Treatment with the fully human anti-interleukin-17 receptor A monoclonal antibody brodalumab is associated with rapid and long-term improvements in skin clearance and quality of life when administered every 2 weeks in patients with moderate to severe plaque psoriasis, a study in the American Journal of Clinical Dermatology suggests.
A phase 2, open-label trial examined the efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis during a 5-year period. Participants who completed the 12-week parent study were randomly assigned to either brodalumab at up to 210 mg (n=148) or placebo (n=33), each administered every 2 weeks. Treatment with brodalumab lasted a median of 264 weeks.
Skin clearance and disease severity were measured with the static physician’s global assessment (sPGA) and psoriasis area and severity index (PASI). The researchers also assessed safety and quality of life, the latter of which was evaluated using the dermatology life quality index.
At week 2 and week 12, the proportion of patients who achieved a “clear or almost clear skin” sPGA score of ≤1 were 63.0% (95% CI, 55.3-70.2) and 90.3% (95% CI, 84.9-94.2), respectively. Approximately 77.3% (95% CI, 69.1-84.3) of patients continued to maintain an sPGA score of ≤1 through 240 weeks. The observed PASI 75 response at 8 weeks was 94.9% (95% CI, 90.5-97.6), and >80% maintained this response at weeks 4 to 264. Observed PASI 100, which defined complete skin clearance, was achieved in approximately 64.0% (95% CI, 56.4-71.1) of patients at 8 weeks and was maintained in ≥50% through 240 weeks. Overall, the researchers observed a mean percent improvement of PASI in 95.4% (95% CI, 93.9-96.9) of patients at 12 weeks.
Limitations of the study include its open-label design, the lack of an active comparator arm, and the potential selection bias for participants more likely to respond to brodalumab.
Although somewhat preliminary, the researchers noted that the data from this study “add evidence that supports brodalumab as an efficacious and well-tolerated biologic therapy for the long-term treatment of moderate-to-severe plaque psoriasis, a lifelong disease.”
Disclosure: A study author declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. This clinical trial was supported by Amgen/AstraZeneca. Please see the original reference for a full list of authors’ disclosures.
Lebwohl MG, Blauvelt A, Menter A, et al. Efficacy, safety, and patient-reported outcomes in patients with moderate-to-severe plaque psoriasis treated with brodalumab for 5 years in a long-term, open-label, phase II study [published online September 6, 2019]. Am J Clin Dermatol. doi:10.1007/s40257-019-00466-2