Real-world Evidence of Brodalumab Safety for the Treatment of Psoriasis.

Plaque psoriasis is a chronic skin disorder involving dysregulated inflammation. While numerous biologic therapies targeting inflammatory mediators have been approved for moderate-to-severe psoriasis, their safety profiles may include an increased risk of adverse events (AEs), such as infections, cardiovascular diseases, and malignancies. Because patients with psoriasis also have increased incidence of comorbidities, long-term real-world AE monitoring is critical to further evaluate the safety of biologic therapies postapproval. Brodalumab is a recombinant, fully human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. The safety profile of brodalumab has been established in clinical trials and industry-sponsored US pharmacovigilance reports. Herein, we summarize AEs reported in nonsponsored open-label and real-world studies of brodalumab. Across all studies, most common AEs were similar to those listed in the brodalumab package insert. While AEs of special interest were not reported comprehensively, their rates were generally low, with 3 cases of major adverse cardiac events, 2 cases of malignancy, 11 cases of depression, and no completed suicides in the overall safety population (N = 1701). There were 6 cases of serious infection and no serious fungal infections. Studies evaluating AEs of interest for brodalumab showed no causal link to suicide and no increase in risk of cardiac events or serious infection compared with other biologics. Together, these studies support a consistent safety profile of brodalumab in real-world use.