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Olumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgOlumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgThis information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the effectiveness of Olumiant® (baricitinib) on nasal, beard, and genital hair in patients with severe alopecia areata?
Baricitinib therapy was associated with clinically meaningful regrowth in nasal (52%), genital (43.5%), and beard hair (52.6%) among participants, along with reduced level of bother from hair loss at these sites
Content Overview
Assessment of Hair Loss in a Prospective Observational Study
The efficacy and safety of baricitinib have been evaluated in the following pivotal, phase 3, placebo-controlled trials in adult patients with severe alopecia areata (AA)
- BRAVE-AA1 (N=654) compared baricitinib 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss, and
- BRAVE-AA2 (N=546) compared baricitinib 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss.1
To complement findings from the BRAVE-AA clinical trials, a real-world prospective observational study was conducted to evaluate the effectiveness of baricitinib for regrowth of nasal, genital, and beard hair.2
The effectiveness of baricitinib was monitored in adult patients with severe alopecia areata (AA) from the US Baricitinib Patient Support Program over 12 months. Participants were surveyed approximately every 3 months after initiation of therapy with baricitinib as the first Janus kinase inhibitor in the previous 60 days.2
For the study, participants completed the Body Hair Symptom and Impact Scale (BHSIS) patient-reported outcomes (PRO) for nasal, genital, and beard hair loss. The degree of hair loss was assessed using 4 categories:
- no hair loss
- a limited amount of hair loss (less than half missing)
- a large amount of hair loss (greater than half missing), and
- complete/nearly complete hair loss.2
Participants rated their feelings about hair loss from 0 to 10 (0 = not at all bothered; 10 = worst imaginable for being bothered).2
In addition, participants completed the Scalp Hair Assessment PRO for scalp hair loss. The degree of hair loss was assessed using 5 categories:
- “No missing hair” (0% of my scalp is missing hair; I have a full head of hair)
- “A limited area” (1%-20% of my scalp is missing hair)
- “A moderate area” (21%-49% of my scalp is missing hair)
- “A large area” (50%-94% of my scalp is missing hair), and
- “Nearly all or all” (95%-100% of my scalp is missing hair).2
For each hair-bearing site, treatment response was defined as achievement of no or limited hair loss among participants with a large amount of or nearly complete hair loss at baseline.2
Descriptive statistics were used to summarize data as observed cases. The impact of body hair loss (degree of bother) was adjusted for baseline score, age, sex, education, and race/ethnicity, and analyzed in participants with at least a little amount of hair loss at baseline; the mean BHSIS scores were also adjusted for the same factors.2
Baseline Demographics and Clinical Characteristics
The baseline demographics and clinical characteristics of the study participants are summarized in Baseline Demographics and Clinical Characteristics of Participants in the Prospective Observational Study.
|
BARI (N=254) |
Age, mean (SD), years |
40 (14) |
Female |
184 (72.4) |
Race |
|
White |
160 (63.0) |
Black or African American |
35 (13.8) |
Asian |
19 (7.5) |
Age at AA diagnosis, mean (SD), years |
31.4 (16.8) |
Current AA episode duration |
|
<6 months |
31 (12.2) |
6 months to <1 year |
44 (17.3) |
1 to <2 years |
35 (13.8) |
2 to ≤4 years |
44 (17.3) |
>4 years |
100 (39.4) |
Hair loss pattern |
|
AA with single spot/patch |
5 (2.0) |
AA with multiple spots/patches |
119 (46.9) |
Ophiasis: Hair loss from behind the ears across the back of head |
17 (6.7) |
Alopecia totalis: Complete/nearly complete hair loss on scalp |
51 (20.1) |
Alopecia universalis: Complete or nearly complete hair loss of all body hair |
62 (24.4) |
Abbreviations: AA = alopecia areata; BARI = baricitinib.
Note: At month 12, 169 participants (66.5%) had completed the survey.
aData are n (%) unless otherwise stated.
The baseline hair loss of scalp, nasal and genital area, and beard is shown in Baseline Proportions of Scalp, Nasal, Genital, and Beard Hair Loss in Participants of a Prospective Observational Study With Baricitinib.
