We appreciate the opportunity to share our findings on the use of baricitinib for severe alopecia areata (AA). AA is an immune-mediated disorder characterized by unpredictable hair loss and a substantial impact on quality of life.1 Although Janus kinase (JAK) inhibitors such as baricitinib have provided new therapeutic opportunities for severe cases, real-world evidence (RWE) regarding their effectiveness and safety remains limited. We believe our findings offer valuable clinical insight into the management of this challenging condition.

In this retrospective study, we analyzed the clinical outcomes of 30 patients (Table 1) treated with baricitinib (2mg or 4mg daily) for at least 36 weeks, with follow-up extending to 52 weeks in most cases. Disease severity was assessed using the Severity of Alopecia Tool (SALT) at multiple time points (weeks 12–52). Based on the post-hoc analysis of the BRAVE-AA clinical trials,2,3 response patterns were categorized as early responders (SALT ≤20 first achieved within 12 weeks), gradual responders (SALT ≤20 first achieved between 12 and 36 weeks), and late responders (SALT ≤20 first achieved after 36 weeks). Adverse events were recorded during routine follow-up visits, during which patients were systematically asked in a nondirected manner about possible side effects. Laboratory-related adverse events were evaluated through routine blood tests performed as part of the standard follow-up protocol.

In the overall cohort, the median SALT score decreased from 76.2 at baseline to 37.7 at week 36 and 36.1 at week 52. At week 36, 50% of patients achieved SALT ≤20, increasing to 59% at week 52 (Figs. 1 and 2). Among patients with alopecia areata universalis, 40% achieved this threshold at week 36 and 50% at week 52. In the nonuniversalis AA group, responses were more favorable, with 70% achieving SALT ≤20 at week 36 and 77.8% at week 52. Most patients were gradual or late responders, highlighting the importance of sustained therapy. Overall, 8 patients (27%) were early responders, 7 (23%) gradual responders, and 3 (10%) late responders. Spearman correlation analysis demonstrated a moderate correlation between disease duration and response timing (Spearman ρ=0.51; 95% CI, 0.042–0.795; P=.031).

Fig. 1.

Reduction in SALT scores and percentage of patients achieving SALT ≤20 during follow-up. Data are stratified for the overall cohort, the alopecia areata universalis subgroup, and the nonuniversalis subgroup. Thirty patients were evaluated up to week 36 and 27 patients up to week 52.

Fig. 2.

Comparative clinical response to baricitinib in three patients with severe alopecia areata. Top panel: early responder with rapid improvement. Middle panel: late responder showing delayed regrowth. Bottom panel: gradual responder with progressive improvement. Images at week 0 (left) and week 36 (right).

A multivariable logistic regression analysis was performed to identify independent predictors of clinical response at week 36 (defined as SALT ≤20), adjusting for age at onset, disease duration, and prior tofacitinib use. Baseline SALT score emerged as the only significant predictor (OR, 0.93; 95% CI, 0.88–0.99; P=.029).

The introduction of new anti-JAK therapies for AA raises questions regarding optimal switching strategies. In our study, a subgroup of 7 patients who switched from tofacitinib to baricitinib showed a reduction in median SALT score from 55 (SD, 33.8) at baseline to 32.14 at week 52, with 57.1% achieving SALT ≤20 at week 52. These findings suggest that baricitinib may represent a viable alternative for patients who fail to respond to other JAK inhibitors.

Off-label use of baricitinib in pediatric patients (n=4; age range, 7–17 years) also showed promising results. At week 36, 50% achieved SALT ≤20, with two patients improving after dose escalation from 2mg to 4mg. These observations support the potential utility of baricitinib in severe pediatric AA, although long-term safety requires further evaluation.

The safety profile of baricitinib in our cohort was consistent with previous RWE studies.4–10 The drug was generally well tolerated, with mild adverse events reported in 53% of patients. Dyslipidemia occurred in 23.3% of patients, including hypercholesterolemia (20%) with mild-to-moderate LDL elevation and hypertriglyceridemia in 1 patient. Most laboratory abnormalities were managed without pharmacologic intervention, although lipid-lowering therapy was required in two patients. Other adverse effects included acneiform eruptions (13.3%), mild infections (6.7%), and seborrheic dermatitis (6.7%). The drug was also well tolerated in three patients with prior oncologic conditions and one patient with primary antiphospholipid syndrome, without adverse events related to these underlying conditions.

Compared with the BRAVE-AA clinical trials, our study demonstrated slightly higher response rates at week 36 (50% vs 38.8%). Baseline SALT scores in our cohort (76.2) were comparable to those reported in other RWE studies, such as Gargiulo (84.4) and Numata (89.2), which included predominantly patients with very severe disease. Variability in response rates may be related to baseline severity and clinical phenotype, as suggested by De Greef (better outcomes in patchy AA) and Moreno-Vílchez (superior results in patients with shorter disease duration). Notably, 96.7% of our patients had previously received systemic immunosuppressants, and 70% had received at least two prior treatment lines (cyclosporine, methotrexate, azathioprine). This detail, rarely specified in previous RWE studies, underscores the refractory nature of our cohort and provides useful context for comparisons with other studies.

Our findings also emphasize the importance of sustained therapy, as patients with higher baseline SALT scores often required prolonged treatment before achieving meaningful hair regrowth.3 In our experience, baricitinib appears particularly useful in patients with alopecia areata universalis or long-standing, treatment-resistant disease. Before initiating treatment, we recommend baseline blood tests, screening for tuberculosis and hepatitis B and C, and vaccination against herpes zoster. Although prior systemic therapy is not mandatory, funding requirements in many hospitals mandate it.

This study has limitations, including the relatively small sample size, retrospective design, and the focus on scalp alopecia.

In summary, our findings provide valuable real-world evidence complementing data from clinical trials and further support the role of baricitinib as a safe and effective therapeutic option with sustained benefits over time in the management of severe alopecia areata.