A new drug for adhesion dermatitis (AD) ! AbbVie oral JAK inhibitor Rinvoq treatment moderate to severe AD Phase III study successful!

July 29, 2020 // AbbVie recently announced that the Phase III AD Up study evaluating oral JAK1 inhibitor Rinvoq (upadacitinib) in combination with localized topical corticosteroids (TCS) for the treatment of atopic dermatitis (AD) has reached the primary and all secondary endpoints.
this is the third critical phase III study to evaluate Rinvoq's treatment of AD.
TCS is the mainstream therapy for AD, and positive data from AD Up provide more insight into Rinvoq's co-use of TCS.
data show that Rinvoq-TCS significantly improves skin and itching symptoms compared to placebo s.TCS.
in particular, a higher percentage of patients treated with Rinvoq can not use TCS while maintaining relief of skin symptoms.
-specific dermatitis (pictured: icresearch.net) AD Up study was conducted in moderate to severe AD adolescents and adults, assessing the efficacy and safety of two doses of Rinvoq (15 mg and 30 mg, once a day) relative to placebo, and all treatment groups received TCS treatment at the same time.
common primary endpoint scored a total or almost complete removal of skin damage (0/1) for the 16th week of treatment, with an improvement of the eczema area and severity index by at least 75% (EASI75), and a validated general assessment of the adhesiondering dermatitis researchers (vIGA-AD).
results showed that in the 16th week of treatment, a significantly higher proportion of patients in any dose of Rinvoq-TSC treatment group showed significantly improved skin loss removal compared to the placebo-TCS treatment group.
specific data are: (1) 65/77% of patients treated with 15/30 mg dose Rinvoq-TCS reachEd EASI75, compared with 26% of patients treated with placebo and TCS (p 0.001) ;(2) 40/59% of patients treated with a 15/30 mg dose of Rinvoq-TCS reached vIGA-AD 0/1, compared with 11% of patients treated with placebo-TCS (p 0.001).
, a higher proportion of patients treated with Rinvoq-TCS had a clinically significant reduction in itching symptoms compared to patients treated with placebo and TCS, defined as the most severe itching numerical lys (NRS) of 4.
specific data for: 52/64% of patients treated with a 15/30 mg dose of Rinvoq-TCS in the 16th week of treatment reached this end point, compared with 15% of patients with placebo and TCS (p.001).
in pre-specified additional analysis, the use of any dose of Rinvoq treatment also resulted in higher average days of non-use of topical corticosteroids (TCS-free days, no TCS days) compared to placebos.
tcS-free days are defined as treatment response to EASI75 or higher, without tcS.
specific data for: patients treated with a 15/30 mg dose of Rinvoq-TCS during 16 weeks of treatment had an average of 34/47 days without TCS in the case of EASI75, compared with 8 days for patients receiving placebo and TCS (nominal p 0.001).
the safety results in this study are consistent with the two previously reported AD III studies.
no new safety risks were observed during the 16-week placebo-control period.
full results of the study will be published at a future medical conference and in a peer-reviewed journal.
-specific dermatitis (AD) is a common, chronic, recurrent, inflammatory skin disease, manifested as repeated circulation of itching and scratching, resulting in skin pain and rupture.
estimates that up to 25 percent of adolescents and 10 percent of adults will be affected by AD at some point in their lives.
20% to 46% of adult AD patients have moderate to severe illness.
the symptoms of the disease can place a significant physical, psychological and economic burden on the patient.
Rinvoq's active drug ingredient is upadacitinib, an oral selective and reversible JAK1 inhibitor found and developed by AbbVie, which is being developed to treat several immuno-mediated inflammatory diseases.
JAK1 is a kinase that plays a key role in the pathophysiological process esccophysiology of a variety of inflammatory diseases.
August 2019, Rinvoq was the world's first in the United States to treat adult patients with moderate to severe active rheumatoid arthritis (RA) who have inadequate or intolerable responsetors to methotrexate (MTX).
December 2019, Rinvoq was approved by the European Union for the treatment of moderate to severe RA adult patients with inadequate response or intolerance of one or more disease-modified anti-rheumatic drugs (DMARD).
in RA, rinvoq approved a dose of 15 mg.
currently, A Phase III clinical study of Rinvoq's treatment of psoriasis arthritis (PsA), RA, mid-axis spinal arthritis (axSpA), Crohn's disease (CD), teriotorthemy (AD), ulcerative colitis (UC), and cytomegaloartis (GCA) is under way.
just recently, AbbVie announced that it had submitted a new indication application for Rinvoq (upadacitinib, 15mg, daily) in the United States and the European Union for the treatment of active PsA adult patients.
the industry is very bullish on Rinvoq's business prospects.
pharmaceutical market research firm Evaluate Pharma, a previous report predicted that Rinvoq's global sales in 2024 will reach $2.57 billion, making it the world's fifth-best-selling anti-rheumatic drug.
() Original source: Third Pivotal Phase 3 Study Shows RINVOQ? (upadacitinib) Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients.