Brodalumab's 8-Year Journey in Plaque Psoriasis: Insights into Efficacy, Safety, and Real-World Evidence.

BACKGROUND: Plaque psoriasis is a chronic immune-mediated disease driven by proinflammatory cytokines. Brodalumab—a recombinant, human monoclonal antibody that functions as an interleukin-17 receptor A blocker—was approved in 2017 in the United States for treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic or phototherapy and have failed to respond to/have lost response to other systemic therapies. While efficacy and safety of brodalumab for moderate-to-severe plaque psoriasis were demonstrated across phase 2 and 3 clinical trials, long-term data from these trials and several real-world studies have since been published.

METHODS: In this review, we summarize efficacy/safety findings from long-term clinical trials and real-world studies. Updated US pharmacovigilance data collected over 8 years of clinical brodalumab usage are also provided.

RESULTS: Across clinical trials and real-world studies, brodalumab consistently delivered rapid skin clearance, high rates of complete response, and sustained disease control, even among patients who have not achieved adequate benefit with other biologics. An integrated analysis of 5 clinical trials showed brodalumab was well tolerated and not associated with increased risk of malignancy, major adverse cardiac events, suicidal ideation/behavior, or fatal adverse events over 52 weeks. This, combined with 8 years of pharmacovigilance experience, affirms a stable safety profile, with no new safety signals and no demonstrated causal links to increased psychiatric events.

CONCLUSION: These findings reinforce that brodalumab is an important, well-tolerated therapeutic option for achieving high levels of disease control in patients with moderate-to-severe psoriasis, including those with prior biologic exposure or difficult-to-treat disease manifestations. &nbsp.