RETROSPECTIVE, SINGLE-CENTER, REAL-WORLD ANALYSIS OF BIOLOGIC AND IMMUNOMODULATOR THERAPY DISCONTINUATION IN ELDERLY IBD PATIENTS

Abstract

Abstract BACKGROUND The population of elderly inflammatory bowel disease (IBD) patients is increasing each year, however use of immunomodulators and biologic therapy in this population remains low. Clinical IBD drug trials limit enrollment of elderly patients. This leads to poor understanding of medication adverse effects and long-term outcomes in this population. Medication sustainability reflects drug efficacy and safety of drugs, which lead to better adherence. The primary aim of this study was to compare the discontinuation rates of various IBD therapies in a cohort of elderly patients and provide some guidance on positioning therapies within this population. METHODS This was a single-center retrospective study conducted at an academic institution. Elderly IBD patients 60 years or older followed between 2016-2022 were included in the study. Patients had to be on either immunomodulator and/or biologic therapy. Chart review was performed to extract demographic data, duration of IBD therapy, and reasons for discontinuation. A Kaplan-Meier survival curve was generated per IBD therapy to depict drug sustainability stratified by reason for discontinuation. Statistical analysis was performed to assess for significant differences across survival curves. RESULTS A total of 224 elderly IBD patients were included in the study analysis. The cohort was comprised of 97 (43.3%) patients with ulcerative colitis (UC) and 127 (56.7%) patients with Crohn’s disease (CD). For both CD and UC, there were no significant differences in biologic drug discontinuation rates due to inadequate disease control (p=0.26 for CD; p=0.74 for UC). There was a significantly increased risk of elderly IBD patients stopping anti-TNF therapy due to medication adverse event compared to those on anti-integrin therapy (p=0.002) and immunomodulator therapy (p=0.003). CONCLUSIONS While the number of biologics used to treat IBD has increased in the last few decades, there is a paucity of studies examining real world sustainability of biologics particularly in elderly patients. With regards to effectiveness, our study showed that there was no significant difference among the three classes of biologics being discontinued due to poorly controlled disease. However, results of our study suggest that anti-TNF therapy is less sustainable in elderly IBD patients compared to other biologics and immunomodulator therapy due to patient experienced adverse events. Our results are pertinent to clinical practice as prescribing biologics other than anti-TNF therapy may increase an elderly patient’s therapy longevity and lead to optimized clinical outcomes. Figure 1 shows time to biologic discontinuation due uncontrolled disease by IBD subtype. For both Crohn’s disease and ulcerative colitis, there was no significant difference in drug survival per biologic with regards to discontinuation due to inadequately controlled disease. Figure 2 shows time to therapy discontinuation due to patient experienced adverse events. This included infections, infusion reactions, systemic reactions, laboratory abnormalities, financial burden, and non-compliance. There was a significantly increased risk of elderly IBD patients stopping anti-TNF over time due to adverse events compared to those on anti-integrin and immunomodulator therapy.