OR WAIT null SECS
Despite a Boxed Warning included in its 2017 FDA approval, the plaque psoriasis biologic was not linked to any causal cases of suicide attempts in 4-year, real-world data.
New real-world, long-term safety surveillance data show brodalumab (SILIQ) is associated with less than 1 mean adverse event occurrence per 100 patient-years across 9 of its 10 most common adverse events.
The findings from the 4-year pharmacovigilance report suggest the real-world safety profile of the plaque psoriasis biologic therapy is consistent with that first observed in its US Food and Drug Administration (FDA) application data.
Led by Mark Lebwohl, MD, chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, investigators sought to review the 4-year reporting period data from adults with moderate-to-severe plaque psoriasis receiving brodalumab.
An interleukin 17 (IL-17) receptor A antagonist, brodalumab was approved by the FDA for adults with plaque psoriasis in February 2017. However, it additionally received a Boxed Warning for risk of suicidal ideation and behavior in the US, “even though pivotal clinical trials and recent pharmacovigilance data do not confirm a causal relationship,” Lebwohl and colleagues wrote.
“No completed suicides and 1 suicide attempt by a patient with a history of depression occurred during the initial 3-year pharmacovigilance reporting period,” investigators continued. “Arthralgia was the most common treatment-specific adverse event in the 2- and 3-year pharmacovigilance reports.”
The team reviewed pharmacovigilance data reported to Ortho Dermatologics by patients and health care providers from August 2017 to August 2021. They uniquely assessed the most commonly reported adverse events (AEs) listed on brodalumab’s package insert, indicating an incidence risk of ≥1%:
Investigators additionally assessed AEs of special interest; each AE was interpreted through exposure-adjusted rates per 100 patient-years. They estimated brodalumab exposure as time between first and last dates authorizing prescription dispensing for each patient.
The final assessment included 4019 US patients, with 4563 estimated patient-years. Of the 2118 unique AE cases reported, 22% came from health care providers and 78% by treated patients. Total events and rates per 100 patient-years were as follows for each of the 10 identified AEs:
A total of 66 (1.6%) patients discontinued therapy due to the observed AEs.
The AEs of special interest included infections (n = 102, 2.24 per 100 patient-years), inflammatory bowel disease (n = 1, 0.04 per 100 patient-years), malignancies (n = 37, 0.81 per 100 patient-years), depression (n = 4, 1.14 per 100 patient-years), and completed suicides (n = 0). In total, investigators linked only 3 of these events to brodalumab—each being a serious infection.
Investigators did note 1 reported suicide attempt from a treated patient during the pharmacovigilance phase, however, there was no “indicated causal relationship” between the drug and the patient’s attempt.
“These US pharmacovigilance data are consistent with the established safety profile of brodalumab reported in long-term clinical trials and 3-year pharmacovigilance data,” investigators concluded. “No completed suicides occurred throughout the 4-year reporting period, and no new cases of suicide attempts were reported since the 3-year report.”
The study, “Brodalumab: 4-Year US Pharmacovigilance Report,” was presented at the Society for Dermatology Physician Assistants (SDPA) 2022 Annual Meeting.