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Trial Shows Engineered Antibody Relieves Psoriasis

Interleukin-17 illustration

Interleukin-17 illustration (Boghog/Wikimedia Commons)

11 November 2014. A late-stage clinical trial shows a monoclonal antibody, a type of engineered biological therapy, cleared more people of the skin condition plaque psoriasis than a placebo or a competitive treatment. The biologic drug, brodalumab, is developed by the biotechnology company Amgen and pharmaceutical maker AstraZeneca.

Plaque psoriasis is the most common type of psoriasis, an autoimmune disorder, where the body’s immune system is tricked into attacking healthy cells, in this case resulting in inflammation and red, scaly patches of dead skin cells typically in the scalp, or near knees and elbows. The companies say some 125 million people suffer from psoriasis, or which 80 percent have plaque psoriasis.

Brodalumab, code-named AMG 827, is an antibody designed for binding to receptors of interleukin-17 cytokines, or chemical signaling cells, that send signals causing inflammation that result in symptoms of psoriasis. The binding action blocks inflammatory signals, thus preventing symptoms from occurring. The interleukin-17 pathway is associated with other inflammatory disease processes and is being investigated by Amgen and AstraZeneca for asthma and psoriatic arthritis.

The clinical trial enrolled 1,881 adult patients with moderate to severe psoriasis at 157 sites in North America and Europe. Participants were randomly assigned to receive brodalumab in doses of 210 or 140 milligrams, a competing biologic therapy ustekinumab, or a placebo. All of the treatments are administered by injections under the skin. Ustekinumab, marketed as Stelara by the Janssen Biotech division of Johnson & Johnson, is administered in doses of 45 or 90 milligrams.

When compared with the placebo, the trial sought to clear at least 75 percent of the skin area with psoriasis, measured with a standard index of psoriasis severity, after 12 weeks of treatment. The results show 85 percent of patients receiving the higher (210 mg) brodalumab dose reached this level of performance, as did 69 percent of the patients getting the lower (140 mg) dose. Only 6 percent of the placebo patients achieved 75 percent clearance of the disease, a statistically reliable difference compared to patients receiving brodalumab.

In comparison with ustekinumab, the trial aimed at achieving total clearance of psoriasis skin symptoms after 12 weeks of treatments, also measured with a standard index of psoriasis severity. Of patients receiving brodalumab, 37 percent of the 210 mg group achieved total clearance of the disease, as did 27 percent of the 140 mg patients. For patients receiving Stelara (ustekinumab), 19 percent reached total skin clearance. Sean Harper, Amgen’s vice-president for R&D, says in a joint statement with AstraZeneca the results “are the first to demonstrate superiority to Stelara in achieving total skin clearance.”

The trial also evaluated safety of the psoriasis treatments and dosages. The most common adverse effects, reported by more than 5 percent of participants, were  common cold, joint pain, upper respiratory tract infection and headache. Serious adverse effects were reported by 0.6 to 1.6 percent of patients in the placebo, ustekinumab, and two dosage levels for brodalumab.

The collaboration, signed in April 2012, calls for AstraZeneca to license 5 monoclonal antibodies from Amgen that target inflammation, including brodalumab. AstraZeneca paid Amgen, in Thousand Oaks, California, $50 million up front, and absorbs 65 percent of the development costs through 2014. Amgen leads development of 2 of the antibiodies, including brodalumab, while AstraZeneca, through its MedImmune subsidiary, has responsibility for the 3 others.

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