Background: Corticosteroids (CS) are effective in the short-term induction of patients with moderate to severe ulcerative colitis (UC) but not for maintenance of remission, due to the associated risks. Vedolizumab (VDZ), a humanized monoclonal anti-α4β7 integrin antibody, is approved for the treatment of adults with moderately-to-severely active UC. This study assessed VDZ treatment persistence and CS discontinuation among UC patients co-induced with CS.
Methods: Adult (≥18 years) CD patients initiating VDZ between 1 May 2014 and 30 September 2016 were identified in the US Optum Research Database. Patients with ≥12 months history (baseline) before their first VDZ claim (index date) and who completed induction (defined as ≥3 infusions in ≥98 days post-index) were included. CS-related measures included: dependence (≥80% CS use during the 6 months immediately prior to index date), co-induction with CS (CS fill for ≥28 days during the induction phase), CS discontinuation (treatment gap ≥60 days between CS fills) while on VDZ therapy. VDZ persistence was defined as no treatment gap ≥90 days between consecutive infusions. CS discontinuation and VDZ persistence were measured using the Kaplan-Meier method.
Results: A total of 151 VDZ patients were included with a mean (SD) age of 42.8 (16.6) years; 41% female, median follow-up period of 251 days. During baseline, 81%, 45% and 90% of patients were treated with aminosalicylates, immunomodulators, and CS, respectively; 68% of patients had received a biologic before initiating VDZ. Of UC VDZ patients, 52% (n=79) were co-induced with CS during the induction phase, of whom, 18% (14/79) were CS-dependent. Overall, 57% (45/79) of CS co-induced patients discontinued their CS and among CS-dependent patients, 36% (5/14) discontinued their CS. CS discontinuation and VDZ persistence are shown in Figures 1a & 1b.
Conclusions: This real-world study, using a nationally representative US database, showed that nearly half of UC patients receiving VDZ were not co-induced with CS. Among VDZ patients co-induced with CS, over half discontinued during the follow-up period. Despite the treatment-refractory patients included in this study, the CS discontinuation rate at 26 weeks among VDZ patients was higher than what was reported from the GEMINI clinical trials. VDZ persistence was similar between CS co-induced patients versus those without CS co-induction. Future studies should examine CS-related outcomes over a longer follow-up period.
The study was funded by Takeda. No medical writing assistance was provided.