Pharma Focus— Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) includes both Crohn’s disease and ulcerative colitis. Approximately one million Americans have IBD, evenly divided between Crohn’s disease and ulcerative colitis, and affecting both genders equally.

Ulcerative Colitis

According to the Crohn’s and Colitis Foundation of America (CCFA), ulcerative colitis (UC) involves inflammation of the lining of the colon and rectum. It varies in clinical severity and can cause mild, moderate or severe disease. The disease tends to "flare up" and then go into remission.

The cause of UC is related to genetics, the immune system, and perhaps the environment. "Foreign substances—antigens—in the environment may be the direct cause of the inflammation, or may stimulate the body’s defenses to produce an inflammation that continues without control," the foundation theorizes. "Researchers believe that once the IBD patient’s immune system is ‘turned on,’ it does not know how to properly ‘turn off’ at the right time. That is why the main goal of medical therapy is to help patients regulate their immune system better."

Although there is no official "cure" for the disease, certain pharmaceuticals have been shown effective in treating the disease—specifically, the inflammation. "This accomplishes two important goals: it permits the colon to heal and also relieves the symptoms of diarrhea, rectal bleeding, and abdominal pain," according to the CCFA.

"Four major classes of medication are used to treat ulcerative colitis," the foundation explains. They include the following:

"Aminosalicylates (5-ASA): This class of anti-inflammatory drugs includes sulfasalazine and oral formulations of mesalamine, such as Asacol®, Colazal®, Lialda®, Dipentum®, or Pentasa®, and 5-ASA drugs also may be administered rectally (Canasa® or Rowasa®). Without inflammation, symptoms such as diarrhea, rectal bleeding, and abdominal pain can be diminished greatly. Aminosalicylates are effective in treating mild to moderate episodes of ulcerative colitis, and are also useful in preventing relapses of this disease.

Corticosteroids: Prednisone and methylprednisolone are available orally and rectally. Corticosteroids nonspecifically suppress the immune system and are used to treat moderate to severely active ulcerative colitis. These drugs have significant short- and long-term side effects and should not be used as a maintenance medication.

Immune modifiers: Azathioprine (Imuran®), 6-MP (Purinethol®), and methotrexate, are used to help decrease corticosteroid dosage. Azathioprine and 6-MP have been useful in reducing or eliminating some patients’ dependence on corticosteroids. They also may be helpful in maintaining remission in selected refractory ulcerative colitis patients (that is, patients who do not respond to standard medications). However, these medications can take as long as three months before their beneficial effects begin to work.

Antibiotics: metronidazole, ampicillin, ciprofloxacin, others.

Biologic therapies: Infliximab (Remicade®). Biologic therapies are the newest class of drugs used for people suffering from moderate-to-severe ulcerative colitis. These drugs are made from antibodies that bind with certain molecules to block a particular action. The intestinal inflammation of ulcerative colitis is a result of various processes, or ‘pathways.’ Because a biologic drug targets a specific pathway, it can help reduce inflammation. That targeted action also keeps side effects to a minimum."

Crohn’s Disease

Crohn’s disease (CD) is a chronic disorder characterized by inflammation of gastrointestinal tract. Most frequently, it affects the small intestine or colon, although it can affect any area of the GI tract from the mouth to the anus.

"Both illnesses do have one strong feature in common," according to the CCFA. "In people with IBD, the immune system reacts inappropriately. Mistaking food, bacteria, and other materials in the intestine for foreign or invading substances, it launches an attack. In the process, the body sends white blood cells into the lining of the intestines, where they produce chronic inflammation. These cells then generate harmful products that ultimately lead to ulcerations and bowel injury. When this happens, the patient experiences the symptoms of IBD."

As with UC, the goal in CD is to suppress the inflammation that leads to GI symptoms. "Several groups of drugs are used to treat Crohn’s disease today," says the CCFA. "They are aminosalicylates (5-ASA); corticosteroids; immune modifiers; antibiotics; and biologic therapies. In August 1998, the FDA approved the first biologic therapy for Crohn’s disease, infliximab (Remicade®), indicated for moderately to severely active Crohn’s in patients who have not responded adequately to conventional therapy. It is also approved for reducing the number of draining enterocutaneous fistulas. In June 2002, infliximab was approved by the FDA for a new indication—maintaining remission."

