Vedolizumab, A New Treatment for Ulcerative Colitis & Crohn's Disease Looks Promising - Info & Clinical Trial Included

Vedolizumab, a potentially new treatment for UC and Crohn's disease is being fast tracked for review by the FDA.  The BLA (biologics license application) will give priority review to the ulcerative colitis application and standard review to the Crohn's disease application.
The part of the clinical trial that is most important to me is the said adverse effects that were found in the patients who participated in the study.  Based on the concluding trial results, the adverse effects of the drug is said to be the same as the placebo.  That's great news.  I'm going to continue to watch this drug for new updates and news pertaining to safety. So far, this new treatment by Takeda Pharmaceuticals looks promising.
I have also included the clinical trial abstract below.  

Gastroenterology & Endoscopy News - New IBD Drug, Vedolizumab, Receives Priority Review Status for Ulcerative Colitis: 

On Sept. 4, Takeda Pharmaceutical Company Ltd., announced that it received priority review status from the FDA for its drug vedolizumab, an investigational antibody for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). Takeda submitted a biologics license application (BLA) to the FDA in June for the treatment of CD and UC; the UC application will receive priority review, and the application for CD will be reviewed under the standard timeline.

NEW TREATMENT OPTION - SIMPONI® Receives Approval in UK for the Treatment of Ulcerative Colitis/ #UC

I just read that today Simponi was approved for the treatment of ulcerative colitis in the UK.  This may be a successful treatment option for people that have not been able to obtain remission with mainstream treatments for the disease.  Some people, like myself, have tried them all with no improvement.  It's very frustrating to hit that wall and run out of effective treatments..... actually, safe effective treatments.  If you just can't seem to get the inflammation and toll taking symptoms under control and you've taken into consideration the risks vs. the benefits, some people may find relief with this new drug.  This particular article does include the potential health risks from TNF-blocking therapies, toward the end of the article.  

If you are considering Simponi (or any immunesuppressing drug), please know everything about it before agreeing to the treatment.   Everyone should know what the risks are versus the benefits before beginning any kind of treatment like this.  Your doctor will not tell you everything about these drugs and from personal experience, most doctors down play the risks and don't even look at  family history/genetics when deciding if these treatments are appropriate.   It's disturbing when you know that the information you completed for your file, (providing family history) and screams *HIGH RISK*, and the doctor recommends the treatment anyway.   Sadly, it's probably because the doctor didn't even scan over this little piece of information that says a lot.  Another reason is because TNF-blocking therapies have become the conventional prescribing treatments for IBD now, despite their high side-effect profile.   

Personally, I would never consider being treated with an immune suppressing drug of this potency because of the numerous possible health problems that could result.  It's not worth it to me to put my entire body at risk of developing something life altering (conditions worse than what I'm treating) with the awareness that there are life changes that I can make that will encourage healing and repair of my digestive tract.  It takes determination to make the changes that are necessary and it takes longer to heal, but in my opinion, it's my overall health that I care about.  You will get there, I did.

Most doctors will say that diet is not a big contributor to IBD however,  it infact makes a huge difference in respects to your success with reaching remission. What foods you choose to eat WILL affect your health negatively or positively, it's a decision that you can control that will have a significance on your overall quality of life.  If you struggle with diet and need some guidance, send me an email.  Years ago I was clueless about what to eat and what not to eat.   I was blessed to have connected with a few very knowledgeable people that helped me in the area of diet.  I'm always willing to help people that need some support and suggestions, so feel free to contact me if you need some support.     

