New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years
PARIS – April 23, 2021 - New analyses from Dupixent® (dupilumab) trials evaluated infection incidence reduction and reinforced the need for no laboratory monitoring in patients six years and older with moderate-to-severe atopic dermatitis. Additional analyses evaluated response rates across a broad population, and the impact of Dupixent on disease extent and severity, quality of life (QoL), and itch. These and other data from real-world settings and clinical trials, including the Dupixent open-label extension (OLE) trials, will be presented at the American Academy of Dermatology (AAD VMX 2021), April 23-25, and at the 20th European Society for Pediatric Dermatology Annual Meeting (ESPD 2021), May 12-14.
“The depth and breadth of data being presented at AAD and ESPD support the use of Dupixent in adults, adolescents and children six years and older, addressing multiple critical disease measures such as itch, disease extent and severity, and certain skin infections,” said Naimish Patel, M.D. Head of Global Development in Immunology and Inflammation at Sanofi. “In addition, our expanded efforts in research and development in the immunology space, including rilzabrutinib, underscores our long-term commitment to addressing serious dermatological conditions with unmet patient needs.”
Results from a subgroup analysis of the Phase 2 study evaluating rilzabrutinib, an investigational oral Bruton’s tyrosine kinase inhibitor (BTKi), for the treatment of pemphigus vulgaris (PV), include the rates of control of disease activity in patients with moderate-to-severe disease. These data will be presented as a late-breaking abstract oral presentation at AAD VMX 2021. PV is a rare, debilitating autoimmune disease that causes blistering of the skin and mucus membranes.
Abstracts to be presented at AAD VMX 2021
Pediatric efficacy and QoL data for Dupixent
Adult efficacy data for Dupixent
Long-term data from Dupixent OLE studies, up to three years in adults and up to one year in adolescents (aged 12-17 years) and children (aged 6-11 years) with moderate-to-severe atopic dermatitis.
Real-world data for Dupixent
Abstracts presenting data on the burden and impact of atopic dermatitis include:
A late-breaking abstract oral presentation for rilzabrutinib:
Abstracts to be presented at ESPD 2021
Abstracts related to data evaluating efficacy, safety and impact on health-related quality of life of Dupixent include:
Results from a qualitative survey on the impact of atopic dermatitis
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis.
Dupixent is approved in the U.S. to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled.
Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including those in the EU and Japan. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP. Across all approved indications globally, more than 260,000 patients have been treated with Dupixent.
Dupilumab Development Program
To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven in part by type 2 inflammation or other allergic processes, including pediatric asthma (6 to 11 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3) and food allergies (Phase 2). The use of dupilumab in these settings is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Rilzabrutinib is an oral, reversible covalent, Bruton’s tyrosine kinase (BTK) inhibitor being investigated for the treatment of immune mediated diseases. BTK is involved in innate and adaptive immune responses and is a signaling molecule in immune mediated diseases. Rilzabrutinib pre-clinical data demonstrate an ability to help block inflammatory immune cells, eliminate autoantibody destructive signaling, and prevent new autoantibody production without depleting B cells. Rilzabrutinib has the potential to target the underlying disease pathogenesis and has not been shown to alter platelet aggregation. The clinical significance of this data is under investigation. Rilzabrutinib is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.
Editor’s Note: Rilzabrutinib has been granted orphan drug designation by the FDA for both pemphigus vulgaris (and from the European Commission for the treatment of pemphigus vulgaris and pemphigus foliaceus) and for its investigational use in immune thrombocytopenia (ITP). In November 2020, we announced that rilzabrutinib was granted FDA Fast Track Designation for ITP.
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