Figure 1 description: Pie charts depict baseline scalp, nasal, genital, and beard hair loss in participants of a baricitinib observational study categorised by severity. Scalp hair loss (N=254): 2.0% no missing hair, 20.5% limited area, 22.4% moderate area, 26.0% large area, 29.1% all/nearly all. Nasal hair loss (N=254): 56.7% no missing hair, 11.4% limited amount, 9.8% large amount, 22.0% complete/nearly complete, with a BHSIS mean of 8.0 (SD 0.7). Genital hair loss (N=254): 53.1% no missing hair, 17.7% limited amount, 10.6% large amount, 18.5% complete/nearly complete, with a BHSIS mean of 3.9 (SD 0.5). Beard hair loss (N=70): 14.3% no missing hair, 31.4% limited amount, 24.3% large amount, 22.9% complete/nearly complete, 7.1% not applicable, with a BHSIS mean of 7.7 (SD 0.7).
Abbreviations: BHSIS = Body Hair Symptom and Impact Scale; BL = baseline. SD = Standard Deviation
a Impact of body hair loss was assessed on participants with at least a limited amount of hair loss at baseline.
b Male participants only, and participants who answered this question as “Not applicable” are not included.
Proportions of Participants Achieving Nasal, Genital, and Beard Regrowth
In the study, 52% of participants achieved nasal hair regrowth after baricitinib treatment with accompanying improvement in degree of bother (see Proportions of Participants Achieving Nasal Hair Regrowth After Baricitinib Treatment With Accompanying Improvement in Degree of Bother).2
Figure 2 description: Graphs show proportions of participants achieving nasal hair regrowth after 12 months of baricitinib therapy in a prospective observational study. At baseline, participants had a BHSIS bothersomeness score of 8. After treatment, 52.0% of participants achieved limited or no nasal hair loss. The mean change in BHSIS bothersomeness score was 5.
Abbreviations: BHSIS = Body Hair Symptom and Impact Scale; LSM = least squares mean; n = number of participants who responded to treatment; Nx = number of participants with nonmissing values
a Among participants with a large amount of or nearly complete hair loss at baseline.
b Adjusted for using a random intercept mixed-effects model and adjusting for covariates of interest (baseline score, age, sex, education, race/ethnicity).
Another 43.5% of participants achieved genital hair regrowth after baricitinib treatment with accompanying improvement in degree of bother (see Participants Achieved Genital Hair Regrowth After Baricitinib Treatment With Accompanying Improvement in Degree of Bother).2
Figure 3 description: Graphs show proportions of participants achieving genital hair regrowth after 12 months of baricitinib therapy in a prospective observational study. At baseline, participants had a BHSIS bothersomeness score of 3.9. After treatment, 43.5% of participants achieved limited or no genital hair loss. The mean change in BHSIS bothersomeness score was 2.
Abbreviations: BHSIS = Body Hair Symptom and Impact Scale; LSM = least squares mean; n = number of participants who responded to treatment; Nx = number of participants with nonmissing values.
a Among participants with a large amount of or nearly complete hair loss at baseline.
b Adjusted for using a random intercept mixed-effects model and adjusting for covariates of interest (baseline score, age, sex, education, race/ethnicity).
For the male participants, 52.6% achieved beard hair regrowth after baricitinib treatment with accompanying improvement in degree of bother (see Participants Achieved Beard Hair Regrowth After Baricitinib Treatment With Accompanying Improvement in Degree of Bother).2
Figure 4 description: Graphs show proportions of participants achieving beard hair regrowth after 12 months of baricitinib therapy in a prospective observational study. At baseline, participants had a BHSIS bothersomeness score of 7.7. After treatment, 52.6% of participants achieved limited or no beard hair loss. The mean change in BHSIS bothersomeness score was 4.9.
Abbreviations: BHSIS = Body Hair Symptom and Impact Scale; n = number of participants who responded to treatment; Nx = number of participants with nonmissing values
a Among participants with a large amount of or nearly complete hair loss at baseline.
b Adjusted for using a random intercept mixed-effects model and adjusting for covariates of interest (baseline score, age, sex, education, race/ethnicity).
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1King 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
2Ko J, Lal K, Tarbox M, et al. Effectiveness of baricitinib for nasal, genital, and beard hair regrowth in patients with severe alopecia areata: 12-month outcomes from a prospective observational study. Poster presented at: Fall Clinical Dermatology Conference; October 23-26, 2025; Las Vegas, USA.
Date of Last Review: October 24, 2025