PR Newswire UK: SIMPONI® Receives European Commission Approval for Treatment of Moderately to Severely... -- LEIDEN, The Netherlands, Sept. 23, 2013 /PRNewswire/ --:

-- First and Only Subcutaneous Biologic Treatment Administered Every Four Weeks Approved for Ulcerative Colitis

Co-pay Assistance Programs List | UCERIS & Other Prescriptions

When I first heard of Uceris, it reminded me of the drug Entocort.  Both treatments are very similar - same active ingredient and both are time-released.  The only difference is that Uceris is released in the colon vs Entocort, which is released in the small intestine.  That explains why Entocort wasn't effective when I tried it years ago. Most of my inflammation at that time was located in the large intestine and part of the small intestine (terminal ileum - the last area of the small intestine connecting to the large intestine). 
People with Ulcerative Colitis experience inflammation specific to the large intestine/colon.  
Hopefully this medication will help with healing the lowest part of my colon - the most difficult area to heal from what I have read.   Maybe this could be an option that some of you may want to try as a safer treatment option .  

• IMPORTANT NOTE TO MENTION - This form of steroid does not produce the horrible side-effects that come with oral prednisone (aka - satans tic-tacs).  We all know what those side effects are if we have ever taken prednisone.  Due to the time-release of the drug at it's target location, very little of the medication is released into the bloodstream.  This is a very good thing!! 

What it says about Uceris @ www.uceris.com

About UCERIS

UCERIS (u-SAIR-us) is a medicine used to treat active, mild to moderate ulcerative colitis (UC). It's for people experiencing UC symptoms or a flare-up who are trying to reach remission, a period of time without symptoms.

UCERIS is a different kind of steroid designed specifically to treat UC. It decreases inflammation throughout the colon with a targeted delivery of medicine throughout the full length of the colon, where the disease is located.

Because of the way UCERIS is absorbed and processed in the body, most of it does not enter the bloodstream, and therefore it has a safety profile similar to placebo (sugar pill). UCERIS also helps heal the lining of the colon. UCERIS decreases the severity of inflammation in the colon, thereby helping to eliminate UC symptoms.

UCERIS is a single pill taken once a day by mouth for up to 8 weeks. Additional 8-week courses can be given for patients whose UC remains active. 

What happens after taking UCERIS? Unlike typical steroids, which act on the whole body, UCERIS targets the area where the disease is located. The medicine travels through the digestive system and stays intact until it reaches the colon. Once it dissolves, UCERIS forms a type of gel and slowly releases medicine to the full length of the colon.

Ok, so I just filled my prescription of Uceris and it's a pretty expensive drug for the time being (too new for a generic form to be available).  People with GI conditions and autoimmune disorders spend a lot of money on maintaining their health, from doctor co-pays to specialty food to the various medications one must take.  The monthly cost of this disease can be devastating.  I wanted to share the different savings offers that are available for qualified individuals.  

• Here is the list -  Please note:  I have not checked SCBN.org or goodrx.com about the offers.  I just did the searching and posting for you.  Offers status at this time on specific drug is unknown, as i didn't read each sites qualifying info andterms of offer.

$25 Co-pay Program | UCERIS (budesonide) Extended Release Tablets: - Manufacturer offer*

http://medicinecoupons.net/Medicine-UCERIS-coupon

http://www.internetdrugcoupons.com/Uceris-Coupon *This site gives people with no drug coverage an option to save.  The manufacturer does not have an offer for cash paying individuals (I have no idea why. Makes no sense when these would be the people that would need the most help paying for medication).

http://www.goodrx.com/uceris

https://www.pparx.org/ The Partnership for Prescription Assistance helps qualifying patients without prescription drug coverage get the medicines they need through the program that is right for them. Many will get their medications free or nearly free.

http://www.needymeds.org/ NeedyMeds is a 501(c)(3) non-profit information resource devoted to helping people in need find assistance programs to help them afford their medications and costs related to health care. 

http://healthfinder.gov/FindServices/SearchContext.aspx?topic=696 US Dept of Health Resource Page

http://www.scbn.org/  

Another Study Reveals Benefits of Medicinal Marijuana -Crohn's Remission

I have read dozens of articles, studies, reports, etc. that read similar to this article!  How many more studies are necessary for people to realize pot is not harmful and isn't going to kill anyone? It's actually almost funny that this herb is still looked at as a dangerous drug.  It's a plant... and it's shown to provide more benefits than harm.   The research always results in a significant benefit when studies are conducted.  I don't ever remember reading anything negative about marijuana, or it causing serious problems for the people that smoke it.  We would definitely know by now if weed were harmful.  Even if there were terrible outcomes from smoking pot, we do not hear these reports because of all the legality issues surrounding the word "marijuana".  It's ridiculous that the plant is still illegal and considered harmful here in the US!  Wake Up America!

