REDHILL BIOPHARM - News -> RHB-104 - Possible Breakthrough Treatment for Crohn's Disease

I get so excited when I read about this possible treatment, RHB-104, for Crohn's!  I've been watching this drug for over a year now.  This is a  treatment that if approved by the FDA, I will be jumping on it as soon as it becomes available.  No doubt!  This is the kind of treatment we need.  Everything else just treats symptoms.
So, why is this so exciting?  If you read current research about what causes Crohn's disease, you will see that researchers are leaning away from considering Crohn's disease an autoimmune condition.  They have found that there is an underlying cause for the immune response to activate.  Crohn's is said to be caused by a combo of 3 factors - Immune system abnormalities, environmental influences and bacteria.  I just wiki'd Crohn's disease and this is what is said about what is believed to be the cause - "Crohn's disease is caused by interactions between environmental, immunological and bacterial factors in genetically susceptible individuals.[4][5][6] This results in a chronic inflammatory disorder, in which the body's immune system attacks the gastrointestinal tract possibly directed at microbial antigens.[5][7] While Crohn's is an immune related disease, it does not appear to be an autoimmune disease (in that the immune system is not being triggered by the body itself)."
What this means is that people that have Crohn's disease do not have the immune system capabilities to destroy a form of bacteria that have been introduced into the body at some point in time.  As research has indicated, a large number of people with Crohn's disease happen to have the MAP bacteria in their body somewhere.  The exact location of the bacteria is not known at this time.  Who cares where it is, as long as a treatment is available that will destroy it is my opinion.
See why this makes me super hopeful?  If Crohn's is caused by this MAP bacteria & if this new combination antibiotic eradicates the MAP bacteria from people with Crohn's disease, this could be the answer to the Crohn's disease epidemic!  Can someone say CURE :)
Wouldn't that be glorious?  

Clinical trial for a new antibiotic therapy for Crohn’s treatment started:

Crohn’s disease is an inflammatory bowel disease which may affect gastrointestinal tract from mouth to anus, and has a wide variety of symptoms. Mycobacterium avium subspecies paratuberculosis (MAP) is believed to be associated with Cronh’s disease. Professor Dr. Saleh Naser, UFC College of Medicine, believes that MAP is the cause of the disease. He said, "Crohn's disease affects more than 750,000 Americans, yet traditional treatments only address the symptoms of inflammation and not the cause." He further added, "I have seen case studies where patients' lives have been restored following treatment, which removes MAP. I have high hopes that this clinical trial may lead to finding a cure." Dr. Saleh Naser will soon conduct clinical trials on a new antibiotic therapy acquired by RedHill Biopharma for curing the disease. 240 participants will be recruited for this double blind clinical trial.

http://health-beauty-2468.blogspot.com/2013/09/clinical-trial-for-new-antibiotic.html



RedHill Biopharma to initiate phase III trial of RHB 104 in Crohn's disease patients

UCF College of Medicine professor Dr. Saleh Naser soon will participate in a clinical trial to test whether a new antibiotic therapy acquired by RedHill Biopharma can be used to treat Crohn's disease patients.

The FDA-approved phase III trial is expected to commence within weeks by RedHill Biopharma, which licensed Naser's DNA technology for detecting Mycobacterium aviumsubspecies paratuberculosis, known as MAP. It is believed to be associated with Crohn's disease. RedHill Biopharma developed the anti-MAP antibiotic regimen known as RHB 104. Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract characterized by cramping and diarrhea.

Naser developed and patented a way to detect MAP from milk, blood and tissue clinical samples. The bacterium is known to cause inflammation in the intestines of cows. It is also linked to Crohn's disease, although its role has been debated for more than a century. Naser believes MAP is an underlying cause of the disease.

"Crohn's disease affects more than 750,000 Americans, yet traditional treatments only address the symptoms of inflammation and not the cause," Naser said. "I have seen case studies where patients' lives have been restored following treatment, which removes MAP. I have high hopes that this clinical trial may lead to finding a cure."

