Friday, February 13, 2009

Ustekinumab helps Psoriatic Arthritis, FDA still delays approval

Here is another article about the effectiveness of blocking IL-23. Right now there are no IL-23 blockers on the market. Ustekinumab would be the first. In the article below clinical trial results have been releasedishowing it to help PsA as well as psoriasis (not to mention Graft versus Host Disease), yet the FDA still delays approval.

No approval means no access for sufferers like my son. Way to go FDA. Keep it up. Who is paying you guys off?

Read the article below and then wonder why this drug hasn't been rushed to approval instead of delayed time and again by the FDA bureaucrats.

Ustekinumab has already been shown (September 2008) to give better results for psoriasis than Enbrel in head to head trials.

It was recommended by 100% of the outside panel (June 2008) who reviewed the results of the clinical trials.

It has been TWO YEARS since "stunning results" were released at the conclusion of phase II clinical trials.

Still FDA will not approve it.

My son still has NO ACCESS to the drug. He has been turned down four different times for clinical trials as he is too sick.

He has been turned down for a compassionate use individual trial by Centocor.

How long must he wait and suffer? What does a father have to do to get his suffering son access?

The article:

Tufts University, Health Sciences

Investigational study of ustekinumab in the treatment of psoriatic arthritis

published BOSTON (Feb. 11, 2009) – A group of patients suffering from potentially debilitating psoriatic arthritis showed significant and prolonged improvement after treatment with ustekinumab, according to data from a randomized, double-blind, placebo-controlled study in patients with moderate to severe psoriatic arthritis (PsA). The Phase 2 study was published in the British medical journal The Lancet.

"This is a positive development for patients living with the joint pain and swelling that characterizes the disease, even as more research is needed to further test the efficacy of this treatment in psoriatic arthritis," said Alice Gottlieb, MD, Chairperson of the Department of Dermatology at Tufts Medical Center and lead author of the study.

Tufts Medical Center was among several academic medical centers which participated in the study. Tufts Medical Center is a 451-bed hospital in Boston and the primary teaching hospital for Tufts University School of Medicine.

Ustekinumab is a human immunoglobulin monoclonal antibody that is also being studied for treatment of patients with moderate-to-severe plaque psoriasis. Researchers conducting the study published in The Lancet reported that at week 12 of the study, 42 percent of patients given 63 or 90 mg of the drug at weeks 0, 1, 2 and 3 showed significant improvement in their pain, stiffness and other symptoms defined by the American College of Rheumatology (ACR20) score compared with 14 percent of patients who received placebo (NOTE THE EVIL USE OF A PLACEBO GROUP. This research was done at Tufts in the United States under the guidelines of the criminals at the FDA. The FDA motto: LET THEM SUFFER WITHOUT MEDICATION SO WE CAN GET PRETTY NUMBERS for our study. Outrageous!) at the same time points (P < n="3)">

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