Real-world Effectiveness of Advanced Therapies Among Patients With Moderate to Severe Ulcerative Colitis in the United States

Long MD1, Smith TW2, Dibonaventura M2, Gruben D3, Bargo D2, Salese L4, Quirk D4. Inflamm Bowel Dis. 2019 Sep 27. pii: izz204. doi: 10.1093/ibd/izz204. [Epub ahead of print]


Author information

Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, NC, USA.

Pfizer Inc, New York, NY, USA.

Pfizer Inc, Groton, CT, USA.

Pfizer Inc, Collegeville, PA, USA.


BACKGROUND: Ulcerative colitis (UC) treatment aims to induce response and maintain steroid-free remission. For patients with moderate to severe UC and/or nonresponse to conventional treatment, advanced therapies (immunosuppressants and biologics) are available. We assessed real-world effectiveness of advanced UC therapies.

METHODS: This retrospective analysis of claims data included adult patients with UC initiating immunosuppressant or biologic therapy, with 12 months' continuous enrollment pre- and postinitiation. Patients had no prescription for biologic therapy (and/or immunosuppressant if initiating immunosuppressant) in the previous 12 months. Proportion of patients remaining steroid-free (excluding 14-week tapering period), hospitalizations, and costs in the 12 months postinitiation were assessed.

RESULTS: In total, 3562 patients were included in the analysis. Most patients (83.0%) used steroids in the 12 months before initiating advanced therapy. Overall, 47.8% remained steroid-free after 12 months (excluding tapering). After adjusting for patient characteristics, remaining steroid-free was significantly more likely with infliximab (43.9%) than with adalimumab (39.4%; P < 0.05); golimumab (38.2%) and vedolizumab (41.4%) were not significantly different vs adalimumab. Overall, 12.2% of patients had a UC-related hospitalization within 12 months of initiation, with a mean (SD) total length of stay of 8.2 (8.9) days and no significant differences between biologic therapies. Mean, unadjusted, UC-related costs in the 12 months postinitiation were $42,579 and were similar between therapies.

CONCLUSIONS: Patients with UC initiating advanced therapy frequently continued using steroids for at least a year. Some patients experienced extended UC-related hospitalizations, with high UC-related costs overall. This suggests an ongoing challenge in managing patients with moderate to severe UC.

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