RedHill will be enrolling 240 subjects from the United States, Canada and Israel in this double blind clinical trial in which blood and intestinal biopsy specimens from Crohn's patients will be tested for MAP before, during and following the one-year treatment with the antibiotic RHB 104.

"Since we acquired the license to Dr. Saleh Naser's MAP detection technique in 2011, we have had an excellent collaboration with UCF," said RedHill's CEO Dror Ben-Asher. "The UCF team of researchers- is at the forefront of global academic research on MAP and its detection."

Naser is looking forward to the trial and hopes this will end the academic debate regarding MAP and Crohn's disease.

"I am ecstatic to be part of a team, which will help determine whether or not MAP is associated with Crohn's disease; certainly a final answer to a one hundred-year old controversy," Naser said.

Source: University of Central Florida

http://www.news-medical.net/news/20130918/RedHill-Biopharma-to-initiate-phase-III-trial-of-RHB-104-in-Crohns-disease-patients.aspx

RedHill Readying Phase III Trials In Crohn's

With a PDUFA target date of Feb. 3, 2014 for its migraine drug, RHB-103, and NDA filing planned for the first quarter of 2014 for the anti-emetic drug, RHB-102, RedHill Biopharma (RDHL) is now focusing its efforts on its flagship programs: RHB-104 for Crohn's disease and RHB-105 for Helicobacter pylori (H. pylori).

RedHill is preparing to begin a potential groundbreaking Phase III study in the current quarter in North America and Israel (the MAP U.S. Study) of Crohn's disease, using a novel patent-protected formulation that combines three antibiotic ingredients in a single capsule, and is planning and preparing a parallel Phase III study in Europe (the MAP Europe Study).

"Following the discovery of the link between H. pylori bacterium and peptic ulcers, there is a growing body of evidence supporting the proposition that Crohn's disease and other so-called autoimmune diseases, such as multiple sclerosis, are linked to infections," chief business officer Guy Goldberg says in an interview with BioTuesdays.com, referring to emerging scientific evidence that the microbiome, or the trillions of intestinal microbes, plays a major role in health and disease.

"There's a paradigm shift of viewing the body not as a single organism but as a collection of organisms, with the microbiome as the habitat within the body," he adds.

In 2005, researchers in Australia won the Nobel Prize for identifying H. pylori bacterium and the role it plays in causing peptic ulcers. Stress and lifestyle were long believed to be the primary cause of intestinal ulcers. Fellow Australian, Prof. Thomas Borody, who is now a member of RedHill's advisory board, developed the first antibiotic treatment for ulcers.

RedHill's two lead drug candidates - RHB-104, for Crohn's disease and multiple sclerosis (MS), and RHB-105, forH. pylori - were built on the success of Prof. Borody's approaches to gastrointestinal tract diseases and infections.

"RHB-104 is the biggest program in our pipeline," Mr. Goldberg says. "To the best of our knowledge, we are the only company with a Phase III combination antibiotic approach for treating Crohn's disease, even though there is a lot of academic research connecting Crohn's to a bacterial infection."

RedHill is currently advancing six clinical programs; two of which are expected to be reviewed by the FDA during 2014, and three that are entering pivotal clinical studies.

In a research report last month, Bioassociate Innovative Consulting reiterated its "buy" rating and price target of $14.91 per RedHill American Depositary Share, "given the multiple milestones approaching and the company being on-track with the clinical programs' timelines."

Crohn's is a severe inflammatory disease in the GI tract. Existing drugs, such as Remicade, treat the inflammatory symptoms of the disease by suppressing the immune system. However, they are widely considered to have a poor safety profile and limited long-term efficacy. "There clearly is a strong unmet medical need for a better alternative for Crohn's patients," Mr. Goldberg contends. The global market to treat Crohn's exceeded $3.5-billion in 2012.

(Click to enlarge)

Phase II Study Pictures in Crohn's Patients (Borody et al (2002), Digest Liver Dis 34:29-38)

He explains that RHB-104 is a novel and proprietary combination of three approved antibiotic ingredients - clarithromycin, clofazimine and rifabutin - targeting Mycobacterium Avium Paratuberculosis (MAP). Crohn's patients are believed to have seven times greater likelihood of being MAP-positive than non-Crohn's patients.

The MAP U.S. Study will enroll 240 moderately-to-severely active Crohn's patients at 50 sites in North America and Israel. The primary endpoint is the state of remission at week 26. The study will also examine safety, the maintenance of remission through week 52, efficacy outcome measures in relation to the presence of MAP infection and other secondary endpoints.

If the study is successful, RedHill may submit a new drug application to the FDA in 2015. RHB-104 previously received orphan drug status from the FDA for pediatric use. Mr. Goldberg says discussions are underway with European regulators to begin a second Phase III study with RBH-104 in Europe - the MAP Europe Study.

RedHill also is developing RHB-104 to treat patients with relapsing remitting MS. In June, the company commenced a Phase IIa proof-of-concept trial in Israel. "This is the first time that this type of antibiotic therapy will be tested on MS patients in a Phase II clinical trial," Mr. Goldberg contends.

RedHill's second lead program is RHB-105 in development to treat H. pylori bacteria, which plays an important role in gastritis, peptic ulcers and gastric cancer. Mr. Goldberg points out that H. pylori is increasingly developing resistance to treatment with clarithromycin and metronidazole, and that standard therapy fails in up to 30% to 40% of patients who continue to remain H. pylori-positive.

A Phase IIa study in 2005 by Prof. Borody in Australia demonstrated over 90% eradication of the bacteria in 130 patients who had previously failed standard therapy with clarithromycin. Approximately three millionH. pylori-infected patients are treated annually in the U.S. market, resulting in a potential market estimated at $1-billion to $1.5-billion.

Mr. Goldberg explains that RHB-105 is a novel all-in-one combination of two antibiotics - rifabutin and amoxicillin - and a proton pump inhibitor, omeprazole. RedHill plans to begin a Phase II/3 clinical trial with RHB-105 during the quarter, he says, adding that a successful study could lead to an NDA filing in 2014.

http://seekingalpha.com/article/1645962-redhill-readying-phase-iii-trials-in-crohns?source=yahoo

Post-Diverticulitis Irritable Bowel Syndrome - New form of IBS Found by UCLA Researchers

This is interesting...  UCLA researchers have found that a form of IBS may be developed after a period where a person is diagnosed with diverticulitis.  The new condition is called post-diverticulitis irritable bowel syndrome (PDV-IBS).  The research also found that an increase in mood disorders was highly likely for people that suffer from IBS.  Read the article for the details.

UCLA researchers describe new form of irritable bowel syndrome / UCLA Newsroom:

UCLA researchers have described a new form of irritable bowel syndrome that occurs after an acute bout of diverticulitis, a finding that may help lead to better management of symptoms and relief for patients.

The discovery of this new condition, called post-diverticulitis irritable bowel syndrome (PDV–IBS), validates the irritable bowel symptoms that many patients report long after suffering a bout of diverticulitis but that many physicians have waved off as being part of the original condition, said Dr. Brennan Spiegel, an associate professor of medicine at the David Geffen School of Medicine at UCLA and senior author of the research.

"We've known for a long time that after some people develop diverticulitis, they're a different person. They experience recurrent abdominal pains, cramping and diarrhea that they didn't have before," Spiegel said. "The prevailing wisdom has been that once diverticulitis is treated, it's gone. But we've shown that IBS symptoms occur after the diverticulitis, and they may result from an inflammatory process, like a bomb going off in the body and leaving residual damage."

