December 7, 2022

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The first JAK inhibitor to treat alopecia areata!

The first JAK inhibitor to treat alopecia areata!



 

 

The first JAK inhibitor to treat alopecia areata!

 

Eli Lilly/Incyte Olumiant successfully treats severe alopecia areata Phase 3 clinical success: Significantly promotes hair regrowth!

 

Eli Lilly and its partner Incyte recently announced the positive top-line results of BRAVE-AA2, a Phase 3 study evaluating the oral JAK inhibitor Olumiant (baricitinib) in the treatment of severe alopecia areata (AA) in adults. The study evaluated the efficacy and safety of two doses of Olumiant (2mg, 4mg, once a day).

The results showed that at the 36th week of treatment, the study reached the primary efficacy endpoint: compared with patients who received placebo, patients who received two doses of Olumiant had a statistically significant improvement in scalp hair regrowth.

 

It is worth mentioning that BRAVE-AA2 is the first phase 3 study to obtain positive results in AA patients. Data from another Phase 3 study of baricitinib in AA will be provided in the first half of this year. The detailed results of the BRAVE project will be announced at an upcoming medical conference and published in a peer-reviewed journal later this year.

AA is the second potential therapeutic indication for baricitinib in the field of dermatology after atopic dermatitis (AD).

 

Olumiant’s active pharmaceutical ingredient is baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte and developed by Eli Lilly under the license of Incyte. In November 2020, Olumiant received EU approval for its second indication 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).

 

Alopecia areata (AA) is an autoimmune disease that can cause flaky hair loss on the scalp, face, and sometimes other parts of the body. Currently, there are no drugs approved by the US FDA for the treatment of AA. Previously, the US FDA has granted breakthrough drug designation (BTD) for baricitinib to treat AA.

BTD is a new drug review channel created by the FDA in 2012. It aims to accelerate the development and review of the treatment of serious or life-threatening diseases, and there is preliminary clinical evidence that the drug is in one or more of the existing therapeutic drugs.

New drugs that have significantly improved clinically significant endpoints. BTD-obtained drugs can receive closer guidance including high-level FDA officials during development to ensure that patients are provided with new treatment options in the shortest time.

 

 

BRAVE-AA2 is a multicenter, randomized, double-blind, placebo-controlled phase 3 study, enrolling a total of 546 cases of severe alopecia instrument (SALT) score ≥50 (ie scalp alopecia ≥50%) and current severe AA attacks persist Adults who are at least 6 months but not more than 8 years old. The study included different patient groups from multiple countries.

 

The safety results of baricitinib in the BRAVE-AA2 study are consistent with its established safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD). There were no deaths, major adverse cardiovascular events (MACE), or venous thromboembolic events (VTE) reported in the study.

 

Dr. Brett King, associate professor of dermatology at Yale University School of Medicine, said: “These positive results are very promising and show that baricitinib has the potential to address the urgent needs of patients with alopecia areata. This level of high-quality research promotes our understanding of this often devastating disease. Necessary for understanding and treatment.”

 

Lotus Mallbris, MD, Vice President of Immunology Development at Eli Lilly, said: “For patients with alopecia areata, alopecia areata is not a cosmetic condition. It is a devastating autoimmune disease. They lose more than just their hair. , May have a significant psychological impact. We look forward to sharing all the data of the overall clinical development project of baricitinib as the first potential treatment drug for alopecia areata.”

 

Olumiant’s active pharmaceutical ingredient is baricitinib, which is a selective and reversible JAK1 and JAK2 inhibitor that is taken orally once a day. It is currently in clinical development for the treatment of a variety of inflammatory and autoimmune diseases, including Rheumatoid arthritis (RA), psoriasis, diabetic nephropathy, atopic dermatitis, systemic lupus erythematosus (SLE), etc.

There are 4 types of JAK enzymes, namely JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines are involved in the pathogenesis of various inflammations and autoimmune diseases, suggesting that JAK inhibitors may be widely used in the treatment of 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 licensed to Eli Lilly. In the United States and more than 70 countries, baricitinib has been approved for marketing under the trade name Olumiant for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA). In the European Union and Japan, Olumiant is also approved for the treatment of adult patients with moderate to severe atopic dermatitis (AD).

 

In 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 worth noting that Olumiant’s US drug label is accompanied by a black box warning, indicating the risk of serious infection, malignant tumors and thrombosis.

 

Currently, baricitinib is also being evaluated in clinical studies for the treatment of systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), and new coronavirus pneumonia (COVID-19).

 

 

 

 

(source:internet, reference only)


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