The U.S. Food and Drug Administration (FDA) has approved brodalumab, a monoclonal antibody that targets interleukin 17 (IL-17).1,2Brodalumab (Siliq) was approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond to, or have lost response to, other systemic therapies. The treatment, which is administered as a subcutaneous injection, binds to the IL-17 receptor and inhibits inflammatory signaling by preventing the binding of several IL-17 types to the receptor.
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Brodalumab has a Boxed Warning for risks in patients with a history of suicidal thoughts or behavior. Therefore, the treatment was approved with a Risk Evaluation and Mitigation Strategy (REMS). The REMS involves a one-time enrollment for physicians and a one-time informed consent for patients. Suicidal ideation and suicidal behavior have been reported with this agent.
In three randomized, placebo-controlled clinical trials, the safety and efficacy of brodalumab was established in 4,373 adults with moderate to severe plaque psoriasis who were candidates for systemic therapy or phototherapy. More brodalumab-treated patients compared with placebo-treated patients achieved 100% improvement in the psoriasis area and severity index (PASI100). This primary endpoint meant that patients had skin that was clear, or almost clear, at the end of the study.
The most common adverse reactions in clinical trials were arthralgia, diarrhea, fatigue, headache and oropharyngeal pain. Brodalumab is contraindicated in patients with Crohn’s disease. Serious infections have occurred in patients treated with the agent. Therefore, physicians should exercise caution when considering brodalumab use in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to starting therapy.
Brodalumab will be marketed beginning in the second half of this year.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- U.S. Food and Drug Administration. News release: FDA approves new psoriasis drug. 2017 Feb 15.
- Valeant Pharmaceuticals International Inc. News release: Valeant receives FDA approval of Siliq (brodalumab) for moderate to severe plaque psoriasis. 2017 Feb 16.