The research was published Sept. 5 in the peer-reviewed journal Clinical Gastroenterology and Hepatology.

As they age, most people develop diverticulosis, or pouches in the lining of the colon. More than 50 percent of people over 60 have the condition, but the pouches usually don't cause any problems. Occasionally, the pouches become inflamed, leading to diverticulitis, which causes pain and infection in the abdomen. Doctors usually treat it with antibiotics, or in more severe cases with surgery.

"A major surprise in our study was that diverticulitis patients not only developed IBS at a higher rate than the controls, but they also developed mood disorders like depression and anxiety at a higher rate," Spiegel said. "Because IBS and mood disorders often go hand in hand, this suggests that acute diverticulitis might even set off a process leading to long-standing changes in the brain–gut axis."

The discovery of PDV–IBS could mean better attention to patients complaining of symptoms after diverticulitis, symptoms that up until now may have been dismissed by physicians. 

"Patients often report ongoing IBS symptoms after the diverticulitis has long passed, and this study supports their beliefs and introduces a new diagnosis," Spiegel said. "If doctors recognize this, they may take the symptoms more seriously and manage them actively, just as they can manage IBS actively with various new drugs on the market and currently in development."

More than 1,000 patient records from the West Los Angeles Veteran's Affairs Medical Center were examined for the two-year study, including those of patients who had suffered acute diverticulitis and those of another group of patients who had not. The groups were matched for age and sex and had similar co-morbidities — other existing health problems. The groups were followed for many years as UCLA researchers tracked the differences in IBS diagnoses and mood disorders.

"This study expands our understanding a little bit about what might cause IBS," Spiegel said. "It's such a common condition, and there may be different flavors. We've now added a new flavor to the menu — a new risk factor for developing IBS. By learning more, we might be able to expand the therapies we can use on these patients."

The study was funded by Shire Pharmaceuticals.

"Our findings support the evolving paradigm of diverticular disease as a chronic illness — not merely an acute condition marked by abrupt complications. Far from a self-limited episode, acute diverticulitis may become a chronic disorder in some patients," the study states. "Diverticulitis is correlated with not only chronic IBS symptoms, but also long-term emotional distress beyond the event itself. Awareness of this possible risk is important because persistent, untreated gastrointestinal symptoms and comorbid depression may worsen outcome and increase the economic burden of an already prevalent disease."

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.

The FDA grants priority review status for drugs that are designed to treat a serious condition, and that if approved, would provide a significant improvement in safety or effectiveness. Priority review designation allows for an eight-month review period compared with the standard 12-month review.

“The need to seek new treatment options is well recognized,” said William J. Sandborn, MD, chief, Division of Gastroenterology, and professor of medicine, University of California, San Diego School of Medicine, in a press statement. “Vedolizumab has demonstrated the potential to be another possible treatment option for people with moderately to severely active CD and UC.”

Vedolizumab is a humanized monoclonal antibody that specifically antagonizes α4β7 integrin and inhibits it from binding to its target receptor, mucosal addressin cell adhesion molecule-1 (MAdCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. It interacts with α4β7 integrin, which is expressed on a subset of circulating white blood cells, to mediate the inflammatory process in patients with CD and UC.

Takeda’s BLA submission is supported by four Phase III clinical studies—GEMINI I, II and III, and GEMINI LTS (Long-Term Safety)—which comprise the GEMINI Studies^TM, a clinical program designed to investigate the efficacy and safety of vedolizumab in clinical response and remission in patients with moderate to severe CD and UC. Patients enrolled in the studies failed at least one conventional therapy for inflammatory bowel disease, including corticosteroids, immunomodulators and/or a tumor necrosis factor–alpha antagonist. The results of the Phase III studies of vedolizumab in patients with CD and UC were published recently in the New England Journal of Medicine (Sandborn WJ et al. N Engl J Med2013;369:711-721 and Feagan BG et al. N Engl J Med 2013;369:699-710, respectively).

