Lilly Reveals Positive Phase 3 Results For Adolescent Alopecia Areata Treatment With Baricitinib

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(RTTNews) - Eli Lilly and Co. (LLY) and Incyte's (INCY) late-breaking results from Phase 3 BRAVE-AA-PEDS study found adolescent patients (ages 12 to under 18) with severe alopecia areata treated with once-daily, oral baricitinib 4 mg and 2 mg saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows and eyelashes at Week 36. The study results were presented in a late-breaker presentation at the American Academy of Dermatology (AAD) Annual Meeting taking place March 7-11 in Orlando.

Alopecia areata or AA is an immune system condition that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress over time. Approximately 40% of patients with AA experience first onset by 20 years of age.

In the BRAVE-AA-PEDS study, 257 patients were randomized to receive once-daily baricitinib 4 mg, baricitinib 2 mg or placebo. The primary endpoint of this study was a Severity of Alopecia Tool (SALT) score =20 (i.e., 80% or more scalp hair coverage) at Week 36. At the start of the study, patients had an average of 89% scalp hair loss (near total hair loss), 65% had minimal or no eyebrow hair and 57% had minimal or no eyelash hair.

At Week 36, 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg saw at least a 50% improvement in their disease, compared to 5.7% on placebo. Additionally, 42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo. Furthermore, 36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage, compared to 2.3% on placebo.

Moreover, 50.0% of patients receiving baricitinib 4 mg and 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth, compared to 0% on placebo. Finally, 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth, and 25.5% of patients receiving baricitinib 2 mg saw improved eyelash regrowth, compared to 14.0% on placebo.

According to the companies, results achieved by adolescents at 36 weeks were comparable to results achieved by adults after 52 weeks of treatment, suggesting that hair regrowth may be faster in adolescents compared to adults. In the BRAVE-AA1 and BRAVE-AA2 studies, 40.9% of adult patients treated with baricitinib 4 mg and 21.2% of patients treated with baricitinib 2 mg achieved 80% or more scalp hair coverage at Week 52.

The most common treatment-emergent adverse events in BRAVE-AA-PEDS included acne, influenza and upper respiratory tract infection. A higher frequency of serious adverse events was seen in the placebo group compared to baricitinib groups. No deaths, opportunistic infections, major adverse cardiovascular events, venous thromboembolic events or malignancies were reported in the trial.

In 2022, the U.S. Food and Drug Administration approved baricitinib (commercially available as Olumiant) for adult patients with severe AA, making it the first systemic treatment approved in the U.S. for severe disease.

Baricitinib is also approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis, in more than 40 countries for the treatment of patients down to the age of two with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in Europe and Japan for adult patients with severe AA. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for baricitinib in multiple countries.

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