Journal of the European Academy of Dermatology and Venereology

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Alopecia areata (AA) is an autoimmune condition leading to hair loss. Baricitinib, a Janus kinase (JAK) inhibitor, has demonstrated efficacy in controlled clinical trials, but real‐world data on its long‐term effectiveness and safety remain limited.</jats:p></jats:sec><jats:sec><jats:title>Objectives</jats:title><jats:p>This study aimed to assess the real‐life effectiveness and safety of baricitinib 4 mg daily in Italian adult patients with severe AA over a 48‐week treatment period.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a 48‐week retrospective, observational, multicenter study across 27 Italian university hospitals. Adult patients (18–65 years) with severe AA (Severity of Alopecia Tool [SALT] score ≥ 50) who initiated baricitinib 4 mg daily treatment between November 2022 and October 2023 were included. Effectiveness was measured by the percentage of patients achieving SALT ≤20 at week 48. Secondary outcomes included changes in mean SALT score, trichoscopic findings, patient‐reported quality of life (Skindex‐16, Hospital Anxiety and Depression Scale [HADS]), and Clinician‐Reported Outcomes (ClinRO) for eyebrows and eyelashes. Adverse events were also documented.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 253 patients (66.8% females, mean age 40.0 ± 12.6 years) were included. By week 48, 63.2% achieved SALT ≤20, and 75.5% achieved SALT ≤30. The mean SALT score significantly decreased from 93.7 ± 14.1 at baseline to 26.5 ± 33.0 at week 48 (<jats:italic>p</jats:italic> &lt; 0.001). Trichoscopic assessment showed a decline in yellow dots (97.6%–50.2%), black dots (43.5%–9.1%), and dystrophic hairs (14.6%–4.3%), whilst regrowing hairs increased (7.1%–80.2%). Skindex‐16 scores improved significantly (57.1 ± 25.0 to 30.0 ± 17.8, <jats:italic>p</jats:italic> &lt; 0.001), as did HADS Anxiety (8.21 ± 9.38 to 4.62 ± 4.21, <jats:italic>p</jats:italic> &lt; 0.001) and HADS Depression (6.36 ± 4.55 to 3.70 ± 4.11, <jats:italic>p</jats:italic> &lt; 0.001). Adverse events were reported in 9.4% of patients.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>This real‐world study confirms the effectiveness of baricitinib in achieving significant hair regrowth and improving psychological well‐being in severe AA patients.</jats:p></jats:sec>

publication_history

received

accepted

published

Eli Lilly and Company

Alopecia areata investigational assessment guidelines–part II. National alopecia areata foundation

