Of the patients treated with a higher dose of the drug, 35% achieved at 80% or more scalp hair coverage

Oral Janus kinase (JAK) inhibitor baricitinib helped patients with alopecia areata to achieve ‘significant’ hair regrowth, according to new results from two Phase III clinical trials. 

 

Alopecia areata is an autoimmune condition that causes an individual to experience small patches of hair loss on the scalp, face and other areas of the body. The condition is believed to develop when the body’s immune system incorrectly attacks cells in the hair follicles, leading to hair loss. 

 

In two late-stage studies – BRAVE-AA1 and BRAVE-AA2 – over a nine-month period, patients with severe alopecia areata were given either baricitinib 2 mg or 4 mg. Across both dosing groups patients reported experiencing improved scalp hair regrowth with baricitinib compared to placebo. 

 

Severe alopecia was defined in the trials as a Severity of Alopecia Tool (SALT) score of over 50%, in addition to a current episode of alopecia areata lasting at least six months and no longer than eight years. 

 

At week 36 in the BRAVE-AA1 trial, 35% of patients who received the higher baricitinib dose reached 80% or more scalp hair coverage, with 22% of patients treated with baricitinib 2 mg also reaching this endpoint. Meanwhile, only 5% of patients in the placebo group hit this amount of scalp hair coverage. 

 

Similarly in the BRAVE-AA2 trial, at week 36 the number of patients reaching 80% or more scalp hair coverage was 33%, 17% and 3% in the baricitinib 4 mg, baricitinib 2mg and placebo groups, respectively. 

 

In both studies, the number of patients who self-reported at least 80% scalp hair coverage was also found to be ‘significantly’ greater in both baricitinib dose groups compared to placebo at week 36. 

 

The most common treatment emergent events observed across the studies included upper respiratory tract infections, headache and acne. 

 

In addition, no deaths or venous thromboembolic events (VTEs) were reported in the trials, with the safety profile of the JAK inhibitor found to be consistent with the known safety profile of the drug in rheumatoid arthritis and atopic dermatitis patients.