Core Viewpoint - Eli Lilly's Olumiant (baricitinib) has received a positive opinion from the European Medicines Agency's CHMP for expanded use in adolescents aged 12 to under 18 with severe alopecia areata, based on promising data from the Phase 3 BRAVE-AA-PEDS study [1][2]. Group 1: Clinical Study Results - The Phase 3 BRAVE-AA-PEDS study showed that 42.4% of adolescents treated with Olumiant achieved 80% or more scalp hair coverage at 36 weeks, compared to 4.5% in the placebo group [1]. - Near-complete scalp hair coverage (90%) was achieved by 36.5% of patients on Olumiant, while only 2.3% of those on placebo reached this level [1]. - Significant eyebrow regrowth was observed in 50% of patients on Olumiant, compared to 0% in the placebo group [1]. - Eyelash regrowth was reported in 42.9% of patients treated with Olumiant, versus 14.0% in the placebo group [1]. Group 2: Regulatory and Market Implications - The positive CHMP opinion is a step towards European regulatory approval, with a decision from the European Commission expected in the next one to two months [1]. - Lilly has also submitted Olumiant for approval in the U.S. for treating severe alopecia areata in adolescents, with a decision anticipated in the second half of 2026 [1][2]. - Olumiant is already approved for adult patients with severe alopecia areata in the U.S. and Europe, marking it as the first JAK inhibitor approved for this indication [1][2]. Group 3: Safety and Efficacy Profile - The safety profile of Olumiant in adolescents aligns with previous clinical trials for other conditions, such as juvenile idiopathic arthritis and atopic dermatitis [1]. - Over 14,600 patients have participated in clinical trials involving Olumiant, with more than 1,200 being children and adolescents [1]. - The ongoing BRAVE-AA-PEDS trial includes a cohort of children aged 6 to under 12 years, further expanding the understanding of Olumiant's safety and efficacy in younger populations [1].

Core Insights - AbbVie announced positive topline results from two Phase 3 studies evaluating the safety and efficacy of upadacitinib (RINVOQ) for treating non-segmental vitiligo (NSV) [1][2] Efficacy Results - Upadacitinib achieved co-primary endpoints of a 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) and a 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) at week 48 compared to placebo [4][2] - In Study 1, 19.4% of patients on upadacitinib achieved T-VASI 50, while 5.9% in the placebo group did. For F-VASI 75, 25.2% achieved this endpoint compared to 5.9% in the placebo group [3] - In Study 2, 21.5% achieved T-VASI 50 and 23.4% achieved F-VASI 75 on upadacitinib, compared to 5.9% and 6.9% in the placebo group, respectively [3] Safety Profile - The safety profile of upadacitinib was consistent with previous studies, with no new safety signals identified [2] - The most common treatment-emergent adverse events (TEAEs) included upper respiratory tract infections, acne, and nasopharyngitis [3] - Serious adverse events (TESAEs) occurred in 3.9% and 4% of patients in the upadacitinib and placebo groups in Study 1, and 2% and 1% in Study 2, respectively [3] Background on Vitiligo - Vitiligo is a chronic autoimmune disease affecting approximately 0.5% to 2.3% of the global population, with non-segmental vitiligo (NSV) being the most common form [6] - NSV accounts for roughly 84% of vitiligo cases and can lead to significant psychosocial challenges, including depression and anxiety [6] Clinical Trial Design - The trials involved 614 participants across 90 sites worldwide, randomized in a 2:1 ratio to receive either upadacitinib 15 mg or placebo for 48 weeks [6] - Participants who completed the initial period were eligible for a 112-week open-label extension where all received upadacitinib [6]

Core Insights - The BRAVE-AA-PEDS trial is the first and largest study focused on children and adolescents with severe alopecia areata, showing that 71% of adolescents treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year [1][2][4] - Eli Lilly plans to submit the trial data to global regulators for a potential label update for baricitinib, commercially known as Olumiant [1][9][10] Group 1: Trial Results - At one year, 54.1% of patients receiving baricitinib 4 mg and 31% receiving baricitinib 2 mg achieved successful hair regrowth, defined as 80% or more scalp hair coverage [7] - Among patients with severe disease, 71% receiving baricitinib 4 mg and 58.6% receiving baricitinib 2 mg achieved successful hair regrowth [7] - In a post-hoc analysis, 80% of adolescents diagnosed with severe AA less than two years before treatment achieved successful hair regrowth with baricitinib 4 mg [4] Group 2: Safety Profile - The safety profile of baricitinib in adolescents was consistent with that seen in adult trials, with no new safety signals observed after one year [5][8] - Common treatment-emergent adverse events included acne, upper respiratory tract infection, and influenza, with no deaths or major adverse cardiovascular events reported [5][8] Group 3: Future Plans and Context - Lilly intends to enroll a new cohort of children ages 6 to under 12 in the BRAVE-AA-PEDS trial in the next year [9][12] - Baricitinib is the most-researched JAK inhibitor in alopecia areata, with over 1,300 adults and 423 adolescents enrolled in clinical trials [10]

Core Insights - Eli Lilly and Incyte presented late-breaking results showing that 42.4% of adolescents treated with baricitinib 4 mg achieved 80% or more scalp hair coverage at Week 36, indicating significant hair regrowth potential for severe alopecia areata [1][2][3] - The Phase 3 BRAVE-AA-PEDS study demonstrated that baricitinib can provide clinically meaningful improvements in hair regrowth for adolescents, with results comparable to those seen in adults after a longer treatment duration [2][3] - Baricitinib is positioned as a leading treatment option for severe alopecia areata, with ongoing studies expected to provide further data and regulatory discussions in the near future [2][5] Study Results - In the BRAVE-AA-PEDS study, 257 patients were randomized to receive either baricitinib 4 mg, 2 mg, or placebo, with the primary endpoint being a SALT score of ≤20 at Week 36 [1][7] - At Week 36, 60.0% of patients on baricitinib 4 mg and 36.9% on 2 mg saw at least a 50% improvement in their disease, compared to only 5.7% on placebo [3] - Significant eyebrow and eyelash regrowth was also observed, with 50.0% and 42.9% of patients on baricitinib 4 mg achieving notable improvements, respectively [3] Safety Profile - The most common treatment-emergent adverse events included acne, influenza, and upper respiratory tract infections, with a higher frequency of serious adverse events in the placebo group [4] - The safety profile of baricitinib in adolescents aligns with previous findings in trials for juvenile idiopathic arthritis and atopic dermatitis, indicating a consistent safety record [4][5] Regulatory and Market Position - Baricitinib, marketed as Olumiant, is already approved for adult patients with severe alopecia areata and has received regulatory approval for other conditions, including rheumatoid arthritis and atopic dermatitis [5][6] - The company plans to present additional data from the BRAVE-AA-PEDS study at scientific meetings and submit results for peer-reviewed publication, reinforcing its commitment to advancing treatment options for alopecia areata [5][6]