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female hair growth four months after starting baricitinib

An 11-year-old female with alopecia totalis (A) experienced nearly complete hair regrowth four months after starting baricitinib 2 milligrams daily (B). Courtesy of Ingrid Polcari, M.D., FAAP.

JAK inhibitors could change treatment landscape for alopecia areata

June 1, 2024
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Approximately one in 1,000 children and adolescents is affected by alopecia areata (AA), an autoimmune disease that leads to disfiguring hair loss (McKenzie PL, et al. JAMA Dermatol. 2022;158:547-551).

AA also has been shown to have a negative impact on psychosocial well-being. A recent survey found that 48% of pediatric patients with AA were embarrassed by their hair loss, and 33% admitted to staying home from school at least once due to AA (Christensen T, et al. Skin Appendage Disord. 2017;3:115-118).

The majority of pediatric AA is mild and self-limited. Earlier ages of onset, however, correlate with more severe and chronic disease, and those with more extensive disease involvement historically have responded poorly to traditional treatment options.

The Food and Drug Administration (FDA) recently approved a new class of medications for the treatment of extensive AA, thereby changing the landscape of this challenging disease. 

Steroids, adjunctive therapies

Widespread or severe disease typically is managed by dermatologists. A variety of treatment options are available, most of which are non-FDA approved.

High-potency topical or intralesional steroids are tried first as gold-standard therapies. Topical steroids have a favorable safety profile, with potential side effects of scalp atrophy or folliculitis (Barton VR, et al. J Am Acad Dermatol. 2022;86:1318-1334).

Intralesional injections allow for steroid placement near follicular inflammation. However, younger patients may not tolerate injections, and treatments often need to be repeated over several sessions.

Adjunctive off-label therapies for mild-to-moderate pediatric AA include topical minoxidil, topical sensitizing agents such as squaric acid dibutyl ester, low-dose oral minoxidil and low-level laser light therapy (Barton VR, et al. J Am Acad Dermatol. 2022;86:1318-1334; Avci P, et al. Lasers Surg Med. 2014;46:144-151).

Immunosuppressive medications

As more is understood about the significant psychosocial effects of alopecia areata in children and adolescents, dermatologists might offer a more aggressive treatment approach for severe cases such as alopecia totalis (total absence of scalp hair) or alopecia universalis (total absence of scalp and body hair).

Immunosuppressive medications such as methotrexate and prednisone have been used off label for severe cases. In a recent multicenter, double-blind, randomized clinical trial, five of 16 (31.2%) patients with alopecia totalis or alopecia universalis achieved near-complete to complete hair regrowth after receiving methotrexate for 12 months and prednisone for six months (Joly P, et al. JAMA Dermatol. 2023;159:403-410). 

JAK inhibitors

Janus kinase (JAK) inhibitors, an emerging class of medications for treatment of autoimmune conditions such as arthritis and inflammatory bowel disease, have shown promise in the treatment of AA (Behrangi E, et al. J Cosmet Dermatol. 2022;21:6644-6652).

In June 2022, the FDA approved baricitinib (Olumiant) for use in adults with AA. In June 2023, ritlecitinib (Litfulo) became the first FDA-approved medication for AA in pediatric patients ages 12 and up. In a recent phase 2b/3 randomized, double-blind, placebo-controlled trial of ritlecitinib, nine of 34 (26.5%) adolescents on treatment achieved near-complete to complete hair regrowth at week 24 compared to none of the 19 patients in the placebo group (Hordinsky M, et al. Pediatr Dermatol. 2023;40:1003-1009).

Dermatologists expect the indications for these drugs to expand, as a phase 1 clinical trial for ritlecitinib in children 6-12 years recently concluded, and a phase 3 clinical trial of baricitinib in children as young as 6 years old is underway (ClinicalTrials.gov). 

The use of JAK inhibitors has the potential to revolutionize care of alopecia areata and has brought an unprecedented sense of optimism for this historically refractory disease. This class of medicine tends to be well-tolerated in the pediatric population but carries potential risks put forth by the FDA based on clinical trials of tofacitinib, a JAK inhibitor commonly used to treat arthritis. While these risks were rare to nonexistent in the clinical trials for baricitinib, patients and their families still are informed about potential opportunistic infections (0%), malignancy (0-0.4%), cardiovascular events (0-0.5%) and blood clots (0%), with laboratory monitoring (e.g., tuberculosis screening, complete blood counts, lipid profile) recommended by drug manufacturers (Singh R, Driscoll MS. J Drugs Dermatol. 2023;22:935-940; Eli Lilly and Company).

More studies are needed to fully understand the risks of long-term use of these medications, especially in the pediatric population. Early studies on the durability of JAK inhibitors suggest that disease returns in some patients after stopping or decreasing the dose (King B, et al. Skin. 2023;7:s184). Dermatologists engage in shared decision-making with patients and their families regarding the use of these therapies. 

Dr. Polcari is an associate professor of dermatology at the University of Minnesota and a member of the AAP Section on Dermatology. Dr. Hordinsky is professor and chair of the Department of Dermatology at the University of Minnesota. Ms. Nguyen is a dermatology research fellow in the Department of Dermatology at University of Minnesota.

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