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P2334 - Risk of Reoccurrence of Perianal Fistulas in Patients With Crohn’s Disease in the United States: A Retrospective Claims Database Study

Tuesday, October 29

10:30 AM - 4:00 PM

Location: Exhibit Halls 3 and 4 (Street Level)

Presenting Author(s)

SC

Sarah Campbell-Hill, MA, MSc, DPhil

London, England, United Kingdom

Haridarshan Patel, PharmD¹, Dominick Latremouille-Viau, MSc², Didier Serre, MSc², Trevor Lissoos, MBBCh, FACG³, Kyle D. Null, PharmD, PhD⁴, Glynn Owen, PhD⁵, Sarah Campbell-Hill, MA, MSc, DPhil⁶

¹Takeda Pharmaceuticals International, Inc., Chicago, IL; ²Analysis Group, Inc., Montreal, PQ, Canada; ³Takeda Pharmaceuticals U.S.A., Inc., Indianapolis, IN; ⁴Takeda Pharmaceuticals U.S.A., Inc., Deerfield, IL; ⁵Takeda Pharmaceuticals International, Inc., Wooburn Green, England, United Kingdom; ⁶Takeda Pharmaceuticals International, Inc., London, England, United Kingdom

Introduction: Perianal fistulas (PAF) in patients with Crohn’s disease (CD) are associated with morbidity and impaired quality of life. Limited data is available on the risk of PAF among patients with CD and long-term PAF relapse rates.

Methods: A retrospective cohort study on US adult patients with CD identified in an US administrative claims database (2001-2018) was conducted. Patients with PAF were identified using diagnosis or procedure codes in medical claims. A PAF episode, starting from the first PAF occurrence, was defined as consecutive PAF-related codes ≤120 days of each other. PAF reoccurrence was defined as a new PAF-related code occurring after a PAF-free period of ≥180 days (proxy for remission) following the end of the first PAF episode. Time from the 180-day PAF-free period to PAF reoccurrence was estimated using KM analyses. A similar analysis was conducted in CD patients with a PAF-free period of ≥360 days.

Results: 5,482 patients with a PAF-free period of ≥180 days after their first PAF episode were included (CD-PAF cohort; mean age=43.8 years and proportion of males=51.8%). Over a mean follow-up duration of 2.6 years, 28.8% had a PAF reoccurrence. Estimated rates of PAF reoccurrence in these CD-PAF patients were 23.7%, 32.0%, 42.1% and 47.8% at 1, 2, 5, and 10 years, respectively (Table 1).

In the 12 months before first PAF occurrence, 70.8% of CD-PAF patients received non-biologic therapies: corticosteroids (46.5%), antibiotics (44.4%), aminosalicylates (5-ASA) (32.5%) and immunomodulators (IMDs)/immunosuppressants (IMs) (21.1%); 25.3% used ≥1 biologic therapy; and 19.2% had ≥1 CD-related surgery. In the 4 months after first PAF occurrence, 66.5% of CD-PAF patients received non-biologic therapies: antibiotics (39.6%), corticosteroids (30.3%), 5-ASA (27.4%) and IMDs/IMs (22.1%); 31.8% used ≥1 biologic therapy; and 47.2% had ≥1 CD-related surgery.
In patients with a longer PAF-free period of ≥360 days (CD-PAF360 cohort), a numerically lower proportion had a PAF reoccurrence (20.5%) and estimated rates of reoccurrence were numerically lower at every time point (32.6% at 5 years and 39.4% at 10 years) vs the CD-PAF cohort.

Discussion: In this retrospective US claim database analysis, the 5-year and 10-year rates of PAF reoccurrence following PAF remission of ≥180 days were 42.1% and 47.8% among patients with CD, respectively. Patients achieving longer-term remission (≥360 days) had numerically lower rates of PAF reoccurrence.

Table 1. Kaplan-Meier rates of reoccurrence of perianal fistulas among patients with Crohn’s disease [a] Duration of follow-up starts from the end of the PAF-free period following the first PAF episode [b] KM rates of PAF reoccurrence from the end of the PAF-free period of 180 days (CD-PAF) or 360 days (CD-PAF360) following the first PAF episode. KM rates are estimated at given time points and represent cumulative incidence accounting for right censoring [c] Similar findings were observed in the sensitivity analysis defining a PAF episode as all consecutive PAF within 180 days of each other (vs. 120 days)

Disclosures:

Haridarshan Patel: Takeda – Employee.

Dominick Latremouille-Viau: Analysis Group, Inc. – Employee, I am an employee of Analysis Group, Inc., which has received consulting fees from Takeda for this study.

Didier Serre: Analysis Group, Inc. – Employee, I am an employee of Analysis Group, Inc., which has received consulting fees from Takeda for this study.

Trevor Lissoos: Eli Lilly & Company – Employee. Takeda Pharmaceuticals USA, Inc – Previous Employee.

Kyle Null: Takeda Pharmaceuticals – Employee.

Glynn Owen: Takeda UK Ltd – Employee.

Sarah Campbell-Hill: Takeda International – Employee.

Citation: Haridarshan Patel, PharmD; Dominick Latremouille-Viau, MSc; Didier Serre, MSc; Trevor Lissoos, MBBCh, FACG; Kyle D. Null, PharmD, PhD; Glynn Owen, PhD; Sarah Campbell-Hill, MA, MSc, DPhil. P2334 - RISK OF REOCCURRENCE OF PERIANAL FISTULAS IN PATIENTS WITH CROHN’S DISEASE IN THE UNITED STATES: A RETROSPECTIVE CLAIMS DATABASE STUDY. Program No. P2334. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.