In results reported at the European Academy of Dermatology and Venereology Congress, two-week and four-week doses of the subcutaneous drug proved efficacious in improving patient skin.
Amy S. Paller, MD
New phase 3 trial data reports that monotherapy dupilumab (Dupixent) significantly improves symptoms in adolescents with moderate-to-severe atopic dermatitis (AD).
The results, presented at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France, this weekend, showed the therapy is capable of addressing quality of life measures in a patient population lacking efficient AD control.
In the late-breaking presentation, investigators detailed the findings of the pivotal efficacy and safety outcome trial, in which 251 patients aged 12-17 years old with moderate-to-severe AD were randomized into 3 different treatment groups: subcutaneous dupilumab injection 200 mg or 300 mg every 2 weeks (based on weight), initial 600 mg dose followed by dupilumab 300 mg every 4 weeks, or placebo every 2 weeks.
Patients included in the study had diagnosed AD which was previously uncontrolled by topical medications, or had condition severity which dictated no topical treatment be advised.
Investigators tested for co-primary endpoints of proportion of patients to achieve 75% or greater skin improvement, as measured by Eczema Area and Severity Index (EASI-75) at week 15, plus the proportion of patients with an investigator global assessment (IGA) score of 0-1 at week 16 (on a five-point skin lesion severity scale ranging from 0 [clear] to 4 [severe]).
With respect to trends of overlapping atopic conditions—as defined by the atopic march—investigators noted that 92% of the patients were diagnosed with at least 1 other atopic or allergic condition. In the patient population, 66% had allergic rhinitis, 61% had food allergy, 54% had asthma, 29% had hives, and 23% had allergic conjunctivitis.
At study’s end, 41.5% of patients receiving dupilumab every 2 weeks achieved EASI-75, compared with 38% of patients receiving therapy every 4 weeks, and just 8% of patients receiving placebo (P < .001). Patients receiving two-week dupilumab doses also led in IGA-based skin lesion metrics—24% reached a score of 0-1, versus 18% of patients receiving dupilumab every 4 weeks, and just 2% of patients receiving placebo (P < .001).
Investigators also found that about an improvement of about two-thirds in patients administered dupilumab (66% in two-week patients; 65% in four-week patients) in EASI score from baseline after 16 weeks. All patients administered the therapy also had significantly improved scores in quality of life scales including the Children's Dermatology Life Quality Index (CDLQI) and patient-reported symptoms measured by the Patient-Oriented Eczema Measure (POEM) compared to patients administered placebo (P < .001).
After being approved by the US Food and Drug Administration (FDA) for adults with AD in March 2017, dupilumab has been evidenced as a beneficial therapy across multiple atopic and allergic indications. It was approved as an add-on asthma maintenance therapy in March of this year, and is additionally being investigated for the treatment of nasal polyps and eosinophilic esophagitis.
With these new EADV findings, investigators have shown its benefit for the “unbearable symptoms” of AD that adolescents are subjected to, Amy S. Paller, MD, principal investigator director of the Northwestern University Skin Disease Research Center, said.
“Limited treatment options leave adolescents with uncontrolled moderate-to-severe atopic dermatitis to cope with intense, unrelenting itch and skin lesions," Paller said.