. Xeljanz [package insert]. New York, NY: Pfizer, Inc; 2018.

8. Actemra [package insert]. South San Francisco, CA: Genentech, Inc; 2018.

Glossary

AE = adverse event

BARI = baricitinib

GI = gastrointestinal

IR = incidence rate

NSAID = nonsteroidal anti-inflammatory drug

PY(s) = patient year(s)

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 2018 M04 18


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