Persistence of advanced therapies in patients with inflammatory bowel disease: retrospective cohort study using a large healthcare claims database in Japan

Abstract

Background/aims: There are few studies that comprehensively report real-world persistence for first-line advanced therapies used to treat inflammatory bowel disease. We aimed to describe persistence of first-line advanced therapies among incident biologic or Janus kinase inhibitor users with inflammatory bowel disease.

Methods: Retrospective cohort study using the Japan Medical Data Center database from January 1, 2010, until September 30, 2022. Patients aged ≥15 years with relevant diagnostic and treatment codes were included. All eligible patients were observed until study end (September 30, 2022), death, or disenrollment, whichever occurred first.

Results: Among 1,115 patients with Crohn's disease included in the analysis, 41.4% initiated adalimumab, 37.4% infliximab, 18.1% ustekinumab, and 3.0% vedolizumab. Median age was 31.2-34.8 years, 72.8% to 85.9% were male. Persistence at 12 months was 84.7% for adalimumab, 87.7% for infliximab, 91.3% for ustekinumab, and 53.1% for vedolizumab. Persistence at 24 months was 76.3%, 76.8%, 80.4%, and 28.6%, respectively. Among 1,942 patients with ulcerative colitis, 24.8% initiated adalimumab, 33.6% infliximab, 11.2% golimumab, 17.5% vedolizumab, 5.6% ustekinumab, and 7.3% tofacitinib. Mean age was 38.2-40.4 years, 57.4% to 65.8% were male. Persistence at 12 months was 57.6% for adalimumab, 87.7% for infliximab, 54.9% for golimumab, 69.7% for vedolizumab, and 84.0% for ustekinumab. At month 24, persistence for ustekinumab was 75.0%, versus 42.9%-59.4% for other treatments.

Conclusions: Index treatment with ustekinumab resulted in high persistence through 24 months after initiation in patients with Crohn's disease or ulcerative colitis. Our study provides insights into the real-world usage of advanced treatments for patients with IBD in Japan.

Keywords: Crohn disease; Inflammatory bowel disease; Persistence; Ulcerative colitis; Ustekinumab.

Fig. 1.

Patient selection. ICD-10, International Classification of Disease 10; CD, Crohn’s disease; UC, ulcerative colitis; JAK, Janus kinase.

Fig. 2.

A 12-month persistence of advanced therapies by hospital admission status on the index date: (A) Crohn’s disease and (B) ulcerative colitis. IP, inpatient; OP, outpatient.

Fig. 3.

Estimates for the likelihood of discontinuation or switching after initiation of the first advanced treatment for Crohn’s disease (Kaplan-Meier method). (A) Adalimumab persistence. (B) Ustekinumab persistence. (C) Infliximab persistence. (D) Vedolizumab persistence. X-axes show the number of patients at risk.

Fig. 4.

Sankey diagram of treatment sequence in patients with Crohn’s disease initiating advanced treatment.

Fig. 5.

Estimates for the likelihood of discontinuation or switching after initiation of the first advanced treatment for ulcerative colitis (Kaplan-Meier method). (A) Adalimumab persistence. (B) Ustekinumab persistence. (C) Infliximab persistence. (D) Vedolizumab persistence. (E) Golimumab persistence. (F) Tofacitinib persistence. X-axes show the number of patients at risk.

Fig. 6.

Sankey diagram of treatment sequence in patients with ulcerative colitis initiating advanced treatment.