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Biologics are effective pharmacological treatments for Inflammatory Bowel Disease (IBD). To date, in the context of these pathologies, the formulations that can be administered subcutaneously are available for all the biological agents on the market (infliximab, adalimumab, golimumab, vedolizumab and ustekinumab) and can guarantee self-administration of the therapy at home with a reduction in hospital admissions , improved pharmacokinetics and pharmacoeconomic benefits For these reasons, the consolidation of the clinical practice of switching biological drugs to subcutaneous administration in patients with IBD in clinical remission could be a good strategy in terms of therapeutic efficacy and tolerability.
To date, intravenous and subcutaneous therapy for the biologics considered in the present study is considered equivalent both from a pharmacokinetic point of view ("bioequivalence" of the drug) and from a clinical point of view due to the available efficacy and safety data. The clinical choice of one or the other formulation generally takes into consideration the patient's concern, the subject's venous availability and the experience of the prescribing doctor. This protocol aims to collect the "real life" clinical experience and describe the clinical progress of the patients.
The study is designed as a prospective, retrospective, 24-month observational cohort study. Patients' eligibility for enrolment will be assessed during the baseline visit at the Centre for Diseases of the Digestive System (CEMAD), Agostino Gemelli University Polyclinic Foundation IRCCS Università Cattolica del Sacro Cuore. Subjects meeting all inclusion criteria will be enrolled, and all subjects meeting at least one exclusion criterion will be excluded.
A cohort of patients suffering from IBD undergoing therapy with biological drugs, already undergoing (retrospective cohort) or who will undergo (prospective cohort) for clinical practice reasons a switch from the intravenous formulation to the corresponding subcutaneous formulation (in particular, from intravenous vedolizumab or infliximab to subcutaneous vedolizumab or infliximab) will be considered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients affected by IBD in therapy with biological therapies | cohort of patients affected by IBD in therapy with biological drugs, already subjected (retrospective cohort) or who will undergo (prospective cohort) for reasons of clinical practice to switch from the intravenous indication to the corresponding subcutaneous prescription (in particular, from vedolizumab or intravenous infliximab intravenously and to vedolizumab or subcutaneous infliximab). |
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| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients who maintain clinical remission | percentage of patients who maintain clinical remission after switching to subcutaneous therapy without further changes in current therapy | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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subjects who meet all the inclusion criteria, and all subjects who meet at least one exclusion criterion will be excluded. cohort of patients with IBD on biologic therapy, who have already undergone (retrospective cohort) or who will undergo (prospective cohort) for clinical practice reasons a switch from the intravenous formulation to the corresponding subcutaneous formulation (in particular, from vedolizumab or intravenous infliximab intravenously and to vedolizumab or subcutaneous infliximab).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franco Scaldaferri, PI | Contact | +393334975975 | franco.scaldaferri@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Franco Scaldaferri, PI | Fondazione Policlinico Gemelli, Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD | Recruiting | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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