76 A Retrospective US Claims Database Study Highlights Unmet Treatment Needs in Patients With Crohn’s Disease (CD)

Background: CD is a chronic gastrointestinal disorder with a high disease burden and impact on quality of life. Despite the advent of several advanced therapies (ATs), there is a need for data on their use in clinical practice. A real-world analysis of patients with CD newly initiated on AT or an immunosuppressant (IMS) showed that many patients required combination or multiple lines of therapy (LoTs), suggesting inadequate disease control and highlighting the need for durable, effective, and tolerable therapies (Jairath V, et al. Am J Gastroenterol 2024;119(10S):S819–S820). Here, we further investigate therapy sequence and duration in patients with CD initiated on AT. Methods: This retrospective US claims database (MerativeTM Marketscan®) study assessed therapy sequencing over 24 months in adults with CD newly initiated on AT (January 1, 2017–March 31, 2021). FDA-approved therapies through March 2021 were included. Patients had to be enrolled continuously for at least 12 months pre-index (date of first AT prescription; baseline period) and at least 24 months post-index (follow-up period). Therapy sequencing and duration of use were assessed using descriptive statistics. Results: Overall, 4,043 patients with CD received AT for the first time; of those, the most common were AT monotherapy (84.3%) and AT+corticosteroids (CS; 10.5%). Adalimumab (ADM) and infliximab (IFX) were the most common first-line monotherapy ATs. Of the 4043 patients, a total of 1,637 received second-line therapy; AT monotherapy (48.6%) and AT+CS (7.4%) were the most common regimens that included AT. ADM and ustekinumab were the most common second-line monotherapy ATs. Of 2,072 patients who received first-line ADM, 56.5% did not receive any additional LoT, 26.6% received AT in second-line, 10.1% received AT in subsequent lines after a non-AT second-line therapy, and 6.9% received no further AT. Of 921 patients who received IFX as first-line AT, 58.1% did not receive additional LoT, 24.8% received AT in second-line, 8.0% received AT in subsequent lines after a non-AT second-line therapy, and 9.1% received no further AT. Additionally, 19% of patients who received AT received at least a third LoT. Median duration of first-line therapy was 24.3 months in patients who received ADM and 21.9 months in patients who received IFX. Median duration of second-line AT in patients who received ADM or IFX as first-line therapy was 8.5 months and 8.9 months, respectively. Conclusions: These real-world data, describing the therapy patterns of patients with CD, show that patients often require multiple therapy options, suggesting that first-line therapies may not be sufficient to achieve and/or maintain remission. Early disease control and the ability to adjust therapies in response to CD flares in a timely manner are key to disease management and prevention of disease progression. Together, this highlights the need for first-line therapies that are efficacious and tolerable in achieving remission and durable in maintaining remission.

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