Dave - Promising new drug for Crohn's disease

[Guest guest]

Hi Dave,

I just want to thank you very much for always responding to everyone with all kinds of questions. You always offer great info and are so knowelgable. It is a lot of work and takes a lot of time to respond to everyone. Not sure what the PSC group would do without you. I am sure everyone else feels the same way. Thanks again!

Lori A.

"Aggressively Pursuing Solutions To Your Real Estate Needs!"

First Weber Group

Cell:

1507 E. Sunset Drive

Waukesha, WI 53189

LoriUSA@...

www.Lori.FirstWeber.com

Re: Promising new drug for Crohn's disease

>> Dave, how old is this drug. What are the potentially dangerous side effects?Hi Lori;It's relatively new ... just approved by FDA in February 2008 for treatment of psoriasis. It's made by a company called Centocor. Please see this article for details:http://www.medicaln ewstoday. com/printerfrien dlynews.php? newsid=96802I understand that it has had few reported adverse effects:http://www.medscape .com/viewarticle /563787"Ustekinumab is a very high performance drug,

utterly much more effective for psoriasis than any currently available agent," lead investigator Craig Leonardi, MD, an associate clinical professor of dermatology from St. Louis University Medical School in Missouri, told Medscape Dermatology. "Patients had a terrific response, it's infrequently administered, and the best part is that its safety profile is very clean.""So far, the data that have been presented show great efficacy and good safety," Dr. Feldman said. "Even a single dose can give some patients considerable and persistent improvement. ""This agent is more effective than currently available treatments," Dr. Okamoto said. "However, the judgment of the safety of this agent [compared with] currently available treatments requires additional studies.""Overall, adverse events (AE) in PHOENIX 2 were similar between groups. Through week 12, at least 1 AE occurred in 49% of the

placebo group, in 53% of the ustekinumab 45-mg group, and in 48% of the 90-mg group. Study discontinuation because of an AE occurred in 0.2% of the ustekinumab 45-mg group, 1% of the ustekinumab 90-mg group, and 2% of the placebo group. At least 1 serious AE occurred in 2%, 1%, and 2% of patients in the respective groups.""The most common AE was nasopharyngitis, which occurred with similar frequency in all groups. All other AEs occurred at a frequency of less than 2%, including headache, upper respiratory infection, arthralgia, fatigue, and diarrhea. There was 1 death, from cardiomyopathy, in the high-dose group, which was judged not to be treatment related. No changes in laboratory parameters were noted."Best regards,Dave R.