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Olumiant ® (baricitinib)
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Olumiant® (baricitinib) in alopecia areata: what is the incidence of acne?
A TEAE of acne was reported more frequently in patients treated with baricitinib compared to placebo. No cases were severe or resulted in treatment interruption. One patient was permanently discontinued from the trial due to AE of acne of mild severity.
Content overview
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 alopecia areata clinical trials
The baricitinib alopecia areata (AA) clinical trial program includes
- BRAVE-AA1, an adaptive phase 2/3 study (NCT03570749), and
- BRAVE-AA2, a phase 3 study (NCT03899259).2-4
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 November 11, 2021) and from BRAVE-AA2 (data cut-off November 5, 2021). Data cut-off represents all patients who either completed 76 weeks of the study or discontinued from the trial.5,6
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.
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
|
36-Week Placebo-Controlled BARI AA |
Extended BARI AA |
All BARI AA |
|||
Placebo |
BARI 2 mg |
BARI 4 mg |
BARI 2 mg |
BARI 4 mg |
All Doses |
|
Acne (HLT) |
8 (2.2) [3.3] |
22 (6.0) [9.4] |
32 (5.9) [9.1] |
27 (7.1) [6.2] |
38 (6.7) [4.9] |
85 [4.7] |
Acne |
4 (1.1) [1.6] |
21 (5.8) [9.0]a |
30 (5.6) [8.5]a |
26 (6.8) [6.0] |
36 (6.4) [4.7] |
81 [4.5] |
Dermatitis acneiform |
4 (1.1) [1.6] |
1 (0.3) [0.4] |
2 (0.4) [0.5] |
1 (0.3) [0.2] |
2 (0.4) [0.2] |
4 [0.2] |
Acne conglobata |
0 |
0 |
0 |
0 |
1 (0.2) [0.1] |
1 [0.1] |
Abbreviations: AA = alopecia areata; BARI = baricitinib; HLT = high-level term; adj = adjusted; IR = incidence rate.
Data Cutoff: November 5, 2021, for BRAVE-AA2 and November 11, 2021, for BRAVE-AA1.
ap<.001 vs placebo.
In the All BARI AA dataset, acne was of mild severity in more than 80% of the cases.5
Of the 85 patients who reported TEAEs,
- none were considered serious
- none led to temporary interruption, and
- 1 (0.3 %, IR=0.2) led to permanent discontinuation.6
The permanent discontinuation was a 25-year-old female treated with baricitinib 2 mg who reported facial acne of mild severity. The patient recovered after 13 days.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
Analysis Set |
Description |
36-Week placebo-controlled BARI AA |
Assesses BARI 4 mg, BARI 2 mg, and placebo.
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
Evaluation time period included randomization up to data cutoff, November 5, 2021, for BRAVE-AA2 and November 11, 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 1303 (total PYE=1868.3) patients from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 studies who were exposed to any BARI dose, including
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. Br J Dermatol. Published online November 11, 2022. https://academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljac059/6821292
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 11 November 2022