A small retrospective study presents real-world outcome and safety data for three different treatment options.
A Spanish observational study has found Janus kinase inhibitors lead to improvements in scalp, eyebrow, and eyelash involvement in paediatric alopecia areata patients.
“To our knowledge, this is one of the largest real-world paediatric series reporting outcomes in children treated with different JAK inhibitors,” the researchers wrote in the Australasian Journal of Dermatology.
Researchers recruited 46 patients aged 18 years and under with dermatologist-confirmed AA who had been prescribed baricitinib (n = 22), tofacitinib (n = 14), or ritlecitinib (n = 10).
The patients were predominantly female (58.7%) and had a mean age of 11.3 years. Patients had been living with AA for an average of 4.5 years, had gone an average of 3.1 years between diagnosis and starting the JAKi, and were followed up for an average of 1.9 years.
The average BMI was 22.6, and the average Severity of Alopecia Tool (SALT) score at baseline was 76.2. Around one in five patients (21.7%) had atopic dermatitis as a comorbidity, while hypothyroidism (15.2%) and mental disorders (including anxiety, depression, and ADHD; 10.9%) were other common comorbidities.
Almost all patients had previously used or were currently using topical corticosteroids (93.5%), with fewer patients using intralesional (47.8%) or oral (33.3%) corticosteroids.
The proportion of patients achieving the primary outcome – a ≥50% reduction in their baseline SALT score – increased over time, from 21.6% at weeks four to eight to 82.4% at week 72. There was a corresponding decrease in the mean SALT score over time, with each of the three JAKis showing a similar trend across the follow-up timepoints.
Between-drug comparisons were not possible due to the study’s observational design, imbalances between treatment cohorts at baseline, and missing data.
A higher baseline SALT score was associated with lower odds of achieving a ≥50% reduction in SALT by week 16 in an unadjusted analysis. However, this association did not remain after the alopecia universalis phenotype was accounted for.
Improvements in the Eyebrow Assessment and Eyelash Assessment scores were also seen over time. Baricitinib, tofacitinib, and ritlecitinib all showed similar trends.
Sixteen adverse events were reported among the 46 patients. Acne/seborrheic dermatitis was the most frequently reported adverse event (8.7% of patients), ahead of recurrent nasopharyngitis (6.5%) and transient creatine kinase elevation, transient transaminase elevation, and diarrhoea/abdominal pain (all 4.3%).
“Overall, the safety profile was favourable, with most adverse events being mild, and few discontinuations were attributed to toxicity. These findings align with the paediatric experience reported elsewhere,” said the researchers.
Related
“Nevertheless, careful surveillance remains essential. The US Food and Drug Administration’s boxed warning for JAKi, derived primarily from adult rheumatoid arthritis cohorts, highlights potential risks that require individualised risk stratification and long-term pharmacovigilance in paediatric dermatology.”
Key limitations of the study were its small sample size and declining outcome availability throughout the follow-up period. Data were missing for nine patients (19.6% of the sample) at weeks four to eight, 10 patients at week 16 (21.7%), 15 patients at week 24 (32.6%), 21 patients at week 48 (45.7%), and 29 patients at week 72 (63.0%).
“Missing outcome data were primarily related to non-systematic factors, including missed or delayed follow-up visits, variable follow-up duration, and shorter exposure for patients initiating treatment later in the study period, particularly for more recently introduced agents,” the researchers wrote.
In addition, other outcomes such as nail involvement, patient preferences and satisfaction, and the psychosocial impact of AA, were not captured.
Despite these limitations, the researchers were keen to push the real-world aspect of their findings.
“Because these data were generated outside of controlled trials, they provide practical evidence that JAKi could deliver a significant clinical benefit to children and adolescents with AA in scalp, eyebrow, and eyelash areas,” they wrote.
“Looking ahead, the therapeutic landscape in paediatric AA is rapidly expanding. Beyond baricitinib, tofacitinib, and ritlecitinib, other JAK pathway agents, including ruxolitinib (JAK1/2) and upadacitinib (JAK1), are under evaluation.
“Non-JAK strategies, such as dupilumab and procedural approaches like CO2 laser protocols or intralesional triamcinolone, are also being studied.”
