Timothy W. Smith, PhD1, Marco DiBonaventura, PhD1, David Gruben, PhD2, Danielle Bargo, MSc1, Leonardo Salese, MD3, Daniel Quirk, MD, MPH, MBA3
1Pfizer Inc., New York, NY; 2Pfizer Inc., Groton, CT; 3Pfizer Inc., Collegeville, PA
Introduction: Treatment goals for ulcerative colitis (UC) focus on inducing a response and maintaining long-term disease remission. The aim of this study was to describe the real-world effectiveness of advanced therapies, as defined by the need for concomitant steroids and UC-related hospitalizations.
Methods: This retrospective analysis used Truven MarketScan™ Commercial and Medicare Supplemental Database claims data from January 1, 2012 to March 31, 2017. Patients aged ≥18 years with UC (ICD9:556.* or ICD10 K51.*) naive to advanced therapy who initiated an immunomodulator (IM) or a biologic (adalimumab [ADA], infliximab [IFX], vedolizumab [VEDO], golimumab [GOL]) and had 12 months continuous enrollment prior to (pre-index) and after (post-index) first drug claim (index) were included. Patients with Crohn’s disease or a history of biologic therapy in the pre-index period were excluded. Steroid use, dosage, and duration were reported descriptively. Time spent steroid free (allowing for an initial 14 week steroid tapering period) and hospitalizations in the post-index period were used as measures of real-world effectiveness.
Results: N=3562 patients with UC were included (51.4% male; age=45.1 years (SD=15.1); disease duration=1.3 years (SD=1.2)) with the following treatments at index: N=1231 on an IM without a biologic, N=1291 on ADA, N=810 on IFX, N=127 on GOL, and N=103 on VEDO. Most patients (83.0%) had used steroids in the pre-index period. Ignoring steroid use during the tapering period, a total of 52.2% of patients were steroid-free in the post-index period with the mean time to first steroid (among the 48.8% who used steroids) being 174.2 days (SD=71.6). This varied by index therapy: IM only=52.7% (184.3 and183.3 days for 6-MP and AZA, respectively), ADA=43.6% (170 days), IFX=48.3% (172 days), GOL=41.7% (160 days), and VEDO=46.6% (168 days). Similarly, the average days supply of steroids in the post-index period was 60.5 days (SD=77.2). This also varied by index treatment: ADA=65.2 days, IFX=53.3 days, GOL=71.7 days, VEDO=48.0 days, AZA=62.1 days, 6-MP=56.6 days. 12.2% of patients had a UC-related hospitalization in the post-index period with an average stay of 8.2 days (SD=8.9).
Discussion: UC patients who initiate their first advanced therapy frequently use steroids and for long periods. A number of patients also experience extended UC-related hospitalization stays. These results suggest an ongoing challenge in managing these patients.
Disclosures: Does Disclose
Citation: Timothy W. Smith, PhD; Marco DiBonaventura, PhD; David Gruben, PhD; Danielle Bargo, MSc; Leonardo Salese, MD; Daniel Quirk, MD, MPH, MBA. REAL WORLD EFFECTIVENESS OF ADVANCED THERAPIES AMONG PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS IN THE UNITED STATES. Program No. P0485. ACG 2018 Annual Scientific Meeting Abstracts. Philadelphia, Pennsylvania: American College of Gastroenterology.