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News on April 28, 2021 // - Eli Lilly (Eli Lilly) and partner Incyte recently in 2021 virtual American Academy of Dermatology meeting announced the oral JAK inhibitor Olumiant (baricitinib) on experience (AAD VMX) special treatment of new data dermatitis (AD) should be of
.
Through a new analysis of BREEZE-AD5 Phase 3 clinical trial data and an expanded safety analysis covering multiple clinical trials , Olumiant (2 mg orally once a day) has shown improvements in key treatment outcomes compared to placebo.
And help to further describe the long-term safety of Olumiant in adult patients with moderate to severe AD
.
Eli Lilly Conference Clinical Trials.
Through a new analysis of BREEZE-AD5 Phase 3 clinical trial data and an expanded safety analysis covering multiple clinical trials , Olumiant (2 mg orally once a day) has shown improvements in key treatment outcomes compared to placebo.
And help to further describe the long-term safety of Olumiant in adult patients with moderate to severe AD
.
Olumiant's active pharmaceutical ingredient is baricitinib, which is an oral JAK1/JAK2 inhibitor discovered by Incyte and developed by Eli Lilly under the license of Incyte
.
In November 2020, Olumiant was approved by the European Union for the treatment of moderate to severe AD adult patients suitable for systemic therapy
.
It is worth mentioning that Olumiant is the world's first JAK inhibitor approved for the treatment of atopic dermatitis (AD)
.
In the United States, in early April this year, the FDA extended the review period for Olumiant's treatment of AD indications by 3 months, to the beginning of the third quarter of 2021
.
Eli Lilly Olumiant is the world's first JAK inhibitor approved for the treatment of atopic dermatitis (AD) by the FDA.
In November 2020, Olumiant was approved by the European Union for the treatment of moderate to severe AD adult patients suitable for systemic therapy
.
It is worth mentioning that Olumiant is the world's first JAK inhibitor approved for the treatment of atopic dermatitis (AD)
.
In the United States, in early April this year, the FDA extended the review period for Olumiant's treatment of AD indications by 3 months, to the beginning of the third quarter of 2021
.
In an analysis of the BREESE-AD5 Phase 3 trial, as measured by the percentage of change from baseline, Olumiant improved the severity and scope of AD as early as one week after treatment, as well as other major changes compared to placebo.
Symptoms, quality of life
.
In a separate analysis of the BREEZE-AD5 trial, in 10-50% of adult patients who were physically affected at baseline, treatment with Olumiant significantly improved the severity and scope of the disease compared with placebo
.
In an integrated safety analysis of 8 Olumiant treatment of AD studies, the incidence of adverse events (TEAE), serious adverse events (SAE), and serious infections during long-term treatment of Olumiant compared with the placebo-controlled period No increase
.
Symptoms, quality of life
.
In a separate analysis of the BREEZE-AD5 trial, in 10-50% of adult patients who were physically affected at baseline, treatment with Olumiant significantly improved the severity and scope of the disease compared with placebo
.
In an integrated safety analysis of 8 Olumiant treatment of AD studies, the incidence of adverse events (TEAE), serious adverse events (SAE), and serious infections during long-term treatment of Olumiant compared with the placebo-controlled period No increase
.
Lilly immunology Dr.
Lotus Mallbris vice president of development, said: "Atopic dermatitis is the most common adult chronic inflammatory skin disease, patients will bring great challenges
those of us new analysis of the results of research BREEZE-AD5 feel.
Encouragingly, it shows that Olumiant has shown early improvement in a variety of symptoms in patients with moderate to severe atopic dermatitis
.
We are pleased that the expanded safety analysis has helped to further determine the long-term safety of Olumiant in the treatment of atopic dermatitis
.
"
Eli Lilly ImmunologyLotus Mallbris vice president of development, said: "Atopic dermatitis is the most common adult chronic inflammatory skin disease, patients will bring great challenges
those of us new analysis of the results of research BREEZE-AD5 feel.
Encouragingly, it shows that Olumiant has shown early improvement in a variety of symptoms in patients with moderate to severe atopic dermatitis
.
We are pleased that the expanded safety analysis has helped to further determine the long-term safety of Olumiant in the treatment of atopic dermatitis
.
"
Atopic dermatitis (picture source: icresearch.
net)
net)
Olumiant (2mg) treatment improved the scope, severity, and key symptoms of the disease as early as one week:
Olumiant (2mg) treatment improved the scope, severity, and key symptoms of the disease as early as one week:In a post-hoc analysis of the BREEZE-AD5 study, measured by the percentage change from baseline compared with placebo, as early as 1 week of treatment, patients who received Olumiant 2mg were in the range, severity, and major of AD.
Symptoms (such as itching, waking up from itching at night, skin discomfort and pain, and quality of life) showed statistically significant improvements and simultaneous improvements
.
Compared with placebo, Olumiant-treated patients had statistically significant improvements in all measurement indicators at 1 and 4 weeks from the baseline percentage change ( Olumiant group vs.
placebo group: p<0.
05 ):
Lumiant group vs placebo group: p＜0. Symptoms (such as itching, waking up from itching at night, skin discomfort and pain, and quality of life) showed statistically significant improvements and simultaneous improvements
.
Compared with placebo, Olumiant-treated patients had statistically significant improvements in all measurement indicators at 1 and 4 weeks from the baseline percentage change ( Olumiant group vs.
placebo group: p<0.
05 ):
05
——Skin measurement results: Eczema Area and Severity Index (EASI) is a validated clinical scoring system used to measure the scope and severity of AD, at 1 week (25.
3% vs 7.
2%), at 4 weeks (50.
9 % vs 24.
0%)
.
——Skin measurement results:3% vs 7.
