Olumiant® ▼ (baricitinib): Patients With a History of Gastrointestinal Disorders (Perforations and Diverticulitis)

Baricitinib Phase 3 Program

• Patients with a history or presence of GI disorders that, in the opinion of the investigator, could constitute a risk when taking BARI or could interfere with the interpretation of data were excluded from the phase 3 clinical development program.¹

Each of the 4 phase 3 studies in the clinical program evaluated a distinct treatment population of patients with moderate-to-severe RA.

• RA-BEGIN compared BARI 4 mg monotherapy, BARI 4 mg plus MTX, and MTX monotherapy in patients who had limited or no prior treatment with MTX and were naïve to other DMARDs.²

• RA-BEAM compared BARI 4 mg vs placebo or adalimumab, with background MTX, in patients with inadequate response to MTX.³ 

• RA-BUILD compared BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with inadequate response to csDMARDs.⁴

• RA-BEACON compared BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in patients with an inadequate response to at least one TNF inhibitor, who may also have had an inadequate response to one or more non-TNF inhibitor biologic DMARDs.⁵

The study population of DMARD-naïve patients from the RA-BEGIN study is not included in the approved label. However, the RA-BEGIN study is supportive for the target population of patients with an inadequate response to, or intolerance to, other DMARDs.⁶

Patients With Medical History of GI Perforations in the Baricitinib Phase 3 Program

• Medical history, including GI perforation, was recorded upon enrollment into each of the BARI phase 3 clinical studies.

• In the 4 phase 3 BARI clinical trials in patients with RA, 4 patients treated with BARI had a pre-existing condition or historical diagnosis of GI perforation.¹

Patients With Medical History of Diverticulitis in the Baricitinib Phase 3 Program

• Medical history, including diverticulitis, was recorded upon enrollment into each of the BARI phase 3 clinical studies.

• In the 4 phase 3 BARI clinical trials in patients with RA, 11 patients treated with BARI had a pre-existing condition or historical diagnosis of diverticulitis.¹

The individual phase 3 clinical trials were not designed to detect differences in the efficacy and safety of BARI for the treatment of moderate to severe RA in patients with or without a GI disorders. Due to the small numbers of patients with a medical history of GI perforation or diverticulitis in the BARI phase 3 clinical program for RA, an analysis of the efficacy and safety of BARI in these patients was not conducted.

Information From the Label

Events of diverticulitis and gastrointestinal perforation have been reported in clinical trials and from postmarketing sources.⁶

Baricitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis: nonsteroidal anti-inflammatory drugs, corticosteroids, and opioids.⁶

References

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

2. Fleischmann R, Schiff M, van der Heijde D, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol. 2017;69(3):506-517. http://dx.doi.org/10.1002/art.39953

3. Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med. 2017;376(7):652-662. http://dx.doi.org/10.1056/NEJMoa1608345

4. Dougados M, van der Heijde D, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study [published correction appears in Ann Rheum Dis. 2017;76(9):1634. http://dx.doi.org/10.1136/annrheumdis-2016-210094corr1 ]. Ann Rheum Dis. 2017;76(1):88-95. http://dx.doi.org/10.1136/annrheumdis-2016-210094

5. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(13):1243-1252. http://dx.doi.org/10.1056/NEJMoa1507247

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

Glossary

BARI = baricitinib

csDMARD = conventional synthetic disease-modifying antirheumatic drug

DMARD = disease-modifying antirheumatic drug

GI = gastrointestinal

MTX = methotrexate

RA = rheumatoid arthritis

TNF = tumor necrosis factor

▼ 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.