Olumiant® (Baricitinib)

Para consultar la información para prescribir completa de Olumiant® (Baricitinib) de clic en el siguiente enlace: Información para prescribir

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Baricitinib: Patients With a History of Gastrointestinal Disorders (Perforations and Diverticulitis)

Patients with a history of a gastrointestinal (GI) perforation or diverticulitis were not specifically excluded from the baricitinib (BARI) Phase 3 development program.

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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

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.

References

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

2Fleischmann 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

3Taylor 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

4Dougados 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. Ann Rheum Dis. 2017;76(9):1634. http://dx.doi.org/10.1136/annrheumdis-2016-210094corr1

5Genovese 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

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

Fecha de la última revisión: 2019 M05 15


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