Olumiant ® (baricitinib)

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Olumiant (baricitinib)® in Alopecia areata: What is the Incidence of Folliculitis?

In the clinical trials, the incidence of folliculitis was numerically higher with baricitinib compared to placebo.

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Folliculitis in the Baricitinib Alopecia Areata Clinical Trials

Folliculitis is listed as common adverse reaction (≥ 1/100 to < 1/10) in the Olumiant Summary of Product Characteristics.1

In the alopecia areata (AA) trials, the incidence of folliculitis was numerically higher with baricitinib treatment compared to placebo. Most events involved the scalp and were mild. No patients interrupted or discontinued treatment due to folliculitis. More information on the clinical trials and safety datasets is available in Clinical Trials and Integrated Safety Datasets.

Incidence of Treatment-Emergent Folliculitis

The incidence of treatment-emergent folliculitis reported in the baricitinib AA clinical trials is presented in Incidence of Folliculitis in the 36-Week Placebo-Controlled Period, Extended, and All BARI Integrated Datasets.

Incidence of Folliculitis in the 36-Week Placebo-Controlled Period, Extended, and All BARI Integrated Datasets2

 

36-Week Placebo-Controlled BARI AA
n (%) [IR] 

Extended BARI AA
n [IR] 

All BARI AA
 n [IR]

Placebo 
(n=371)

BARI 2 mg
(n=365)

BARI 4 mg 
(n=540)

BARI 2 mg
(n=365)

BARI 4 mg
(n=540)

All Doses
(N=1244)

Folliculitis

3 (0.8) [1.2]

5 (1.4) [2.1]

12 (2.2) [3.3]

6 [1.5]

15 [2.4]

30 [2.2]

Abbreviations: AA = alopecia areata; BARI = baricitinib; IR = incidence rate. 

Data Cutoff: March 24, 2021 for BRAVE-AA2 and March 31, 2021 for BRAVE-AA1.

During the 36-week placebo-controlled period of the trials, patients treated with baricitinib reported a numerically higher incidence of folliculitis compared to those receiving placebo as described in Incidence of Folliculitis in the 36-Week Placebo-Controlled Period, Extended, and All BARI Integrated Datasets.2

During the extended evaluation period, the incidence rates of folliculitis with baricitinib were similar to or lower than what was observed in the placebo-controlled period as seen in Incidence of Folliculitis in the 36-Week Placebo-Controlled Period, Extended, and All BARI Integrated Datasets.2

In the All BARI AA dataset, of the 30 patients who reported 32 events of folliculitis, 

  • the scalp was involved in 80% of patients
  • no events were serious
  • no events were severe
  • 87% were mild and 13% were of moderate intensity
  • 70% of patients recovered or were recovering, and
  • no patient interrupted or discontinued study drug due to the adverse event.2

Additional Information Relevant to Folliculitis

Clinical Trial Criteria Related to Folliculitis

Folliculitis was not a specific exclusion criteria in the BRAVE-AA1 and BRAVE-AA2 studies.3

However, patients were excluded from enrollment if they had 

  • received treatment with topical corticosteroids applied to the scalp or eyebrows within 1 week prior to randomization, or
  • a current or recent and/or serious viral, bacterial, fungal, or parasitic infection within 4 weeks of randomization that, in the opinion of the investigator, would have posed an unacceptable risk to the patient if participating in the study.3

Potential Cause of Folliculitis With Baricitinib Treatment in Patients With Alopecia Areata

Folliculitis may have infectious causes or may be due to irritation of the hair follicle from regrowing hair.2,4

Given that the majority of folliculitis reported in the All BARI AA dataset involved the scalp, this might be related to irritation of the hair follicle from regrowing hair rather than from an infectious cause, which would likely affect other body areas as well.2

Clinical Trials and Integrated Safety Datasets

The baricitinib alopecia areata (AA) clinical trial program includes

The incidence of folliculitis in the BRAVE-AA trials were 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 dose or treatment change, or data cut-off, 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.7

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).7

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 .

Note: BARI 1 mg was studied in pivotal trials, however it is not approved. Please refer to section 4.2 of the Olumiant Summary of Product Characteristics for approved dosage.

Integrated Analysis Datasets Used to Evaluate Safety in Alopecia Areata Clinical Trials2,7 

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.

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

3King 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

4Satter EK. Folliculitis. Medscape website. https://emedicine.medscape.com/article/1070456-overview. Updated October 8, 2020. Accessed April 26, 2022.

5A 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

6A 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

7King 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

Date of Last Review: 26 April 2022


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