Olumiant ® (baricitinib)

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Olumiant® (baricitinib): what is the efficacy and safety in patients with severe alopecia areata and historical or preexisting cardiac disorders?

The efficacy and safety of baricitinib in patients with severe alopecia areata and historical or preexisting cardiac disorders have not been studied.

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Overview of BRAVE-AA Phase 3 Placebo-Controlled Clinical Trials

The efficacy and safety of baricitinib (BARI) have been evaluated in the following pivotal, phase 3, placebo-controlled trials in adult patients with severe alopecia areata (AA)

  • BRAVE-AA1 (N=654) compared BARI 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss, and
  • BRAVE-AA2 (N=546) compared BARI 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss.1

BRAVE-AA Clinical Trial Criteria

Patients were excluded from enrollment in BRAVE-AA1 and BRAVE-AA2 if they had

  • a history or presence of cardiovascular disorder that, in the opinion of the investigator, could constitute an unacceptable risk when taking the investigational product or interfere with the interpretation of data
  • screening electrocardiogram abnormalities that, in the opinion of the investigator, were clinically significant and indicated an unacceptable risk for the patient’s participation in the study, or
  • experienced any of the following within 12 weeks of screening
    • myocardial infarction
    • unstable ischemic heart disease
    • stroke, or
    • New York Heart Association Stage III/IV heart failure.1

Patients With Alopecia Areata and Historical or Preexisting Cardiac Disorders

A subgroup analysis of the efficacy and safety of baricitinib in patients with severe AA and historical or preexisting cardiac disorders has not been conducted.

The number of patients in the combined analysis of the pivotal phase 3 BRAVE-AA1 and BRAVE-AA2 clinical trials with severe AA and historical or preexisting cardiac disorders is presented in Summary of Patients With Historical Cardiac Disorders in the Combined Analysis of the Pivotal Phase 3 BRAVE-AA1 and BRAVE-AA2 Trials (Safety Analysis Set Population) and Summary of Patients With Preexisting Cardiac Disorders in the Combined Analysis of the Pivotal Phase 3 BRAVE-AA1 and BRAVE-AA2 Trials (Safety Analysis Set Population). Historical illness was defined as a medical condition that occurred prior to the entry into the study. Preexisting conditions included medical conditions that were ongoing at the entry into the study.2

Summary of Patients With Historical Cardiac Disorders in the Combined Analysis of the Pivotal Phase 3 BRAVE-AA1 and BRAVE-AA2 Trials (Safety Analysis Set Population)2

Historical Illnessa

Placebo (n=371)
n (%)

BARI 2 mg (n=365)
n (%)

BARI 4 mg (n=540)
n (%)

Cardiac disorders

3 (0.8)

2 (0.5)

3 (0.6)

Myocardial infarction

2 (0.5)

1 (0.3)

2 (0.4)

Arrhythmia supraventricular

0

0

1 (0.2)

Acute myocardial infarction

0

1 (0.3)

0

Stress cardiomyopathy

1 (0.3)

0

0

Abbreviations: AA = alopecia areata; BARI = baricitinib.

aHistorical illness is a medical condition that occurred prior to the entry into the study.

Summary of Patients With Preexisting Cardiac Disorders in the Combined Analysis of the Pivotal Phase 3 BRAVE-AA1 and BRAVE-AA2 Trials (Safety Analysis Set Population)2

Preexisting Conditiona

Placebo (n=371)
n (%)

BARI 2 mg (n=365)
n (%)

BARI 4 mg (n=540)
n (%)

Cardiac disorders

11 (3.0)

8 (2.2)

16 (3.0)

Mitral valve prolapse

0

1 (0.3)

3 (0.6)

Bundle branch block left

1 (0.3)

1 (0.3)

2 (0.4)

Coronary artery disease

1 (0.3)

0

2 (0.4)

Ventricular extrasystoles

0

0

2 (0.4)

Aortic valve incompetence

0

0

1 (0.2)

Atrial fibrillation

2 (0.5)

2 (0.5)

1 (0.2)

Mitral valve incompetence

0

0

1 (0.2)

Palpitations

0

0

1 (0.2)

Pulmonary valve incompetence

0

0

1 (0.2)

Sinus arrhythmia

0

0

1 (0.2)

Supraventricular extrasystoles

0

0

1 (0.2)

Tachycardia

0

1 (0.3)

1 (0.2)

Tricuspid valve incompetence

0

0

1 (0.2)

Angina pectoris

2 (0.5)

0

0

Arrhythmia

1 (0.3)

0

0

Bradycardia

1 (0.3)

0

0

Bundle branch block right

1 (0.3)

0

0

Cardiac dysfunction

0

1 (0.3)

0

Cardiomegaly

0

1 (0.3)

0

Heart valve incompetence

0

1 (0.3)

0

Sinus bradycardia

1 (0.3)

0

0

Wolff-Parkinson-White syndrome

1 (0.3)

0

0

Abbreviations: AA = alopecia areata; BARI = baricitinib

aPreexisting conditions include medical conditions that were ongoing at the entry into the study.

Clinical Use

Eli Lilly and Company cannot provide a recommendation on whether to use BARI in a patient with severe AA and historical or preexisting cardiac disorders. The treating physician may use the information provided, the patient’s prior medical history and concomitant medications, and other individual factors, in formulating an assessment and approach. The treating physician should consider potential risks and benefits of treatment options, and monitor appropriately.

References

1King B, Ohyama M, Kwon O, et al; BRAVE-AA investigators. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(18):1687-1699. https://doi.org/10.1056/nejmoa2110343

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: 14 April 2022


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