Q&A With a UC Patient and a CCFA Official

Kimberly Frederick, vice president, patient & professional services for the CCFA

Kimberly Frederick, MSW, LCSW, is the vice president of patient & professional services for the CCFA. She was recently instrumental in launching the foundation’s Information Resource Center (IRC), which provides disease-specific education, support, and treatment information to the 1.4 million Americans living with IBD.

Q: Are there charity programs or other funding that can cover the cost of patients’ treatments? Or programs to help them out in other ways?

A: Modest Needs is an organization that provides one-time grants to financially needy families/individuals. Operations Blessings is an organization that provides financial assistance. Lotsa Helping Hands is a free online service that helps manage the everyday tasks of friends, family and coworkers supporting a loved one. This free service provides an easy-to-use, private group calendar specifically designed for organizing helpers and tasks.

Q: What interventions are available for treating UC? Do some work for UC but not Crohn’s?

A: The most common methods of treatment are oral therapies known as 5-aminosalicylates (5-ASAs) but patients may also use rectal or topical therapies. Patients should speak with their doctor about appropriate treatments for their individual needs.

Eating foods that don’t aggravate UC or CD is also helpful in staving off flares. Regular exercise, which helps reduce stress, can also benefit patients. As each individual’s condition varies, different management methods will work for different people.

Q: What types of community support or other groups are available to help people with IBD?

A: The Crohn’s & Colitis Foundation of America (CCFA) offers a variety of educational programs and support services for both patients and healthcare professionals:

• The foundation has a local presence in 50 states, as well as Puerto Rico and the District of Columbia, including 36 staffed chapters and four volunteer and affiliate offices that offer support and sponsor educational and fundraising events for those affected by UC and Crohn’s disease.
• CCFA.org offers a wide array of resources, including tips on how patients can find the appropriate specialist or treatment center, suggestions on how to be prepared for flares while traveling, and testimonials from others who can describe experiences with diet and treatment.
• The foundation also offers an Information Resource Center (IRC), 888.MY.GUT.PAIN, which provides callers with accurate and current information on IBD. The IRC helps callers understand more about the diagnosis and treatment of colitis and Crohn’s and is available Monday-Friday, 9 a.m. to 5 p.m. EST.
• UC patients can register with MyUCGuide.com to receive e-mails from a virtual UC guide, who can offer day-to-day tips for coping with UC, information about the disease and links to valuable online resources.
• UCSuccess.org is being updated in 2008 to include testimonials from contest entrants who can share their inspiring stories of how they’ve overcome their own obstacles to manage their UC.
• Patients can also contact hospitals in their area to determine if there are additional local UC support groups.

Josh Reineke, UC patient and spokesperson for "Celebrating UC Success"

Josh Reineke is a 28-year old triathlete, husband, father, and graduate student at Brown University in Providence, R.I., pursuing his doctorate. Reineke was diagnosed with ulcerative colitis (UC) in the summer of 2005 while studying at Brown and training for his race season. He lives in Providence with his wife, Noi and two and a half year-old daughter, Jaixai.

Reineke works in the Department of Molecular Pharmacology, Physiology and Biotechnology at Brown University. His work focuses on microsphere drug delivery systems for oral administration. Reineke is also a scientific consultant for biotechnology companies in Providence.

Q: Please discuss the embarrassing effects of UC and Crohn’s disease and how IBD can affect a patient’s lifestyle.

