Efficacy and safety of biologic agents on crohn's disease elderly patients: A retrospective analysis

ABSTRACT

Introduction: There is limited literature available regarding the safety and efficacy of biological agents in Crohn's disease for patients aged 65 years old (yo) or greater (≥65). Existing knowledge from other autoimmune diseases regarding the initiation and maintenance of biologics in these patients has created skepticism given the potential risk of poor outcomes and mortality. We present a retrospective analysis of mortality, adverse events, rates of hospitalization, and remission in this vulnerable population compared with younger patients (<65 yo). Methods: Data was gathered retrospectively from January 2010 to December 2020. Cohorts consisted of patients ≥ 18 yo with Crohn's disease and no other co-existing autoimmune disease who were prescribed biologics agents. Patient demographics were summarized as mean or proportions (%). Outcomes of interest were compared between groups according to age cutoff (≥ 65 yo vs <65 yo) with the use of Pearson's chi-square or Fisher's exact test as appropriate. Multivariate analysis was conducted using logistic regression to identify independent variables associated with any of the outcomes of interest in both age groups. Results: 82 patients were included. Baseline demographic characteristics were similar between both groups (Table 1). Infection (30% vs 22%;P=0.63), mortality (10% vs 0%;P=0.34), and neoplasm events (0% vs 3%;P=0.15) did not reach statistical significance. Remission and hospitalization at the 1,3, 5-year endpoint after biologic prescription were similar (p>0.05). Age stratification revealed those greater than 70 yo had higher intraabdominal (IA) infections (p<0.01), whereas 65-70 yo subgroup had higher occurrence of skin abscess and rash (p<0.01). Mild skin adverse events (itching) along with mortality (N=1;COVID/Pneumonia) were higher in the 75-80 yo subgroup (p <0.01). Conclusion: In a diverse multicultural population treated with biologic agents, the occurrence of infection, neoplasm, and skin adverse events were similar in both groups. Intraabdominal infection was associated with viral and bacterial diarrhea (not clostridium difficile) when ≥70 yo. On the other hand, rash and skin abscesses were predominant in those aged 65-70 yo and itching in those 75-80 yo. Efficacy (readmission or remission) does not change despite the age group. Safety when age ≥65 yo is not guaranteed and clinical judgment should be used in each case. Larger studies in these affected age subgroups may be beneficial in understanding the clinical significance..