According to Takeda, vedolizumab has been studied in 2,700 patients in nearly 40 countries, making it the largest Phase III clinical trial program to date to simultaneously evaluate CD and UC. GEMINI LTS is an ongoing, open-label, long-term safety study of vedolizumab and is designed to collect data on the occurrence of important clinical safety events resulting from the administration of vedolizumab.

—Based on a press release from Takeda Pharmaceutical Company Ltd.

Clinical Trial - PUBMED.gov

 N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.

Vedolizumab as induction and maintenance therapy for ulcerative colitis.

Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group.

Collaborators (225)

Source

Robarts Clinical Trials, Robarts Research Institute, and Department of Medicine, University of Western Ontario, London, Canada. bfeagan@robarts.ca

Abstract

BACKGROUND:

Gut-selective blockade of lymphocyte trafficking by vedolizumab may constitute effective treatment for ulcerative colitis.

METHODS:

We conducted two integrated randomized, double-blind, placebo-controlled trials of vedolizumab in patients with active disease. In the trial of induction therapy, 374 patients (cohort 1) received vedolizumab (at a dose of 300 mg) or placebo intravenously at weeks 0 and 2, and 521 patients (cohort 2) received open-label vedolizumab at weeks 0 and 2, with disease evaluation at week 6. In the trial of maintenance therapy, patients in either cohort who had a response to vedolizumab at week 6 were randomly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks. A response was defined as a reduction in the Mayo Clinic score (range, 0 to 12, with higher scores indicating more active disease) of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.

RESULTS:

Response rates at week 6 were 47.1% and 25.5% among patients in the vedolizumab group and placebo group, respectively (difference with adjustment for stratification factors, 21.7 percentage points; 95% confidence interval [CI], 11.6 to 31.7; P<0 .001="" 41.8="" 44.8="" 4="" 52="" 8="" and="" at="" ayo="" clinic="" clinical="" continued="" every="" in="" no="" of="" patients="" receive="" remission="" score="" subscore="" to="" vedolizumab="" week="" weeks="" were="" who="">1), as compared with 15.9% of patients who switched to placebo (adjusted difference, 26.1 percentage points for vedolizumab every 8 weeks vs. placebo [95% CI, 14.9 to 37.2; P<0 .001="" 17.9="" 29.1="" 40.4="" 4="" adverse="" and="" ci="" events="" every="" for="" frequency="" groups.="" in="" of="" p="" percentage="" placebo="" points="" similar="" the="" to="" vedolizumab="" vs.="" was="" weeks="">

CONCLUSIONS:

Vedolizumab was more effective than placebo as induction and maintenance therapy for ulcerative colitis. (Funded by Millennium Pharmaceuticals; GEMINI 1 ClinicalTrials.gov number, NCT00783718.).

Comment in

• Inhibition of leukocyte trafficking in inflammatory bowel disease. [N Engl J Med. 2013]

PMID:

 

23964932

 

[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/?term=23964932

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

LEIDEN, The Netherlands, Sept. 23, 2013 /PRNewswire/ -- Janssen Biologics B.V. ("Janssen") announced today that the European Commission has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.  The European Commission approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2013 recommending the use of SIMPONI.  UC, a chronic inflammatory bowel disease (IBD) affecting 1.1 million individuals in Europe^[1]  and 2.5 million people worldwide,^[2]  is marked by inflammation and ulceration of the colonic mucosa, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.

"The European Commission approval of SIMPONI for the treatment of moderately to severely active ulcerative colitis is an important milestone for patients and the gastroenterology community," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC.  "SIMPONI demonstrated efficacy across multiple disease parameters in the study of this devastating inflammatory bowel disease according to the PURSUIT clinical development program, which represents the largest conducted for an anti–tumor necrosis factor-alpha therapy in the treatment of ulcerative colitis."

