Olumiant ® (baricitinib)

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Olumiant® (baricitinib): what is the incidence of venous thromboembolism during treatment for alopecia areata?

No patients had a venous thromboembolic event in the alopecia areata clinical trial program as of the last database cutoff of March 24, 2021 (BRAVE-AA2) and March 31, 2021 (BRAVE-AA1).

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Warnings and precautions related to venous thromboembolism 

Cases of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib.1

Baricitinib should be used with caution in patients with risk factors for DVT/PE, such as

  • older age,
  • obesity,
  • a medical history of DVT/PE, or
  • patients undergoing surgery and immobilisation.1

If clinical features of DVT/PE occur, treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.1

Alopecia areata clinical trial exclusion criteria

In the AA clinical trials, patients were excluded if they had

  • uncontrolled arterial hypertension characterized by a repeated systolic blood pressure >160 mm Hg or diastolic pressure >100 mm Hg in a seated position
  • a history of VTE, or are considered at high risk for VTE, as deemed by the investigator, or have 2 or more of the following risk factors for VTE:
    • aged >65 years
    • body mass index (BMI) >35 kg/m2
    • oral contraceptive use AND current smoker status
  • screening electrocardiogram abnormalities that, in the opinion of the investigator, are clinically significant and indicate an unacceptable risk for the patient's participation in the study
  • a history or presence of cardiovascular or other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk or interfere with the interpretation of data, or
  • experienced within 12 weeks of screening
    • a myocardial infarction
    • unstable ischemic heart disease
    • stroke, or
    • New York Heart Association Stage III/IV heart failure.2

Incidence of venous thromboembolism in the baricitinib alopecia areata clinical trials

The baricitinib alopecia areata (AA) clinical trial program includes

The incidence of venous thromboembolism (VTE), which includes DVT and PE, from the baricitinib AA trials is reported in 3 integrated safety datasets, including the

  • 36-week placebo-controlled BARI AA dataset with patients exposed to placebo, baricitinib 2 mg and baricitinib 4 mg from randomization to week 36
  • extended BARI AA dataset with patients exposed to baricitinib 2 mg or 4 mg from randomization to data cutoff, and
  • All-BARI-AA dataset with all patients exposed to any baricitinib dose (1-mg, 2-mg, or 4-mg) at any time during the studies.5

Safety data were integrated from the BRAVE-AA1 Phase 2 and 3 cohorts (data cut-off March 31, 2021) and from BRAVE-AA2 (data cut-off March 24, 2021).

More details on patient exposure and censoring rules in each dataset are provided in Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials .

Assessment of venous thromboembolism

Possible VTE events were identified by the investigative site or through medical review and were sent to a blinded, external Clinical Event Committee for adjudication.6

As of the last database cutoff of March 24, 2021 (BRAVE-AA2) and March 31, 2021 (BRAVE-AA1), no VTE events were reported.6

Venous Thromboembolic Events Beyond the March 2021 Data Cut-off

Venous thromboembolic adverse events, including DVT and PE, were observed after Week 52 and beyond the March 2021 data cut-off date in the AA clinical trials.7 These events included

  • a PE in a 62 year old female originally randomized to placebo and rescued to baricitinib 2 mg (comorbid conditions included COVID-19 pneumonia and prothrombin gene heterozygosity), and 
  • a DVT and PE in a 42 year old female randomized to baricitinib 2 mg (comorbid conditions included hyperlipidemia, type 2 diabetes, and obesity, patient was also on oral contraceptives).6

Baricitinib treatment was permanently discontinued in both patients.6

Description of integrated safety dataset

Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials5,6 

Analysis Set

Description

36-Week placebo-controlled BARI AA

Assesses BARI 4 mg, BARI 2 mg, and placebo.

Includes patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were randomized to

  • BARI 4 mg (n=540, PYE=363.4)
  • BARI 2 mg (n=365, PYE=240.6), or
  • placebo (n=371, PYE=243.2).

Evaluation time period included randomization to week 36.

Extended BARI AA

Assesses BARI 4 mg and BARI 2 mg including extended evaluations.

Includes patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were randomized to

  • BARI 4 mg (n=540, PYE=624.3), or
  • BARI 2 mg (n=365, PYE=371.5).

Evaluation time period included randomization up to data cutoff, March 24, 2021 for BRAVE-AA2 and March 31, 2021 for BRAVE-AA1. Data were censored after a patient was switched to another dose or treatment.

All BARI AA

No between-group assessments.

Includes 1244 (total PYE=1362.2) patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were exposed to any BARI dose, including

  • BARI 4 mg (n=938, PYE=858.9)
  • BARI 2 mg (n=564, PYE=488.9), or
  • BARI 1 mg (n=28, PYE=14.6).

Evaluation time period included any time points during the studies either from randomization or from switch or rescue from placebo.

Abbreviations: AA = alopecia areata; BARI = baricitinib; PYE = patient-years of exposure.

References

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

2King 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

3A study of baricitinib (LY3009104) in adults with severe or very severe alopecia areata (BRAVE-AA2). ClinicalTrials.gov identifier: NCT03899259. Updated January 26, 2022. Accessed March 4, 2022. https://clinicaltrials.gov/ct2/show/NCT03899259

4A study of baricitinib (LY3009104) in participants with severe or very severe alopecia areata (BRAVE-AA1). ClinicalTrials.gov identifier: NCT03570749. Updated February 3, 2022. Accessed March 4, 2022. https://clinicaltrials.gov/ct2/show/study/NCT03570749

5King B, Mostaghimi A, Shimomura Y, et al. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. Poster presented at: Annual Meeting of the American Academy of Dermatology Association (AAD); March 25-29, 2022; Boston, MA. Accessed April 29, 2022. https://aad-eposters.s3.amazonaws.com/AM2022/poster/33966/Integrated+safety+analysis+of+baricitinib+in+adults+with+severe+alopecia+areata+from+two+randomized+clinical+trials.pdf

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

7Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.

Date of Last Review: 15 June 2022


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