Lilly's JAK Inhibitor Olumiant Demonstrates Significant Improvements in Disease Extent, Severity, and Patient-Reported Outcomes in Phase 3 Atopic Dermatitis Trial

April 28, 2021 News /BioValleyBIOON/ --Eli Lilly(Eli Lilly) and its partner Incyte recently at the 2021 American Academy of Dermatology VirtualMeetingNew data on the oral JAK inhibitor Olumiant (baricitinib) for the treatment of atopic dermatitis (AD) were presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX). The presentation included a new analysis of Phase 3 clinical trial data from BREEZE-AD5, as well as coverage across multipleClinical Trialan extended safety analysis, Olumiant (2 mg orally once daily) demonstrated improvements in key treatment outcomes compared with placebo and helped further characterize the long-term safety of Olumiant in adult patients with moderate-to-severe AD.

The active pharmaceutical ingredient of Olumiant is baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, byEli LillyDeveloped under license from Incyte. In November 2020, Olumiant received European Union approval for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. Notably,Olumiant is the first JAK inhibitor approved globally for the treatment of atopic dermatitis (AD).. In the United States, in early April this year,FDAThe review period for Olumiant’s indication in the treatment of AD was extended by three months, to early Q3 2021.

In an analysis of the BREEZE-AD5 Phase 3 trial, Olumiant demonstrated improvements in both the severity and extent of atopic dermatitis (AD), other key symptoms, and quality of life as early as one week after initiation of treatment, compared with placebo, as measured by the percentage change from baseline. In a separate analysis of the BREEZE-AD5 trial, among adult patients with 10–50% body surface area involvement at baseline, treatment with Olumiant resulted in significant improvements in both disease severity and extent compared with placebo. In an integrated safety analysis of eight studies of Olumiant for the treatment of AD, the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and serious infections during long-term treatment with Olumiant was not increased compared with the placebo-controlled period.

Eli LillyImmunologyDr. Lotus Mallbris, Vice President of Development, stated, “Atopic dermatitis is the most common chronic inflammatory skin disease in adults and poses significant challenges to patients. We are encouraged by these new analyses of the BREEZE-AD5 study results, which demonstrate early improvements across multiple symptoms in patients with moderate-to-severe atopic dermatitis treated with Olumiant. We are pleased that the expanded safety analysis helps further characterize the long-term safety profile of Olumiant for the treatment of atopic dermatitis.”

Atopic Dermatitis (Image source: icresearch.net)

In a post hoc analysis of the BREEZE-AD5 study, patients treated with Olumiant 2 mg demonstrated statistically significant and concurrent improvements in the extent and severity of atopic dermatitis (AD), as well as in key symptoms (such as pruritus, night-time awakenings due to pruritus, skin discomfort and pain, and quality of life), as early as 1 week after treatment initiation, when measured by the percentage change from baseline compared with placebo. Compared with placebo, patients treated with Olumiant showed statistically significant improvements in the percentage change from baseline for all measures at Weeks 1 and 4 (OLumiant group vs. placebo group: p < 0.05）：

—— Skin Measurement Results:The Eczema Area and Severity Index (EASI) is a validated clinical scoring system used to assess the extent and severity of atopic dermatitis (AD), at week 1 (25.3% vs 7.2%) and week 4 (50.9% vs 24.0%).

—Key Symptoms:(1) Itch Numerical Rating Scale (NRS): at Week 1 (12.0% vs 2.6%) and Week 4 (29.0% vs 12.5%); (2) Skin Pain NRS (skin discomfort and pain): at Week 1 (12.0% vs 2.6%) and Week 4 (27.6% vs 13.6%); (3) Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) (number of nighttime awakenings due to itching): at Week 1 (20.9% vs 3.9%) and Week 4 (37.6% vs 14.1%).

—— Comprehensive results, including quality of life:(1) Dermatology Life Quality Index (DLQI): at 1 week (27.2% vs 12.9%), at 4 weeks (40.4% vs 17.5%); (2) Patient-Oriented Eczema Measure (POEM): at 1 week (18.0% vs 6.7%), at 4 weeks (29.3% vs 10.8%).

Atopic Dermatitis (AD) is a severe chronic inflammatory skin disease, primarily characterized by intense pruritus, significant eczematous changes, and xerosis. The disease often onset in infancy and childhood, with some patients affected throughout their lifetime. It can severely impair patients' quality of life due to chronic recurrent eczematous rashes, severe pruritus, sleep deprivation, dietary restrictions, and psychosocial impacts.

The active pharmaceutical ingredient of Olumiant is baricitinib, a selective, reversible JAK1 and JAK2 inhibitor administered orally once daily, currently under clinical development for various inflammatory diseases andAutoimmunityTreatment of sexually transmitted diseases, including classRheumatoid Arthritis(Rheumatoid Arthritis), Psoriasis,DiabetesKidney disease, atopic dermatitis, systemicLupus Erythematosus(SLE), etc. There are four JAK enzymes: JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines are involved in various inflammatory andAutoimmunityThe pathogenesis of immune-mediated diseases suggests that JAK inhibitors may be widely used for the treatment of various inflammatory disorders. In kinase assay tests, baricitinib demonstrated 100-fold greater inhibitory potency against JAK1 and JAK2 than against JAK3.

Baricitinib was discovered by Incyte and licensed toEli Lilly. In the United States and more than 70 countries, baricitinib has been approved for marketing under the brand name Olumiant for the treatment of moderate to severe active rheumatoid arthritisRheumatoid Arthritis(RA) adult patients. In the EU and Japan, Olumiant is also approved for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD).

For the treatment of RA, the approved doses of Olumiant are 4 mg and 2 mg in the European Union, and 2 mg in the United States. Olumiant is administered orally once daily, either as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (non-biologic DMARDs). Concomitant use of Olumiant with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (such as azathioprine and cyclosporine) is not recommended. Notably, the US prescribing information for Olumiant includes a Boxed Warning regarding serious infections and malignancy.Tumorand the risk of thrombosis.(Bioon.com)

Original Source: OLUMIANT® Showed Significant Improvements in the Severity and Extent of Atopic Dermatitis and Other Patient-Reported Outcomes in Phase 3 Study Analyses