Inflammatory bowel disease (IBD) includes two major types of chronic, idiopathic, autoimmune conditions of the gastrointestinal (GI) tract: Crohn’s disease and ulcerative colitis (UC). Both result in significant morbidity, impairment in function and quality of life, and healthcare costs. IBD is caused by a complex interaction of genetic, microbial/intestinal, immunologic, and environmental factors. Both conditions are chronic and progressive—worsening over time.
During a presentation at the Asembia 2020 Summit, Rolf Benirschke, CEO of Legacy Health Strategies in San Diego, CA, and former San Diego Chargers football player who has IBD, moderated a discussion between Patrick Nichols, PharmD, clinical pharmacist at Vanderbilt University Medical Center in Nashville, TN, and Christopher Owens, PharmD, MPH, associate VP for health sciences and associate professor at the Idaho State University College of Pharmacy in Pocatello, ID, about the burden of IBD, treatment options, and the role of the specialty pharmacist in the management of these conditions.
Specialty pharmacists can improve or enhance patient care through counseling, ensuring access to specialty medications, encouraging adherence to achieve treatment goals, providing information about therapeutic drug monitoring, and discussing the importance of smoking cessation and other non-pharmacologic options.
The American College of Gastroenterology has provided separate treatment guidelines for Crohn’s disease and UC that focus on mucosal healing and objective evidence of disease control. The guidelines also note that all biologics are appropriate first-line options for patients whose disease severity warrants it.
Goals of therapy including preventing complications, such as adverse events, hospitalizations, surgery, and cancer risk, as well as enhancing quality of life, such as pain and discomfort, weight and nutrition, sleep quality and energy, social and physical activities, and occupational productivity.
The window of opportunity for improved IBD outcomes is very early in the disease course. Treatment should consider the dosage form and patient preference and convenience regarding route of administration. Insurance coverage should also be considered.
Mr. Benirschke discussed how he was diagnosed with IBD in 1978, and “back then, there weren’t a lot of [treatment] choices. But we’ve come a long way since then,” he said and asked Dr. Owens to discuss new approvals for IBD that offer new hope to patients.
“Over the last couple of decades, we’ve learned about the GI tract and the intricacies of the enteric immune response within the gut,” said Dr. Owens. “A few years ago, we had very non-specific drugs that targeted a very general inflammatory response.” He said that biologics have taken “center stage” in the treatment paradigm that target the issues leading to IBD. Ustekinumab is approved to treat adults with moderate to severe UC, and tofacitinib extended release was also approved to treat moderate to severe UC in patients who had an inadequate response or intolerance to tumor necrosis factor blockers.
There are several treatments in the IBD pipeline as well. Vedolizumab is a subcutaneous (SC) agent being developed as an alternative to its intravenous (IV) formulation. The phase III VISIBLE 1 clinical trial demonstrated that SC vedolizumab was as effective as the IV formulation as maintenance therapy for patients with moderate to severe UC who had a clinical response to IV vedolizumab. Various interleukin-23 inhibitors (risankizumab, mirikizumab, guselkumab, tildrakizumab, and brazilkumab) are being studied for Crohn’s disease and UC. Two new investigational Janus kinase inhibitors are also being studied: upadacitinib and filgotinib, both of which are currently approved to treat rheumatoid arthritis.
Specialty pharmacists can ensure proper treatment administration using medication possession ratios and other adherence measures to track fill/claims history. Utilize adherence measures to identify patients who may require a pharmacist intervention and counsel patients on the importance to adherence, as well as address barriers to adherence, which may require a medication change or referral back to the physician. “There’s no one-size-fits all treatment,” Dr. Nichols reminded. Calendar and phone reminders can be a good tool to alert patients to their necessary dose. Still, challenges persist, including obtaining coverage for certain biologics and biosimilars, dose optimization, gaps in treatment due to changes in employment or insurance, and treatment failure.
Presentation: Inflammatory Bowel Disease: A Panel Discussion on Clinical and Operational Strategies for Biologic Usage. Asembia 2020 Specialty Pharmacy Summit Virtual Experience, May 9, 2020.