2%), at 4 weeks (50.
9 % vs 24.
0%)
.
——Key symptoms: (1) Numerical Rating Scale for Itching (NRS), at 1 week (12.
0% vs 2.
6%), at 4 weeks (29.
0% vs 12.
5%); (2) Skin pain NRS (skin discomfort and pain) , At 1 week (12.
0% vs 2.
6%), at 4 weeks (27.
6% vs 13.
6%); (3) AD Sleep Scale (ADSS) item 2 (the number of awakenings due to itching at night), at 1 week (20.
9% vs 3.
9%), at 4 weeks (37.
6% vs 14.
1%)
.
——Key symptoms:0% vs 2.
6%), at 4 weeks (29.
0% vs 12.
5%); (2) Skin pain NRS (skin discomfort and pain) , At 1 week (12.
0% vs 2.
6%), at 4 weeks (27.
6% vs 13.
6%); (3) AD Sleep Scale (ADSS) item 2 (the number of awakenings due to itching at night), at 1 week (20.
9% vs 3.
9%), at 4 weeks (37.
6% vs 14.
1%)
.
——Comprehensive results, including quality of life: (1) Dermatological Quality of Life Index (DLQI), at 1 week (27.
2% vs 12.
9%), at 4 weeks (40.
4% vs 17.
5%); (2) Patient-oriented Measurement of eczema (POEM) at 1 week (18.
0% vs 6.
7%) and at 4 weeks (29.
3% vs 10.
8%)
.
-Comprehensive results, including quality of life:2% vs 12.
9%), at 4 weeks (40.
4% vs 17.
5%); (2) Patient-oriented Measurement of eczema (POEM) at 1 week (18.
0% vs 6.
7%) and at 4 weeks (29.
3% vs 10.
8%)
.
Atopic dermatitis (AD) is a serious chronic inflammatory skin disease, mainly manifested by severe itching, obvious eczema-like changes and dry skin
.
The disease often begins in infants and young children, and some patients last their entire lives.
It can seriously affect the quality of life of patients due to chronic recurrent eczema-like rash, severe itching, lack of sleep, dietary restrictions, and psychosocial effects
.
.
The disease often begins in infants and young children, and some patients last their entire lives.
It can seriously affect the quality of life of patients due to chronic recurrent eczema-like rash, severe itching, lack of sleep, dietary restrictions, and psychosocial effects
.
Olumiant active pharmaceutical ingredient is baricitinib, the drug is one kind of a daily oral selective, reversible JAK1 and JAK2 inhibitors currently in clinical development for various inflammatory diseases and autoimmune treatment of diseases, including class rheumatoid arthritis (RA), psoriasis, diabetic nephropathy, atopic dermatitis, systemic lupus erythematosus (SLE) and the like
.
There are 4 types of JAK enzymes, namely JAK1, JAK2, JAK3 and TYK2
.
JAK- dependent cytokines are involved in a variety of inflammatory and autoimmune pathogenesis of the disease, suggesting JAK inhibitors can be widely used for the treatment or various inflammatory diseases
.
In the kinase detection test, baricitinib showed 100 times stronger inhibition against JAK1 and JAK2 than JAK3
.
Autoimmune rheumatoid arthritis diabetes lupus erythematosus autoimmunity.
There are 4 types of JAK enzymes, namely JAK1, JAK2, JAK3 and TYK2
.
JAK- dependent cytokines are involved in a variety of inflammatory and autoimmune pathogenesis of the disease, suggesting JAK inhibitors can be widely used for the treatment or various inflammatory diseases
.
In the kinase detection test, baricitinib showed 100 times stronger inhibition against JAK1 and JAK2 than JAK3
.
baricitinib was discovered by Incyte and authorized to Eli Lilly
.
In the United States and more than 70 countries, baricitinib has been approved under the trade name Olumiant marketed for the treatment of moderate to severe active class of rheumatoid arthritis (RA) in adult patients
.
In the European Union and Japan, Olumiant is also approved for the treatment of adult patients with moderate to severe atopic dermatitis (AD)
.
Eli Lilly rheumatoid arthritis.
In the United States and more than 70 countries, baricitinib has been approved under the trade name Olumiant marketed for the treatment of moderate to severe active class of rheumatoid arthritis (RA) in adult patients
.
In the European Union and Japan, Olumiant is also approved for the treatment of adult patients with moderate to severe atopic dermatitis (AD)
.
For the treatment of RA, Olumiant's approved doses in the EU are 4mg and 2mg, and the approved dose in the United States is 2mg
.
In terms of medication, Olumiant is taken orally once a day, as a single agent or in combination with methotrexate (MTX) or other non-biologic disease modified anti-rheumatic therapies (non-biologic DMARDs)
.
It is not recommended to combine Olumiant with other JAK inhibitors, or biological DMARDs, and powerful immunosuppressants (such as azathioprine and cyclosporine)
.
It is noteworthy that, Olumiant drug labeling in the United States with a black box warning, suggesting severe infection, malignant tumor risk and thrombosis
.
()
Tumor.
In terms of medication, Olumiant is taken orally once a day, as a single agent or in combination with methotrexate (MTX) or other non-biologic disease modified anti-rheumatic therapies (non-biologic DMARDs)
.
It is not recommended to combine Olumiant with other JAK inhibitors, or biological DMARDs, and powerful immunosuppressants (such as azathioprine and cyclosporine)
.
It is noteworthy that, Olumiant drug labeling in the United States with a black box warning, suggesting severe infection, malignant tumor risk and thrombosis
.
()
Original Source: OLUMIANT® Showed Significant Improvements in the Severity and Extent of Atopic Dermatitis and Other Patient-Reported Outcomes in Phase 3 Study Analyses
