Olumiant® (Baricitinib)

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Baricitinib: Use in Patients With a History of Malignancy

Baricitinib (BARI) no se estudió sistemáticamente en pacientes con AR moderada a grave y enfermedad maligna.

Clinical Trial Criteria

Patients with a history of malignancy were not uniformly excluded from the BARI phase 3 clinical development program.1

Patients who were able to participate in the BARI phase 3 clinical trials included patients with

  • cervical carcinoma in situ that had been resected with no evidence of recurrence or metastatic disease for at least 3 years, and

  • basal cell or squamous epithelial skin cancers that had been completely resected with no evidence of recurrence for at least 3 years.1

However, patients were excluded from the phase 3 trials if they had

  • a history of lymphoproliferative disease

  • signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly

  • active primary or recurrent malignant disease, or

  • been in remission from clinically significant malignancy for <5 years.1

Baricitinib Phase 3 Program

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 Malignancy in the Baricitinib Phase 3 Program

Medical history, including malignancy, was recorded upon enrollment into each of the BARI phase 3 clinical studies.1

A history of malignancy was defined as malignancy that was previously diagnosed and resolved prior to study entry.1

As shown in Table 1, the number of patients who had a historical diagnosis of malignancy at baseline included

  • 1.8% (12/684) in RA-BUILD

  • 2.1% (11/527) in RA-BEACON

  • 1.3% (17/1305) in RA-BEAM, and

  • 2.2% (13/584) in RA-BEGIN.1

Patients With Preexisting Malignancy in the Baricitinib Phase 3 Program

A preexisting malignancy was defined as malignancy that was previously diagnosed and was ongoing at study entry.1

In RA-BEGIN, 1 patient (0.2%) in the MTX treatment group reported preexisting malignant tumors and skin neoplasms at enrollment Table 1.1

Efficacy and Safety Analysis of Patients With a History of Malignancy

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 medical history or pre-existing condition of malignancy. Due to the small numbers of patients with a medical history or preexisting condition of malignancy in the BARI phase 3 clinical program for RA, an analysis of the efficacy and safety of BARI in these patients is not feasible.

Table 1. Comorbid Conditions of Special Interest in the Baricitinib Phase 3 Studies1

 

RA-BUILD

(N=684)

RA-BEACON

(N=527)

RA-BEAM

(N=1305)

RA-BEGIN

(N=584)

Selected preexisting conditions (mITT)

Malignancies, n (%)

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.2)

Selected historical diagnoses (mITT)

Malignancies, n (%)

12 (1.8)

11 (2.1)

17 (1.3)

13 (2.2)

Abbreviations: mITT = modified intent-to-treat. 
Percentages are based on the number of patients in the analysis.

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

Glossary

BARI = baricitinib

csDMARD = conventional synthetic disease-modifying antirheumatic drug

DMARD = disease-modifying antirheumatic drug

MTX = methotrexate

PBO = placebo

RA = rheumatoid arthritis

TNF = tumor necrosis factor

Fecha de la última revisión: 2019 M05 13


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