Why is this important?
Alopecia areata (AA) is an alopecia areata of autoimmune origin against which Janus kinase (anti-JAK) inhibitors have recently been developed: baricitinib is the first oral JAK1/JAK2 inhibitor to have been approved by the European agency for the treatment of severe forms of AA in adults (developing in children). The studies available to date have been conducted over 36 weeks, but since hair growth is particularly slow, it was interesting to assess whether the clinical improvement provided by these treatments could be greater after 52 weeks. Also, this study made it possible to analyze the data from the extension periods of the two pivotal studies BRAVE-AA1 and BRAVE-AA2.
Methodology
The BRAVE-AA1 and BRAVE-AA2 studies included adult patients with an SALT score (Severity of Alopecia Tool) ≥ 50, i.e. hair loss ≥ 50% on the scalp, for more than 6 months without lasting improvement of more than 10 SALT points, (duration < 8 years). Both had randomized (2:2:3) the patients between baricitinib 2mg, baricitinib 4mg and a placebo for 36 weeks. Then, an extension phase was proposed until the 68th week, those who were non-responders on placebo then having the possibility of switching to baricitinib. Since most patients initially on placebo did not respond to treatment, no statistical comparisons with placebo were possible.
Principle results
In total, the study was conducted in 184 and 281 patients on baracitinib 2 and 4mg in the BRAVE-AA1 study (mean age 37.0 years, 58.9% female, mean SALT 85.9 points out of 100) and in 156 and 234 people on baracitinib 2 and 4mg in the BRAVE-AA2 study (mean age 38.4 years, 63.3% women, mean SALT 85.1 points). In addition, they were respectively, 59 to 69% according to the arms of the study to have a significant or total loss of eyebrows and eyelashes at the beginning of the study.
At the end of 52 weeks, patients achieving a SALT score ≤ 20 reached 40.9% and 36.8% in the two baracitinib 4mg groups, and 21.2% and 24.4% in the two baracitinib 2mg groups . Note that they were even 28.5% and 26.1% to reach SALT90 at week 52 under baracitinib 4mg, against 11.4% and 14.1% in the two baracitinib 2mg groups. Eyelash and eyebrow response rates also increased during the extension period.
In terms of safety, treatment-emergent adverse events were reported in 69.6% and 58.5% of the two baracitinib arms in BRAVE-AA1 and 77.3% and 74.2% in those of the BRAVE-AA2 study. Most were of mild or moderate severity and corresponded to upper respiratory tract infections, headaches, nasopharyngitis, urinary tract infection and increased creatinine phosphokinase.
Funding
This study was sponsored by Eli Lilly and Company.