P602 Vedolizumab subcutaneous influencing disease course in Constant-care app solution
Nørgaard, J.(1);Malte, R.(1);Charlotte, P.L.(1);Mette, B.(1);Eva, F.(1);Petra, W.(1);Dorit, A.(1);Lotte, S.(1);Johan, B.(1);Pia, M.(1);
(1)Northern Zealand Hospital, Gastroenterological department, Frederikssund, Denmark
The Constant-care app solution (CC) has been shown to empower patients with mild-moderate Ulcerative Colitis (UC) in 5-ASA treatment and improve disease specific quality of life (1). Here we present preliminary data on our study to investigate the effects of CC on quality of life in patients with moderate-severe UC or Crohns Disease (CD) treated with s.c.vedolizumab, launched in June 2020 in Denmark.
The study is an ongoing non-interventional, observational study. Patients are homemonitored via CC for 24 months. CC shows data on patient’s disease status, grouping them into three: green (remission), yellow (worsening), red (severe disease). Patients were recruited from the outpatient clinic at the Department of Gastroenterology, North Zealand University Hospital, Greater Copenhagen. Simple Clinical Colitis Index (SCCAI), Harvey-Bradshaw Index (HB-I), Fecal calprotectin (FC) and short QoL (0-70) are measured every two months or during a flare up between fixed screenings. Serious adverse events (SAE) and adverse events (AE) are monitored.
19 patients out of 40 have been included, 8 with CD and 11 with UC. None experienced SAEs. Five experienced AEs, of which four discontinued treatment. One patient experienced treatment failure during this study.
Table 1: AEs and how these where handled.
|Severe injection site swelling||Changed back to i.v. vedolizumab|
|Leukopenia||Changed back to i.v. vedolizumab|
|Sensory disturbance of the face||Changed drug|
|Developed allergy to eggs||Stayed on s.c. vedolizumab|
|Severe Headache||Changed drug|
IBD CC has proven a usefull tool for surveillance and maintenance of remission in IBD patients treated with s.c. vedolizumab. S.c. vedolizumab has in this patientgroup, shown to provide sustainable QoL, sustained remission, and to have few AEs.
1) Elkjaer M, Shuhaibar M, Burisch J, Bailey Y, Scherfig H, Laugesen B, et al. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided 'Constant-care' approach. Gut. 2010;59(12):1652-61.