Olumiant ® (baricitinib)

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What was the incidence of acne during baricitinib treatment for alopecia areata?

In the alopecia areata clinical trials, acne was reported more frequently in patients treated with baricitinib than with a placebo. None of the cases was severe or resulted in treatment interruption or discontinuation.

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Safety profile of baricitinib for the risk of acne

Acne was reported as a common (≥ 1/100 to < 1/10) adverse drug reaction. 1

Incidence of acne in the baricitinib alopecia areata clinical trials

The baricitinib alopecia areata (AA) clinical trial program includes

The incidence of acne 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 or dose treatment change, 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).5

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.

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 .

Incidence of treatment-emergent acne

A high-level term (HLT) cluster analysis was performed to assess acne and related preferred terms (PTs) associated with acne. The HLT cluster and treatment-emergent adverse events (TEAEs) by PT related to acne are reported in Incidence of Acne From the 36-Week Placebo-Controlled Period, Extended, and All BARI Integrated Datasets.6

Incidence of Acne From the 36-Week Placebo-Controlled Period, Extended, and All BARI Integrated Datasets5,6

 

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)

Acnes (HLT)

8 (2.2) [3.3]

22 (6.0) [9.4]

32 (5.9) [9.1]

25 [6.7]

36 [5.9]

77 [5.8]

Acne

4 (1.1) [1.6]

21 (5.8) [9.0]a

30 (5.6) [8.5]a

24 [6.4]

34 [5.5]

73 [5.5]

Dermatitis acneiform

4 (1.1) [1.6]

1 (0.3) [0.4]

2 (0.4) [0.5]

1 [0.3]

2 [0.3]

4 [0.3]

Abbreviations: AA = alopecia areata; BARI = baricitinib; HLT= high-level term; IR = incidence rate.

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

ap<.001 vs placebo.

A total of 77 patients reported 82 events from the acnes (HLT) cluster in the All-BARI-AA analysis set, including

  • 95% who reported the PT of acne, mostly located on the face
  • 5% who reported the PT of dermatitis acneiform, and the face was involved in all cases.6

Of the 82 events,

  • 85% were mild
  • 15% were moderate, and
  • no events were severe.6

No patient temporarily interrupted or discontinued study drug due to acne.6

Although the biologic plausibility for an association between janus kinase (JAK) inhibitors and the occurrence of acne is unclear, acne has been reported in patients treated with JAK inhibitors and has been recognized as an adverse drug reaction for baricitinib.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.

Date of Last Review: 04 March 2022


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