Stelara update: can keep working for 3 years, safely

http://www.psoriasis-cure-now.org/2010/08/15/stelara-update-can-keep-working-for-3-years-safely/

Stelara update: can keep working for 3 years, safely
August 15th 2010 by Psoriasis Cure Now
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Even before it received U.S. Food and Drug Administration (FDA) approval in September 2009, Stelara (ustekinumab) had considerable buzz in the psoriasis community. Imagine a treatment that (after two initial doses) you take just four times a year! But the early buzz was based on 12 week, and later 40 week, studies. That left two big questions for patients contemplating Stelara: would it work for years, not weeks; and would it be safe to take for the long-term?

Centocor Ortho Biotech, the company behind Stelara in the U.S., is funding ongoing studies to try to answer these questions, and the data is now in for patients on Stelara for three years. The news is good.

Can it work for years?

In one study, the investigators took patients who had maintained a 75% improvement in psoriasis symptoms after about 9 months of Stelara treatment, and kept them on treatment every 12 weeks thereafter. Patients under 220 pounds received 45 mg doses of Stelara, and patients over 220 pounds received 90 mg doses of Stelara (these are the current, standard doses.) After 2.8 years, 88% of patients in the under 220 pounds group, and 72% in the over 220 pounds group, maintained that 75% improvement (called PASI 75, this is the benchmark used by the FDA in evaluating psoriasis treatments). Also noteworthy, 48% and 44% of those groups, respectively, achieved a “PASI 90″ response, a 90% improvement in their psoriasis symptoms. These are impressive numbers.

In short, it says that if Stelara is working for you after 9 months, it is likely still to be working for you after 2.8 years, and almost half of patients will be enjoying a 90% improvement as their third anniversary of Stelara treatment approaches. The study is continuing, with its five year data to be collected in October 2011. (This means we should get four year data announced in 2011, and the five year analysis published in 2012.)

Two cautionary notes. First, this study only included those who had achieved success with Stelara at 9 months of treatment. Of course, most of those who were not doing well on Stelara would switch treatments long before 9 months, but it’s worth noting that these success figures at 2.8 years had already screened out those ‘failing’ on Stelara.

Second, among those weighing more than 220 pounds (a significant proportion of American adults), almost 3 in 10 had slipped below the 75% threshold of success by 2.8 years. [This is particularly relevant right now with the news about golf star Phil Mickelson and his battle with psoriatic arthritis. Much of the early media coverage seemed to suggest that he would just take his biologic and his problems would be solved for good. We quickly issued a press statement to note that (among other things) for many psoriasis and psoriatic arthritis patients, treatments lose effectiveness over time.] We’ll have to see how the five-year data plays out for this group of patients.

Is it safe to take for the long-term?

The company also noted data that included patients taking Stelara for up to 3 years. It reported that rates of serious infections, non-cutaneous malignancies and major cardiovascular events “remained stable over time and were consistent with expected rates in both general or psoriasis populations.” More good news. But again, a pair of cautionary notes.

In the 2.8 year study, noted above, 6% of patients in the study dropped out due to “adverse events,” typically negative health issues that lead someone to quit a study. The company summary of the study does not detail these; when we find out more about these we will update this post.

Also, the study included just a few hundred patients for the 2.8 years. A related study they reported on included 3,000+ patients who averaged treatment of just roughly 1.5 years. Compare that to another biologic, Remicade (infliximab), made by the same company. More than one million patients have used Remicade worldwide for a variety of diseases, and Remicade has been around for more than a decade. Also, Stelara is the first and only anti-IL12/23 treatment that is FDA approved. We simply do not yet know whether Stelara can maintain this safety record over the long haul.

Bottom line? Stelara continues to add to its clinical trial successes with more good news regarding its effectiveness and safety over periods of up to three years. But the total patient population exposed to Stelara is still quite small compared to those of three other psoriasis biologics, Remicade, Enbrel (etanercept), and Humira

听说很贵的哦，一年得打5针，要花100000块左右哦！

强烈要求stelara上市！至少给了很多人改善生活的希望，总比不敢实验（事实上美国人已在前面帮我们做了实验）坐着等死或者生不如死强的多！

楼主有些激动了，（事实上美国人已在前面帮我们做了实验），参加实验的也是病友吧，再有，北京这也有病友参加了实验，也有一些病友体检没过去，就刷下来了，并且参加试药的病友也写了心得。

没怎么看懂，哪位朋友能翻译下，Stelara

stelara,可以持续安全的作用3年。
在stelara于2009年9月通过fda之前，stelara已经在P病患者中左了大量的实验。但是，最初的实验做了12个月，后来的做了40个月。那么就给关注sterala的患者留下了2个问题。1，他可以多年而不是几个星期有效吗。2，长期用药安全吗。
centocor ortho biotech，成产sterala的美国公司，建立了持续的实验以回答这些问题，这些数据在使用sterala的患者中进行了3年。结果不错。
可以持续有效吗？
在实验中，调查员选取那些使用sterala治疗9个月后，皮损恢复了75%的患者。然后每12个星期给药一次。220磅以下给予45mg，超过220磅给予90mg（这是现在的标准剂量）。2.8年后88%低于220磅，75%高于220磅的病人维持了75%的恢复。（叫做PASi75%，这也是FDA用来衡量银屑病治疗的基准）48%和44%的上述患者，达到了90%的恢复。这是个令人印象深刻的数字。
简单的说，如果你用sterala9个月，它将会持续起作用2.8年。而且有将近半数患者在用药3年后有90%的恢复。。这个实验仍在持续，在2011/11会得到5年数据。（这意味着，我们在2011年得到4年数据的发布，在2012年发布5年数据分析）
2点要注意，1，这个实验只包括那些用药9个月后取得成功的患者，当然，那些对sterala无效的患者中的大部分会在9个月前更换治疗方式，值得一提的是，那些在2.8年后取得成功的数据除开了那些对stelara无效的患者。2，对于那些超过220磅的患者（很大一部分美国成年人）大概会有30%的患者滑到75%的2.8年成功值门槛。我们将会烤炉如何计算这部分人（超过220）的5年数据。
长期用药安全吗？
公司也记录了用药块3年的患者的数据。报告称，严重感染，非皮肤恶性肿瘤和严重心血管事件的比率“一直稳定，并与正常人或银屑病患者患这些病的比率一致”。这是个好消息。同时，2个提醒。
1，在2.8年的实验种，6%的患者因不良反应排除在统计之外。因负面健康问题，导致一些人退出实验。公司的实验统计中并没有给出细节，如果我们有更多的消息，将会更新。
2，这个实验只有几百人做了2.8年，相对于这个公司做的另一个实验，这个实验（也是stelara)做了3000+人，但只持续了1.5年。对比另一个生物制品，remicade,在全球不同类型患者中做了超过100万人。而且remicade用了超过20年，同时，stelara是FDA批准的第一个抗IL12/23的药物。我们并不知道stelara可不可以长期的保持这个安全记录。
底线?stelara继续着临床实验的成功，尽管它的效果和安全超过了3年。但对比于另外3种银屑病药物remicade,enbrel,humira来说，用这个药的病人仍太少。

谢谢3楼帮忙翻译，从目前看药效是可以的，只可惜价格令人望而却步。

注意，3楼的翻译有一点好像错误了，那些治疗9个月之后有效的病人需继续用药3年才得到以上数据，所以外国的试验是一直不停给药的，持续几年时间。对于这点我也很失望！

顶！希望有更多的好药。

这个就是说目前看来3年内一直用药不会有什么抗药性和副作用吧。