Baricitinib Tablets (Olumiant)
By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.
Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
The FDA has approved the first systemic treatment of alopecia areata (AA).1 Baricitinib is a Janus kinase (JAK) inhibitor initially approved in 2018 to treat rheumatoid arthritis and, more recently, COVID-19. The agency granted an accelerated/priority review and breakthrough therapy designation for AA.1 Baricitinib is marketed as Olumiant.
INDICATIONS
Baricitinib can be prescribed to adults with AA.2 Clinicians also can prescribe this for adults with moderately to severely active rheumatoid arthritis who have inadequately responded to one or more tissue necrosis factor inhibitors and for COVID-19 in hospitalized adults requiring supplemental oxygen or non-invasive or invasive mechanical ventilation.
DOSAGE
The recommended initial dose for alopecia areata is 2 mg once daily.2 The dose may increase to 4 mg once daily if response is inadequate. For those with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider starting at 4 mg. The dose should be lowered to 2 mg daily when adequate response has been achieved. Dosage modifications are recommended for infections, cytopenias, anemia, renal impairment, and in combination with strong organic anion transporter-3 inhibitors.2 Baricitinib is available as 1 mg, 2 mg, and 4 mg tablets.
POTENTIAL ADVANTAGES
Baricitinib is the first FDA-approved systemic treatment of AA.
POTENTIAL DISADVANTAGES
Baricitinib carries a boxed warning for high risk of serious infections (bacterial, fungal, viral, and opportunistic infections), all-cause mortality (e.g., sudden cardiac death), major adverse cardiovascular events, malignancies, and thrombosis.2 Elevation of liver enzymes and lipid parameters have been associated with baricitinib.2 Long-term treatment may be required, as relapse is likely after therapy discontinuation.3
COMMENTS
The JAK signal transducer and activation of transcription pathway appears to play a key role in the pathogenesis of AA.4 Baricitinib interrupts the JAK signaling pathway and blocks the inflammatory response. The efficacy of baricitinib was evaluated in two randomized, double-blind, placebo-controlled, 36-week trials that included 1,200 subjects with AA.2,5 Eligible subjects recorded a Severity of Alopecia Tool (SALT) score of 50 or higher. The score ranges from 0 to 100 based on no scalp hair loss (0) to complete hair loss (100). The mean SALT score of trial subjects was about 85, with more than 50% presenting with severe disease. Subjects were randomized to 2 mg or 4 mg of baricitinib or placebo. The primary endpoint was a SALT score of ≤ 20 (i.e., a meaningful 80% of scalp hair recovery). In trial 1, 22% of those randomized to 2 mg achieved the predetermined success criteria vs. 35% for the 4 mg and 5% for placebo. In trial 2, percentages were 17%, 32%, and 3%, respectively. Those with baseline SALT scores between 50% and 94% responded better than those with scores between 95% and 100%. It took 16 weeks to 24 weeks for the 4 mg dose to show significant improvement over placebo and 24 weeks to 36 weeks for the 2 mg dose.5 In subjects who achieved adequate response at 52 weeks on 4 mg daily (n = 82), down-titration to 2 mg maintenance for 24 weeks reduced the success rate to 75% (30/40) vs. 98% (41/42) for those who remained on the 4 mg dose.2
CLINICAL IMPLICATIONS
AA is the most common autoimmune-mediated hair loss condition. The immune system attacks its own hair follicles, particularly during the active growth phase.4 It is a relapsing-remitting disease, with a prevalence of 0.2%.4 Approximately 40% of patients develop chronic-persistent or chronic-relapsing and remitting disease. Current treatments include corticosteroids (intralesional injection, topical), minoxidil, anthralin, and methotrexate.6 About 20% to 34% of subjects treated with baricitinib achieved a meaningful dose-related response. Long-term therapy seems to be needed to maintain the response, and therapy is not without risks. Affordability may be an issue, too. A 30-day supply is $2,497.20 for the 2 mg dose and $4,994.40 for the 4 mg dose ($30,383 and $60,765 annually, respectively).
REFERENCES
1. U.S. Food & Drug Administration. FDA approves first systemic treatment for alopecia areata. June 13, 2022.
2. Eli Lilly and Company. Olumiant prescribing information. June 2022.
3. Dillon KL. A comprehensive literature review of JAK inhibitors in treatment of alopecia areata. Clin Cosmet Investig Dermatol 2021;14:691-714.
4. Ismail FF, Sinclair R. JAK inhibition in the treatment of alopecia areata - a promising new dawn? Expert Rev Clin Pharmacol 2020;13:43-51.
5. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med 2022;386:1687-1699.
6. American Academy of Dermatology Association. Hair loss types: Alopecia areata diagnosis and treatment.
Baricitinib is the first FDA-approved systemic treatment of alopecia areata.
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