J Am Acad Dermatol

Two phase 3 trials of Baricitinib for alopecia areata

N Engl J Med

The hospital anxiety and depression scale

Health Qual Life Outcomes

Alopecia areata (AA) is an autoimmune condition leading to hair loss. Baricitinib, a Janus kinase (JAK) inhibitor, has demonstrated efficacy in controlled clinical trials, but real-world data on its long-term effectiveness and safety remain limited.
This study aimed to assess the real-life effectiveness and safety of baricitinib 4 mg daily in Italian adult patients with severe AA over a 48-week treatment period.
We conducted a 48-week retrospective, observational, multicenter study across 27 Italian university hospitals. Adult patients (18-65 years) with severe AA (Severity of Alopecia Tool [SALT] score ≥ 50) who initiated baricitinib 4 mg daily treatment between November 2022 and October 2023 were included. Effectiveness was measured by the percentage of patients achieving SALT ≤20 at week 48. Secondary outcomes included changes in mean SALT score, trichoscopic findings, patient-reported quality of life (Skindex-16, Hospital Anxiety and Depression Scale [HADS]), and Clinician-Reported Outcomes (ClinRO) for eyebrows and eyelashes. Adverse events were also documented.
A total of 253 patients (66.8% females, mean age 40.0 ± 12.6 years) were included. By week 48, 63.2% achieved SALT ≤20, and 75.5% achieved SALT ≤30. The mean SALT score significantly decreased from 93.7 ± 14.1 at baseline to 26.5 ± 33.0 at week 48 (p < 0.001). Trichoscopic assessment showed a decline in yellow dots (97.6%-50.2%), black dots (43.5%-9.1%), and dystrophic hairs (14.6%-4.3%), whilst regrowing hairs increased (7.1%-80.2%). Skindex-16 scores improved significantly (57.1 ± 25.0 to 30.0 ± 17.8, p < 0.001), as did HADS Anxiety (8.21 ± 9.38 to 4.62 ± 4.21, p < 0.001) and HADS Depression (6.36 ± 4.55 to 3.70 ± 4.11, p < 0.001). Adverse events were reported in 9.4% of patients.
This real-world study confirms the effectiveness of baricitinib in achieving significant hair regrowth and improving psychological well-being in severe AA patients.
WHAT IS THE DISEASE?: Alopecia areata (AA) is an autoimmune condition that causes sudden hair loss on the scalp, face, or body. Severe forms can result in complete loss of scalp hair (alopecia totalis) or all body hair (alopecia universalis). It affects both men and women and can significantly impact emotional well‐being.
This study was conducted in Italy, involving 27 university hospitals.
We wanted to understand how well baricitinib, a medicine that blocks specific immune signals (JAK1/2), works and how safe it is for adults with severe AA in everyday clinical practice over 48 weeks.
We reviewed the medical records of 253 adults (aged 18–65 years) with severe AA who started baricitinib 4 mg daily between November 2022 and October 2023. We measured hair regrowth using the Severity of Alopecia Tool (SALT) and assessed eyebrow/eyelash changes, scalp examination with a dermatoscope (trichoscopy), quality of life, mood, and treatment safety.
After 48 weeks, 63% of patients had major scalp hair regrowth (SALT ≤20), and over 75% had moderate regrowth (SALT ≤30). Trichoscopy showed more regrowing hairs and fewer disease signs. Quality‐of‐life scores improved, and symptoms of anxiety and depression decreased. Side effects occurred in about 9% of patients, mostly mild.
In real‐world settings, baricitinib can restore hair and improve mental health in many people with severe AA. Regular follow‐up is important to monitor progress and detect side effects.

Effectiveness and safety of baricitinib in severe alopecia areata: 48-week results.

Effectiveness and safety of baricitinib in severe alopecia areata: 48‐week results

Journal of the American Academy of Dermatology

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Pfizer

Utility of azathioprine, methotrexate and cyclosporine as steroid-sparing agents in chronic alopecia areata: a retrospective study of continuation rates in 138 patients

J Eur Acad Dermatol Venereol

Killing two birds with one stone: oral tofacitinib reverses alopecia universalis in a patient with plaque psoriasis

J Invest Dermatol

Lymphocytes, neuropeptides, and genes involved in alopecia areata

J Clin Invest

Alopecia areata is driven by cytotoxic T lymphocytes and is reversed by JAK inhibition

Nat Med

Two phase 3 trials of baricitinib for alopecia areata

Ruxolitinib cream for the treatment of patients with alopecia areata: a 2-part, double-blind, randomized, vehicle-controlled phase 2 study

A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata

Arch Dermatol Res

Tofacitinib 2% ointment, a topical Janus kinase inhibitor, for the treatment of alopecia areata: a pilot study of 10 patients

Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis

A review of safety outcomes from clinical trials of baricitinib in rheumatology, dermatology and COVID-19

Adv Ther

Less is more? Failure of one JAK inhibitor does not predict failure of another one in a patient with alopecia areata

Dermatol Ther

Development of the alopecia areata scale for clinical use: results of an academic-industry collaborative effort

Combination tofacitinib and oral minoxidil treatment for severe alopecia areata

Janus kinase (JAK) inhibitors have ushered in a new era in alopecia areata (AA). Historically, moderate-to-severe AA was refractory to treatment. JAK inhibitors have changed that; now, treatment of moderate-to-severe AA is possible. Here, we briefly review the history of and rationale for JAK inhibitor treatment of AA, phase 3 clinical trial data, and considerations regarding differences among JAK inhibitors, safety, and patient selection.

Janus kinase inhibitors for alopecia areata.

Janus kinase inhibitors for alopecia areata

Papers