SIMPONI is the first and only subcutaneous anti–tumor necrosis factor (TNF)-alpha treatment administered as an every-4-week maintenance therapy for UC.  For patients with a body weight less than 80 kg, SIMPONI is given subcutaneously as an initial dose of 200 mg, followed by 100 mg at week 2 and then 50 mg every 4 weeks thereafter.  For patients with a body weight greater than or equal to 80 kg, SIMPONI is given as an initial dose of 200 mg, followed by 100 mg at week 2 and then 100 mg every 4 weeks thereafter. 

Data from the clinical development Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT), which served as the basis for European Commission approval, showed that induction treatment with SIMPONI induced clinical response, clinical remission, mucosal healing and improved quality of life as measured by the inflammatory bowel disease questionnaire (IBDQ) in patients with moderately to severely active UC.  Further, per the European Commission–approved Summary of Product Characteristics, maintenance therapy with SIMPONI maintained clinical response through week 54.  In addition, in patients who had initially responded to induction therapy with SIMPONI, more SIMPONI-treated patients demonstrated sustained clinical remission and mucosal healing at weeks 30 and 54 compared with patients in the placebo group.^[3]

About PURSUITThe Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) included Phase 3 multicenter, randomised, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of subcutaneous induction and every-4-week maintenance regimens of SIMPONI in adults with moderately to severely active UC. All trial patients had failed to respond to or tolerate treatment with 6-MP, AZA, corticosteroids and/or 5-aminosalicylate (5-ASA), or were corticosteroid dependent.  Study participants were naive to treatment with TNF inhibitors and had a baseline Mayo score between 6 and 12 and an endoscopic subscore of 2 or more.  The Mayo score is a 12-point clinical assessment and colonoscopy-based measure of disease activity, which assesses improvement in symptoms based on rectal bleeding, endoscopic findings, stool frequency and a physician's global assessment.

The induction trial (PURSUIT-SC) had an adaptive design with a Phase 2 dose-finding portion, followed by a Phase 3 dose-confirming component.  The primary endpoint was clinical response at week 6.  Secondary endpoints at week 6 included clinical remission and mucosal healing (Mayo endoscopy score of 0 or 1).  Overall, 1,065 patients were treated in the study; 761 of these patients were randomised into the Phase 3 component of the study.

Patients responding to induction treatment with SIMPONI were eligible to be randomised in the Phase 3 PURSUIT-Maintenance study.  The primary endpoint in this study was maintenance of clinical response through week 54, and secondary endpoints included clinical remission and mucosal healing (Mayo endoscopy score of 0 or 1 at both weeks 30 and 54).

The safety results of SIMPONI observed in the PURSUIT studies were consistent with the known safety profile of SIMPONI in labeled rheumatologic indications.  For more information regarding the safety profile for SIMPONI, please see "Important Safety Information" below.

About Ulcerative Colitis Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) affecting 1.1 million individuals in Europe^[1] and 2.5 million worldwide,^[2] is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.^[4]  Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus.^[4]  Symptoms of the disease may lead to loss of appetite, subsequent weight loss and fatigue.^[4]  On average, people are diagnosed with UC in their mid-30s, but the disease can occur at any age.^[4] As many as 30 percent of people living with UC will require surgery at some point in their life.^[5]  UC is a chronic disease, and there is no cure.  Although progress has been made in IBD research, researchers do not know what causes this disease.^[4] 

About SIMPONI® (golimumab)SIMPONI is a human monoclonal antibody that targets and neutralises excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.  SIMPONI is approved in 70 countries for rheumatologic indications, including the European Union (EU), where SIMPONI received European Commission approval in October 2009 for the treatment of moderate-to-severe, active rheumatoid arthritis in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis alone or in combination with methotrexate and for the treatment of severe, active ankylosing spondylitis.  In September 2013, SIMPONI received European Commission approval for the treatment of moderately to severely active ulcerative colitis.  SIMPONI is available either through the SmartJect® autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection.  For more information about SIMPONI in the EU, visit www.SIMPONI.eu.  

