TRALOKINUMAB is a fully human monoclonal antibody that has been shown to improve atopic dermatitis (AD) symptoms in patients with moderate-to-severe AD in a randomised, double-blind, placebo-controlled, dose-ranging Phase IIb study involving 204 patients.
Patients were randomised to receive placebo or 45 mg, 150 mg, or 300 mg tralokinumab, administered every other week subcutaneously for 12 weeks. All study participants had an Eczema Area Severity Index (EASI) score of ≥12 and an Investigator Global Assessment (IGA) score of ≥3. The coprimary endpoints were designated as a change in EASI at Week 12 compared to baseline and the percentage of patients with clear (0) or almost clear (1) IGA scores.
The study results showed that AD patients in the high-dose tralokinumab treatment groups had the greatest adjusted mean difference in EASI scores compared with placebo; the 150 mg group had an adjusted mean difference of 4.36 (p=0.03) and 4.94 (p=0.01) was recorded for the 300 mg patients. Changes in EASI scores in the 300 mg group were identified as early as Week 4 and were sustained beyond 12 weeks. The greatest IGA differences were also seen in the 300 mg treatment arm compared to placebo. In addition, researchers found that patients who had higher levels of IL-13-associated biomarkers showed the greatest improvement and only mild or moderate treatment-emergent adverse events were considered related to the study drug.
These results are particularly poignant because, at present, there is no cure for AD and most treatments are steroidal, used to prevent inflammation and itching. This new treatment option could therefore greatly enhance the quality of life of AD patients, particularly those whose symptoms cannot be effectively managed solely with glucocorticoids.