Risk of Malignancy Comparable Between Biologics

10/26/2018
biologic

A recent poster study, presented at the 2018 Fall Clinical Dermatology Conference, found similar rates of malignancy between brodalumab (Siliq), an IL-17A inhibitor, and ustekinumab (Stelara), an IL-12 and IL-23 inhibitor, among participants with plaque psoriasis.

“Although the role of the IL-17 pathway in malignancy risk is not well characterized, potential malignancies are considered an event of interest with immunomodulatory biologics,” the researchers stated.

In the study, the researchers analyzed data pooled from phase 2 trials, and 3 large, randomized phase 3 trials that compared the efficacy of brodalumab, ustekinumab, and placebo among participants with moderate to severe plaque psoriasis. They assessed all adverse events that were reported as neoplasms benign, malignant, and unspecified (including cysts and polps), and classified confirmed events as adjudicated malignancies. Exposure- or time-adjusted event rates for malignancies were determined per 100 patient-years using data from the 12-week, 52-week, and long-term pools.

During the 12-week period, few malignancies were reported, with 2 among participants who received ustekinumab and 4 among those who received brodalumab. The researchers found that the exposure-adjusted malignancy event rate through week 52 was lower among participants who received brodalumab compared with those who received ustekinumab, with the majority of malignancies reported as grade 2 or less. In addition, the ratio of basal cell carcinoma to squamous cell carcinoma was 3:8:1 for the brodalumab groups compared with 4:1 for the ustekinumab group. Rates of malignancies from analyses of the long-term data were consistent with the findings from the 52-week period.

Two participants in the brodalumab groups experienced grade 4 serious malignancy adverse events (bile duct adenocarcinoma and follicle center lymphoma), and 1 participant in the ustekinumab group died from pancreatic carcinoma.

“In clinical studies of brodalumab, rates of malignancy were generally low compared to those previously reported for IL-17A inhibitors secukinumab (Cosentyx) and ixekizumab (Taltz). There was no increased risk of malignancy with brodalumab relative to ustekinumab through 52 weeks” the researchers concluded. “Longer follow up time is needed to fully characterize the risk of malignancy with brodalumab.”

Reference

Lebwohl M, Gordon K, Green L, et al. Malignancy rates in the brodalumab psoriasis clinical studies. Presented at: 2018 Fall Clinical Dermatology Conference; Las Vegas, NV; October 18-21, 2018.