Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis

Abstract

In two phase 3 trials of identical design involving patients with atopic dermatitis, dupilumab improved the signs and symptoms of atopic dermatitis, including pruritus, symptoms of anxiety and depression, and quality of life, as compared with placebo. Trials of longer duration are needed to assess the long-term effectiveness and safety of dupilumab. (Funded by Sanofi and Regeneron Pharmaceuticals; SOLO 1 ClinicalTrials.gov number, NCT02277743 ; SOLO 2 ClinicalTrials.gov number, NCT02277769 .).

Biomarkers for atopic dermatitis

“…The findings from our study are consistent with recent phase 3 data from the Th2 targeting drug dupilumab in AD, demonstrating that around half of the patients treated with dupilumab did not achieve the primary endpoint of reduction in IGA. 84 This emphasizes the need for biomarkers to identify those patients that would most optimally respond to this treatment and even more important those that may not.…”

Addressing the Immunopathogenesis of Atopic Dermatitis: Advances in Topical and Systemic Treatment

“…These 16-week efficacy results are summarized in Figure 3. 7 Adverse events occurred during the treatment period in 65% of patients in the dupilumab treatment groups in SOLO 1 and in 73% of patients in SOLO 2, vs 65% and 73% of patients in the corresponding placebo groups, respectively. Serious adverse events were seen in 1% and 3% of patients in the SOLO 1 and SOLO 2 dupilumab treatment groups, respectively, and in 5% and 6% in the corresponding placebo groups.…”

“…Two identically designed phase III, 16-week trials of dupilumab monotherapy (SOLO 1 and SOLO 2) in adult patients with mild to moderate AD have been completed, and the results have been published. 7 The studies involved 1,379 patients, 18 years of age and older, whose AD was not adequately controlled with topical agents or who were not candidates for topical medication. To be eligible for enrollment, patients were required to have a score of 3 or 4 on the IGA scale.…”

Emerging roles of innate lymphoid cells in inflammatory diseases: Clinical implications

“…Anti-IL4Ra seems promising for the management of AD. 115 Combination approaches will be required to obtain optimal efficacy, as described above for leukotriene and prostaglandin co-inhibition, 104 whereby interventions typically affect pathways beyond ILC2s.…”