Investigational Dupixent Significantly Eases Uncontrolled Atopic Dermatitis

November 22, 2016

A pair of identically designed phase 3 trials found that Dupixent (dupilumab; Sanofi/Regeneron) improved symptoms of moderate-to-severe atopic dermatitis, including itching, anxiety and depression, and quality of life, compared with placebo, according to research in the New England Journal of Medicine.

Dupixent (dupilumab) is an investigational human monoclonal antibody that inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines believed to be major drivers in atopic dermatitis.

“These results support the growing body of evidence for Dupixent as a potential new treatment option for patients with moderate-to-severe atopic dermatitis who are struggling to control their disease,” Eric Simpson, MD, of the Oregon Health and Science University, said in a press release. “The phase 3 SOLO 1 and SOLO 2 clinical trials are the first large pivotal studies where a systemic investigational therapy has demonstrated significant reduction in the signs and symptoms of atopic dermatitis, and showed improvement in studied quality-of-life measures.”

The SOLO 1 trial enrolled 671 adults with inadequately controlled moderate-to-severe atopic dermatitis, and SOLO 2 included 708 such participants.  

After 16 weeks, 37% of patients in SOLO 1 and 36% of patients in SOLO 2 who received Dupixent  300 mg every week, as well as 38% and 36% of patients who received Dupixent  300 mg every 2 weeks, achieved clearing or near-clearing of skin lesions as measured by the investigator’s global assessment scale. Just 10% of patients in SOLO 1 and 8% of patients in SOLO 2 achieved the primary endpoint with placebo.

In addition, 52% of patients in SOLO 1 and 48% of patients in SOLO 2 who received Dupixent  300 mg weekly, and 51% of SOLO 1 and 44% of SOLO 2 participants who received Dupixent  300 mg every 2 weeks, demonstrated a 75% or greater reduction in their eczema area and severity index score, researchers reported. Just 15% and 12% of patients who received placebo achieved the secondary endpoint.

Study findings also linked Dupixent with improvement in pruritus, decreased symptoms of anxiety and depression, and quality-of-life gains.

“The reduction of itch intensity is important,” Dr Simpson added, “because itching is one of the most burdensome symptoms for patients and can impact other aspects of their lives, such as sleep.”—Jolynn Tumolo