Phase III (BRAVE-AA1 and BRAVE-AA2) trials of Olumiant shows superiority to placebo at at 24 weeks in alopecia.

Significant improvements in scalp hair regrowth compared to placebo were achieved at 36 weeks for patients taking Olumiant 2-mg and 4-mg oral doses, as previously disclosed in topline findings from BRAVE-AA1 and BRAVE-AA2 earlier this year.

In both studies, a greater proportion of patients taking Olumiant 4-mg compared to placebo also achieved full regrowth or regrowth with minimal gaps in coverage of eyebrow and eyelash hair at 36 weeks, which were key secondary endpoints of the studies. In BRAVE-AA1, statistically significant improvement in scalp hair regrowth occurred as early as 16 weeks among patients treated with Olumiant 4-mg and 24 weeks with Olumiant 2-mg, compared to placebo. At 16 weeks, nearly 1 in 5 patients (18.5%, n=52) taking Olumiant IANT 4-mg achieved 80 percent or more scalp hair coverage (as measured by a SALT score of at most 20) as compared to placebo (4.2%, n=8). At 24 weeks, 1 in 10 patients (11.4%, n=21) taking Olumiant 2-mg achieved 80% or more scalp hair coverage as compared to placebo (4.8%, n=9, p=0.013). In BRAVE-AA2, statistically significant improvement occurred as early as 24 weeks for patients treated with Olumiant 4-mg, with more than 1 in 4 patients (28.2%, n=66) reaching 80% or more scalp hair coverage as compared to placebo (1.3%, n=2).

Across both studies at 36 weeks – the study's primary endpoint – 1 out of 3 patients treated with Olumiant 4-mg (BRAVE-AA1=35.2% [n=99]; BRAVE-AA2=32.5% [n=76]) and approximately 1 out of 5 patients treated with Olumiant 2-mg (BRAVE-AA1=21.7% [n=40]; BRAVE-AA2=17.3% [n=27]) achieved 80% or more scalp hair coverage, compared to 5.3% of patients taking placebo (n=10) and 2.6% (n=4) in BRAVE-AA1 and BRAVE-AA2, respectively.

The safety profile of Olumiant was consistent with previously-published safety data, and no new safety signals were observed in the 36-week duration of these clinical trials. These results, along with safety data in adult patients with moderate to severe atopic dermatitis (AD), are being presented virtually at the 30th European Academy of Dermatology and Venerology (EADV) Congress, taking place from Sept. 29-Oct. 2, 2021.