Inflammatory bowel disease (IBD; including ulcerative colitis and Crohn’s disease) is a chronic, heterogenous immune-mediated inflammatory disorder, for which early, multidisciplinary interventions to induce and maintain mucosal remissions are critical to prevent disease progression and long-term complications. During a presentation at NAMCP 2020 Virtual Spring Managed Care Forum, Stephen B. Hanauer, MD, professor of medicine at Northwestern University, discussed ways to optimize care in this patient population.
Getting the most out of initial therapy is key, and the three pillars of IBD course are early intervention, target to treat, and tight control. Dr. Hanauer also discussed distinguishing between patient activity (reflects cross-sectional assessment of biologic inflammatory impact on symptoms, signs, endoscopy, histology, and biomarkers) versus severity (includes longitudinal and historical factors that provide a more complete picture of the prognosis and overall burden of disease). Disease severity can impact patient symptoms, quality of life, fatigue, and disability.
Next, he highlighted the American Gastroenterological Association (AGA) clinical care pathway that stratifies patients based on colectomy risk. The AGA suggests early use of biologic agents with or without immunomodulator therapy or tofacitinib rather than a gradual step therapy after failure of 5-aminosalicylates.
A target to treat approach involves pre-defining a treatment target in consultation with the patient, continuously monitoring disease activity, and modifying treatment until the target is reached. This approach aims to avoid the development of serious complications and disability in patients with chronic conditions and involves ongoing and regular monitoring of the target and/or surrogate marker with optimization of treatment when the target is not met.
Dr. Hanauer highlighted a 2017 study published in Clinical Gastroenterology and Hepatology that retrospectively assessed 264 patients with IBD receiving infliximab maintenance therapy. Patients received proactive or reactive drug monitoring based on measurements of first infliximab concentration and antibodies to infliximab. The study found that proactive monitoring improved clinical outcomes, including greater drug durability, less need for IBD-related surgery or hospitalization, and lower risk of antibodies to treatment or serious infusion reactions, compared with reactive monitoring.
The goals of target to treat approach in early disease are complete absence of symptoms, no disease progression, no complications or disability, and normal quality of life. In late-stage disease, the goals are stabilization on non-inflammatory symptoms, no progression of damage or disability, and improved quality of life.
Dr. Hanauer noted that there is a paucity of head-to-head clinical trials that inform clinicians on the appropriate, efficacious, and safe treatment regimens for IBD. Potential areas of consideration for treatment choice include rapid induction of remission, early non-clinical signs of response, durability of remission, patient preference for mode of administration, safety profile, time on the market, immunogenicity, mucosal healing, and impact on extraintestinal manifestations.
Many health plans dictate that patients fail certain therapies prior to approval to receive a new one. However, inadequate treatment can lead to serious consequences. For example, up to 25% of patients are hospitalized with severe ulcerative colitis, around 30% of patients require a colectomy, patients with ulcerative colitis have a 2.4-fold greater risk of colorectal cancer, and patients with IBD can experience cardiovascular disease, such as stroke and myocardial infarction, especially during disease flares.
Dr. Hanauer concluded by proposing a patient “IBD Care Bill of Rights”:
- Patients should have informed providers who make the diagnosis quickly.
- Patients should have access to expert care and second opinions.
- Patients and providers should understand the goals of management and a systematic, thoughtful approach to relapse or loss of response.
- There must be adequate support for an engaged and collaborative multidisciplinary team.
- There must be appropriate education of available treatment options and shared decision-making between patients and their primary IBD providers.
- The care of IBD must be affordable for the individual and our society.
- Patients and providers must have access to needed therapies in a timely manner.
- There must be an appropriate, transparent, and expedited appeals process for decisions by payers.
- Patients should have appropriate accommodation for their condition at school, at work, and in public spaces.
Presentation: Advances in Treatment of Inflammatory Bowel Disease: Expert Strategies for Optimal Management. NAMCP 2020 Virtual Spring Managed Care Forum, April 16-17.