Background: Vedolizumab is a humanized immunoglobulin G1 monoclonal antibody (mAb) directed towards the integrin α4β7. Clinical trials in inflammatory bowel diseases (IBD) represent highly selected patient population and there is still limited data available of vedolizumab in real-word patient population. Therefore, we aimed to assess real-world treatment outcomes of vedolizumab in Finnish patients with IBD.
Methods: This was a nationwide, retrospective, non-interventional, multi-centre chart review study. All the adult (≥18 years of age) patients with a diagnosis of UC or CD and at least one vedolizumab infusion since the availability of the product in Finland in 2014 from 27 centres were included in the study. The exclusion criteria were the initiation of vedolizumab within <6 months of the data collection, participation in a clinical trial during the follow-up period or planned cessation of vedolizumab treatment within follow-up period. Data were collected retrospectively from medical charts in a standardized case report form. The key data collection points were at baseline, week 14 and month 6 of vedolizumab treatment. The primary objective was to determine treatment persistence 6 months post initiation.
Results: A total of 232 patients (CD 105, UC 127) were included. Based on Physician's Global Assessment, 101 (96.1%) CD patients had either moderately or severely active disease (Harvey-Bradshaw index mean ± SD, 12.7±8.5; moderate disease), and 112 (92.5%) UC patients had either mildly or moderately active disease (Partial Mayo score 5.2±1.7; moderate disease) at baseline. Majority of the patients were treatment refractory to previous anti-TNF-alpha treatment: 97.1% of CD patients and of 94.5% of UC patients were anti-TNF-alpha experienced. The majority (CD 43.8%, UC, 62.2%) were using concomitant steroids at baseline (Table 1).
Of all CD patients, 77 (73.3%) and of UC patients 84 (66.1%) were persistent on vedolizumab therapy 6 months post treatment initiation. The most common reason for discontinuation was primary lack of response (CD 63.0%; UC 75.0%), followed by secondary loss of response (CD 7.4%; UC 5.0%), adverse events (CD 14.8%; UC 17.5%), and other reasons (CD 18.5%; UC 12.5%).
Conclusions: Vedolizumab provides effective and well-tolerated treatment option in a real-world clinical setting even among treatment refractory IBD patients.