Patients with ulcerative colitis (UC) and Crohn disease (CD) are frequently treated with immunosuppressive agents including immunomodulators and biologics. Over the years, more biologic classes have been developed, including inhibitors of tumor necrosis factor-alpha (TNF-α), integrin, and interleukin (IL)-12/23. Depending on the type, prognosis, and severity of inflammatory bowel disease (IBD), physicians and patients may opt to follow a “top-down” (which favors early use of biologics) or “bottom-up” (starting with corticosteroids and agents such as 5-aminosalicylic acids [5-ASAs]) approach to treatment.
Although the definition of remission varies across the literature, the goal of treatment for IBD is to achieve and sustain remission. A frequent question asked by patients when discussing treatment options and goals is if and when IBD medications can be de-escalated or discontinued overall.
This decision is typically multifactorial, with safety outcomes, relapse rates, and costs being frequently voiced concerns. Because many IBD medications affect the patient’s immune system, patients often express concern about infection and malignancy risk.
Looking at the SToRi Study
The Study of Infliximab (IFX) Discontinuation in Crohn Disease Patients in Stable Remission on Combined Therapy with Immunosuppressors (STORI) was conducted by Louis et al and published in Gastroenterology in 2012.1 This prospective multicenter study conducted in 20 centers in France and Belgium included 115 patients with CD who were treated for at least 1 year with IFX and an antimetabolite and were in corticosteroid-free remission for at least 6 months. After stopping IFX, the 1-year relapse rate was 43.9%±5.0%.
Some of the risk factors associated with relapse were found to be male sex, absence of prior surgical resection, C-reactive protein (CRP) level 5.0 mg/L or greater, and fecal calprotectin level 300 µg/g or greater. Patients with 1 or 2 of these risk factors had comparatively lower rates of relapse (15%). Of patients who experienced a relapse, 88% were successfully re-treated with IFX.
Torres et al Continue the Work
A subsequent study was conducted by Torres et al and published in Gastroenterology in 2015.2 This systematic review included 69 studies with a total of 4672 patients. Of patients with CD on immunomodulator-only therapy who stopped their medication after remission, 75% had a relapse within 5 years. Of patients with CD receiving combination therapy with a biologic therapy and an immunomodulator, 55% to 60% had relapses 24 months after they stopped their immunomodulator, which is similar to that experienced by patients who continued on their immunomodulator.
When evaluating UC and CD together, approximately 40% to 50% of patients who discontinued treatment with an anti-TNF agent experienced a relapse within 2 years. Remission rates continued to decline as time progressed, with rates of 35% and 12% at 7 and 10 years postdiscontinuation, respectively. Predictors of relapse included poor prognostic features (eg, ileal disease location, perianal disease, and younger age), prior disease course, and/or markers of subclinical disease activity.
This article originally appeared on Gastroenterology Advisor