A: I was diagnosed with UC in 2005, so I’ve lived the majority of my life without it. After my diagnosis, the most embarrassing part of the disease was the frequency and urgency of bowel movements. These symptoms, along with intense abdominal pain, had a disruptive impact on my lifestyle. In the beginning, it really seemed like my life was no longer in my control, and I didn’t want to ask for help because I was afraid that people would not want to hear about obstacles related to my symptoms. I have friends with Crohn’s disease and I know that most of them share this sentiment. IBD symptoms can be embarrassing, and most people do not want to talk about them! For me, keeping everything inside—my fears, my frustrations, even my successes—was limiting me almost as much as my UC. Talking about the disease helped me to get over my embarrassment, and more importantly, it helped me to get the support that I needed. I really hope the Celebrating UC Success program will show other patients that openly talking about their disease can be a really empowering, healthy step in getting control of UC.

Q: What is the effect of IBD on families and friends of patients? How does it impact them?

A: I have been very fortunate to have family and friends who have been understanding and patient. The impact on my family was formidable, particularly in the early stages (immediately before and after diagnosis) when there was no clear understanding of my condition or ability to recover. My wife, Noi, was scared because of the sudden impact on my active lifestyle (I initially had difficulty even leaving my bed and had many visits to the emergency room), and as a result, her lifestyle was greatly impacted. At the same time we had a one-year old daughter, Jaixai, to care for, which sparked worries about my physical ability to be a father and financial ability to support a family. The impact of my UC condition reached beyond me and my family, affecting my extended family, friends and coworkers in many ways. I’m excited that Celebrating UC Success wants to recognize the family and friends of UC patients. For many of us, they are huge part of the solution.

Q: What types of side effects can patients expect from the various interventions? Do certain medications or surgical interventions tend to cause less disruption to their lives?

A: I can only speak to my experience, and I have had great success taking Asacol. In fact, the only effects I’ve ever noticed are when I don’t take it. It’s critical that people are diligent about taking their medication and communicate openly with their doctors to achieve the correct therapy; it’s the way to keep this condition from being disruptive. In my case, I know that if I don’t take my Asacol, I’ll be in trouble, so it’s worth taking it every day. Ultimately, adhering to my medicinal routine allows me to enjoy my everyday routine!

Celebrating UC Success

The Crohn’s & Colitis Foundation of America (CCFA), in partnership with Procter & Gamble (P&G) Pharmaceuticals, has launched an educational program called "Celebrating UC Success," designed to recognize and inspire people whose lives are affected by ulcerative colitis (UC).

For nearly half a million Americans living with UC—and the families, friends and healthcare providers who support them—leading a normal everyday life can be a challenge.

Celebrating UC Success is a program to help educate and encourage people not to let UC control their lives. The program features an essay contest, which enables those touched by UC (patients, healthcare providers, families and friends) to share their success stories, learn from them and inspire each other. Individuals who are able to live fuller lives despite this chronic illness can help others through their inspiring stories and lives.

Many patients, especially at initial diagnosis, find it difficult to talk about the disease with family, friends and coworkers. But some people living with ulcerative colitis say that being open about the condition is an important first step in taking control.

Entrants can submit essays of 200 words or less for one of three categories: UC Patients, Supportive Family Members/Friends, and Healthcare Providers. Everyone who enters the contest will be recognized. Those who submit an essay will be awarded a certificate of appreciation; a copy of Comfort Zones (a guidebook for UC patients); and a one-year membership to the foundation. Twenty semi-finalists will win additional $50 gift cards to the foundation’s online store.

Seven contest finalists will win a three-day/two-night trip for two to the foundation’s 2008 National Advocacy Conference, "IBD Day on the Hill," held in Washington, D.C., on Wednesday, May 14 and Thursday, May 15, 2008, where they will be recognized during a reception as individuals who have taken significant steps to manage their UC and are an inspiration to others.

Individuals can enter via mail by obtaining a Celebrating UC Success brochure and application from their physician or by downloading the documents from www.ucsuccess.org. Contestants should submit their essay to the address below:

Celebrating UC Success
P.O. Box 5622
Blair, NE 68009-5622

Individuals can also enter electronically at www.ucsuccess.org . Essays must be received no later than March 14, 2008. For more information visit www.ucsuccess.org or call 1-888-645-8259.

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