REAL-WORLD LONG-TERM TREATMENT PERSISTENCE AMONG BIO-NAÏVE PATIENTS WITH CROHN’S DISEASE AND HISTORY OF FISTULA INITIATED ON USTEKINUMAB

Abstract

Abstract BACKGROUND Fistula is a common complication of Crohn’s disease (CD). Treatment with certain biologics have been associated with fistula healing and closure, reduction of symptoms and need for surgical treatments. In clinical practice, biologic persistence and effectiveness are correlated. This study described long-term persistence among bio-naïve patients with CD and history of fistula who were initiated on ustekinumab (anti-interleukin 12/23 antibody). METHODS Adults with CD and history of intestinal fistula initiated on ustekinumab (index date) between 9/23/2016 and 3/2/2022 were selected from the IQVIA PharMetrics® Plus database and followed for the maximum of 24 months. Patients were bio-naïve (i.e., no claim for CD-indicated biological agents) in the 12-month baseline period before the index date. Patients with other auto-immune diseases during the baseline period were excluded. Persistence on ustekinumab was defined as the absence of gaps between days of therapy supply of >120 days (i.e., over twice the duration of the US label maintenance cycle of 8 weeks or 60 days). Composite endpoints of being persistent while on monotherapy (no immunomodulators or biologics other than ustekinumab) and persistent while corticosteroid-free (<14 consecutive days of corticosteroid supply after day 90 post-index) were also assessed. Persistence endpoints were assessed from the index date until the earliest of discontinuation (event), immunomodulator or non-index biologic use (event), corticosteroid use (event), 24 months follow-up or data end (censoring) using Kaplan-Meier analyses. RESULTS The sample included 445 patients (mean age: 42.8 years; 56.6% female; Fig. 1). Among these, 63.1% had CD involving the small intestine, and 59.6% had CD involving the large intestine. The most common type of fistula was anal fistula (36.0%). At 24 months after ustekinumab initiation, 64.2% of patients remained persistent (95% confidence interval [CI]: 55.8-71.4; Fig. 2a). Furthermore, 53.3% of patients were persistent while on monotherapy (95%CI: 45.1-60.7; Fig. 2b). Finally, 45.6% of patients were persistent while being corticosteroid-free (95%CI: 36.9-53.8; Fig. 2c). CONCLUSIONS This study quantified long-term persistence on ustekinumab among bio-naïve patients with CD and history of fistula. Over half of patients initiated on ustekinumab were persistent and persistent while on monotherapy 24 months after the treatment initiation. These findings support ustekinumab as a treatment option for long-term management of CD with history of fistula. Figure 1 Selected baseline characteristics Figure 2 (a) Persistent on ustekinumab, (b) persistent and on monotherapy, c) persistent and corticosteroid-free