Eventually, pot will be legal in all US states, but it's going to take a long time for all of them to adopt legislation (NY will probably be one of the last states to legalize it).  Turtle pace.... because that's how the US of A rolls.  Nice and s loooooooooooowwww. 

Medical Marijuana Causes 'Complete Remission' In Crohn's Disease Patients Without Side Effects, Study Finds : Latin Times:

Crohn's Disease has long been a fickle illness that requires meticulous attention to treat and live with. Researchers at the Department of Gastroenterology and Hepatology, Meir Medical Center in Israel, however, may have found relief for patients of the disease in medical marijuana. The study split 21 patients who received a high Crohn's disease activity index and were not responding to other treatments into two groups. One group was given a joint to smoke twice a day while the other group were given placebos lacking cannabinoids for the duration of eight weeks.

The study found complete remission for 45 percent of the group that smoked cannabis, or 5 out of 11 patients, as compared to the control group, which only experienced a 1 in 10 remission rate, the Huffington Post reported. It is speculated that cannabinoids with their anti-inflammatory properties are likely the cause of relief for the disease, which causes inflamation of the bowels. This inflammation can lead to extreme discomfort, diarhrea that may contain blood, weight loss, vomiting, rashes, inflammation of other parts of the body and tiredness among other symptoms, SF Gate reported. Others in the cannabis group reported lessened strength in their usual symptoms without the side effects caused by steroids often used to treat the illness.

"THC-rich cannabis produced significant clinical, steroid-free benefits to 11 patients with active Crohn's disease, compared with placebo, without side effects," the researchers wrote in the study. "Subjects receiving cannabis reported improved appetite and sleep, with no significant side effects."

The study, the authors conceded, was not a complete success as it was hypothesized that induced remission would occur for all or most of the patients. Still, researchers say that the relative success of this study is worth noting. The results have indeed produced a need for further investigation, the study says.

RELATED: Marijuana Diabetes: Pot Smokers Have Lower Diabetes Risk; Are Pot Smokers Skinnier? 

Crohn's disease is highly prevalent for whites, with 43.6 percent of every 100,000 being affected by the disease, one study by the Department of Family Medicine in San Bernardino, Calif. found. Latinos, by contrast, have the lowest rate of the disease with only 4.1 percent in every group of 100,000 being affected. Latinos, especially immigrants to the U.S., however, have notably higher rates of ulcerative colitis than most whites, VOXXI reported. A study in the American Journal of Gastroenterology, the urgency of treatment also contrasted non-Hispanics. Whites needed surgery at a much higher rate than Hispanics. Access to care may influence how often the disease is actually diagnosed, but researchers said that it does not explain the difference between U.S.-born and foreign-born Hispanics in terms of the prevalence of the disease.

"It is unclear what is responsible for this observation, but possibilities include changes in the environment with migration, diet and other factors related to acculturation," Daniel Sussman, assistant professor of clinical medicine in the Division of Gastroenterology, Jackson Memorial Hospital and University of Miami, said. "Our research did not measure the incidence or prevalence of IBD in Hispanics. Available population-based studies show that the incidence of IBD in some Latin American countries is higher than anticipated; this may be a result of the "westernization" of many Latin-American countries. As the Hispanic population continues to grow in the U.S., we expect that the number of Hispanic patients with IBD will also rise."

New Law -> Regulates Antibiotic Use On Farm Animals

The FDA should have taken action a long time ago with regulating the use of antibiotics for farm animals, especially the healthy animals that don't need them.  Of course, everytime we eat non-organic meat (sometimes I even wonder about the quality of "organic" meat in the US) we are pretty much swallowing antibiotics and most people don't even recognize this or think about it... OR they just don't care.  As the article says:  

"The over-use of these antibiotics contributes to the development of so-called ’superbugs,’ or infections that cannot be treated with existing medicines." 

