Real-World Treatment Patterns and Clinical Characteristics Among Patients With Crohn’s Disease Receiving First- and Second-Line Biologic Treatments in The United States
Author(s)
Alyssa Parian, MD1, Chi-Yin Liao, PhD2, Aisha Vadhariya, BS, PhD3, Michael Head, MS4, Nicholas Bires, PharmD2, Michael Grabner, PhD4, K. Paige Ball, MPH4, Raven A. Perez, MPH4, Deborah A Fisher, MD2, Amar Naik, MD5;
1Johns Hopkins Medicine, Baltimore, MD, USA, 2Eli Lilly and Company, Indianapolis, IN, USA, 3Eli Lilly and Company, Advisor, Indianapolis, IN, USA, 4Carelon Research, Wilmington, DE, USA, 5Midwest Digestive Health & Nutrition, Des Plaines, IL, USA
1Johns Hopkins Medicine, Baltimore, MD, USA, 2Eli Lilly and Company, Indianapolis, IN, USA, 3Eli Lilly and Company, Advisor, Indianapolis, IN, USA, 4Carelon Research, Wilmington, DE, USA, 5Midwest Digestive Health & Nutrition, Des Plaines, IL, USA
OBJECTIVES: This study described real-world clinical characteristics and treatment patterns among patients with Crohn’s Disease (CD) in the United States who discontinued first-line (1L) biologic therapy and subsequently initiated second-line (2L) biologic therapy.
METHODS: This retrospective, observational study of the Healthcare Integrated Research Database (HIRD®) included adult patients with ≥1 claim for 2L therapy during 10/01/2016-05/31/2023 (index period), ≥1 claim for the 1L therapy in the 365 days prior to initiation of 2L therapy (index date), ≥2 encounters for CD, and continuous enrollment of ≥365 days pre- and post-index date. Demographics, clinical characteristics, adherence (≥80% proportion of days covered), and discontinuation (90-day gap) were evaluated. Cohorts were defined by transitions from 1L to 2L therapies, and included infliximab, adalimumab, vedolizumab, or ustekinumab (a total of nine mutually exclusive treatment sequences).
RESULTS: The study included 2725 patients (mean age range across cohorts, 36.7-47.4 years; females, 50.8%-58.6%). Across all nine cohorts, the mean (standard deviation [SD]) baseline Charlson Comorbidity Index score was highest in the infliximab-to-vedolizumab cohort (0.82 [1.32]; p = <0.01). The mean [SD] baseline Kim Frailty Index Score was highest in the infliximab-to-vedolizumab and vedolizumab-to-ustekinumab cohorts (0.18 [0.07]; p = 0.02); 15.7% of patients in the vedolizumab-to-ustekinumab cohort were frail (≥0.25). Baseline anemia was most prevalent in the vedolizumab-to-ustekinumab cohort (41.9%). At 12 months follow-up, the overall 2L-adherence rate was 68.0% (range: 61.0%-71.3%); the lowest rate (61.0%) occurred in the infliximab-to-ustekinumab cohort (p=0.05). The overall 2L-discontinuation rate was 23.6% (range: 17.1%-31.4%); the highest rate (31.4%) occurred in the vedolizumab-to-infliximab/adalimumab cohort (p<0.01).
CONCLUSIONS: Clinically meaningful differences in patient characteristics (comorbidity burden and frailty) and treatment patterns (adherence and discontinuation rates) were observed across treatment sequences. Additional analysis evaluating outcomes controlling for characteristics that may influence choice of therapy is important for determining optimal treatment sequences in patients with CD.
METHODS: This retrospective, observational study of the Healthcare Integrated Research Database (HIRD®) included adult patients with ≥1 claim for 2L therapy during 10/01/2016-05/31/2023 (index period), ≥1 claim for the 1L therapy in the 365 days prior to initiation of 2L therapy (index date), ≥2 encounters for CD, and continuous enrollment of ≥365 days pre- and post-index date. Demographics, clinical characteristics, adherence (≥80% proportion of days covered), and discontinuation (90-day gap) were evaluated. Cohorts were defined by transitions from 1L to 2L therapies, and included infliximab, adalimumab, vedolizumab, or ustekinumab (a total of nine mutually exclusive treatment sequences).
RESULTS: The study included 2725 patients (mean age range across cohorts, 36.7-47.4 years; females, 50.8%-58.6%). Across all nine cohorts, the mean (standard deviation [SD]) baseline Charlson Comorbidity Index score was highest in the infliximab-to-vedolizumab cohort (0.82 [1.32]; p = <0.01). The mean [SD] baseline Kim Frailty Index Score was highest in the infliximab-to-vedolizumab and vedolizumab-to-ustekinumab cohorts (0.18 [0.07]; p = 0.02); 15.7% of patients in the vedolizumab-to-ustekinumab cohort were frail (≥0.25). Baseline anemia was most prevalent in the vedolizumab-to-ustekinumab cohort (41.9%). At 12 months follow-up, the overall 2L-adherence rate was 68.0% (range: 61.0%-71.3%); the lowest rate (61.0%) occurred in the infliximab-to-ustekinumab cohort (p=0.05). The overall 2L-discontinuation rate was 23.6% (range: 17.1%-31.4%); the highest rate (31.4%) occurred in the vedolizumab-to-infliximab/adalimumab cohort (p<0.01).
CONCLUSIONS: Clinically meaningful differences in patient characteristics (comorbidity burden and frailty) and treatment patterns (adherence and discontinuation rates) were observed across treatment sequences. Additional analysis evaluating outcomes controlling for characteristics that may influence choice of therapy is important for determining optimal treatment sequences in patients with CD.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR155
Topic
Patient-Centered Research
Topic Subcategory
Adherence, Persistence, & Compliance
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Gastrointestinal Disorders