THE IMPACT OF TREATMENT SWITCH AMONG PATIENTS WITH ULCERATIVE COLITIS NEWLY TREATED WITH A BIOLOGIC – A JAPAN RETROSPECTIVE CLAIMS DATABASE STUDY

Abstract

Abstract INTRODUCTION Biologics have largely expanded treatment options for ulcerative colitis (UC) patients. Despite advanced treatments, up to 50% of patients treated with any biologic also suffer loss of response or intolerance. This study assessed the healthcare resource utilization (HCRU) associated with treatment switch as an indicator of suboptimal treatment of UC in patients newly treated with a biologic in a real-world setting in Japan. METHODS A retrospective cohort analysis was performed using the Japan Medical Data Center (JMDC) claims database for the period from 01/01/2016 through 09/30/2022. Adult patients with at least two UC diagnoses and newly treated with a biologic on or after the UC diagnosis were included. The index date was defined as the date of the first observed biologic prescription fill or injection after the UC diagnosis. Patients with a record of pregnancy one year before or one year after the index date and patients with at least two CD diagnosis were excluded. Patients were classified as switchers if they discontinued their index biologic treatment and switched to another biologic or 5-aminosalicylic acid or immunomodulator during a 12-month study period after the index date. All-cause HCRU during the study period were described and compared (unadjusted) between the 2 cohorts (switchers vs non-switchers). RESULTS Among 47,572 patients diagnosed with UC, 1,214 met criteria for inclusion, of which 261 (21.5%) were in the switchers cohort and 953 (78.5%) in the non-switchers cohort. Overall, the mean age (SD) was 41.3 (12.4) years old and 31% (n=376) were female. In the switchers group, 85.8% (n=224) discontinued index treatment and switched to another biologic, 5.0% (n=13) to a 5-ASA and 11.1% (n=29) to an immunomodulator. Among switchers, 59.0% (n=154) of switching occurred during the first 6 months after index treatment. During the 12-months follow-up period, the mean number of outpatient visits were similar between cohorts (15.5 visits vs 14.3 visits, p = 0.01). However, a greater proportion of the switchers cohort experienced inpatient hospitalization compared to non-switchers (43.7% [n=114] vs 19.6% [n=187], p<0.001). In addition, the inpatient hospitalizations had a longer mean length of stay in the switchers group vs non-switchers (12.9 days vs 4.5 days, p<0.001). CONCLUSION This real-world analysis using the JMDC database showed that roughly one out of five patients newly treated with a biologic switched to another treatment within 12 months of the treatment initiation. Those who experience treatment switch were also more likely to be hospitalized and had a longer length of stay versus patients who did not switch treatment. These findings highlight the continued burden of non-remission associated with treatment switch and the need for more efficacious and safe treatment interventions early in disease management.