Inquiry on Ustekinumab

[Guest guest]

Hello,

I was wondering if anyone had any information on where clinical trials with

Ustekinumab stood and how close it is to approval in the US. I know it's a human

monoclonal antibody directed against interleukins IL-12 and IL-23 and is

presently undergoing clinical trials to determine its safety and effectiveness

against multiple sclerosis, psoriasis, and psoriatic arthritis. The results of

Phase III trials for psoriasis have been encouraging and showed ustekinumab to

be safe and effective for moderate to severe psoriasis. Ustekinumab is approved

in Canada and Europe to treat moderate to severe plaque psoriasis and is

currently under review in the United States. In September 2008,the result of a

study comparing etanercept and ustekinumab were released. The entanercept group

received subcutaneous injections of the drug twice weekly for 12-weeks while the

ustekinumab group received 2 injections, one-month apart, of either 90 or 45

milligrams. At twelve weeks, psoriatic plaques were reduced by at least

three-quarters in 68% of the low-dose ustekinumab group and 74% of the high-dose

group. Both groups fared better than the etanercept group, 57% of whom saw such

improvement. Patients enrolled in clinical trials are scheduled to receive the

drug by subcutaneous injections at doses of either 45 or 90 mg. Generally the

initial dosing interval is once per week followed by a step-down to once per

month or even once every three months. I had very good results with Enbrel 3

years ago (it cleared my psoriasis & PA) & was able to taper off under the

advice of my rheumatologist & dermatologist within a year. I have been in

remission now for 2 years until a recent trip abroad where I contracted a

respiratory infection. The PA has stayed in remission, but I had a flareup. What

appeals to me about this new drug is it needs to be taken only oce every 1-3

months. Until a cure is found, this seems like the next best thing because of

the low frequency of dosing. Any information on where trials currently stand in

the US for approval or anyone's experience with this new drug would be greatly

appreciated.

Thank you,

Sriom