Investigational Drug Brodalumab Effective for Patients With Psoriasis

An experimental, biologic treatment, brodalumab, appears to be more effective than ustekinumab in reducing psoriasis symptoms, according to a study published online today in the New England Journal of Medicine.

Brodalumab is a monoclonal antibody, akin to proteins built by the human immune system to recognise and block specific target molecules. It was designed to block the function of the immune signalling protein interleukin 17 (IL-17).

"Brodalumab is the only IL-17 receptor antagonist in clinical development," said Mark Lebwohl, MD, Icahn School of Medicine at Mount Sinai, New York, New York. "Studies demonstrate that brodalumab binds to the IL-17 receptor, thus preventing IL-17 and its partner molecules or ligands from doing so, to counter inflammatory diseases. When it comes to complete clearing, our results are better than any previously published and confirm that targeting the IL-17 receptor is highly effective in the treatment of moderate to severe plaque psoriasis. Treatment was so effective that many patients did not have a dot of psoriasis left on their bodies."

The main measure of success in the newly published phase 3 clinical studies was the degree of reduction in the Psoriasis Area Severity Index or (PASI).

In one study, after 12 weeks, 44% of patients randomised to receive brodalumab 210 mg every other week dosage had achieved PASI 100, compared with 22% of patients treated with ustekinumab.

In the second study, 37% of patients randomised to receive brodalumab 210 mg every other week achieved PASI 100, compared with 19% of patients treated with ustekinumab.

In addition, 86% of patients receiving brodalumab achieved PASI 75.

The most common adverse events were upper respiratory tract infection, headache, joint pain, low white blood cell count, inflammation of the mucous membranes, and yeast infection.

Two patients of the 3,712 (0.05%) enrolled in the study committed suicide (1 brodalumab-treated patient in the 52-week controlled period and 1 in the open-label extension of the present studies during which all patients received brodalumab). Independent of therapy, psoriasis patients are at increased risks for depression, anxiety, and suicidal ideation. No causality between brodalumab and these events has been established.