12 compared to placebo (92.8% vs 14.4%, respectively) in a post hoc analysis of the phase 3 trial.4 An effect was noted as early as 2 weeks (67.6% vs 6.7%). Similar efficacy was noted at week 12 in a subanalysis of a phase 2 Japanese placebo-controlled trial with mean PSSI improvement being 94.5% vs 12.6% for brodalumab vs placebo, respectively.34
Data on efficacy of brodalumab on palmoplantar psoriasis is scarce and exploratory. Nonetheless, a case series by Politou et al assessed brodalumab in 16 patients who failed prior secukinumab treatment and found that 4 out of 4 (100%) patients with palmoplantar pustulosis achieved complete skin clearance at week 16.35
Brodalumab Safety and Pharmacovigilance
Despite the safety profile of brodalumab being well elucidated in multiple phase 2/3 studies and US pharmacovigilance reports, there remains a boxed warning regarding suicidal ideation and behavior that is included in the US package insert.36 Unlike other biologic programs, inclusion of subjects in the brodalumab clinical trials was not based on screening for history of drug abuse, depression, or suicidal behavior.37
At the time of this writing, the most recent pharmacovigilance report published in April 2023 summarized 4 years of the most common adverse events from the package insert and those of special interest in the United States from 2017 to 2021.38 Data were collected from 4019 patients with an estimated exposure of 4563 patient years (PYs). There was a single case of suicide attempt but no causal relationship with brodalumab was established. Since approval, there have been zero completed suicides in the United States. Furthermore, only 4 of 52 cases of depression were determined to be related to brodalumab.
With regard to the most common adverse events (with an incidence of ≥ 1%) listed on the package insert, arthralgia was the most frequently reported (115 events). This is followed by serious infections where 3 of 102 reported cases were deemed to be related to brodalumab. Twenty-six COVID-19 cases were also reported. There were no serious fungal infections. In addition, 37 malignancies were reported in 32 cases, but none were determined to be related to brodalumab.
Cost-Effectiveness
It is important to consider the economic burden of the available treatments in conjunction with that of the disease itself. With the high costs of research and development of biologics, it is not surprising that biologics initially may be expensive and may increase the economic burden on patients and healthcare systems.39 However, the long-term benefits of effective psoriasis treatment, including improved quality of life and reduced comorbidities, can ultimately lead to cost savings. As such, cost-effectiveness studies of drugs are often considered by payers when making decisions on coverage, formulary position, and budgets.39 While initial decisions are based on the drug’s pre-launch estimated cost, post-launch studies significantly aid in reevaluating a drug’s cost-effectiveness and the placement of the drug in formularies.
According to the analysis by the Institute for Clinical and Economic Review (ICER) on the cost-effectiveness of targeted immunomodulatory drugs for the treatment of moderate-to-severe plaque psoriasis, brodalumab was estimated to be the second most cost-effective IL-17 drug (behind secukinumab) and the fourth most
According to the analysis by the Institute for Clinical and Economic Review (ICER) on the cost-effectiveness of targeted immunomodulatory drugs for the treatment of moderate-to-severe plaque psoriasis, brodalumab was estimated to be the second most cost-effective IL-17 drug (behind secukinumab) and the fourth most
