March 24, 2015

High-Dose Brodalumab Superior to Ustekinumab in Helping Patients With Psoriasis Reach PASI 100

By Louise Gagnon

SAN FRANCISCO -- March 24, 2015 -- At an elevated dose, brodalumab produced greater clearance of disease in patients with moderate-to-severe plaque psoriasis than the biologic therapy ustekinumab, according to data presented here on March 20 at the 73rd Annual Meeting of the American Academy of Dermatology (AAD).

“Both drugs were exceptional in performance, but at the end points that were studied, at 12 weeks and at week 52, the high dose was superior in its impact on psoriasis,” said Mark Lebwohl, MD, Mount Sinai School of Medicine, New York, New York.

The drug was administered at doses of 140 mg and 210 mg, and investigators found the 210-mg dose of the human anti-interleukin-17 receptor A antibody, when compared with ustekinumab, produced a significantly greater proportion of patients who reached Psoriasis Area Severity Index 100 (44% vs 22%; adjusted P < .001) as well as PASI 75 responses (86% vs 70%; adjusted P = .078; nominal P < .001).

The investigators did not find a statistically significant difference on the PASI 100 between the therapies when the lower dose (140mg) of brodalumab was administered.

Toxicities with both drugs were not serious and occurred with minor frequency, said Dr. Lebwohl.

Through week 12, the most common adverse events were nasopharyngitis, joint pain, upper respiratory tract infection, and headache.

“It gives us hope,” he said, referring to brodalumab. “It was encouraging that all we saw were mild to moderate events in a small proportion of patients. You would expect to see chronic mucocutaneous candidiasis, particularly in patients who were born with mutations in the receptor, which is what the therapy blocks.”

Funding for this study was provided by Amgen Inc.

[Presentation title: AMAGINE-2: A Randomized, Double-Blind, Phase 3 Efficacy and Safety Study of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Patients]

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