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Olumiant ® (baricitinib)
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Olumiant® (baricitinib): How is severe alopecia areata defined?
In the baricitinib trials, severe alopecia areata was defined by a Severity of Alopecia Tool score ≥50 lasting more than 6 months to less than 8 years. In clinical practice, physicians may use different assessment methods to evaluate patient’s severity.
Assessment of Severe Alopecia Areata
Baricitinib is indicated for the treatment of severe alopecia areata (AA) in adult patients.1
In the baricitinib AA registration trials, BRAVE-AA1 and BRAVE-AA2, patients were eligible for inclusion if they had severe AA. In the trials, severe AA was defined by a
- Severity of Alopecia Tool (SALT) score of ≥50, and
- current episode of AA lasting >6 months to <8 years, without spontaneous improvement during the previous 6 months.2
Patients with severe forms of alopecia areata including alopecia totalis (AT) and alopecia universalis (AU) were eligible for enrollment in the BRAVE-AA trials.2
Alopecia totalis refers to complete hair loss on the scalp whereas alopecia universalis refers to complete hair loss on the scalp and body.3
Severity of Alopecia Tool Score
The SALT score represents the extent in percentage of scalp hair loss (range 0 [no scalp hair loss] to 100 [complete scalp hair loss]) and has been a typical scoring system used to measure efficacy in AA trials.4,5
However, many prescribers may not use the SALT scoring system in the clinical setting.5 This may be because severity of eyebrow, eyelash, and nail involvement are often assessed separately from SALT score to allow for a clear understanding of improvement of these different features but are not incorporated into the overall assessment of AA severity.5 Additionally, the SALT score does not account for psychosocial impact, emotional burden, or presence of other symptoms.5
Alopecia Areata Scale
A newer clinical practice scale has been developed by a group of leading experts in AA that incorporates
- extent of scalp hair loss
- involvement of special hair-bearing sites
- prior response to treatment
- diffuse, rapid hair loss, and
- psychosocial impact of the disease.5
This scale was not evaluated in the baricitinib clinical trial program for AA.2
Clinicians may use different clinical methodology to assess AA disease severity, and their interpretations may be subjective. It is ultimately up to the clinician to determine the best way to assess the severity of AA and then use clinical judgement to treat accordingly.6
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
3What you need to know about the different types of alopecia areata. National Alopecia Areata Foundation. Accessed August 15, 2022. https://www.naaf.org/alopecia-areata/types-of-alopecia-areata
4Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata investigational assessment guidelines–part II. J Am Acad Dermatol. 2004;51(3):440-447. https://doi.org/10.1016/j.jaad.2003.09.032
5King BA, Mesinkovska NA, Craiglow B, et al. Development of the alopecia areata scale for clinical use: results of an academic-industry collaborative effort. J Am Acad Dermatol. 2022;86(2):359-364. https://doi.org/10.1016/j.jaad.2021.08.043
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 13 September 2022