Janssen Biotech, Inc. discovered and developed SIMPONI and markets the product in the United States.  The Janssen Pharmaceutical Companies market SIMPONI in Canada, Central and South America, the Middle East, Africa and Asia Pacific. 

In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. 

In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution rights to SIMPONI to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries. 

For further information about SIMPONI, please consult the relevant official product information applicable to that country location.

Important Safety Information In the European Union, SIMPONI is contraindicated in patients with active tuberculosis, severe infections such as sepsis, opportunistic infections, in patients with moderate or severe heart failure (NYHA Class III/IV), as well as in patients who are hypersensitive to SIMPONI or any of its excipients.  Serious infections, including sepsis, pneumonia, tuberculosis (TB), invasive fungal and other opportunistic infections have been observed with the use of TNF antagonists including SIMPONI.  Some of these infections have been fatal. SIMPONI should not be given to patients with a clinically important, active infection.  Caution should be exercised when considering the use of SIMPONI in patients with a chronic infection or a history of recurrent infection.  Patients must be monitored closely for infections including TB before, during and after treatment with SIMPONI.  If a patient develops a new serious infection or sepsis, SIMPONI therapy should be discontinued and appropriate antimicrobial therapy should be initiated until the infection is controlled.  Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate.  For patients who have resided in or traveled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of SIMPONI treatment should be carefully considered before initiation of SIMPONI therapy.  All patients must be evaluated for the risk of TB, including latent TB, prior to initiation of SIMPONI.  If active TB is diagnosed, SIMPONI must not be initiated.  If latent TB is suspected or diagnosed then the benefit/risk balance of SIMPONI treatment should be considered.  Treatment of latent tuberculosis infection should be initiated prior to therapy with SIMPONI.  Antituberculosis therapy prior to initiating SIMPONI should also be considered in patients who have several or highly significant risk factors for tuberculosis infection and have a negative test for latent tuberculosis.  Patients receiving SIMPONI should be monitored closely for signs and symptoms of active tuberculosis during and after treatment, including patients who tested negative for latent tuberculosis infections. 

The use of TNF blocking agents including SIMPONI has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of the virus.  Some of these cases have been fatal.  Patients should be tested for HBV infection before initiating treatment with Simponi.  Carriers of HBV who require treatment with Simponi should be closely monitored during treatment with, and for several months following discontinuation of SIMPONI.  In patients who develop HBV reactivation, SIMPONI should be discontinued.

Lymphomas and leukemia have been observed in patients treated with TNF blocking agents, including SIMPONI.  The incidence of non-lymphoma malignancies was similar to controls, and lymphoma is seen more often than in the general population.  The potential role of TNF-blocking therapy in the development of malignancies is not known.  Based on an exploratory clinical trial in patients with COPD using another anti-TNF agent, caution should be exercised when using any TNF-blocking therapy in COPD patients, as well as in patients with an increased risk for malignancy due to heavy smoking.  Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents.  This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. 

Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting. A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.

It is not known if SIMPONI treatment influences the risk for developing dysplasia or colon cancer.  All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma, or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.

Melanoma has been reported in patients treated with TNF-blocking agents, including Simponi. Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.

Worsening and new onset congestive heart failure (CHF) and increased mortality due to CHF have been reported with another TNF blocker.  SIMPONI has not been studied in patients with CHF.  SIMPONI should be used with caution in patients with mild heart failure and must be discontinued if new or worsening symptoms of heart failure appear. 

TNF-blocking agents, including SIMPONI, have been associated in rare cases with new onset or exacerbation of demyelinating disorders, including multiple sclerosis.  The benefits and risks of anti-TNF treatment should be carefully considered before initiation of SIMPONI therapy in patients with pre-existing or recent onset of demyelinating disorders. 

