S1834 Treatment Discontinuation in Inflammatory Bowel Disease (IBD) Patients Receiving Biologic Therapies That Require Intravenous (IV) Induction and Subcutaneous (SC) Maintenance Using Two Large US Claims Databases

Introduction: Adherence to biologic therapies in patients with ulcerative colitis (UC) or Crohn’s disease (CD) can be challenging, particularly for those undergoing an intravenous (IV) infusion induction followed by subcutaneous (SC) maintenance doses. This difficulty is partly due to the need for multiple prescriptions and prior authorizations from health insurance providers for IV and SC doses. This study assessed the discontinuation rates of biologic therapies that involve IV induction and SC maintenance dosing in patients with UC or CD in the US prior to starting maintenance therapy. Methods: A retrospective cohort study used claims from de-identified HealthVerity (HV) TaXonomy (X) (1/1/2021-7/31/2024), including closed medical and pharmacy claims from multiple data providers, and Optum Clinformatics® Data Mart Database (1/1/2021-6/30/2024), including claims solely from UnitedHealth. Treatment discontinuation was defined as a gap ≥2.5 times the dosing interval between 2 consecutive doses in the FDA label. Results: 19,777 patients were identified in HV: 2,869 treated with risankizumab (RZB), and 16,908 with ustekinumab (UST). 3,261 were identified in Optum: 635 with RZB, 2,626 with UST. No mirikizumab-treated patients were identified in either database. Baseline characteristics were similar across 2 databases. Among patients with FDA-labeled numbers of IV infusions, 23.5% and 24.2% of the RZB patients in HV and Optum respectively, discontinued during the transition from induction to maintenance therapy. Among the UST patients, 16.1% in HV and 19.9% in Optum discontinued during the transition. By indication, the discontinuation rate was 17.7% among CD patients and 15.5% for UC patients in HV (21.2% and 18.9% in Optum respectively). Conclusion: In patients with UC or CD treated with UST or RZB, around one-fifth of patients discontinued during the transition from induction to maintenance, a finding consistent in both databases. These findings emphasize that the route of administration may pose a significant challenge in maintaining patients on injectable biologics. Considerations regarding adherence should be given when deciding the route of administration of a drug, with a fully SC drug potentially offering advantages in treatment continuity.

Publication Details

Journal
The American Journal of Gastroenterology
Published
2025-10-01
DOI
https://doi.org/10.14309/01.ajg.0001134796.63332.d7
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
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article

S1834 Treatment Discontinuation in Inflammatory Bowel Disease (IBD) Patients Receiving Biologic Therapies That Require Intravenous (IV) Induction and Subcutaneous (SC) Maintenance Using Two Large US Claims Databases

The American Journal of Gastroenterology
Biosimilars and Bioanalytical Methods
article

S1834 Treatment Discontinuation in Inflammatory Bowel Disease (IBD) Patients Receiving Biologic Therapies That Require Intravenous (IV) Induction and Subcutaneous (SC) Maintenance Using Two Large US Claims Databases

article en

Abstract

Introduction: Adherence to biologic therapies in patients with ulcerative colitis (UC) or Crohn’s disease (CD) can be challenging, particularly for those undergoing an intravenous (IV) infusion induction followed by subcutaneous (SC) maintenance doses. This difficulty is partly due to the need for multiple prescriptions and prior authorizations from health insurance providers for IV and SC doses. This study assessed the discontinuation rates of biologic therapies that involve IV induction and SC maintenance dosing in patients with UC or CD in the US prior to starting maintenance therapy. Methods: A retrospective cohort study used claims from de-identified HealthVerity (HV) TaXonomy (X) (1/1/2021-7/31/2024), including closed medical and pharmacy claims from multiple data providers, and Optum Clinformatics® Data Mart Database (1/1/2021-6/30/2024), including claims solely from UnitedHealth. Treatment discontinuation was defined as a gap ≥2.5 times the dosing interval between 2 consecutive doses in the FDA label. Results: 19,777 patients were identified in HV: 2,869 treated with risankizumab (RZB), and 16,908 with ustekinumab (UST). 3,261 were identified in Optum: 635 with RZB, 2,626 with UST. No mirikizumab-treated patients were identified in either database. Baseline characteristics were similar across 2 databases. Among patients with FDA-labeled numbers of IV infusions, 23.5% and 24.2% of the RZB patients in HV and Optum respectively, discontinued during the transition from induction to maintenance therapy. Among the UST patients, 16.1% in HV and 19.9% in Optum discontinued during the transition. By indication, the discontinuation rate was 17.7% among CD patients and 15.5% for UC patients in HV (21.2% and 18.9% in Optum respectively). Conclusion: In patients with UC or CD treated with UST or RZB, around one-fifth of patients discontinued during the transition from induction to maintenance, a finding consistent in both databases. These findings emphasize that the route of administration may pose a significant challenge in maintaining patients on injectable biologics. Considerations regarding adherence should be given when deciding the route of administration of a drug, with a fully SC drug potentially offering advantages in treatment continuity.

The American Journal of GastroenterologyVol. 120(10S2)
Openalex Percentile: Top 38%
Biosimilars and Bioanalytical Methods
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S1834 Treatment Discontinuation in Inflammatory Bowel Disease (IBD) Patients Receiving Biologic Therapies That Require Intravenous (IV) Induction and Subcutaneous (SC) Maintenance Using Two Large US Claims Databases · The American Journal of Gastroenterology (2025) | TGRS Research Map | TGRS