LAUSR

Background: Inflammatory Bowel Disease (IBD), defined as Ulcerative Colitis (UC) or Crohn's Disease (CD), affects 1.3 million Americans, with recurrent episodes of disease flare causing significant morbidity. Moderately-to-severely active disease may be treated with biologic therapy such as anti-tumour necrosis factor alpha following failure of or inadequate control with conventional therapies. Vedolizumab is approved as a treatment option for these patients, but its use as a first-line biologic is less well characterised in real-world clinical practice. We present analysis of healthcare utilization and IBD-related flare in biologic-naïve patients who initiate vedolizumab in real-world clinical practice. Methods: Data from the Explorys Universe database, (∼50 million patients across 317,000 providers and 15% of the US population), was analysed. Eligible patients had: diagnosis of CD (ICD-9555.xx) or UC (ICD-9556.xx); initiated vedolizumab between May 20, 2014 and January 27, 2016; no record of previous biologic therapy; ≥12 months of medical history before vedolizumab treatment, and; ≥6 months of follow-up post-index. IBD flare was defined as the occurrence of ≥1 of the following: prescription of intravenous (IV) corticosteroid; IBD-related hospitalization; IBD-related surgery; or documented abdominal pain. Annualized rates for all-cause or IBD-related hospitalizations, the occurrence of IBD-related surgeries, and the percentage of patients who experience flare, were calculated for the 6 months pre-treatment/follow-up periods. The proportion of patients who received ≥1 corticosteroid prescription (oral/IV/rectal) 6 months pre-treatment, during induction (0–98 d follow-up), and post-induction (99–180 d follow-up) were also reported. Results: A total of 122 biologic-naive IBD patients initiated vedolizumab: 78 CD patients (51.3% female; mean age 47 yr [standard deviation, SD: 16.7]; mean time since diagnosis 4.9 yr [SD: 3.8]) and 44 UC patients (40.9% female; mean age 45 yr, [SD:16.5], mean time since diagnosis 3.7 yr [SD: 3.0]). Among CD patients, the rate of IBD-related hospitalization was 1.2 per patient-year pre-treatment, and 0.2 during follow-up (P < 0.01). Only CD patients underwent IBD-related surgical intervention: 4 during pre-treatment, and 1 patient during follow-up (post-treatment procedures associated with perianal abscess). 60.3% (n = 47) of CD patients were treated with corticosteroids prior to initiating VDZ treatment, which fell to 33.3% (n = 26) during induction, and 16.7% (n = 13) by 6 months. Over half (59%, n = 46) of CD patients experienced flare in the 6 months pre-vedolizumab, and over one-quarter (28.2%) in the 6 months thereafter. The pre-index rate of IBD-related hospitalization in UC patients was 0.4 per patient-year: no UC patient experienced IBD-related hospitalization during follow-up. During pre-vedolizumab, induction, and post induction periods, 59.1% (n = 26), 34.1% (n = 15), and 25.0% (n = 11) were treated with corticosteroids respectively. In the 6 months pre-vedolizumab 34.1% (n = 15) experienced flare: this proportion was numerically lower in the 6 month follow-up (18.2%, n = 8). Conclusions: IBD-related hospitalizations in biologic-naive CD and UC patients initiated on vedolizumab were lower during follow-up compared to pre-treatment. In addition, there were decreases in the proportions of patients experiencing flare or prescribed corticosteroids following vedolizumab initiation. This study provides further evidence of treatment benefit of vedolizumab in patients previously untreated with biologics. Further research will help confirming these findings.