Novel monoclonal antibody shows promise against moderate to severe AD
A phase I, single-centre, open-label study has found that repeated intravenous infusions of KHK4083, an investigational human monoclonal antibody, is sufficiently safe and clinically effective for the treatment of moderate to severe atopic dermatitis (AD).
Twenty-two patients (mean age, 33.6±11.4 years; 81.8 percent male) were given 10-mg/kg intravenous KHK4083 on days 1, 15, and 29. The primary outcome was the safety and tolerability profile of the investigational drug, while pharmacokinetics, immunogenicity, and preliminary efficacy were secondary endpoints. Patients were followed until day 155.
Treatment-emergent adverse events (TEAEs) were recorded in 77.3 percent (n=17) of the participants, though all were of mild or moderate severity. The most common drug-related TEAEs were pyrexia, chills, aphthous ulcers, and elevated blood uric acid levels, among others.
There were no reports of deaths, serious adverse events, or trial discontinuations due to TEAEs. There were also no anaphylactic reactions.
In terms of efficacy, scores in the Eczema Area and Severity Index (EASI) dropped by –24.25±27.55 percent from baseline to week 6. By week 22 (day 155), the mean EASI score was 9.09±8.53, down from 24.50±12.50 at baseline. Similarly, the Investigator’s Global Assessment tool reported continued improvements throughout the follow-up period.
There were no clinically meaningful changes in laboratory values, vital signs, and electrocardiogram results. Antibody activity against the investigational drug was low.
The findings of this early-stage trial suggest that “KHK4083 may be a novel therapeutic option for patients with moderate to severe AD,” the researchers said.