Patients showed significant improvements in the primary and secondary endpoints.

Nemolizumab, an interleukin-31 (IL-31) receptor alpha antagonist, demonstrated significant efficacy in adults and adolescents with atopic dermatitis (AD) in a pair of identical trials, according to new study results presented during the Late Breaking Clinical Trials session at Maui Derm 2024. 

Researchers conducted two identical 48-week randomized double-blind phase 3 studies (ARCADIA 1 and ARCADIA 2) to evaluate the efficacy of nemolizumab, which had demonstrated significant improvements in skin lesions and itch, along with a favorable safety profile, in phase 2 studies in adults with AD. The global phase 3 ARCADIA studies looked nemolizumab after a 16-week treatment period in adults with moderate-to-sever AD that was inadequately controlled by topical treatments.

Eligible patients had moderate-to-severe AD and associated pruritus and were randomized to either nemolizumab 30 mg (60 mg at baseline) or placebo, which was given subcutaneously every 4 weeks (along with concomitant background topical corticosteroids [TCS] or low- and medium-potency topical calcineurin inhibitors [TCI]). The co-primary endpoints were Investigator’s Global Assessment (IGA) success (defined as IGA score of 0/1 with a reduction of ≥2 points from baseline) at week 16. Additionally, there were key secondary endpoints: evaluation of itch response (≥4-point improvement in peak pruritus numeric rating scale [PP NRS] score at week 16 and earlier timepoints), as well as improvement in sleep disturbance (≥4-point improvement in sleep disturbance numeric rating scale score [SD NRS]) at week 16.

According to the results, the studies both met the co-primary endpoint, as well as key secondary endpoints, and the outcomes were reported to be consistent between studies by the authors. A significantly greater proportion of patients treated with nemolizumab saw significant and clinically meaningful improvements in skin lesions vs. placebo in both studies. A larger proportion of patients in the treatment groups in both studies also saw early and sustained improvements in itch, as well as improvements in PP NRS scores at week 1, which increased through week 16. Improvements in sleep disturbance were also reported in both studies as well. Most treatment-emergent adverse events were reported to be non-serious and mild or moderate in severity.  

“The results of ARCADIA 1 and 2 extend the efficacy and safety findings from the phase 2b study of nemolizumab in patients with moderate-to-severe AD,” the researchers reported in their poster. “Nemolizumab [administered every 4 weeks] with background TCS or TCI was well-tolerated and led to clinically meaningful and statistically significant improvements in core signs and symptoms of AD in adults and adolescents with moderate-to-severe disease. Resolution of itch and sleep disturbance was rapid and sustained through week 16.”

Source: Silverberg J, Thaci D, Papp K, et al. Nemolizumab improves skin lesions, itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis: Results from two identical phase 3 multinational studies (ARCADIA 1 and ARCADIA 2). Abstract Presented at: Maui Derm, January 22-26, 2024.

Disclosures

The study was sponsored by Galderma.