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NCT05696106
Risk of Incident IMID in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID
Conditions: Inflammatory Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 750000
Sponsor: Assistance Publique - Hôpitaux de Paris
Location: France
Summary
Individuals with immune-mediated inflammatory diseases (IMIDs) are at increased risk of developing other IMIDs, possibly through shared pathogenic inflammatory pathways, and up to 25% of patients with IMIDs have at least one other IMID.
Additionally, a concomitant diagnosis of a second IMID is associated with a higher burden of disease, which usually requires therapeutic escalation.
Thus, this risk should be taken into account in the benefit-risk balance of IMIDs-related treatment.
While the risk of other major adverse events, such as serious infection, cancer, and cardiovascular events, have been assessed in patients exposed to immunosuppressive drugs and biologics, the impact of these drugs on the risk of incident IMIDs remains largely unknown.The main aim of this study is to assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID (either inflammatory bowel disease, inflammatory rheumatic diseases, or cutaneous psoriasis).
Eligibility Criteria
Inclusion Criteria:Aged 18 years or older at index date (≥ 18 years)Identified with a first IMID diagnosis prior to index date, among IBD (Crohn's disease and ulcerative colitis), inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis), or inflammatory skin diseases (psoriasis).Exclusion Criteria:Patients with a diagnosis of more than one of the IMIDs of interest at index date.Patients exposed to biologics or immunosuppressive drugs of interest in 2006 or 2007.
Source: ClinicalTrials.gov (NCT05696106). StuddyBuddy aggregates publicly available trial information.