Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
Olumiant ® (baricitinib)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
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.
Table of Contents
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.
|
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 |
|
Folliculitis |
3 (0.8) [1.2] |
5 (1.4) [2.1] |
12 (2.2) [3.3] |
10 [2.1] |
19 [2.1] |
42 [1.9] |
Abbreviations: AA = alopecia areata; BARI = baricitinib; IR = incidence rate.
Data Cutoff: May 24, 2022 for BRAVE-AA1 and May 10, 2022 for BRAVE-AA2.
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 a previous analysis of the All BARI AA dataset (March 2021) that included 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
- BRAVE-AA1, an adaptive phase 2/3 study (NCT03570749), and
- BRAVE-AA2, a phase 3 study (NCT03899259).3,5,6
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 May 24, 2022) and from BRAVE-AA2 (data cut-off May 10, 2022). Data cut-off represents all patients who either completed 104 weeks of the study or discontinued from the trial.2
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.
Description of Integrated Safety Datasets
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, May 10, 2022 for BRAVE-AA2 and May 24, 2022 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=2217.9) 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.
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. Br J Dermatol. Published online November 11, 2022. https://academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljac059/6821292
Date of Last Review: 26 October 2022