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  3. What Olumiant® (baricitinib) safety data are available for patients with a history of malignancy and rheumatoid arthritis?
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Olumiant ® (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

What Olumiant® (baricitinib) safety data are available for patients with a history of malignancy and rheumatoid arthritis?

Baricitinib was not systematically studied in patients with moderate to severe rheumatoid arthritis and malignant disease.

UK_cFAQ_BAR053A_HISTORY_OF_MALIGNANCY_RA
UK_cFAQ_BAR053A_HISTORY_OF_MALIGNANCY_RA
en-GB

Information from the label

Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma.1

Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including baricitinib.1 

In a large randomized active‑controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and non-melanoma skin cancer (NMSC) was observed with tofacitinib compared to TNF inhibitors.1

In patients over 65 years of age, patients who are current or past long-time smokers, or with other malignancy risk factors (e.g. current malignancy or history of malignancy) baricitinib should only be used if no suitable treatment alternatives are available.1

Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.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

Clinical Trial Criteria Related to Malignancy

Patients with a history of malignancy were not uniformly excluded from the BARI phase 3 clinical development program.6

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.6

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.6

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.

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

As shown in Comorbid Conditions of Special Interest in the Baricitinib Phase 3 Studies, 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.6

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.6

In RA-BEGIN, 1 patient (0.2%) in the MTX treatment group reported preexisting malignant tumors and skin neoplasms at enrollment Comorbid Conditions of Special Interest in the Baricitinib Phase 3 Studies.6

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 baricitinib 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 baricitinib phase 3 clinical program for RA, an analysis of the efficacy and safety of baricitinib in these patients is not feasible.

Comorbid Conditions of Special Interest in the Baricitinib Phase 3 Studies6

 

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

1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: 18 April 2022

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