with a history of malignancy were not uniformly excluded from the
BARI phase 3 clinical development program.1
who were able to participate in the BARI phase 3 clinical trials
included patients with
carcinoma in situ that had been resected with no evidence of
recurrence or metastatic disease for at least 3 years, and
cell or squamous epithelial skin cancers that had been completely
resected with no evidence of recurrence for at least 3 years.1
patients were excluded from the phase 3 trials if they had
history of lymphoproliferative disease
or symptoms suggestive of possible lymphoproliferative disease,
including lymphadenopathy or splenomegaly
primary or recurrent malignant disease, or
in remission from clinically significant malignancy for <5
Phase 3 Program
of the 4 phase 3 studies in the clinical program evaluated a distinct
treatment population of patients with moderate-to-severe RA.
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
BARI 4 mg vs placebo or adalimumab, with background MTX, in patients
with inadequate response to MTX.3
BARI 2 mg and 4 mg vs placebo, with background csDMARD therapy, in
patients with inadequate response to csDMARDs.4
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
With Medical History of Malignancy in the Baricitinib Phase
history, including malignancy, was recorded upon enrollment into each
of the BARI phase 3 clinical studies.1
history of malignancy was defined as malignancy that was previously
diagnosed and resolved prior to study entry.1
shown in Table 1, the
number of patients who had a historical diagnosis of malignancy at
(12/684) in RA-BUILD
(11/527) in RA-BEACON
(17/1305) in RA-BEAM, and
(13/584) in RA-BEGIN.1
With Preexisting Malignancy in the Baricitinib Phase 3
preexisting malignancy was defined as malignancy that was previously
diagnosed and was ongoing at study entry.1
RA-BEGIN, 1 patient (0.2%) in the MTX treatment group reported
preexisting malignant tumors and skin neoplasms at enrollment Table
and Safety Analysis of Patients With a History of Malignancy
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.
1. Comorbid Conditions of Special Interest in the Baricitinib Phase 3
preexisting conditions (mITT)
historical diagnoses (mITT)
mITT = modified intent-to-treat.
Percentages are based on
the number of patients in the analysis.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
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.
Taylor PC, Keystone EC, van der Heijde D, et al. Baricitinib versus
placebo or adalimumab in rheumatoid arthritis. N Engl J Med.
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.
]. Ann Rheum Dis. 2017;76(1):88-95.
Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with
refractory rheumatoid arthritis. N Engl J Med.
= conventional synthetic disease-modifying antirheumatic drug
= disease-modifying antirheumatic drug
= tumor necrosis factor