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Novel monoclonal antibody shows promise against moderate to severe AD

19 Sep 2020

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.

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Jairia Dela Cruz, 05 Oct 2020
Drinking more than two cups of coffee per day may just be the intervention that prevents hundreds of thousands of liver disease‐related deaths globally, a study reports.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
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Insulin icodec, an in-development basal insulin analogue administered once weekly, was as effective as once-daily insulin glargine in patients with type 2 diabetes (T2D) insufficiently controlled with metformin with or without a DPP-4* inhibitor, according to a phase II trial presented at EASD 2020.

08 Oct 2020
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