AMAGINE-1 trial: Brodalumab versus Ustekinumab in patients with moderate-to-severe plaque psoriasis


Additional results from AMAGINE-1, a pivotal, multi-arm phase 3 trial evaluating two doses of Brodalumab in patients with moderate-to-severe plaque psoriasis were presented at the Psoriasis: From Gene to Clinic International Congress in London.
Brodalumab is the only investigational treatment in development that binds to the interleukin-17 ( IL-17 ) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines ( A, F and A/F ) to the receptor.
The IL-17 receptor and cytokine family play a central role in the development and clinical manifestations of plaque psoriasis.

The AMAGINE-1 trial assessed the safety and efficacy of Brodalumab given every two weeks via subcutaneous injection at two doses ( 140 mg or 210 mg ) compared with placebo after 12 weeks of treatment in patients with moderate-to-severe plaque psoriasis.
Another purpose of the study was to assess safety and efficacy when patients treated with Brodalumab, who responded to treatment, continued receiving Brodalumab compared to patients who had treatment withdrawn and began receiving placebo. Data presented include results through week 52.

The AMAGINE program comprises three pivotal phase 3 studies designed to assess the efficacy and safety of Brodalumab in more than 4,200 patients with moderate-to-severe plaque psoriasis.
Positive top-line results from AMAGINE-1 were released in May 2014. Positive top-line results from AMAGINE-2 and AMAGINE-3, comparing Brodalumab with Ustekinumab ( Stelara ) and placebo, were announced in November 2014. AMAGINE-2 and AMAGINE-3 are identical in design.

Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands from activating the receptor, Brodalumab prevents the body from receiving signals that may lead to inflammation.
The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.
In addition to moderate-to-severe plaque psoriasis ( phase 3 ), Brodalumab is currently being investigated for the treatment of psoriatic arthritis ( phase 3 ) and asthma ( phase 2 ). ( Xagena )

Source: Amgen, 2014

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