PracticeUpdate Conference Series World Congress of Dermatology 2019

Oral Baricitinib Relieved Symptoms of Atopic Dermatitis In Two Phase III Trials If approved, this novel agent may help fill an unmet clinical need.

T he JAK inhibitor baricitinib significantly relieved symptoms of moderate-to-severe atopic der- matitis relative to placebo, according to the results of two identical, double-blind phase III trials BREEZE-AD1 and BREEZE-AD2. Baricitinib shows potential to fill an unmet need in atopic dermatitis, study presenter Eric Simpson, MD, of the Oregon Health and Science University in Portland told Elsevier’s PracticeUpdate . “There are no FDA-approved oral therapy options for moderate-to-severe atopic dermatitis, except for oral steroids, which are not appropriate for long- term treatment. A big therapeutic gap exists [for] a safe and effective long-term oral therapy,” he said. In the BREEZE-AD1 (n=624) and BREEZE-AD2 (n=615) trials, patients were randomized 2:1:1:1 to receive placebo or baricitinib at doses of 1 mg, 2 mg, or 4 mg, each for 16 weeks. The primary endpoint was proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0

or 1 with a ≥2-point improvement from baseline at week 16. Significantly more patients achieved the primary endpoint when receiving baricitinib 4 mg (16.8% in BREEZE-AD1 and 13.8% in BREEZE-AD2) or baricitinib 2 mg (11.4% in BREEZE-AD1 and 10.6% in BREEZE-AD2), rather than placebo (4.8% in BREEZE-AD1 and 4.5% in BREEZE-AD2). In addition, significantly more patients achieved a 75% reduction in Eczema Area and Severity Index (EASI75) when receiving baricitinib 4 mg (24.8% in BREEZE-AD1 and 21.1% in BREEZE-AD2) or baricitinib 2 mg (18.7% in BREEZE-AD1 and 17.9% in BREEZE-AD2), rather than placebo (8.8% in BREEZE-AD1 and 6.1% in BREEZE-AD2). “Clinically relevant reductions in itch were seen very soon after dose administration, with very clear and statistically significant changes detected at 1 week [for baricitinib 4 mg],” Dr. Simpson said. Statistically significant changes were detected as early as week 2 for baricitinib 2 mg. “The majority of patients experienced clinically rele- vant improvements in quality of life and symptoms within the first 1 to 2 weeks,” he added, including nighttime awakenings, skin pain, dermatology life quality index, and Patient-Oriented Eczema Measure (POEM), for both baricitinib 4 mg and baricitinib 2 mg. Adverse events occurred in 55% of patients receiv- ing placebo, in 54% of those receiving baricitinib 1 mg, in 58% receiving baricitinib 2 mg, and in 56% of patients receiving baricitinib 4 mg. The most common reported adverse events were headache and nasopharyngitis. Serious adverse events were reported among 3% of patients receiving placebo, 4% receiving baric- itinib 1 mg, 1.2% receiving baricitinib 2 mg, and 1.2% of patients receiving baricitinib 4 mg. “The study was very reassuring, as it found treatment with baricitinib at the doses used was extremely safe, with no increase in total adverse events above placebo,” Dr. Simpson concluded. He noted that future work will evaluate long-term safety and efficacy of baricitinib as well as its effects in the pediatric population. “This is the first step towards applying for baricitinib approval in Europe and Japan. Several more phase III studies are underway.” The BREEZE studies were supported by Eli Lilly and Company.

Dr. Eric Simpson

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WCD 2019 • PRACTICEUPDATE CONFERENCE SERIES