Thursday, October 27, 2011


Praise God!  Yes, you heard right.  Stelara has been approved.  We got  the call last night around 8pm (left on voicemail).  Don't know all the details yet, but we should get a call from CVS Speciality Pharamacy regarding the details. I don't know if it is going to be shipped to my house premixed in a syringe, or shipped as a powder with sterile water for us to mix or what.  It may even be shipped to Mayo and I have to go there to receive the shot.

We should know something by the end of the week.  We have been working on this since the 26th of September.  Took initial request with 3 appeals to get it to go through, and lots of prayers.

I don't know what it will cost, but should be between $8 and $125 a treatment. That is better that $40k per year (8 treatments I believe).  Treatments are given at week 0,week 4, week 8, week 12, and then every 12 weeks afterwards  There are 2 doses given also, 45mg and 90mg.  I am not sure which dose has been requested for me.  That is based on severity of disease and body weight. 

I am noticing the arthritic symptoms of crohn's returning now. My hands are swelling, my knucles are swollen, red, tender and warm to the touch.  Many of my  joints are tender and swollen, though the redness/warmth can't be seen/felt.  Slowly if the intestinal part of crohn's isn;t controled,the whole body goes under attack.

Crohn's can attack the intestines, which is most common.  It causes arthritis (a kin to rheuemetiod), inflamation of the eyes (and ulcers in the eyes), mouth ulcers, skin uclers and lessons (called pyroderma gangernsum - usually at the site of some sort of trauma), ulcers on the liver, and ulcers in the lungs.

Thankfully, all I have experienced is intestinal, mouth/tongue, pyroderma, and arthritis. These are painful enough as it is.

The gastro and surgeon said that even with the complete removal of my large intestine and rectum there wouldn't be a 100% cure.  Crohn's could continue either in the small intestine (where it normally occurs) or in one of the other forms.

This is why Stelara is such a needed medication.  My body has stopped repsonding to TNF  inhibitors (Remicade  - inflixamab, Humira - adalibumab, and Cimzia - Certolizumab).  These 3 were in the class of Monoclonial Antiboties (MAB's)   Stelara (Ustekinumab) is similar in that it is a MAB, but differs in that it is an Interlukin 12/23 inhibitor.  There are other interlukins that have been found responsible for inflamation in crohn's - specifically IL 12, IL17, and IL23.  These are also responsible for plaque psoriasis, psoriatic arthritis, and rheumetoid arthirtis.

These new series of MABs offer hope to people like me who have had long term anti-TNF treatment of failed TNF treatment.  There is another set of anti-TNF drugs like Enbrel (Etanercept).  There are a couple in this class but due to the way they work, I am unable to take them. 

I had  run out  of options till we found Stelara - even though it is still not FDA approved for crohn's.  Clinical trials have been done and they look very promising.

"New study findings showed that treatment with STELARA® (ustekinumab) induced and maintained clinical response in patients with moderate to severe Crohn's disease who had previously failed or were intolerant to at least one tumor necrosis factor (TNF) antagonist.  Investigators presented findings from a Phase 2b study at Digestive Disease Week, which showed nearly 40 percent of patients receiving STELARA 6 mg/kg achieved clinical response, defined as a 100 point reduction in the Crohn's Disease Activity Index (CDAI), at week 6, the primary endpoint of the study."From Stelara Clinical Trial info

No comments:

Post a Comment