[الحاجة هدى]

الأخوة الأعزاء بالمنتدى
قرأت اليوم فى جريدة الأخبار المصرية خبر بأنه قد طرح فى الأسواق العالمية عقار جديد لعلاج الصدفية اسمه (ستيلارا) معتمد من منظمة الصحة العالمية (FDA) بخلاف (الكالاولا) الذى لم يعتمد رسمياً على و يأخذه المرضى على مسئوليتهم الشخصية

و ببحثى على الجوجل وجدت الآتى - عسى ان يفيدنا الأطباء منكم

أولا اسم الموقع

http://www.psoriasis-cure-now.org/st...stekinumab.php

و قرأت الآتى :
telara (ustekinumab)

Stelara has been approved by the US Food and Drug Administration (FDA) for patients 18 years or older with moderate to severe plaque psoriasis. It is the first in a new type of biologic for moderate to severe psoriasis that would provide powerful psoriasis relief with infrequent dosing. Stelara is given twice in the first month, followed by dosing just four times per year. According to the product website, Stelara "should only be given by a healthcare provider as directed by your doctor." (Some biologics are self-administered at home.)

The big question is whether it will prove safe and effective for long-term use. It is too new to know at this point. Stelara is also approved for use in Canada and the U.K. Stelara (ustekinumab) was discovered by Centocor and will be marketed by Centocor in the United States and by Janssen-Cilag companies in other countries. Both are subsidiaries of Johnson & Johnson.

How is it administered? Stelara is administered by simple injection under the skin as few as four times per year after two initial doses in the first month.

Advantages Stelara has proven very effective for moderate to severe psoriasis in clinical trials lasting up to a year. Only time and longer studies will show if Stelara can maintain that effectiveness over time. Its very infrequent dosing will also be welcomed by many psoriasis patients. Its safety profile, in studies conducted to date, has been impressive.

Drawbacks Unlike some other biologics that have been used and/or tested in patients (with psoriasis and/or other diseases like rheumatoid arthritis [RA] and Crohn's disease) for a decade or longer, Stelara has roughly three years of clinical testing data in humans. No one can yet say whether it will prove safe over longer period of time. Given that the average psoriasis patient will battle the disease for 50 years, and that psoriasis typically first appears in early adulthood (and often sooner), long-term safety is critically important. Also, Stelara is administered by a health care provider (doctor or nurse, etc.), rather than by the patient at home. That may make it less convenient for some patients.

How does it work? Stelara (ustekinumab) blocks interleukin-12 and interleukin-23, immune-system proteins linked to inflammation.

In the summer of 2008, a U.S. Food and Drug Administration (FDA) panel of outside experts voted unanimously to approve this experimental biologic for the treatment the treatment of moderate to severe plaque psoriasis. As Reuters reported at the time:


An experimental Johnson & Johnson drug should be approved for treating adults with moderate or severe psoriasis, an advisory panel unanimously ruled Tuesday.
The ability of the drug, ustekinumab, to relieve symptoms of the skin disorder outweighed concerns treatment might increase the risk of cancer, the outside experts that advise the Food and Drug Administration said.
"It's quite striking how well it works compared to other things that we have available," said panel chairman Michael Bigby, associate professor of dermatology at Beth Israel Deaconess Medical Center in Boston.
But the panel said the manufacturer's post-approval monitoring plans were insufficient to gauge long-term risks. Members also voted 7-4 that the drug should be injected by prescribers rather than patients themselves.
The FDA will consider the advice before making a final decision. The agency usually follows panel recommendations.
… [Most existing biologics for psoriasis] work by blocking an inflammation-causing protein called tumor necrosis factor (TNF).
Ustekinumab blocks interleukin-12 and interleukin-23, two other immune-system proteins linked to inflammation.
FDA reviewers said animal studies showed blocking those proteins increased the chances of developing cancer, which raised concern about the effect in people. …
Panel members said doctors and patients should be informed of the cancer concern, but it was not enough to keep the drug off the market.
"We don't know if it's going to hurt them ... I think ethically we have to make this available" in light of the drug's effectiveness, said Lynn Drake, a dermatologist at Massachusetts General Hospital.
Officials with J&J unit Centocor said no increase in cancer was seen in people studied as long as 18 months and the company would monitor cancer cases after approval.
The prescribing information for the TNF-blocking drugs come with a warning about a possible risk of cancer.


Michael Paranzino, president of Psoriasis Cure Now, appeared at the hearing and spoke to the Committee about the seriousness of psoriasis and the need for additional treatment options. He read excerpts from patient emails testifying to the debilitating nature of psoriasis, and on behalf of Psoriasis Cure Now he urged approval of ustekinumab. He also urged the FDA to allow patients to be given the option to inject the medication at home, rather than requiring the patient to receive the injections at a physician’s office.

Paranzino also expressed disappointment with the FDA for failing to address, in its briefing materials for the committee, the profoundly negative impact that psoriasis can have on a patient’s quality of life. Finally, he urged the FDA and Centocor to agree on a robust, long-term study of the potential safety issues surrounding ustekinumab and for Centocor to see the study through to completion and publication.

The clinical trials showed ustekinumab to be both effective and highly convenient. What’s more, its 18-month safety data appear strong. What remains to be seen is how patients will fare over the long haul, both in terms of its effectiveness and whether any dangers emerge over time that would not be seen this early in a treatment’s use. Additional studies must be undertaken to help us understand the benefits and risks of IL-12/IL-23 inhibitors as psoriasis treatments; and certainly, patients should carefully evaluate with their physician any new treatment before using it.