There is limited safety experience of SIMPONI treatment in patients who have undergone surgical procedures, including arthroplasty.  A patient who requires surgery while on SIMPONI should be closely monitored for infections, and appropriate actions should be taken. 

The possibility exists for TNF-blocking agents, including SIMPONI, to affect host defenses against infections and malignancies.  Treatment with SIMPONI may result in the formation of auto-antibodies and, rarely, in the development of a lupus-like syndrome. 

There have been postmarketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers.  Cytopenias including pancytopenia, have been infrequently reported with SIMPONI in clinical trials.  Discontinuation of SIMPONI should be considered in patients with significant hematologic abnormalities. 

The concurrent administration of TNF-antagonists with anakinra or abatacept is not recommended.  Concurrent administration has been associated with increased infections, including serious infections without increased clinical benefit.  The concomitant use of Simponi with other biological therapeutics used to treat the same conditions as Simponi is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.  Patients should continue to be monitored when switching from one biologic to another.

Patients treated with SIMPONI may receive concurrent vaccinations, except for live vaccines.  In postmarketing experience, serious systemic hypersensitivity reactions have been reported following Simponi administration.  Allergic reactions may occur after first or subsequent administration of SIMPONI.  If an anaphylactic reaction or other serious allergic reactions occur, administration of SIMPONI should be discontinued immediately and appropriate therapy initiated. 

The needle cover on the syringe in the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.  SIMPONI also contains sorbitol; patients with rare hereditary problems of fructose intolerance should not take SIMPONI. 

Patients should be given detailed instructions on how to administer SIMPONI.  After proper training, patients may self inject if their physician determines that this is appropriate.  The full amount of SIMPONI should be administered at all times.   

Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last SIMPONI treatment.  Women must not breast feed during and for at least 6 months after SIMPONI treatment.

The most common adverse drug reaction reported in the controlled portion from clinical trials was upper respiratory tract infection (12.6 percent of SIMPONI-treated patients compared with 10.7 percent in control-treated patients).  In the controlled periods of pivotal trials, 5.1 percent of SIMPONI-treated patients had injection site reactions compared with 2.0 percent in control-treated patients.  The majority of the injection site reactions were mild and moderate, and the most frequent manifestation was injection site erythema.

The SIMPONI Patient Alert Card provides safety information to the patient.  It should be given and explained to all patients before treatment.  Patients must show the Alert Card to any doctor involved in his/her treatment, during and up to 6 months after SIMPONI treatment.

For complete EU prescribing information, please visit www.ema.europa.eu.

About Janssen Biologics B.V. and Janssen Research & Development, LLCAt Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people with serious diseases throughout the world.  Beyond its innovative medicines, Janssen is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.

Janssen Biologics B.V. and Janssen Research & Development, LLC are two of the Janssen Pharmaceutical Companies of Johnson & Johnson.  Please visit www.janssen.com for more information.

References:

[1]     European Federation of Crohn's and Ulcerative Colitis Associations. What is IBD? http://www.efcca.org/index.php/about-efcca/what-are-ibd. Accessed August 14, 2013.

[2]     World IBD Day. About us. http://worldibdday.org/aboutus.html. Accessed August 6, 2013.

[3]     SIMPONI [Summary of Product Characteristics]. Leiden, The Netherlands: Janssen Biologics B.V.; September 2013.

[4]     Crohn's & Colitis Foundation of America. What is ulcerative colitis? http://www.ccfa.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis. Accessed August 6, 2013. 

[5]     Crohn's & Colitis Foundation of America. Colitis treatment options. http://www.ccfa.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/colitis-treatment-options.html. Accessed August 6, 2013.

SOURCE Janssen Biologics B.V.

http://www.prnewswire.co.uk/news-releases/simponi-receives-european-commission-approval-for-treatment-of-moderately-to-severely-active-ulcerative-colitis-224821222.html

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."