What Pharmacists Should Know About Trends in IBD Treatment

Pharmacists can play an integral role in managing patients with inflammatory bowel disease (IBD) through medication management.

IBD includes the 2 conditions, Crohn disease and ulcerative colitis (UC), which involve chronic inflammation of the gastrointestinal (GI) tract. Crohn disease is characterized by inflammation that can affect any part of the GI tract.¹ Inflammation occurs in the large intestine (colon) and rectum for UC.² Symptoms of IBD include diarrhea, fever, abdominal pain, bloody stool, reduced appetite, and weight loss.²

Treatments and Counseling Points

Treatment for IBD generally involves either pharmacotherapy or surgery. An important counseling point is to avoid nonsteroidal anti-inflammatory drugs such as ibuprofen or naproxen, as these medications can exacerbate IBD symptoms and increase the risk of bleeding.^3,4 Pharmacists can recommend acetaminophen for patients with IBD needing pain relief. The American College of Gastroenterology (ACG) clinical guidelines recommend management based upon disease extent, severity, and prognosis.^3,4

Many of the same medications can be used to treat both UC and Crohn disease. Patients with mild UC can be treated with anti-inflammatory medications such as aminosalicylate therapies (5-ASA) as a first step in the treatment process.³ The 5-ASA medications (eg sulfasalazine, mesalamine, olsalazine) are generally well tolerated, and adverse effects may include headache, nausea, abdominal pain, vomiting, rash, and fever. Sulfasalazine has shown to be effective for treating mild-to-moderate symptoms of colonic Crohn disease.⁴

Corticosteroids (eg prednisone, budesonide) are generally reserved for patients with moderate-to-severe UC or Crohn disease.^3,4 However, long-term use is not recommended due to the high risk of adverse effects including hypertension, increased blood glucose, cataracts, weight gain, osteoporosis, and psychiatric symptoms. One study showed that there was excessive steroid use in approximately 15% of patients with IBD.⁵

Anti-tumor necrosis factor (anti-TNF) medications such as adalimumab (Humira), golimumab (Simponi), or infliximab (Remicade) are biologics that can reduce symptoms and heal the intestine in patients with UC.⁵ Adalimumab, certolizumab pegol (Cimzia), and infliximab are the most effective anti-TNF therapies to treat moderate-to-severe Crohn disease.⁶ These medications may cause injection site reactions, increase the risk of developing infections, and may cause changes in liver function so patients should be closely monitored.

Biosimilar products are available for many of the anti-TNF drugs, which could make these medications more affordable for patients. Vedolizumab (Entyvio) is a biologic that is another option for UC and Crohn disease in patients who have failed other medications.^3,4 Tofacitinib (Xeljanz), an immunomodulatory drug that decreases inflammation, is another option for UC.³ The FDA added a Boxed Warning regarding an increased risk of blood clots in patients taking tofacitinib 10 mg twice daily dose and discussed that this medication should be reserved as second-line therapy for individuals who failed or cannot tolerate anti-TNF drugs.⁶ Natalizumab (Tysabri) is effective for Crohn disease in patients who do not respond to conventional therapies, but it is associated with a rare brain disease known as multifocal leukoencephalopathy.⁴ Individuals must be enrolled in a special program to use the medication. Ustekinumab (Stelara) is used for moderate-to-severe Crohn disease that has failed other therapies and just received FDA approval on October 21, 2019 for UC.⁷

References:

• CDC. Inflammatory Bowel Disease (IBD). CDC’s website. https://www.cdc.gov/ibd/index.htm. Last reviewed March 14, 2017. Accessed January 9, 2020. 

• Mayo Clinic. Inflammatory Bowel Disease (IBD). Mayo Clinic’s website. https://www.mayoclinic.org/diseases-conditions/inflammatory-bowel-disease/symptoms-causes/syc-20353315. Last reviewed December 24, 2019. Accessed January 10, 2019.

• Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384–413. https://doi.org/10.14309/ajg.0000000000000152.

• Lichtenstein GR. Loftus EV, Isaacs KL, Regueiro MD, Gerson LB, Sands BE. ACG clinical guideline: management of Crohn’s disease in adults. Am J Gastroenterol.  2018;113:481-517. Doi:10.1038/ajg.2018.27.    

• Selinger CP, Parkes GC, Bassi A, et al. Assessment of steroid use as a key performance indicator in inflammatory bowel disease-analysis of data from 2385 UK patients. Aliment Pharmacol Ther. 2019;50:1009-1018. Doi:10.1111/apt.15497.

• FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) [press release]. FDA’s website. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-boxed-warning-about-increased-risk-blood-clots-and-death-higher-dose-arthritis-and. Published July 26, 2019. Accessed January 12, 2020.

• Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis [press release]. Janssen’s website. https://www.multivu.com/players/English/8627251-janssen-stelara-fda-approval-ulcerative-colitis/. Published October 21, 2019. Accessed January 12, 2020.

• Arena Pharmaceuticals. Etrasimod. Arena Pharmaceuticals’ website. https://www.arenapharm.com/pipeline/etrasimod/#. Accessed January 12, 2020.

• EA Pharma. Development pipeline. EA Pharma website. https://www.eapharma.co.jp/en/pipeline/index.html. Accessed January 12, 2020.