- Dupixent is the first and only biologic that significantly improved skin clearance, and reduced itch and overall disease severity in children as young as 6 months old in a Phase 3 trial
- Published results reinforce well-established efficacy and safety profile of Dupixent across age groups
The Lancet has published positive results from a Phase 3 Dupixent ®( dupilumab) trial in children progressed 6 months to 5 times with unbridled moderate- to-severe atopic dermatitis. These data were the base for theU.S. Food and Drug Administration( FDA) blessing of Dupixent in June 2022 and for a nonsupervisory submission presently under review by the European Medicines Agency.
Data from this trial showed that adding Dupixent to low- energy topical corticosteroids( TCS) significantly bettered skin concurrence and reduced overall complaint inflexibility and itch compared to TCS alone( placebo) at 16 weeks. also, Dupixent cases endured significant enhancement in measures of sleep quality and skin pain, as well as patient- or caregiver- reported issues and health- related quality of life. A mainly lower proportion of Dupixent cases demanded deliverance specifics, compared to those on placebo.
About Atopic Dermatitis
Atopic dermatitis is a habitual type 2 seditious skin complaint. Eighty- five to ninety percent of cases first develop symptoms before 5 times of age, which can frequently continue through majority. Symptoms include violent, patient itch and skin lesions that cover important of the body, performing in skin blankness, cracking, pain, greenishness or darkening, and encrusting and oozing. In theU.S., further than,000 children progressed 5 times and youngish have unbridled moderate- to-severe complaint and are most in need of new treatment options. Moderate- to-severe atopic dermatitis may also significantly impact the quality of life of a youthful child and their caregivers. Current treatment options in this age group are primarily topical steroids, which can be associated with safety pitfalls and may vitiate growth when used long- term.
About the Dupixent Trial
The Phase 3 randomized, double-eyeless, placebo- controlled trial estimated the efficacity and safety of Dupixent added to standard- of- care low- energy TCS compared to low- energy TCS alone in 162 children progressed 6 months to 5 times with unbridled moderate- to-severe atopic dermatitis. Cases treated with Dupixent entered either 200 mg or 300 mg( grounded on weight) every four weeks.
The primary endpoints assessed the proportion of cases achieving an Investigator’s Global Assessment( IGA) score of 0( clear) or 1( nearly clear) and at least a 75 enhancement in Eczema Area and Severity Index( EASI- 75) at week 16.
Secondary endpoints further assessed complaint measures and quality of life. Disease measures included fresh EASI issues, itch reduction, percent of body face area affected, skin pain, complaint inflexibility as measured by the Case acquainted Eczema Measure, as well as SCORing Atopic Dermatitis measuring a combined assessment of complaint area and inflexibility, itch and sleep. Quality of life measures were assessed for children( by Children’s Dermatology Life Quality Index for children progressed 4 to 17 times and babies ’ Dermatitis Quality of Life Index for children lower than 4 times of age) and families( by the Dermatitis Family Impact questionnaire), as well as sleep quality.
Dupixent is a completely mortal monoclonal antibody that inhibits the signaling of the interleukin- 4( IL- 4) and interleukin- 13( IL- 13) pathways and isn’t an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a drop in type 2 inflammation in Phase 3 trials, establishing that IL- 4 and IL- 13 are crucial and central motorists of the type 2 inflammation that plays a major part in multiple affiliated and frequentlyco-morbid conditions. These conditions include approved suggestions for Dupixent similar as asthma, atopic dermatitis, habitual rhinosinusitis with nasal polyposis( CRSwNP) and eosinophilic esophagitis( EoE), as well as investigational conditions similar as prurigo nodularis.
Dupilumab Development Program
Dupilumab is being concertedly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across further than 60 clinical trials involving further than,000 cases with colorful habitual conditions driven in part by type 2 inflammation.
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