Brodalumab demonstrates low immunogenicity in moderate to severe psoriasis
The immunogenicity of brodalumab in patients with moderate to severe plaque psoriasis was low and did not compromise the efficacy or safety profile of the drug, according to Kristian Reich, MD, of Dermatologikum Berlin and SCIderm Research Institute in Hamburg, Germany, and his associates.
Data from a 12-week, phase 2 trial with a 352-week, open-label extension and three 52-week phase 3 trials were included in the analysis. Antidrug antibodies (ADAs) were tested, and positive samples were further analyzed for neutralizing ADAs by a cell-based assay.
Out of the 4,461 patients who received brodalumab, 122 (2.7%) were positive for ADAs after starting brodalumab. The incidence rate ranged from 1.9% to 3.4% between all dosing groups (140 mg, 210 mg, variable dosing, and 210 mg of brodalumab after ustekinumab). In 58 (1.4%) of patients, ADAs were transient. No patients had neutralizing ADAs, and no evidence of altered pharmacokinetics, loss of efficacy, or changes in the safety profile of brodalumab in subjects positive for ADAs was seen.
No significant difference was seen in the incidence rate of hypersensitivity or injection site reactions in brodalumab, compared with placebo or ustekinumab. The most common injection site reactions were injection site pain, erythema, and bruising.
The study was supported by Amgen. The study authors reported numerous disclosures. Two authors are employees of Leo Pharma, one author is a former employee of the company.