Tag: crohns

05 Jun 2018

New Hope in Ulcerative Colitis

Xeljanz (tofacitinib) garnered a lot of interest back in 2012 when it was developed and approved for the treatment of rheumatoid arthritis. Then, in 2017, studies found that this oral medication also treated psoriatic arthritis and FDA approval was added for that indication.

Last week, yet another FDA approval for Xeljanz came: this medication now has an expanded FDA approval for adults with moderately to severely active ulcerative colitis. This makes Xeljanz the first oral prescription option for ulcerative colitis. In other words, this is big news and a potential game changer for the nearly one million Americans with this form of inflammatory bowel disease. All of the other FDA-approved treatments for chronic ulcerative colitis involve either intravenous infusion or subcutaneous injection. So, clearly, an oral alternative is welcome news to many patients.

This latest FDA approval was spurred after results from three clinical trials in patients with ulcerative colitis showed remission for patients on Xeljanz in up to 47% of patients taking the medication long term. Safety data was collected, with the more common adverse effects being diarrhea, elevated cholesterol levels, and headache. Although there are some less common adverse effects that led to Xeljanz coming with a box warning for serious infections and malignancy. Xeljanz cannot be used at the same time as biological therapies or with potent immunosuppressants (e.g., azathioprine and cyclosporine).

Inflammatory bowel diseases, which include both ulcerative colitis and Crohn’s disease, are chronic inflammatory diseases of the bowel. They can develop as a result of genetic or environmental factors (e.g., smoking, diet, or any alteration of the normal human gut flora) that trigger an immune response, which in turn creates mucosal damage to the GI tract.

Symptoms of inflammatory bowel disease range from diarrhea, abdominal pain, and perianal fistulas to fatigue, weight loss, and/or bowel obstruction. While ulcerative colitis is more closely associated with changes to the inner lining of the colon, Crohn’s disease can affect any segment of the gastrointestinal tract: all the way from mouth to anus.

The BioPlus Specialty Pharmacy team is ready to help patients and their health care providers access Xeljanz for ulcerative colitis.


Press release. FDA approves new treatment for moderately to severely active ulcerative colitis. FDA May 30, 2018.

29 May 2018

Autoimmune Diseases: Facing More Than One

Multiple sclerosis is an autoimmune disease. The family of autoimmune diseases include such diseases as lupus, rheumatoid arthritis, Crohn’s disease, type 1 diabetes, and ulcerative colitis. Unfortunately, someone with one autoimmune disease has an increased risk of also developing a second disease in this category. For example, there is a trend for someone with multiple sclerosis to be at risk for the inflammatory bowel disease of Crohn’s disease (and vice versa).

This elevated risk of several autoimmune diseases occurring in certain individuals continues to be researched. For example, recently birth cohort patterns were studied to better understand this issue. One important finding from this study was that the risk of an autoimmune disease may not only be accounted for by internal risk factors (e.g., genetics), but external factors can also be at play.

It appears that exposure to certain environmental risk factors during an early period in life can increase the risk of both Crohn’s disease and multiple sclerosis. These risk factors might be similar or even be the same factors influencing both of these diseases. Although more remains to be understood on this issue, what is currently known is that autoimmune diseases overall are more likely in those consuming a typical Western diet which is higher in salt and saturated fats (the type of fat found in animal foods, such as red meat), as well as those with certain bacterial and viral infections early in life or exposed to certain medications (e.g., procainamide or hydrolyzine).

While these connections between autoimmune diseases continues to be uncovered, one important take-away in the meantime for patients who have one autoimmune disease is this: be aware of the increased risk of developing an additional autoimmune disease. Symptoms of a second autoimmune disease should be discussed with a health care provider.


Sonnenberg A, Ajdacic-Gross V. Similar birth-cohort patterns in Crohn’s disease and multiple sclerosis. Mult Scler 2018;24(2):140-149. doi:10.1177/1352458517691620.

15 May 2018

How Sweet It’s Not: Crohn’s and Splenda

More than 1.5 million Americans suffer from inflammatory bowel diseases, which include both Crohn’s disease and ulcerative colitis. Each year, another 70,000 individuals hear this diagnosis. With Crohn’s disease, the key troubling symptoms are diarrhea, abdominal pain, weight loss, and fatigue. The disease is thought to develop when the immune system mistakenly attacks the digestive system.

There are treatments to manage the disease, although a cure remains elusive. In the meantime, it can be helpful to consider one’s diet. Certain foods can trigger symptoms, although which foods are triggers can vary by individual. It can take some time and attention to determine which foods are best avoided. Although in general the following foods are commonly reported by those with Crohn’s disease to serve as triggers:

  • Alcohol
  • Oils/fats
  • Soda
  • Coffee
  • Dairy
  • High-fiber foods
  • Red meat

It can be useful to keep a food diary (including symptom tracking) to sleuth out which foods could be problematic for each individual.

