Hey UC’ers, how the heck you all doing?
Here’s my first post since getting back from my camping/rafting trip and its not a typical one, but because I get so much email and there’s so much chatter about Humira amongst the colitis folks of the world, I thought this would be of interest to many of you who might be making medication decisions if you’re treating your UC that way. And at the same time, I thought it would be a nice opportunity to come way out of the closet and make darn sure that all users of the site realize that just because I don’t use medications to treat my UC, I know a HUGE chunk of you do. And that is awesome, especially if you’re getting great results. The reality is that there’s so many options on how to treat UC, and it’s so easy for you (me) to think you know “the best” thing when it’s working for you…….BUTT, let’s not fool ourselves, positive results come in many shapes, sizes, forms, capsules, yoga moves, food, drink and whatever else. Do you feel what I’m trying to get at here??? If you’re popping pills, or shooting up meds, getting your colon removed…whatever the case may be, it is a free world, and hopefully always will be. And if you’re cranking good results that you’re happy with, right on amigos! (now back to the original broadcast…)
Earlier today the Food and Drug Administration (FDA) released an update regarding their review of the medication Humira for the intended treatment of ulcerative colitis. The GIDAC (Gastroenterologist Drugs Advisory Committee) will be holding a formal meeting on Tuesday August 28, 2012 to vote on the potential approval of Humira.
Within the FDA’s formal review, they explain how Abbott Labratories (the producer of Humira) has proposed the following:
“HUMIRA is indicated for reducing signs and symptoms, and inducing and maintaining induction of clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.”
There has already been some lengthy discussion between Abbott and the FDA regarding Humira and Ulcerative Colitis in the past, back in January of 2011, Abbott had submitted some documentation to the FDA about efficacy studies regarding UC patients and Humira, however the FDA requested more information to help determine if Humira was something which should be approved to treat UC.
Two Files You Can Download and Read Now:
Most recently, Abbott prepared a formal response to the FDA (in PDF format): Abbott Labs Humira FDA Information
The current FDA briefing information in response to Abbott’s documentation submitted above: FDA August 28 2012 Humira Review Response
(you can find both of these files also on the FDA website)
If you are interested in learning about the FDA approval process for new medications, such as this biologic medication Humira (which is expected to bring in over $1 Billion in sales to Abbott if approved in the US for UC) you might enjoy reading through the summaries which are the first sections of both of the pdf files listed above. I myself learned quite a bit in reading through them early this morning.
What was praticularly interesting for me to learn was how the Food and Drug Administration feels about treatment options for our disease. Below is a direct reference from the second PDF file listed above:
Current Treatment Options for Ulcerative Colitis
Decisions about treatment of UC weigh such factors as disease activity, disease extent and duration, previous treatment attempts and the patient’s preference. The goal is to stop the patient’s active acute disease (induction of remission) and then maintain the patient in remission.
Aminosalicylate preparations, given orally, rectally or in combination, are the first line of treatment for induction of remission (aminosalicylates are approved to treat mildly or moderately active UC including, for certain products, maintenance of remission). Patients with mild-to-moderate UC that is refractory to aminosalicylates are often advanced to oral corticosteroids (approved to “tide the patient over a critical period”) and immunosuppressive agents (e.g., azathioprine or 6-mercaptopurine; widely used but unapproved). Use of any of the preceding has come to be considered part of “conventional therapy.”
Currently, Remicade (infliximab) is the only TNFα-antagonist approved for induction and maintenance of remission in patients with moderately to severely active UC who have inadequate response to conventional therapy. Remicade has been shown to be effective in this population and has an acceptable safety profile; however, many patients do not respond initially, lose response over time, and/or develop intolerance.
Colectomy is still required for many when medical therapy fails or when epithelial dysplasia is found on surveillance. Total proctocolectomy with ileal pouch–anal anastomosis (IPAA) is currently the procedure of choice because it preserves anal sphincter function. While the mortality of the procedure is low, long-term morbidity is not. Pouchitis, often intermittent and recurrent, is a prevalent problem with symptoms that include increased stool frequency, urgency, incontinence, seepage, and abdominal and perianal discomfort.
(It’s called the “Food and Drug Administration” right?…Well…why the heck is there NO mention of food in the excerpt above?)
So for anybody who is interested in learning more about Humira, and what may/may not happen on Tuesday, stay tuned. I’m sure there will be some big final news after the FDA vote coming up which might affect some of you and your decision making.
As some of you might remember, back when I was using medications to treat my UC, I had a pretty awful experience myself with Humira. It was not an approved medication by the FDA, but I was able to get insurance clearance for it and gave it a go. You can read more about my humira experience here if you like along with many comments from other UC’ers.
Have a great weekend everyone, lots more UC stories I’ll be posting on the site in the coming days from those of you who have submitted your stories and pictures.