One-Year Pharmacovigilance Update of Brodalumab

August 2020 | Volume 19 | Issue 8 | Editorials | 807 | Copyright © August 2020


Published online July 24, 2020

Mark Lebwohl MDa, Craig Leonardi MDb, Jashin J. Wu MDc, Paul Yamauchi MDd, Nicole Rawnsley PharmD BSc,e, Mohammed Merchant DOf, Binu Alexander MDDSf, Abby Jacobson MS, PA-Ce

aIcahn School of Medicine at Mount Sinai, New York, NY bSaint Louis University School of Medicine, St Louis, MO cDermatology Research and Education Foundation, Irvine, CA dDermatology Institute & Skin Care Center, Santa Monica, CA eOrtho Dermatologics, Bridgewater, NJ fBausch Health, Bridgewater, NJ

Abstract
Efficacy and safety of brodalumab, a fully human anti– interleukin-17 receptor A monoclonal antibody, have been demonstrated in one phase 2 and three phase 3 trials (AMAGINE-1/-2/-3).1-3 Here, we report an update of brodalumab 1-year pharmacovigilance in the United States (August 15, 2017–August 14, 2018). Observational data reported to Ortho Dermatologics were collected for 826 US patients who received brodalumab within the first 12 months of US Food and Drug Administration approval. Adverse events (AEs) were reported through pharmacovigilance reporting from healthcare providers and patients. AEs were categorized by Medical Dictionary for Regulatory Activities preferred term and system organ class, seriousness, and (company-determined) causality. Brodalumab exposure was estimated by first shipment date to last dose date plus 55 days (ie, 5 half-lives of brodalumab). This calculation may be an underestimation considering these data were derived from a subset of 13 contracted pharmacies. AEs were summarized with descriptive statistics and as exposureadjusted rates per patient-year (PY).

There were no reports of completed suicides or suicide attempts, major adverse cardiac events, new-onset ulcerative colitis, or new-onset Crohn’s disease. Most commonly reported AEs were psoriasis flare, drug ineffectiveness, arthralgia, depression, diarrhea, and pain (Table 1). Reports did not describe therapies patients were transitioning from or duration of time from last therapy to brodalumab initiation. Approximately 78.3% of the cases were reported by non–healthcare provider reporters. For psoriasis flare and drug ineffectiveness, 73% and 72% of AEs, respectively, were patient reported (information was incomplete with regard to prior therapies or length of time on brodalumab).

No reported depression events were serious. Among 11 patients reporting depression, 4 discontinued brodalumab, and 2 had a history of depression (mental health history was not provided in 6 reports). Notably, studies have demonstrated that people with psoriasis are more likely to have depression than those without psoriasis.4 Of 9 patients reporting diarrhea, 4