Now there’s another “problem food” researchers are eyeing in terms of triggering Crohn’s flare-ups. An animal model study conducted at Case Western Reserve University School of Medicine reports that the artificial sweetener sucralose – known as Splenda – intensifies gut inflammation in animals with a disease like Crohn’s, but doesn’t cause any problems in animals without the disease. This study backs up the anecdotal reports from people with Crohn’s: about one in ten note that artificial sweeteners make them feel worse.

For now, it seems prudent for anyone with Crohn’s disease to avoid Splenda, unless they have used the artificial sweetener without negative effects. And if symptoms do develop, then Splenda should be considered as a potential trigger food.


Rodriguez-Palacios A, Harding A, Menghini P, et al. The artificial sweetener Splenda promotes gut proteobacteria, dysbiosis, and myeloperoxidase reactivity in Crohn’s disease-like ileitis. Inflam Bowel Dis 2018 DOI: 10.1093/ibd/izy060

10 Apr 2018

Crohn’s Disease: Heading Toward its 100th Birthday

Could a cure for Crohn’s disease be in the future? There are several research directions that are moving forward with hopeful results, although a “cure” appears to remain an unsatisfying way in the distance. Crohn’s disease – as a specific type of inflammatory bowel disease – was first described back in 1932. As we head toward the centennial of naming this disease, researchers continue to work hard on new treatment options, as well as the long hoped for cure, by that anniversary.

Since 1932, the core treatment options for Crohn’s disease have included corticosteroids, aminosalicylates, thiopurines, and methotrexate. Only in the past two decades did new therapy agents start to appear: three tumor necrosis factor antagonists, two anti-integrins, and an anti-interleukin 12/23 antibody. Clearly, however, much work remains to be done, since as many as 25% of patients do not respond to these treatment options.

This is where an investigational once-daily, oral medication comes in: filgotinib, which is being developed by Galapagos. Filgotinib is a selective JAK1 inhibitor. JAK1 is an enzyme necessary in the inflammation process. Early research indicates effectiveness of filgotinib in the treatment of moderate-to-severe Crohn’s disease.

In one study, the group of 128 Crohn’s disease patients taking filgotinib found that 47% reached clinical remission by week 10 of treatment (compared to 23% of the placebo group). This is the most hopeful outcome that’s been seen in research for quite some time. Additional research continues to be conducted with filgotinib, including for long-term safety.


A cure for Crohn’s disease by 2032. Lancet 2017;389:226.

Ananthakrishnan AN. Filgotinib for Crohn’s disease—expanding treatment options. Lancet 2017;389:228-9.

Vermeire S, Schreiber S, Petryka R, et al. Clinical remission in patients with moderate-to-severe Crohn’s disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet 2017;389:266-75.

06 Mar 2018

Personalizing Crohn’s Disease Treatment

Guest blog by: Marianne Shenouda, Pharm.D., Clinical Pharmacy Specialist, BioPlus Specialty Pharmacy

Inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis, are chronic inflammatory diseases of the bowel. These diseases can develop as a result of genetic or environmental factors, such as smoking, diet, or any alteration of the normal human gut flora. These factors spur a progressive immune response, which in turn creates mucosal damage to the GI tract.

Symptoms of inflammatory bowel disease run the gamut from diarrhea, abdominal pain, and perianal fistulas to fatigue, weight loss, and/or bowel obstruction. While ulcerative colitis is more closely associated with changes to the inner lining of the colon, Crohn’s disease can affect any segment of the gastrointestinal tract: all the way from mouth to anus.

Treatment for Crohn’s disease focuses on two main types of medications: anti-inflammatory agents and biological treatments. The biological treatments include many medication options: Humira, Remicade, Cimzia, Stelara, Entyvio, and Tysabri. These medications work to alter the immune response of the immune system, by targeting specific proteins that cause inflammation. Humira, for example, targets a protein called TNF-alpha.

Crohn’s disease biological medications can bring great benefits to patients; but unfortunately it is not uncommon for a particular medication to become less effective over time. However, monitoring certain elements of the immune system can guide future treatment. Specifically, monitoring levels of adalimumab antibodies (ATAs) can allow determination if a patient needs a dose increase or if it is appropriate for the patient to switch to another medication within the same drug class. It appears that low trough concentrations may be reflective of a loss of response to Humira (trough levels less than or equal to 5 mcg/ml). In this case, testing for antibodies is suggested. For trough concentrations above 5 mcg/ml, the presence of antibodies are not likely, so the patient may benefit from an increased dose. It was also suggested that adalimumab concentration results above 35 mcg/mL should be drawn at a different time-point other than trough.

Overall ATA testing could lead to a more appropriate and cost-effective management strategy for patients with Crohn’s disease, which is part of an overall move to more personalized treatment of disease.