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【medical-news】【资讯翻译】初步研究显示细胞因子抗体有助于治疗糖尿病

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这个帖子发布于7年零253天前，其中的信息可能已发生改变或有所发展。

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原文链接 http://www.medpagetoday.com/Endocrinology/Diabetes/38068

Antibody Tx for Diabetes 'Promising' in Early Study

By Michael Smith, North American Correspondent, MedPage Today
Published: March 26, 2013

An antibody against the cytokine interleukin-1 beta was safe, well tolerated, and had "modest" benefits in patients with type 2 diabetes, researchers reported.

The findings, from an industry-sponsored phase II study, suggest that blocking the activity of the cytokine "holds promise" as an adjuvant therapy for diabetes, according to Joanne Sloan-Lancaster, PhD, of Eli Lilly in Indianapolis, and colleagues.

But larger and longer studies will be needed to establish that promise as a therapeutic option, Sloan-Lancaster and colleagues cautioned online in Diabetes Care.

Research has suggested that higher than normal levels of acute-phase proteins, cytokines, and chemokines may play a role in the pathology of the disease, the researchers noted.

Among them, interleukin-1beta has been a prime suspect -- it has pro-inflammatory effects, blocks beta-cell function, and promotes beta-cell death.

For those reasons, Sloan-Lancaster and colleagues noted, it would make sense that blocking interleukin-1 beta could increase insulin production, improve insulin sensitivity, and slow disease progression.

To test the idea, they studied an investigational antibody against the cytokine -- LY2189102, or LY for short -- against placebo in a multicenter randomized, double-blind trial aimed at determining its efficacy, safety, and tolerability.

Between June 2009 and November 2010, they randomized 106 diabetes patients to get either subcutaneous placebo once a week for 12 weeks, or one of three doses of LY -- 0.6, 18, or 180 milligrams.

The primary endpoint was the change from baseline in average plasma glucose concentration, as measured by glycosylated hemoglobin (HbA1c), but the researchers also analyzed fasting glucose, postprandial glycemia, and inflammatory biomarkers, as well as safety and tolerability.

The primary endpoint was measured in the subgroup of patients -- 79 in all -- who received at least 11 doses of study drug or placebo. The researchers found that, compared with placebo:

The 0.6-milligram dose of LY was associated with 0.27% drop in HbA1c after 12 weeks.
The 18-milligram dose was associated with a 0.38% drop.
And the 180-milligram dose was associated with a 0.25% decline.

The effect was partly reversed by the end of follow-up, 12 weeks after the end of treatment, Sloan-Lancaster and colleagues reported.

Fasting glucose was reduced during treatment but also rebounded after the end of therapy. Also, postprandial glycemia was significantly reduced (P=0.02) at the end of dosing but there was no longer a significant effect by the end of 12 weeks of follow-up.

The researchers saw a significant (P<0.05) and rapid decline in high sensitivity C-reactive protein that was evident by week 4, reached an average decline of 77% at the end of therapy, and persisted until the end of follow-up.

Sloan-Lancaster and colleagues also saw apparent declines in interleukin-6 but they only reached significance for the 180-milligram group at weeks 4 and 12.

The antibody was well tolerated, with similar rates of treatment-emergent adverse events in both the placebo arm and the LY arms -- 74.1% and 77.2%, respectively.

The most common adverse events for all LY doses combined were headache, nasopharyngitis, arthralgia, and diarrhea. Five patients stopped treatment because of adverse events, but the only three serious such events were not judged to be related to the study drug.

Primary source: Diabetes Care
Source reference:
Sloan-Lancaster J, et al "Double-blind, randomized study evaluating the glycemic and antiinflammatory effects of subcutaneous LY2189102, a neutralizing IL-1b antibody, in patients with type 2 diabetes" Diabetes Care 2013; DOI: 10.2337/dc12-1835.