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Key clinical point: Baricitinib plus topical corticosteroids (TCS) improved the signs and symptoms of atopic dermatitis (AD) through 1 year along with a consistent safety profile in patients with moderate-to-severe AD and an inadequate response, intolerance, or contraindication to cyclosporine A (CyA).
Major finding: At week 16, ≥75% improvement in the Eczema Area and Severity Index was achieved by a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS (32% vs 17%; P = .031), with improvements maintained through week 52. Treatment emergent adverse events were more frequent with baricitinib, but were mostly mild or moderate in severity.
Study details: Findings are from the phase 3 BREEZE-AD4 study including 463 patients with moderate-to-severe AD and an inadequate response, contraindication, or intolerance to CyA who were randomly assigned to receive placebo+TCS or 1, 2, or 4 mg baricitinib+TCS for 52 weeks.
Disclosures: Eli Lilly and Company developed baricitinib. Six authors declared being employees and shareholders of Eli Lilly, and other authors reported ties with various sources, including Eli Lilly.
Source: Bieber T et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance, or contraindication to cyclosporine: Results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4). Br J Dermatol. 2022 (Apr 28). Doi: 10.1111/bjd.21630
Key clinical point: Baricitinib plus topical corticosteroids (TCS) improved the signs and symptoms of atopic dermatitis (AD) through 1 year along with a consistent safety profile in patients with moderate-to-severe AD and an inadequate response, intolerance, or contraindication to cyclosporine A (CyA).
Major finding: At week 16, ≥75% improvement in the Eczema Area and Severity Index was achieved by a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS (32% vs 17%; P = .031), with improvements maintained through week 52. Treatment emergent adverse events were more frequent with baricitinib, but were mostly mild or moderate in severity.
Study details: Findings are from the phase 3 BREEZE-AD4 study including 463 patients with moderate-to-severe AD and an inadequate response, contraindication, or intolerance to CyA who were randomly assigned to receive placebo+TCS or 1, 2, or 4 mg baricitinib+TCS for 52 weeks.
Disclosures: Eli Lilly and Company developed baricitinib. Six authors declared being employees and shareholders of Eli Lilly, and other authors reported ties with various sources, including Eli Lilly.
Source: Bieber T et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance, or contraindication to cyclosporine: Results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4). Br J Dermatol. 2022 (Apr 28). Doi: 10.1111/bjd.21630
Key clinical point: Baricitinib plus topical corticosteroids (TCS) improved the signs and symptoms of atopic dermatitis (AD) through 1 year along with a consistent safety profile in patients with moderate-to-severe AD and an inadequate response, intolerance, or contraindication to cyclosporine A (CyA).
Major finding: At week 16, ≥75% improvement in the Eczema Area and Severity Index was achieved by a significantly higher proportion of patients receiving 4 mg baricitinib+TCS vs placebo+TCS (32% vs 17%; P = .031), with improvements maintained through week 52. Treatment emergent adverse events were more frequent with baricitinib, but were mostly mild or moderate in severity.
Study details: Findings are from the phase 3 BREEZE-AD4 study including 463 patients with moderate-to-severe AD and an inadequate response, contraindication, or intolerance to CyA who were randomly assigned to receive placebo+TCS or 1, 2, or 4 mg baricitinib+TCS for 52 weeks.
Disclosures: Eli Lilly and Company developed baricitinib. Six authors declared being employees and shareholders of Eli Lilly, and other authors reported ties with various sources, including Eli Lilly.
Source: Bieber T et al. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance, or contraindication to cyclosporine: Results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4). Br J Dermatol. 2022 (Apr 28). Doi: 10.1111/bjd.21630