Real-World Analysis Supports Ritlecitinib Use in Adolescents With Severe Alopecia Areata

Many patients with severe alopecia areata who received ritlecitinib achieved hair regrowth beyond the scalp, including regrowth of eyebrows and eyelashes, in a multicenter Italian study published in the American Journal of Clinical Dermatology, adding real-world evidence to support the recently approved Janus kinase (JAK) inhibitor.¹

Investigators reported that 40.2% of patients achieved a Severity of Alopecia Tool (SALT) score of 20 or less after 24 weeks of treatment with ritlecitinib 50 mg/day, indicating 20% or less scalp hair loss. Responses appeared more pronounced among adolescents than adults, while quality of life measures and psychological outcomes also improved over the study period.

Alopecia areata is an autoimmune condition characterized by nonscarring hair loss that can affect the scalp, eyebrows, eyelashes, and body hair. Severe forms of the disease are associated with substantial psychosocial burden, particularly among adolescents and young adults.

Alopecia areata can carry a substantial psychosocial burden for adolescents, particularly because the condition often develops during formative years tied to self-image and social development. A 2024 systematic review found that pediatric and adolescent patients with alopecia areata frequently experienced impaired self-esteem, anxiety, depression, social stigma, and diminished quality of life, underscoring the need for both medical and psychosocial support in this population.² Those findings are especially relevant to the present real-world ritlecitinib study, in which nearly 69% of the cohort comprised adolescents aged 12 to 17 years. The age distribution may help explain the strong improvements observed not only in hair regrowth outcomes but also in anxiety, depression, and dermatology-related quality-of-life measures over 24 weeks of treatment.

Although ritlecitinib received approval from the FDA in 2023 for severe alopecia areata in patients aged 12 years and older, the authors noted that real-world evidence outside of clinical trials had remained limited.¹

To address that gap, researchers conducted a retrospective observational study across 20 Italian university dermatology centers. The analysis included 102 patients aged 12 years and older who had severe alopecia areata, defined as a SALT score of at least 50, and who were treated with oral ritlecitinib 50 mg daily for 24 weeks.

The cohort included 55 male patients and 47 female patients, with a mean age of 23.9 years. Adolescents aged 12 to 17 years accounted for 68.6% of participants, whereas 31.4% were adults aged 18 years or older. Mean disease duration was 8.9 years overall, although adults had substantially longer disease duration than adolescents.

At baseline, 44.1% of participants had severe alopecia areata with SALT scores between 50 and 95, whereas 55.9% had very severe disease with SALT scores of at least 95. The mean baseline SALT score was 86.2.

Most participants previously received multiple therapies before starting ritlecitinib. Nearly all patients had used high-potency topical corticosteroids, 66.7% had received systemic corticosteroids, and smaller proportions had previously received cyclosporine, methotrexate, topical immunotherapy, intralesional corticosteroids, or other JAK inhibitors.

By week 24, 41 of 102 patients achieved the study’s primary endpoint of SALT 20 or less. Response rates differed by age group, with 48.6% of adolescents reaching SALT 20 or less compared with 21.9% of adults. Additionally, 31.4% of the overall cohort achieved SALT 10 or less by week 24.

Mean SALT scores declined steadily during treatment, decreasing from 86.2 at baseline to 40.8 at week 24. Investigators also documented improvements in trichoscopic markers associated with disease activity and regrowth. Regrowing hairs increased from 13.7% of patients at baseline to 84.3% at week 24, whereas markers associated with active disease, including yellow dots and exclamation mark hairs, declined over time.

The researchers wrote that “the response to ritlecitinib is greater in adolescents than in adults,” potentially because adolescents in the cohort had shorter disease duration, shorter duration of the current alopecia episode, and greater follicular regenerative potential.

Treatment benefits extended beyond scalp regrowth. Mean clinician-reported eyebrow and eyelash scores improved significantly during follow-up, and nail involvement also lessened among affected patients.

Patient-reported outcomes also suggested reduced psychosocial burden. Skindex-16 scores, which assess the impact of skin disease on quality of life, decreased from 48.4 at baseline to 30.9 at week 24. Anxiety and depression scores measured with the Hospital Anxiety and Depression Scale also improved significantly.

“These parameters may serve as early predictors of treatment response,” the authors wrote regarding trichoscopic improvements observed during treatment.

Ritlecitinib was generally well tolerated throughout the study period. The most frequently reported adverse events included acne, headache, upper respiratory tract infections, constipation, and fatigue. Most events were mild. One patient discontinued treatment because of anemia, and another stopped therapy because of lack of efficacy. No serious infections, thrombosis, or severe treatment-related adverse events were reported.

The authors said the safety findings aligned with prior clinical trial data evaluating ritlecitinib and other JAK inhibitors in alopecia areata.

Still, investigators acknowledged several study limitations. The retrospective and uncontrolled design introduced the potential for selection bias, particularly because participants were recruited from tertiary referral centers and were already considered candidates for systemic therapy. The relatively short 24-week follow-up period also limited assessment of long-term durability and safety. Additionally, the high proportion of adolescents in the study may affect generalizability to broader adult populations with alopecia areata.

The researchers noted that ongoing follow-up through 52 weeks may help clarify long-term treatment trajectories, durability of response, and comparative effectiveness against other JAK inhibitors such as baricitinib.

References

1. Starace M, Rapparini L, Pampaloni F, et al. Ritlecitinib for severe alopecia areata: a 24-week, multicentre, real-world study. Am J Clin Dermatol. 2026;27(3):621-630. doi:10.1007/s40257-026-01022-5

2. Tan IJ, Jafferany M. Psychosocial impact of alopecia areata in paediatric and adolescent populations: a systematic review. J Paediatr Child Health. 2024;60(12):778-782. doi:10.1111/jpc.16678