Brodalumab’s 8-Year Journey in Plaque Psoriasis: Insights into Efficacy, Safety, and Real-World Evidence
March 2026 | Volume 25 | Issue 3 | 211 | Copyright © March 2026
Published online February 26, 2026
Mark G. Lebwohl MDa, James G. Krueger MD PhDb, John Y. Koo MDc, George Han MD PhDa,d, April W. Armstrong MD MPHe, Bruce E. Strober MD PhDf,g, Leon H. Kircik MDa,h,i
aIcahn School of Medicine at Mount Sinai, New York, NY
bCentre for Clinical and Translational Science, The Rockefeller University, New York, NY
cPsoriasis and Skin Treatment Center, University of California San Francisco, San Francisco, CA
dElmhurst Hospital Center, New York, NY
eUniversity of California, Los Angeles, Los Angeles, CA
fCentral Connecticut Dermatology Research, Cromwell, CT
gYale University, New Haven, CT
hIndiana University School of Medicine, Indianapolis, IN
iMedical Director, Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
Abstract
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.
INTRODUCTION
Plaque psoriasis is a chronic immune-mediated disease driven by proinflammatory cytokines, such as interleukin (IL)-17, IL-12, IL-23, and/or tumor necrosis factor-alpha (TNF-alpha).1,2 The joint American Academy of Dermatology and National Psoriasis Foundation guidelines for the management of moderate-to-severe psoriasis include biologics, which are monoclonal antibodies and fusion proteins that block specific cytokines or cytokine receptors critical to psoriasis pathogenesis.2 Brodalumab—a recombinant, human monoclonal antibody—was approved in 2017 for the treatment of moderate- to-severe plaque psoriasis in adults who are candidates for systemic therapy in the European Union (Kyntheum; LEO Pharma)3 and, in the US (Siliq® subcutaneous injection; Bausch Health Companies Inc.), for adults who are candidates for systemic or phototherapy and have failed to respond to or have lost response to other systemic therapies.4
A key contributor to the pathophysiology of psoriasis is IL- 17.5 Once released from immune cells, IL-17 directly activates keratinocytes, driving their proliferation and release of psoriasisassociated chemical messengers, which in turn activate more immune cells, resulting in a feedback loop that promotes further IL-17 release.6 While other approved biologics target the IL-17
