Evaluation of Treatment Patterns and Maintenance Dose Titration Among Patients With Crohn’s Disease Initiating Biologics With 3 Years of Follow-Up

Abstract

**Background:** There is limited real-world evidence on treatment patterns of patients with Crohn’s disease (CD) initiating biologics with an extensive follow-up period. This study describes persistence and dose titration among CD patients with 3 years of follow-up. **Methods:** This retrospective observational study was conducted using the STATinMED RWD Insights all-payer medical and pharmacy data. Adult patients with at least 1 CD medical claim and at least 1 medical/pharmacy claim for a biologic (adalimumab \[ADA\], certolizumab pegol (CZP), infliximab \[IFX\] and its biosimilar products \[IFX-BS\], ustekinumab \[UST\], and vedolizumab \[VDZ\]) between September 2016 and October 2018 were identified. Commercially insured patients with continuous capture for at least 12 months before and at least 36 months after biologics initiation were selected. Confirmed CD patients were included in the final cohort. Baseline patient characteristics and treatment patterns over the 3-year follow-up period were evaluated. Results were summarized using means and SD or counts and percentages. **Results:** A total of 2309 confirmed patients with CD were identified (847 \[36.7%\] IFX, 534 \[23.1%\] ADA, 486 \[21.1%\] VDZ, 394 \[17.1%\] UST, 85 \[3.7%\] CZP, and 72 \[3.1%\] IFX-BS). CZP and IFX-BS were excluded due to small sample sizes. Approximately half of CD patients were between ages 35 and 54. Patients on UST had a higher Charlson Comorbidity Index score. Common comorbidities (>10%) included anemia, anxiety, depression, and hypertension. Persistence over 3 years’ follow-up was highest for UST (61.4%) patients, followed by VDZ (58.0% ), ADA (52.1% , and IFX (48.1%). The discontinuation rate without switch or restart was highest for ADA (37.3%), followed by UST (30.7%), IFX (28.1%), and VDZ (25.3%). Over the 3 years of follow-up, the dose titration rate was highest for IFX (76.5%) and lowest for UST (50.8%). In particular, UST had the lowest dose escalation rate (35.5%) and highest dose-reduction rate (16.5%). **Conclusions:** Patients with CD on UST had the highest persistence and lowest dose escalation across different biologic users over the 3-year follow-up period, possibly suggesting a better clinical response of UST. Future studies with longer follow-up adjusting for confounders are needed to better understand treatment patterns among biologics users.