I recently read that C-Diff has now developed a strain being a superbug.  When I read that 300 people a day die from C-diff... A DAY, my jaw dropped.  I thought the words after 300 would be something more like "people per month".  That sounds about right in my opinion, but things have gotten out of control in this country.  The use of drugs for everything and the medical field's lack of knowledge of NATURAL, more healthy ways of eradicating a pathogen/illness is now biting us in the ass.    

"A recent study published in the medical journal, Clinical Infectious Diseases, found that nearly 50 per cent of grocery store meat was contaminated with antibiotic resistant pathogens, according to the Senator. Approximately 25 per cent of this meat was contaminated with pathogens that were resistant to three or more type of antibiotics." 

Mmmmm yummy!  Makes you want to have a nice steak huh?! Yeah right... ORGANIC ONLY.  The standards that certified organic follow should be the normal standards for all farms and all the food that is allowed into the grocery store for human consumption.  That 50% of meat that is full of pathogens is not even fit for an animal to consume and people are eating it everyday.      Y  U  C  K!    

New Law Introduced to Safeguard Use of Antibiotics in Agriculture - The Pig Site:

New Law Introduced to Safeguard Use of Antibiotics in Agriculture

28 June 2013

US - Senator Dianne Feinstein (D-California) has introduced legislation to combat antibiotic resistant superbugs that develop when antibiotics are misused in animal agriculture.

The Preventing Antibiotic Resistance Act of 2013 directs the Food and Drug Administration to prohibit the use of human antibiotics in the feed and water of healthy farm animals if they jeopardize human health.

The bill requires drug companies and agriculture producers to demonstrate that antibiotics are used to treat clinically diagnosable diseases - not just to fatten livestock. The over-use of these antibiotics contributes to the development of so-called ’superbugs,’ or infections that cannot be treated with existing medicines.

“Antibiotics are the closest thing to a ‘silver bullet’ in human medicine given their ability to wipe out a wide variety of bacterial infections, but we are in danger of losing this weapon in the fight against infectious diseases,” said Senator Feinstein. “When antibiotics are fed in low doses to animals, only the strongest, most resistant bacteria are left behind to reproduce. By the time these resistant pathogens make their way from the animals into our communities, the infections can be costly to treat or untreatable all together.”

A recent study published in the medical journal, Clinical Infectious Diseases, found that nearly 50 per cent of grocery store meat was contaminated with antibiotic resistant pathogens, according to the Senator. Approximately 25 per cent of this meat was contaminated with pathogens that were resistant to three or more type of antibiotics.

“The irresponsible use of antibiotics is dangerous, and tens of thousands of people in the US die each year from antibiotic resistant infections,” Senator Feinstein added. “We must preserve the efficacy of these life-saving drugs by carefully restricting their overuse in our agriculture products.”

The Preventing Antibiotic Resistance Act of 2013:

• directs the Food and Drug Administration to prohibit the use of antibiotics in ways that accelerate antibiotic resistance
• requires drug companies and producers to demonstrate they are using antibiotics to treat clinically diagnosable diseases—not just to fatten their livestock
• applies restrictions to only the limited number of antibiotics that are critical to human health. Any drug not used in human medicine is left untouched by this legislation, and
• preserves the ability of farmers to use all available antibiotics to treat sick animals. If a veterinarian identifies a sick animal, or a herd of animals that are likely to become sick, there are no restrictions on what drugs can be used.

More than 375 public, consumer and environmental health groups, including the American Medical Association, the American Public Health Association, and the Infectious Diseases Society of America, support the legislation.

Senators Susan Collins (R-Maine), Jack Reed (D-Rhode Island), Maria Cantwell (D-Washington), Kirsten Gillibrand (D-New York) and Barbara Boxer (D-California) are co-sponsors of the legislation.

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