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Malignancy Rates in Brodalumab Clinical Studies for Psoriasis
Alice Gottlieb1, Mark Lebwohl2, Clive Liu3
1Icahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA. alice.gottlieb@mountsinai.org.
American Journal of Clinical Dermatology
|March 25, 2020
Summary
Malignancy rates in patients with moderate-to-severe plaque psoriasis treated with brodalumab were low. This study analyzed data from multiple clinical trials, comparing brodalumab to ustekinumab.
Area of Science:
- Immunodermatology
- Clinical trial analysis
- Pharmacovigilance
Background:
- Brodalumab is a monoclonal antibody targeting interleukin-17 receptor A.
- It is an effective treatment for moderate-to-severe plaque psoriasis in adults.
Purpose of the Study:
- To assess and summarize malignancy rates in patients participating in brodalumab psoriasis clinical trials.
- To compare these rates with those observed in patients treated with ustekinumab.
Main Methods:
- Pooled data from one Phase II and three Phase III randomized controlled trials.
- Analysis included studies comparing brodalumab, ustekinumab, and placebo.
- Malignancy rates were calculated as exposure-adjusted event rates per 100 patient-years (PY) at 52 weeks and in long-term follow-up.
Main Results:
- At 52 weeks, brodalumab (n=4019) showed lower exposure-adjusted malignancy rates (0.9/100 PY) than ustekinumab (n=613; 2.6/100 PY).
- SEER-adjudicated malignancy rates were also lower with brodalumab (0.3/100 PY) compared to ustekinumab (0.4/100 PY).
- Long-term analysis of brodalumab treatment showed a stable adjudicated malignancy rate of 0.9/100 PY.
Conclusions:
- Malignancy rates observed in patients with psoriasis treated with brodalumab were generally low.
- Brodalumab demonstrated a favorable safety profile regarding malignancies in clinical studies.
