C反応性蛋白を低下させる新たな方法（Abstract # 874）

Phase IIトライアルの結果、ヒト化モノクローナル抗体は動脈硬化性心血管疾患のハイリスク患者のC反応性蛋白レベルを低下させる可能性が示唆された
Phase II trial suggests that humanized monoclonal antibody can reduce C-reactive protein levels in patients at high risk for atherosclerotic cardiovascular disease
ヒト化モノクローナル抗体MLN1202は動脈硬化性心血管疾患のハイリスク患者のC反応性蛋白（CRP）レベルを低下させる可能性が示唆された、とAmerican Heart Association学会で発表された。このPhase IIトライアルでは高感度CRPレベルが3.0mg/dLを超えている患者108人を組み入れた。患者らはMLN1202単回投与またはプラセボ群に無作為に割り付けられ、約16週間追跡された。その結果、57日後に、MLN1202はプラセボと比較し、CRPレベルを平均26.7%低下させ、この低下は85日後まで持続した。全体的に、実薬群の患者の11.3%においてCRPレベルが2mg/dL以下に低下し、一方プラセボ群におけるその割合は1.9%であった。CRPが有意に低下したのは、ある特異的なDNA（炎症のパスウェイに重要だとして知られる遺伝子における一塩基多型）を有する患者において認められる確率が高かった。この亜型はこのスタディの対象者全体の53%に認められた。
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The novel, humanized monoclonal antibody MLN1202 can reduce C-reactive protein levels in patients at high risk for atherosclerotic cardiovascular disease, according to a presentation at the annual meeting of the American Heart Association.

 

"The anti-inflammatory effect of MLN1202 resulting in lower CRP, represents an exciting novel approach to reducing atherosclerosis by targeting inflammation," said Michael Davidson, MD, Clinical Professor, Director of Preventive Cardiology, The University of Chicago Pritzker School of Medicine and Executive Medical Director, Radiant Research.

 

The placebo-controlled, Phase II trial enrolled 108 patients at high risk for atherosclerosis and with an elevated high-sensitivity C-reactive protein level greater than 3.0 mg/dL. Patients were randomized to receive a single dose of MLN1202 or placebo and were then followed for approximately 16 weeks.

 

The single active dose resulted in a mean reduction in C-reactive protein of 26.7 percent compared with placebo 57 days after dosing, a significant reduction that was maintained up to day 85. Overall, 11.3 percent of actively treated patients had protein level fall to 2 mg/dL or lower compared with 1.9 percent of placebo patients.

 

Significant C-reactive protein reductions were more likely in patients with a specified DNA marker, a single nucleotide polymorphism in a gene known to be important in inflammatory pathways. The variant was found in 53 percent of the study population as a whole.