VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study (DOPER)

Number of patients : 400 patients in approximatively 31 sites in France. Recrutment period : The trial duration for each patient will be 1 year main. Endpoint : The primary endpoint is to assess the rate of persistence of SC vedolizumab at month 12 after switching from IV vedolizumab to SC vedolizumab.

Secondary Endpoint :

• Percentage of clinical remission at months 3 and 12, defined as a Partial Mayo Score (PMS) <2 with each sub-score (stool frequency, rectal bleeding, and physician rating of disease activity) of 1 or less for UC patients and as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients
• Percentage of steroid free clinical remission at month 12
• Percentage of biological remission rates (defined as fecal calprotectin <250 μg/g and C-Reactive-Protein (CRP) <5 mg/L) at month 12
• Percentage of Patient-Reported Outcome 2 (PRO-2, defined as stool frequency and rectal bleeding for UC and stool frequency and abdominal pain for CD) response and remission at month 12
• Percentage of clinical relapse free rates at month 12
• Percentage of loss of response rates at month 12
• Mean change from baseline in PMS or HBI, CRP and fecal calprotectin compared to month 12
• Percentage of patients who switch back to previous IV vedolizumab therapy at month 12after switching from IV vedolizumab to SC vedolizumab
• Proportion of patients with positive antibodies (VDZ, ANA) comparing therapy with IV and SC vedolizumab
• Persistence of SC vedolizumab at month 12 in patients previously treated by IV vedolizumab every 4 weeks, compared to patients treated by IV vedolizumab every 8 weeks
• Twelve-month cumulative surgery rates
• Hospitalization rate at month 12
• Cumulative infection rate at month 12
• Cumulative injection reactions at month 12
• Cumulative adverse events (AEs) rate at month 12
• Comparison between incidence of specific anti-drug antibodies and incidence of AEs

Inclusion criteria

• Male or female subjects who are more than 18 years of age, on the day of signing informed consent
• Documented diagnosis of IBD, established on the basis of standard clinical, endoscopic and/or histological criteria.
• CD or UC remission defined per clinical assessment as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients and a Partial Mayo Score (PMS) < 2 with each sub-score of 1 or less for UC and/or according to ECCO classification within previous 3 months
• Currently treated with IV vedolizumab
• Patients agreeing to switch from IV to SC formulation
• Receiving or not the concomitant following drugs (but must remain on stable dose for 12 weeks):

• Oral 5-aminosalicylates (5ASA) compounds or rectal formulations of 5ASA provided the dose to be stable at least 4 weeks before switching
• Azathioprine, 6-Mercaptopurine or methotrexate provided the dose has been stable for 4 weeks prior to inclusion • Each patient is required to provide written informed consent in order to be included in the study

Exclusion criteria

• Current use of adalimumab, infliximab, golimumab or ustekinumab
• Current use of JAK inhibitors or S1P modulators
• Current use of steroids or within the last three months for IBD
• Treatment with any investigational agent in the past 30 days or five half-lives prior to the screening visit (whichever is longer)
• Active clinically significant infection or HIV, Hep B, Hep C, untreated tuberculosis
• Female subjects with pregnancy or breastfeeding