Special dermatitis (AD) new drug! AbbVie oral JAK inhibitor Rinvoq Phase 3 clinical efficacy beat Sanofi/Regenerative Dupixent!

December 14, 2020 // -- AbbVie recently announced the top-line results of an oral JAK1 inhibitor, Rinvoq (upadacitinib), for the treatment of adiotic dermatitis (AD) Phase 3b Heads Up.
study, conducted in adult patients with moderate to severe AD, compared Rinvoq with Sanofi/regenerative meta-heavy biologics Dupilumab.
study, both drugs were treated as monodr drugs for 24 weeks.
data show that Rinvoq (30mg, oral, once daily) is more effective at the main endpoint than Dupixent (300mg, subsurfic injections, once a week): the proportion of patients who reached EASI75 (eczema area and severity index improved by at least 75%) was higher in week 16 (71% vs 61%).
addition, Rinvoq also showed superiority over Dupixent in all secondary endpoints, including additional skin loss removal and itching stops.
patients in the Rinvoq group had a higher level of improvement in early itching and dermatic removal than in the Dupixent group: 1 week after treatment, itching in the Rinvoq group (measured by the most severe itching numerical score sheet (NRS) The reduction was 31%, the Dupixent group was 9%, and after 2 weeks of treatment, 44% of patients in the Rinvoq group achieved EASI 75 remission, while the Dupixent group had 18% (p<0.001).
study, Rinvoq's security was consistent with those observed in three key Phase 3 studies (Measure Up 1, Measure Up 2, AD Up).
the most common adverse events during 16 weeks of treatment, with acne in the Rinvoq group and conjunctivitis in the Dupixent group.
the rate of serious adverse events was 2.9 per cent in the Rinvoq group and 1.2 per cent in the Dupixent group.
serious infections were reported very rarely in 2 groups (Rinvoq in 1.1% of patients and Dupixent in 0.6% of patients).
Rinvoq group in the United States has died of bronchitis associated with influenza A.
no malignancies were reported in the Rinvoq group, and the Dupixent group reported 1 case of non-melanoma skin cancer.
2 groups did not report severe adverse heart events or venous thromboembolism events.
(Photo: icresearch.net) in October, based on data from three key Phase 3 studies (Measure Up 1, Measure Up 2, AD Up), AbbVie told the FDA and The EU EMA submitted a new adaptation application for Rinvoq: treatment of moderate to severe endexual dermatitis (AD) in adult patients (15mg and 30mg, once a day) and adolescent patients (15mg, once a day).
in Measure Up 1 and Measure Up 2 studies, Rinvoq was not used in a joint application with topical corticosteroid hormone (TCS), and in the AD Up study Rinvoq was used in a joint drug with TCS.
results showed that in all three clinical studies, Rinvoq treatment significantly improved dermatic removal rates and itching levels in adult and adolescent patients with moderate to severe idiopathic dermatitis compared to placebo.
Rinvoq reached a common major endpoint, including treatment with a 16th week eczema area and severity index (EASI) at least 75% improvement over the baseline (EASI 75), and an overall assessment (vIGA AD) score of 0/1 (skin loss removal or near complete removal).
addition, a higher proportion of patients treated with any dose of Rinvoq had a clinically significant reduction in itching symptoms, defined as the most severe itching numerical scale (NRS) ≥4.
(AD) is a common, chronic, recurrent, inflamed skin disease, manifested in itching and scratching of repeated cycles, leading to skin pain, rupture.
estimates that as many as 25 percent of adolescents and 10 percent of adults will be affected by AD at some point in their lives.
20%-46% of adult AD patients will have moderate to severe illness.
the symptoms of the disease can cause significant physical, psychological and economic burdens to the patient.
Rinvoq's active drug ingredient is upadacitinib, an oral selective and reversible JAK1 inhibitor discovered and developed by AbbVie and is being developed to treat several immunomedulated inflammatory diseases.
JAK1 is a kinase that plays a key role in the pathophysiology of a variety of inflammatory diseases.
August 2019, Rinvoq received the world's first treatment in the United States for adult patients with moderate to severe active rheumatoid arthritis (RA) who have inadequate or insatiable response to methotrexate (MTX).
December 2019, Rinvoq was approved by the European Union to treat adult patients with moderate to severe RA who do not respond well or are insatiable to one or more disease-modified rheumatoid drugs (DMARD).
in RA, the approved dose for Rinvoq is 15 mg.
Currently, AbbVie is developing Rinvoq to treat a variety of inflammatory diseases, including psoriasis arthritis (PsA), RA, mid-axis spinal arthritis (axSpA), Crohn's disease (CD), adiopathic dermatitis (AD), ulcerative colitis (UC), and cytoarthritis (GCA).
industry is very bullish on Rinvoq's business prospects.
a report by Evaluate Pharma, a pharmaceutical market research organization, predicted that Rinvoq's global sales would reach $2.57 billion by 2024, making it the world's fifth-best-selling anti-rheumatoid drug.
() Original origin: RINVOQ™ Achieved Superiority Versus DUPIXENT® For Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis