a 24-month real life persistence efficacy and safety study in ibd patients in remission switched from intravenous infliximab to subcutaneous infliximab ct-p13 remsima®sc

Conditions: Inflammatory Bowel Diseases

Summary: descriptive: a 24-month multicentre, observational, prospective cohort study. population: ibd patients under stable clinical and biological remission study treatments: patients who will be proposed to switch, or who have just switched, from the intravenous originator remicade® or one of its biosimilars to the subcutaneous infliximab remsima®sc as part of routine care. all consecutive patients in ibd centers participating in the study will be proposed to participate in the study during their regular outpatients' visits. objectives:the primary objective of perem study is to determine the rate of persistence of subcutaneous infliximab at 48 weeks after switching from iv infliximab to subcutaneous infliximab remsima®sc.

number of patients: 400 patients in approximatively 40 sites in france recrutment period: the trial duration for each patient will be 2 years main endpoint:the primary endpoint is to assess the rate of persistence of subcutaneous infliximab at month 12 after switching from iv infliximab to sc infliximab remsima®sc. secondary endpoint: * percentage of patients on steroid free clinical remission at week 96 after switch. steroid-free clinical remission (cr) is defined as a harvey bradshaw index (hbi) score≤4 cd patients and a partial mayo score (pms) ≤2 with each sub-score of 1 or less for uc. when hbi scoring will be infeasible (stoma, pouch), evaluation of clinical remission will be estimated by stoma emptying count and/or by the physician global assessment (sturm 2019) patients having discontinued subcutaneous infliximab remsima®sc therapy whatever the reason during the 24 months of follow-up as well as patients referred to disease-related surgery and patients lost to follow-up before month 24 will be considered as failure to subcutaneous infliximab remsima®sc therapy (intention to treat analysis) and will be classified in the group of patients having failed to maintain steroid free clinical remission under infliximab remsima®sc during the whole study period. * percentage of patient reported outcomes pro2 rates at inclusion, months 3, 6, 12 and 24 * percentage of biological remission rates (fc \<250 μg/g, crp \<5 mg/l) at inclusion, month 3, 6, 12 and 24. * percentage of clinical relapse free rates at inclusion, month 3, 6, 12 and 24 * percentage of loss of response rates at inclusion, month 3, 6, 12 and 24 * percentage of clinical response and remission at inclusion, month 3, 6, 12 and 24 * mean change from baseline in hbi or pms, and mean change from baseline in crp and fecal calprotectin * proportion of patients with positive antibodies (ifx, ana) comparing therapy with intravenous or one of its biosimilars original and subcutaneous infliximab remsima®sc * measure adherence to subcutaneous infliximab remsima® switch based on pharmacy data during the follow-up with medication possession ratio (mpr ). * twelve-month cumulative surgery rates * hospitalization rate at month 24 * cumulative infection rate at month 24 * cumulative sc reactions at month 24 * discontinuation of subcutaneous infliximab therapy cumulative rates at month 24 * incidence of specific anti-drug antibodies detected during the study

Eligibility criteria:
inclusion criteria: * • male or female subjects who are more than 18 years of age, on the day of signing informed consent. * patient affiliated to the health insurance system. * documented diagnosis of cd or uc established based on standard clinical, endoscopic, and 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 6 months. * currently treated with iv infliximab: originator or biosimilars. * patients agreeing to switch from iv to sc formulation or who have already switched since maximum 3 months. * 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-mp or methotrexate provided the dose has been stable for 4 weeks prior to inclusion (dose must remain stable for 10 weeks after switching). * each patient is required to provide written informed consent to be included in the study. exclusion criteria: * current use of vedolizumab 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 inclusion visit * current cd abscess * active clinically significant infection or hiv, hep b, hep c, untreated tuberculosis * female subjects with pregnancy or breastfeeding

Keywords: ibd uc